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DISTANCE EDUCATION PROGRAMME-CORRESPONDENCE COURSE
XVI TH BATCH (2011-2012)
An project / dissertation on
‘Form-Fill-Seal Machines’
Submitted By
Roll No : DEP/11/084 Name : PURUSHOTTAM N. KATHAR
Submitted To
Indian Institute of Packaging

E-2, MIDC Area, Chakala,
Andheri (East), Mumbai – 400 093
FORM-FILL-MACHINES :
Form, fill and seal machines are packaging equipment that uses flexible, heat-sealable,
plastic film to form packages that can be filled with a product and then sealed, and cut. There
are many types of form, fill, and seal machines. Forming machines form packages, but do not fill
or seal them. Filling machines load previously formed packages with a specific product quantity,
but do not provide closing or sealing action. Seal-only equipment wraps or secures products, but
does not form packages or fill them. Equipment that combines form, fill and seal functions is also
available. Some devices transport the plastic film horizontally. Others transport the film
vertically. Manual machines aid only in the setting or holding of products. Semi-
automatic machines help with both packaging and placement, allowing a single operator to
perform several activities with greater speed and accuracy. Fully automatic equipment requires
limited operator intervention. Typically, operators need only replenish packaging components by
loading supply hoppers or removing completed cartons.
Form, fill and seal machines are used to process liquids, granules, powders, and sprays
for consumer, bulk and original equipment manufacturer (OEM) supply shipments. Packaging
materials include aerosol containers, bags and pouches, blister packs, bottles and jars, cartons
and boxes, cans, capsules, cartridges, cases, cups and trays, drums and kegs, pallets and pails,
and tubes and vials. Intermediate bulk containers (IBCs) have a capacity of not more than 3
cubic meters and are designed to be handled by form, fill and seal machines. There are several
ways to close packages. Examples include caps and lids, corks, glue, heat seals, nails and
staples, tapes, tucks and folds, wrappers, and tamper-resistant materials.
Selecting form, fill and seal machines require an analysis of specifications, features, and
applications. Typically, fully automated machines list the rate, which is usually expressed in
pieces per minute. Some automated machines include an integral feeder and a computer
interface that links to a control network. Others are made from stainless steel for improved
corrosion resistance. Aseptic or sanitary equipment is easy to clean and designed in a manner
that inhibits the growth or presence of pathogenic microrganisms. Portable machinery is
lightweight or includes wheels or casters for ease of movement. In terms of applications, form, fill
and seal machines are used widely in the automotive, chemical, medical, and pharmaceutical

industries. They are also used to process food, beverages, cosmetics, electronics,
semiconductors, stationary, tobacco, and military products.
There are two basic types, horizontal and vertical. A horizontal machine forms a package,
fills with product, and seals in a sequence of operations while the film is being transported in a
horizontal direction. They are widely used for packaging solid foodstuffs. A vertical
machine forms a tube, fills, and seals in a sequence of operations while the film is being
transported vertically downwards. They are widely used for packaging foodstuffs in a liquid,
powder, paste, or granule state.
REQUIREMENTS EQUIPMENT FOR PHARMACEUTICAL PRODUCTS UNDER
SCHEDULE M
1. Form-Fill-Seal Technology or Blow, Fill-Seal Technology. -
1.1 Form-Fill-Seal units are specially built automated machines in which through one continuous
operation, containers are formed from thermoplastic granules, filled and then sealed. Blow, fill-
seal units are machines in which containers are moulded / blown (pre-formed) in separate clean
rooms, by non-continuous operations.
Note: -
(i) These shall be installed in at least Grade C environment.
1.2. Form-Fill-Seal/Blow, Fill-Seal machines used for the manufacture of products for terminal
sterilization shall be installed in at least Grade C environment and the filling zone within the
machine shall fulfill Grade A requirements.
1.3. Terminally sterilized products. -
1.3.1. Preparation of primary packaging material such as glass bottles, ampoules and rubber
stoppers shall be done in at least Grade D environment. Where there is unusual risk to the
product from microbial contamination, the above operation shall be done in Grade C
environment. All the process used for component preparation shall be validated.
1.3.2. Filling of products requiring terminal sterilization shall be done under Grade A
environment with a Grade C background.
1.4 Preparation of solutions, which are to be sterilized by filtration, shall be done in Grade C
environment, and if not to be filtered, the preparation of materials and products shall be in a
Grade A environment with Grade B in background.
1.5 Filtration (membrane).-

(i) Solutions for Large Volume Parenterals shall be filtered through a non-fibre releasing,
sterilizing grade cartridge/membrane filter of nominal pore size of 0.22 µ for aseptic filling
whereas 0.45 µ porosity shall be used for terminally sterilized products.
(ii) A second filtration using another 0.22 µ sterilizing grade cartridge / membrane filter shall be
performed immediately prior to filling. Process specifications shall indicate the maximum time
during which a filtration system may be used with a view to precluding microbial build-up to
levels that may affect the microbiological quality of the Large Volume Parenterals.
(iii) The integrity of the sterilized filter shall be verified and confirmed immediately after use by an
appropriate method such as Bubble Point, Diffusive Flow or Pressure Hold Test. 10.6
Sterilization (Autoclaving).-
1.6.1. Before any sterilization process is adopted, its suitability for the product and its efficacy in
achieving the desired sterilizing conditions in all parts of each type of load pattern to be
processed, shall be demonstrated by physical measurements and by biological indicators, where
appropriate.
1.6.2 All the sterilization process shall be appropriately validated. The validity of the process
shall be verified at regular intervals, but at least annually. Whenever significant modifications
have been made to the equipment and product, records shall be maintained thereof.
1.6.3 The sterilizer shall be double ended to prevent mix-ups.
1.6.4 Periodic bio-burden monitoring of products before terminal sterilization shall be carried out
and controlled to limits specified for the product in the Master Formula.
1.6.5 The use of biological indicators shall be considered as an additional method of monitoring
the sterilization. These shall be stored and used according to the manufacturerís instructions.
Their quality shall be checked by positive controls. If biological indicators used, strict precautions
shall be taken t avoid transferring microbial contamination from them.
1.6.6 There shall be clear means of differentiating ë sterilizedí and ëunsterilizedí products. Each
basket, tray or other carrier of products or components shall be clearly labeled with the name of
the material, its batch number, and sterilization status. Indicators shall be used, where
appropriate, to indicate whether a batch (or sub-batch) has passed through the sterilization
process.
1.6.7 Sterilization records shall be available for each sterilization run and may also include
thermographs and sterilization monitoring strips. They shall be maintained as part of the batch
release procedure.
1.7. Sterilization (by dry heat).-
1.7.1 Each heat sterilization cycle shall be recorded on a time/temperature chart of a suitable
size by appropriate equipment of the required accuracy and precision. The position of
temperature probes used for controlling and/or recording shall be determined during the
validation and, where applicable, shall also be checked against a second independent
temperature probe located in the same position. The chart shall form a part of the batch record.
Container mapping may also be carried out in the case of Large

Volume Parenterals.
1.7.2 Chemical or biological indicators may also be used, but shall take the place of physical
validation.
1.7.3. Sufficient time shall be allowed for the load to reach the required temperature before
measurement of sterilization time commences. This time shall be separately determined for
each type of load to be processed.
1.7.4. After the high temperature phase of a heat sterilization cycle, precautions shall be taken
against contamination of sterilized load during cooling. Any cooling fluid or gas in contact with
the product shall be sterilized unless it can be shown that any leaking container would not be
approved for use. Air inlet and outlets shall be provided with bacterial retaining filters.
1.7.5. The process used for sterilization by dry heat shall include aircirculation within the
chamber and the maintenance of a positive pressure to prevent the entry of non-sterile air. Air
inlets and outlets should be provided with micro-organism retaining filters. Where this process of
sterilization by dry heat is also intended to remove pyrogens, challenge tests using endotoxins
would be required as part of the validation process.
1.8. Sterilization (by moist heat).-
1.8.1 Both the temperature and pressure shall be used to monitor the process. Control
instrumentation shall normally be independent of monitoring instrumentation and recording
charts. Where automated control and monitoring systems are used for these applications, these
shall be validated to ensure that critical process requirements are met. System and cycle faults
shall be registered by the system and observed by the operator. The reading of the independent
temperature indicator shall be routinely checked against the chart-recorder during the
sterilization period. For sterilizers fitted with a drain at the bottom of the chamber, it may also be
necessary to record the temperature at this position throughout the sterilization period. There
shall be frequent leak tests done on the chamber during the vacuum phase of the cycle.
1.8.2 The items to be sterilized, other than products in sealed containers, shall be wrapped in a
material which allows removal of air and penetration of steam but which prevents re-
contamination after sterilization. All parts of the load shall be in contact with the sterilizing agent
at the required temperature of the required time.
1.8.3. No Large Volume Parenteral shall be subjected to steam sterilization cycle until it has
been filled and sealed.
1.8.4 Care shall be taken to ensure that the steam used for sterilization is of a suitable quality
and does not contain additives at a level which could cause contamination of the product or
equipment.
1.9. Completion/finalisation of sterile products.-
1.9.1. All unit operations and processes in the manufacture of a batch shall have a minimum
time specified and the shortest validated time shall be used from the start of a batch to its
ultimate release for distribution.

1.9.2. Containers shall be closed by appropriately validated methods. Containers closed by
fusion e.g. glass or plastic ampoules shall be subjected to 100% integrity testing. Samples of
other containers shall be checked for integrity according to appropriate procedures.
1.9.3 Containers sealed under vacuum shall be tested for required vacuum conditions.
1.9.4 Filled containers parenteral products shall be inspected individually for extraneous
contamination or other defects. When inspection is done visually, it shall be done under suitably
controlled conditions of illumination and background. Operators doing the inspection shall pass
regular eye-sight checks with spectacles, if worn, and be allowed frequent rest from inspection.
Where other methods of inspection are used, the process shall be validated and the
performance of the equipment checked at suitable intervals. Results shall be recorded.
Types of Form Fill Seal machines :
Form Fill Seal (FFS) machines are packaging machines that form fill and seal a package on
the same machine.
The main types are vertical form fill seal (VFFS) and horizontal form fill seal (HFFS)
machines – a term often used in the market place to cover horizontal versions of flow-wrappers,
sachet machines, blister pack machines, four side seal machines and thermoform fill and seal
machines.; in both cases packaging material is fed off a roll, shaped, and sealed. The
bags/packs are then filled, sealed and separated.
Today many FFS systems are highly sophisticated featuring computer interfaces and control
networks. Greater speed and versatility are the major benefits of FFS systems for user
companies. For example snack producers demand systems that have the versatility to provide
fast changeover between many different packaging formats to meet growing demand for single
serve packs. Here VERTICAL FFS is capable of creating virtually any size or shape ranging
from the standard pillow pack to bags sealed on all four sides.
The multiplicity of FFS machines employ a wide range of material types and are used across
numerous markets including food, drinks, cosmetics, electronics, stationary, tobacco, chemical,
medical, and pharmaceuticals.
Form fill seal machines are often divided into the types of packs they produce:
Bags and Pillow packs
Flow-wrapper; lower reel flow-wrapper; vertical form fill and seal; stickpack machines;
mandrel form fill seal.
Bottles/vials
Blow fill seal.
Cartons
Vertical carton board form fill seal.

Pots trays and blisters
Cold form fill seal; thermoform fill seal; blister form fill seal.
Sachets and Envelopes
Edge seal machine; horizontal form fill seal; vertical sachet form fill seal.
Sacks and Bags
Tubular sack form fill seal and vertical form fill seal.
However, each type is introduced individually on the following pages to ensure that
browsers are able to access information on easily.
Products commonly associated with form/fill/seal include:
Crisps; Nuts; Sugar; Rice; Pulses; Sweets & Confectionery; Sauces & Soups; Pet Foods;
Grain; Jams & Preserves; Cakes; Bread; Biscuits; Tea Bags; Condiments; Tablets,
Capsules and Pills, Greetings cards; Phone cards.
Bag Form Fill Seal
Bag Form Fill Seal Machines Packaging machines which use flexible packaging
material, to form a package which is then filled and sealed in a sequence of operations to
form a bag shaped or block bottom bag shaped pack.
Uses: food, confectionery.
Flow Wrapping
A Flow Wrapping Machine is a horizontally operated machine with the packaging
material mounted above the operating level where the product is loaded horizontally with
a longitudinal seal formed below the pack.
Uses: solid products like biscuits, chocolate bars and phone cards.
Lower Reel Flow Wrapping
As above, except the packaging material is mounted below the operating level and the
longitudinal seal is on top.
Uses: delicate products like vegetables and airline cutlery.
Vertical Form Fill Seal (VFFS)
Vertical Form Fill and Seal Machine A packaging machine which uses flexible
packaging material to form a tube, which is then filled vertically with product and sealed in
a sequence of operations whilst the film is transported vertically downwards.

Uses: powders, liquids, free flowing solids.
Vertical Form Fill and Seal Machine for Cartonboard
A vertically operating form fill and seal machine which uses a cartonboard laminate, which
is formed, filled with product and sealed to produce a pack resembling a carton.
Uses: The well-known Tetra Pak carton for milks and juices is a variant of a carton VFFS
pack.
Mandrel Flexible Package Form Fill and Seal Machine
A packaging machine which forms packs from a reel of flexible material, on one or a
number of mandrels, before filling the packs with product and sealing their tops within the
machine. Packs are formed using flexible packaging material on one or more mandrel to
form the pack which is then filled and sealed within the machine.
Uses: Traditionally used for flour and sugar.
Tubular Form Fill Seal (TFFS)
Tubular Form Fill Seal covers two main types that cover larger bags and sacks:
Tubular Bag Form Fill and Seal Machine
A packaging machine which forms a bag from a reel of lay flat tubular flexible packaging
film. The bag is then filled with product and sealed within the machine. Bags are formed
from a tube of lay flat flexible packaging material and then filled and sealed within the
machine.
Tubular Sack Form Fill and Seal Machine
A packaging machine which forms a sack from a reel of lay flat tubular flexible packaging
film. The sack is then filled with product and sealed either within the machine or by
separate machines.
Sachet Form Fill Seal
Packaging machines which use flexible packaging material, to form a package which is
then filled and sealed in a sequence of operations to form a three or four side sealed
sache
There are 3 main types:
Edge Sealing Machine
Horizontally operated form fill seal machine in which the product is placed on a horizontal
web of film before being sealed on 3 or 4 sides to an upper web of film. Machines may
have one or two reels of material and can produce one or more lanes of packs. Uses:
Greeting cards and medical dressings.

Horizontal Sachet FFS
Packs are formed and sealed on 2 or 3 sides and filled vertically with the product before
the remaining side is sealed whilst he film web is moving horizontally but the pack
remains vertical. Uses: liquids, free flowing powders and wipes such as hand cleaners,
cosmetics etc.
Vertical Sachet FFS
Uses one or more webs of film to form a pack which is filled vertically and sealed to
produce a 3 or 4 sided sealed sachet. Can have one or two webs of film and several
lanes of packs. Uses: tea bags and pack liquids and free flowing powders and solids.
Strip Pack
Vertically operated FFS which produces strips of individually sealed packs joined together
in predetermined lengths for a variety of uses including soluble medicines.
Stick Pack
Horizontally or vertically operated FFS machine forming a thin 3 sided sachet from flexible
packaging materials resembling a stick or pen.
Uses: sugar, tea, coffee, sauces, shampoos and toiletries.
Thermoform Fill Seal
A form, fill and seal machine in which a web of thermoformable material is heated and
formed with pressure and/or vacuum, before being filled vertically with product, sealed
with a top film or magazine fed lid and finally cut to produce individual packs. Machines
can produce one or more lanes of packs and may incorporate equipment to evacuate
packages before they are sealed.
Uses: cheese, bacon, fresh and cooked meats.
Blister Thermoform Fill Seal
The most common form of thermoform fill seal used almost exclusively pharma pills &
capsules.
Deep Draw Form Fill and Seal Machine
Packaging machines which use deformable or thermoformable packaging material, to
form a package which is then filled and sealed in a sequence of operations to form a
deep drawn pack.
Cold Form Fill and Seal Machine
A form, fill and seal machine in which a web of deformable material is formed under
pressure in a die press, before being filled vertically with product sealed, with a top film or

magazine fed lid, and finally cut to produce individual packs. Machines can produce one
or more lanes of packs. Uses: single serve jam and preserves.
Modified Atmosphere Packaging (MAP)
The objective is to extend shelf life by modifying, controlling or removing the atmosphere
surrounding perishable products. Sophisticated horizontal and vertical form fill seal
systems are used.
Blow Fill Seal
Blow mould Form Fill and Seal Machine: A Packaging machines in which plastic
granules are melted, extruded, blow moulded to form a container, filled with product and
sealed within the machine.
Uses: pharmaceuticals and related products such as sterile unit doses e.g. eye drops.
B/F/S Process
The ASEP-TECH® System automatically delivers a finished package in five
steps:
Thermoplastic resin is extruded into a tubular shape called a
parison. (Figure a.)
When the parison reaches the proper length, the mold is
closed and the parison is cut. The bottom of the parison is
pinched closed and the top is held in place. The mold is then
conveyed to a position under the blowing and filling nozzle.
(Figure b.)
The blow-fill nozzle is lowered into the parison until it forms a
seal with the neck of the mold. The container is formed by
blowing sterile filtered compressed air into the parison and
expanding it against the walls of the integrally cooled mold
cavity. Next, the sterile air is vented from the container and
the sterile product is metered into the container through the
fill nozzle, which then retracts. (Figure c.)

Separate sealing molds close to form the top and
hermetically seal the container. (Figure d.)
The mold opens, and the formed, filled and sealed container
is conveyed out of the machine. (Figure e.)
B/F/S Machines
Model 603 | Model 624 | Model 628 | Model 640

ASEP-TECH® Blow/Fill/Seal machines are designed and manufactured by
Weiler Engineering, Inc. in Elgin, Illinois. Our team is dedicated to the highest
performance standards in the design and development of Blow/Fill/Seal
packaging systems. This unique combination of world-class engineering,
leading-edge automation and process design, assures years of reliable, high
quality production.
Blow-fill-seal technology, originally developed in Europe in the 1930s and
introduced in the US in the 1960s, has emerged as a preferred method for
aseptic packaging of pharmaceutical and healthcare products due to unrivalled
flexibility in container design, overall product quality, product output and low
oprational costs.
The Weiler design incorporates the multi-step process of blow moulding, aseptic
filling and hermetic sealing of liquid products in one sequential operation on a
compact, automated machine frame with fill volumes ranging from 0.1 millilitre

(ml) to 1,000ml.
A variety of polymers may be used in the process, low and high-density
polyethylene and polypropylene being the most popular. The innate ability to
form the container/closure during the actual aseptic packaging process allows
for custom design of the container to meet the specific needs of the application.
This flexibility not only improves container ease of use, but provides a means of
interfacing with many of today’s emerging drug delivery technologies, most
notably in the field of respiratory therapy. Recent advancements in machine
design allow for insertion of pre-moulded, pre-sterilised components to be
moulded into the container creating additional design options to create multi-use
and injectable product containers.
Furthermore, the blow-fill-seal process flow is normally impacted by only two raw
materials, product and polymer, that are each processed inline, thereby making
the process amenable to large uninterrupted batch sizes, some in excess of
500,000 units, and fill durations of up to 120 hours.
The net effect is routinely an increase in production efficiency and a subsequent
decrease in operational costs for the user. Blow-fill-seal systems represent a
niche market within the larger form-fill-seal marketplace for pharmaceutical
packaging equipment.
The blow-fillseal process is a robust, advanced aseptic processing technology,
recognised by worldwide regulatory authorities for its inherent operational
advantages over conventional aseptic production.
Blow-fill-seal systems offer a unique combination of flexibility in packaging
design, low operating cost and a high degree of sterility assurance. The
machines require aminimum number of operating personnel and have a
relatively small space requirement.
Applications

The ability to provide sterile liquid
products that meet corporate, scientific,
regulatory and end-user requirements
can be a demanding task in today's
environment. Through your
implementation of ASEP-TECH®
Blow/Fill/Seal technology, these
application challenges can be met by
the creative container and closure
designs available with each system.
Several machine models are available
to choose from, designed to
manufacture containers ranging in size
from 0.2mL to 1000mL at production rates of up to 15,000 units per hour,
depending on container configuration.
• Small Volume Parenterals (SVP’s)
• Large Volume Parenterals (LVP’s)
• Ophthalmic's
• Respiratory therapy
• Other applications
• New concepts
Design Services and Prototyping
We offer comprehensive product development, from
container/closure concept to complete production tooling
ready for your in-house manufacturing on ASEP-TECH®
Blow/Fill/Seal machinery. Our skilled craftsmen and
designers can develop virtually any container mold
through the use of sophisticated CAD/CAM technology
and 3-D modeling. These design systems, when
interfaced with the latest in CNC and EDM machinery,
ensure fabrication of key components to precise
tolerances.
See ASEP-TECH® Advantage.
Advantages of horizontal and vertical form filling and sealing

Faster production times.
Because the machinery for form fill and seal incorporates all stages of production automatically,
the process is quick.
Relatively inexpensive.
Can seal product without heavy or expensive packaging material.
Flexible solution.
Solids, dry or liquids can be packaged using vertical form fill and seal (VFFS).
Vertical form fill sealing machine
The Vertical form fill sealing machine (FFS) is a type of automated assembly-line product
packaging system, commonly used to in thepackaging industry for food, and a wide variety of
other products. The machine constructs plastic bags out of a flat roll of plastic film, while
simultaneously filling the bags with product and sealing the filled bags. Both solids and liquids
can be bagged using this packaging system.
The typical machine is loaded with a continuous flat roll of plastic film, which has
had labeling and artwork applied to the exterior or interior of the film. Note that
while plastic is the most commonly used packaging material in the [[food industry], the
technology can also be used to form continuous paper and fabric product containers by
changing the edge sealing/seaming methods.
For some products the film may first be fed through a sterilizing chemical bath and dryer prior
to use in the packaging system.The film approaches the back of a long hollow conical tube,
and when the center of the plastic is near the tube, the outer edges of the film form flaps
that wrap around the conical tube. The film is pulled downward around the outside of the
tube and a vertical heat-sealing bar clamps onto the edges of the film, bonding the film by
melting the seam edges together.
To start the bagging process, a horizontal sealing bar clamps across the bottom edge of the
tube, bonding the film together, and cutting off any film below. The sealed tube end is then
lowered onto a precision weighing table and the product to be bagged is dispensed
through the long conical tube in the center of the bag. When the gross weight of the
product-filled bag is reached, filling stops, and the horizontal sealing bar seals the top of
the bag, and simulatenously forms the bottom of the next bag above. This bag is then cut
off from the tube and is now a sealed package, ready to advance onward into the product
boxing and shipping processes.
During the final sealing process, the bag may be filled with air from a blower or from an inert
gas supply. Inflating the bag helps reduce the crushing of fragile products such as potato
chips, while inflating with an inert gas helps drive out oxygen and retards the growth
of bacteriathat would spoil the product.
The feeding of material and cutting of the pouch can be determined either by pouch length, or
indexing to an eyespot, which is detected by a visual sensor. While single web systems are
popular for food applications, the dual web four side seal system is often popular for IVD
and Medical device products. Closely related is the horizontal form-fill-seal machine, which
is generally uses more floor space than a vertical system. Modern advancements in pouch
forming technology have allowed for smaller and smaller Vertical pouch forming systems.

PLEASE CONTINUE HERE FOR MORE
INFORMATION ABOUT FORM-FILL-SEAL
MACHINES
HORIZONTAL FORM FILL SEAL
02, Singapore 368359. +65 67414077
www.clearpack.com
An Introduction to
HORIZONTAL FORM FILL SEAL MACHINES
www.clearpack.com 1

MACHINESA Clearpack White Paper
134 Joo Seng Road, #04-02, Singapore
Introduction
Horizontal Form Fill Seal Machine:
Flexible packaging has changed in great manner in
the past
point that today, the pack presentation cannot any
longer be a simple package
but a real packaging solution with real shape and
function benefits which will
set the difference between a well presented and
innovative product and the
rest.
Horizontal Form Fill Seal Machine is an intermittent
system. Here the pouch is
sealed on three sides and later filled on the 4
using this principle:
• Strong seal integrity
• Capability to fill from 1cc to 3500cc
• Possibility to do different pack styles in sachet and
stand up pouch.

Flexibility is the main aspect, as using the same
machine. It is possible to
make a wide range of different pack presentations
with maximum efficiency
and keeping high seal integrity.
02, Singapore 368359. +65 67414077
www.clearpack.com
Flexible packaging has changed in great manner in
the past few years, to the
sealed on three sides and later filled on the 4th side.
Following are the benefits
Capability to fill from 1cc to 3500cc

to do different pack styles in sachet and stand up
pouch.
with maximum efficiency
and keeping high seal integrity.
www.clearpack.com 2
few years, to the
side. Following are the benefits
to do different pack styles in sachet and stand up
pouch.

with maximum efficiency A Clearpack White
Paper
Basic Operating Principle
Horizontal Form Fill Seal Machine has a reel
unwinder on which the film
is mounted. This film is released from the unwinder. It
passes through a
forming plough and is further sealed at the
will cut the pouch vertically at the right time
controlled by the photocell. The
pouch opening device opens t
top stretching mechanism stretches the pouch to make
a clean to
02, Singapore 368359. +65 67414077
www.clearpack.com
Basic Operating Principle:
passes through a

forming plough and is further sealed at the bottom
and 2 sides. The scissors
pouch opening device opens the pouch and brings it to
the filling station. The
top stretching mechanism stretches the pouch to make
a clean top seal.
www.clearpack.com 3
passes through a
bottom and 2 sides. The scissors
e pouch and brings it to the filling station. The
p seal.A Clearpack White Paper
HFFS - Machine Layout:
How to select the right machine:
We need to consider the following basic points when
selecting the machine

1. Nature of the Product
2. Product Dimensions
3. Pouch Material
4. Pouch Dimension/Size
5. Pouch Style
6. Speed Required
7. Hourly output of the product to be packed
8. Filling Temperature
02, Singapore 368359. +65 67414077
www.clearpack.com
How to select the right machine:
selecting the machine
Pouch Dimension/Size
Hourly output of the product to be packed
www.clearpack.com 4
selecting the machineA Clearpack White Paper
Pouch Styles – Horizontal Form Fill Seal Machine:
Stand up pouch – Variants:

Stand up pouches are made on HFFS machine using a
film or a laminate.
Stand up pouches gives the packaging an aesthetic
appeal. There are other
features which are added to stand up pouches like a
spout, zip or a straw.
Spouted pouches are either top spout or edge spout
depending on the
requirement. Spouted pouches are used for products
which are free flowing
liquids and pastes. Zipper pouches are used when the
pouc
reclosed after the required amount of product has
been used so that the
product remains fresh for a longer duration or retains
certain properties like
aroma in coffee. Straw pack is also another
application wherein the straw is
already made available within the pouch. The best
application is in beverage.
Stand up pouches offers these variations and also
gives the pouch shelf appeal
and becoming a sales agent

Stand Up Pouch Top Spout
02, Singapore 368359. +65 67414077
www.clearpack.com
Variants:
film or a laminate.
added to stand up pouches like a spout, zip or a straw.
depending on the
liquids and pastes. Zipper pouches are used when the
pouch needs to be

vailable within the pouch. The best application is in
beverage.
and becoming a sales agent.
Top Spout Edge Spout Zipper Pouch
www.clearpack.com 5
film or a laminate.
added to stand up pouches like a spout, zip or a straw.
depending on the
h needs to be

vailable within the pouch. The best application is in
beverage.
Straw Pack
A Clearpack White Paper
Pouch Styles – Horizontal
Variety of products can be filled in these pouches.
This pouch style is
economical and is used for filling of:
• Powder (Pharmaceutical, Energy Drink,
• Liquids (Shampoo, Gel, Creams and Sauce)
• Tablets
Pouches can be made with certain features like Hole
Punch,
and Free Shape on the horizontal form fill seal
machine. This gives the pouch a
value added feature. With the help of Hole Punch and
Euro Hole feature, the

pouch can be displayed in an effective way. The
customized Free Shape given
to the pouch makes it more attracti
and increases the selling ability of the product by
giving it a shelf appeal.
3 Side Seal
Hole pouch
02, Singapore 368359. +65 67414077
www.clearpack.com
orizontal Form Fill Seal Machine:
Variety of products can be filled in these pouches.
This pouch style is
B/F/S Process
The ASEP-TECH® System automatically delivers a finished package in five steps:
Thermoplastic resin is extruded into a tubular shape called a parison. (Figure a.)
When the parison reaches the proper length, the mold is closed and the parison
is cut. The bottom of the parison is pinched closed and the top is held in place.
The mold is then conveyed to a position under the blowing and filling nozzle.
(Figure b.)

The blow-fill nozzle is lowered into the parison until it forms a seal with the neck
of the mold. The container is formed by blowing sterile filtered compressed air
into the parison and expanding it against the walls of the integrally cooled mold
cavity. Next, the sterile air is vented from the container and the sterile product
is metered into the container through the fill nozzle, which then retracts. (Figure
c.)
Separate sealing molds close to form the top and hermetically seal the
container. (Figure d.)
The mold opens, and the formed, filled and sealed container is conveyed out of
the machine. (Figure e.)
B/F/S Machines
Model 603 | Model 624 | Model 628 | Model 640
ASEP-TECH® Blow/Fill/Seal machines are designed and
manufactured by Weiler Engineering, Inc. in Elgin, Illinois. Our team is dedicated to the highest
performance standards in the design and development of Blow/Fill/Seal packaging systems. This unique
combination of world-class engineering, leading-edge automation and process design, assures years of
reliable, high quality production.
Applications

The ability to provide sterile liquid products that
meet corporate, scientific, regulatory and end-user
requirements can be a demanding task in today's
environment. Through your implementation of
ASEP-TECH® Blow/Fill/Seal technology, these
application challenges can be met by the creative
container and closure designs available with each
system. Several machine models are available to
choose from, designed to manufacture containers
ranging in size from 0.2mL to 1000mL at
production rates of up to 15,000 units per hour,
depending on container configuration.
• Small Volume Parenterals (SVP’s)
• Large Volume Parenterals (LVP’s)
• Ophthalmic's
• Respiratory therapy
• Other applications
• New concepts
Design Services and Prototyping
We offer comprehensive product development, from container/closure
concept to complete production tooling ready for your in-house
manufacturing on ASEP-TECH® Blow/Fill/Seal machinery. Our skilled
craftsmen and designers can develop virtually any container mold through
the use of sophisticated CAD/CAM technology and 3-D modeling. These
design systems, when interfaced with the latest in CNC and EDM
machinery, ensure fabrication of key components to precise tolerances.
See ASEP-TECH® Advantage.

Sacmi sinergies for Innovative Technology
ISA Integrated Sleeve Applicator
Since the the beginning Sacmi Imola Group
welcomed
with great interest the idea of a Sleeve Applicator
(ISA) developped recently by Sacmi Labelling to be
Integrated with Benco Pack FFS machines and after
numerous laboratory tests what seemed to be just
a dream was transformed into reality so that it is
now possible to adapt to labelling a wide range of
containers of different shapes directly thermoformed
by a FFS machine.
In a unique structure, the filled and sealed container
is individually treated in a series of closed chambers,
where a jet of steam, with variable duration, but
always
less than 0.6 seconds, causes the “sleeve” label
shrinking onto the container.

An innovative technique allows reducing steam
consumption up to 10 times versus the traditional
heat-shrinkage tunnels thanks to the elimination of the
pre-heating phase and also steam is not pointlessly
consumed when the machine is in standby.
As far as material is concerned, ISA uses “sleeve”
labels made of different types of material: OPS, PET
and PVC manufactured by a wide-range of suppliers
on the international and local markets, among
which customers can choose the most suitable and
convenient for the their needs.
ISA ADVANTAGES
• Packaging appeal: brighter printing and
transparent
colours and higher graphic resolution
• Cup shapes: suitable for a wide range of body
shape
• System integrated in the FFS machine
• Steam consumptions: up to 10 times lower than
the traditional shrinking tunnel
• Suitable for hot filling and for fully aseptic
machine

(isotonic drnks, juices, UHT dairy desserts)
• Decoration on multipacks without format change.
• Machine output from 6.000 to 36.000 cup/h
FORM-FILL-SEAL MACHINES
Description
Definition
Importance
Scope and use of areas
Types of machines
Objectives
Form Fill and
Seal
Machines
Form and seal packaging machines use heat-sealable, flexible plastic, packaging film to form a package; the package
is then filled, heat-sealed, and cut off. There are two basic types, horizontal and vertical. A horizontal machine forms a
package, fills with product, and seals in a sequence of operations while the film is being transported in a horizontal
direction. They are widely used for packaging solid foodstuffs. A vertical machine forms a tube, fills, and seals in a
sequence of operations while the film is being transported vertically downwards. They are widely used for packaging
foodstuffs in a liquid, powder, paste, or granule state.
Form, Fill, and Seal Machines Information
Form, fill and seal machines are packaging equipment that uses flexible, heat-sealable, plastic film to form packages that canbe filled
with a product and then sealed, and cut. There are many types of form, fill, and seal machines. Forming machines form packages, but
do not fill or seal them. Filling machines load previously formed packages with a specific product quantity, but do not provide closing or
sealing action. Seal-only equipment wraps or secures products, but does not form packages or fill them. Equipment that combines form,
fill and seal functions is also available. Some devices transport the plastic film horizontally. Others transport the film
vertically. Manual machines aid only in the setting or holding of products. Semi-automatic machines help with both packaging and
placement, allowing a single operator to perform several activities with greater speed and accuracy. Fully automatic equipment requires
limited operator intervention. Typically, operators need only replenish packaging components by loading supply hoppers or removing
completed cartons.
Form, fill and seal machines are used to process liquids, granules, powders, and sprays for consumer, bulk and original equipment
manufacturer (OEM) supply shipments. Packaging materials include aerosol containers, bags and pouches, blister packs, bottles and
jars, cartons and boxes, cans, capsules, cartridges, cases, cups and trays, drums and kegs, pallets and pails, and tubes and vials.
Intermediate bulk containers (IBCs) have a capacity of not more than 3 cubic meters and are designed to be handled by form, fill and
seal machines. There are several ways to close packages. Examples include caps and lids, corks, glue, heat seals, nails and staples,
tapes, tucks and folds, wrappers, and tamper-resistant materials.
Selecting form, fill and seal machines requires an analysis of specifications, features, and applications. Typically, fully automated
machines list the rate, which is usually expressed in pieces per minute. Some automated machines include an integral feeder and a
computer interface that links to a control network. Others are made from stainless steel for improved corrosion resistance. Aseptic or
sanitary equipment is easy to clean and designed in a manner that inhibits the growth or presence of pathogenic

microrganisms. Portable machinery is lightweight or includes wheels or casters for ease of movement. In terms of applications, form, fill
and seal machines are used widely in the automotive, chemical, medical, and pharmaceutical industries. They are also used to process
food, beverages, cosmetics, electronics, semiconductors, stationary, tobacco, and military products.
[SCHEDULE M]
[See Rules 71, 74, 76 and 78]
GOOD MANUFACTURING
PRACTICES AND
REQUIREMENTS OF
PREMISES,
PLANT AND EQUIPMENT FOR
PHARMACEUTICAL
PRODUCTS.
10. Form-Fill-Seal Technology or Blow, Fill-Seal Technology. -
10.1 Form-Fill-Seal units are specially built automated machines in which through one continuous
operation, containers are formed from thermoplastic granules, filled and then sealed. Blow, fill-seal units
are machines in which containers are moulded / blown (pre-formed) in separate clean rooms, by non-
continuous operations.
Note: -
(i) These shall be installed in at least Grade C environment.
(ii) These shall comply with the limits as recommended in Table at Item 4.2.
4.2 There shall be a written environmental monitoring program and
microbiological results shall be recorded. Recommended limits for microbiological
monitoring of clean areas ìin operationî are as given in the table below:
TABLE
RECOMMENDED LIMITS FOR MICROBIOLOGICAL MONITORING OF CLEAN
AREAS ì IN OPERATIONî
Grade Air sample Settle plates (dia. 90mm. Contact plates (dia. Glove points Cfu/m
2

Cfu/2 hrs. 55mm) cfu per plate (five fingers)
cfu per glove
A < 1 < 1 < 1 < 1
B 10 5 5 5
C 100 50 25 --
D 500 100 50 --
Notes:
(a) These are average values.
(b) Individual settle plates may be exposed for not less than two hours in
Grade B, C and D areas and for not less than thirty minutes in Grade A
area.
10.2. Form-Fill-Seal/Blow, Fill-Seal machines used for the manufacture of products for terminal
sterilization shall be installed in at least Grade C environment and the filling zone within the machine shall
fulfill Grade A requirements.
10.3. Terminally sterilized products. -
10.3.1. Preparation of primary packaging material such as glass bottles, ampoules and rubber stoppers
shall be done in at least Grade D environment. Where there is unusual risk to the product from microbial
contamination, the above operation shall be done in Grade C environment. All the process used for
component preparation shall be validated.
10.3.2. Filling of products requiring terminal sterilization shall be done under Grade A environment with
a Grade C background.
10.4 Preparation of solutions, which are to be sterilized by filtration, shall be done in Grade C
environment, and if not to be filtered, the preparation of materials and products shall be in a Grade A
environment with Grade B in background.
10.5 Filtration (membrane).-
(i) Solutions for Large Volume Parenterals shall be filtered through a non-fibre releasing, sterilizing grade
cartridge/membrane filter of nominal pore size of 0.22 µ for aseptic filling whereas 0.45 µ porosity shall
be used for terminally sterilized products.
(ii) A second filtration using another 0.22 µ sterilizing grade cartridge / membrane filter shall be
performed immediately prior to filling. Process specifications shall indicate the maximum time during
which a filtration system may be used with a view to precluding microbial build-up to levels that may
affect the microbiological quality of the Large Volume Parenterals.
(iii) The integrity of the sterilized filter shall be verified and confirmed immediately after use by an
appropriate method such as Bubble Point, Diffusive Flow or Pressure Hold Test. 10.6 Sterilization
(Autoclaving).-
10.6.1. Before any sterilization process is adopted, its suitability for the product and its efficacy in
achieving the desired sterilizing conditions in all parts of each type of load pattern to be processed, shall
be demonstrated by physical measurements and by biological indicators, where appropriate.
10.6.2 All the sterilization process shall be appropriately validated. The validity of the process shall be
verified at regular intervals, but at least annually. Whenever significant modifications have been made to
the equipment and product, records shall be maintained thereof.
10.6.3 The sterilizer shall be double ended to prevent mix-ups.

10.6.4 Periodic bio-burden monitoring of products before terminal sterilization shall be carried out and
controlled to limits specified for the product in the Master Formula.
10.6.5 The use of biological indicators shall be considered as an additional method of monitoring the
sterilization. These shall be stored and used according to the manufacturerís instructions. Their quality
shall be checked by positive controls. If biological indicators used, strict precautions shall be taken t avoid
transferring microbial contamination from them.
10.6.6 There shall be clear means of differentiating ë sterilizedí and ëunsterilizedí products. Each basket,
tray or other carrier of products or components shall be clearly labeled with the name of the material, its
batch number, and sterilization status. Indicators shall be used, where appropriate, to indicate whether a
batch (or sub-batch) has passed through the sterilization process.
10.6.7 Sterilization records shall be available for each sterilization run and may also include
thermographs and sterilization monitoring strips. They shall be maintained as part of the batch release
procedure.
10.7. Sterilization (by dry heat).-
10.7.1 Each heat sterilization cycle shall be recorded on a time/temperature chart of a suitable size by
appropriate equipment of the required accuracy and precision. The position of temperature probes used for
controlling and/or recording shall be determined during the validation and, where applicable, shall also be
checked against a second independent temperature probe located in the same position. The chart shall
form a part of the batch record. Container mapping may also be carried out in the case of Large
Volume Parenterals.
10.7.2 Chemical or biological indicators may also be used, but shall take the place of physical validation.
10.7.3. Sufficient time shall be allowed for the load to reach the required temperature before measurement
of sterilization time commences. This time shall be separately determined for each type of load to be
processed.
10.7.4. After the high temperature phase of a heat sterilization cycle, precautions shall be taken against
contamination of sterilized load during cooling. Any cooling fluid or gas in contact with the product shall
be sterilized unless it can be shown that any leaking container would not be approved for use. Air inlet and
outlets shall be provided with bacterial retaining filters.
10.7.5. The process used for sterilization by dry heat shall include aircirculation within the chamber and
the maintenance of a positive pressure to prevent the entry of non-sterile air. Air inlets and outlets should
be provided with micro-organism retaining filters. Where this process of sterilization by dry heat is also
intended to remove pyrogens, challenge tests using endotoxins would be required as part of the validation
process.
10.8. Sterilization (by moist heat).-
10.8.1 Both the temperature and pressure shall be used to monitor the process. Control instrumentation
shall normally be independent of monitoring instrumentation and recording charts. Where automated
control and monitoring systems are used for these applications, these shall be validated to ensure that
critical process requirements are met. System and cycle faults shall be registered by the system and
observed by the operator. The reading of the independent temperature indicator shall be routinely checked
against the chart-recorder during the sterilization period. For sterilizers fitted with a drain at the bottom of
the chamber, it may also be necessary to record the temperature at this position throughout the sterilization
period. There shall be frequent leak tests done on the chamber during the vacuum phase of the cycle.
10.8.2 The items to be sterilized, other than products in sealed containers, shall be wrapped in a material
which allows removal of air and penetration of steam but which prevents re-contamination after
sterilization. All parts of the load shall be in contact with the sterilizing agent at the required temperature
of the required time.
10.8.3. No Large Volume Parenteral shall be subjected to steam sterilization cycle until it has been filled
and sealed.

10.8.4 Care shall be taken to ensure that the steam used for sterilization is of a suitable quality and does
not contain additives at a level which could cause contamination of the product or equipment.
10.9. Completion/finalisation of sterile products.-
10.9.1. All unit operations and processes in the manufacture of a batch shall have a minimum time
specified and the shortest validated time shall be used from the start of a batch to its ultimate release for
distribution.
10.9.2. Containers shall be closed by appropriately validated methods. Containers closed by fusion e.g.
glass or plastic ampoules shall be subjected to 100% integrity testing. Samples of other containers shall be
checked for integrity according to appropriate procedures.
10.9.3 Containers sealed under vacuum shall be tested for required vacuum conditions.
10.9.4 Filled containers parenteral products shall be inspected individually for extraneous contamination
or other defects. When inspection is done visually, it shall be done under suitably controlled conditions of
illumination and background. Operators doing the inspection shall pass regular eye-sight checks with
spectacles, if worn, and be allowed frequent rest from inspection. Where other methods of inspection are
used, the process shall be validated and the performance of the equipment checked at suitable intervals.
Results shall be recorded.
http://www.ppma.co.uk/form-fill-
seal/modified-atmosphere-
packaging.htm
Form Fill Seal
Form Fill Seal (FFS) machines are packaging machines that form fill and seal a package on the same machine.
The main types are vertical form fill seal (VFFS) and horizontal form fill seal (HFFS) machines – a term often used in the market place to
cover horizontal versions of flow-wrappers, sachet machines, blister pack machines, four side seal machines and thermoform fill and seal
machines.; in both cases packaging material is fed off a roll, shaped, and sealed. The bags/packs are then filled, sealed and separated.

Today many FFS systems are highly sophisticated featuring computer interfaces and control networks. Greater speed and versatility are the
major benefits of FFS systems for user companies. For example snack producers demand systems that have the versatility to provide fast
changeover between many different packaging formats to meet growing demand for single serve packs. Here VERTICAL FFS is capable of
creating virtually any size or shape ranging from the standard pillow pack to bags sealed on all four sides.
The multiplicity of FFS machines employ a wide range of material types and are used across numerous markets including food, drinks,
cosmetics, electronics, stationary, tobacco, chemical, medical, and pharmaceuticals.
Form fill seal machines are often divided into the types of packs they produce:
Bags and Pillow packs
flow-wrapper; lower reel flow-wrapper; vertical form fill and seal; stickpack machines; mandrel form fill seal.
Bottles/vials
blow fill seal.
Cartons
vertical carton board form fill seal.
Pots trays and blisters
cold form fill seal; thermoform fill seal; blister form fill seal.
Sachets and Envelopes
edge seal machine; horizontal form fill seal; vertical sachet form fill seal.
Sacks and Bags
tubular sack form fill seal and vertical form fill seal.
However, each type is introduced individually on the following
pages to ensure that browsers are able to access information
on easily.
Products commonly associated with form/fill/seal include:
Crisps; Nuts; Sugar; Rice; Pulses; Sweets & Confectionery;
Sauces & Soups; Pet Foods; Grain; Jams & Preserves; Cakes;
Bread; Biscuits; Tea Bags; Condiments; Tablets, Capsules and
Pills, Greetings cards; Phone cards.
Common Terminology
• Horizontal product infeed mechanism
• Film unwind mechanism
• Film folding box
• Longitudinal seal mechanism
• Transverse seal mechanism
• Transverse cutting mechanism
• Discharge conveyor
• Film forming tube
• Automatic filling device
• Film transport mechanism
• Mandrel
• Mandrel bag forming mechanism
• Bag fold and seal
• Bag seal

• Multihead weigher
• hopper
• augur filler
• Bag
• Bag-in-Box
• Block bottom bag
• Deformable material
• Film reel
• Film web
• Flexible packaging material
• Lay flat tube
• Paper/foil laminate
• Pre-made bag
• Pre-made sack
• Sachet
• Pouch
• Side seam seal
• Thermoformable material
• Longitudinal seal
• Magazin
Bag Form Fill Seal
Bag Form Fill Seal Machines Packaging machines which use flexible packaging material, to form a package which is then filled and sealed in a
sequence of operations to form a bag shaped or block bottom bag shaped pack.
Uses: food, confectionery.
Flow Wrapping
A Flow Wrapping Machine is a horizontally operated machine with the packaging material mounted above the operating level where the
product is loaded horizontally with a longitudinal seal formed below the pack.
Uses: solid products like biscuits, chocolate bars and phone cards.
Lower Reel Flow Wrapping
As above, except the packaging material is mounted below the operating level and the longitudinal seal is on top.
Uses: delicate products like vegetables and airline cutlery.
Vertical Form Fill Seal (VFFS)
Vertical Form Fill and Seal Machine A packaging machine which uses flexible packaging material to form a tube, which is then filled vertically
with product and sealed in a sequence of operations whilst the film is transported vertically downwards.
Uses: powders, liquids, free flowing solids.
Vertical Form Fill and Seal Machine for Cartonboard

A vertically operating form fill and seal machine which uses a cartonboard laminate, which is formed, filled with product and sealed to
produce a pack resembling a carton.
Uses: The well-known Tetra Pak carton for milks and juices is a variant of a carton VFFS pack.
Mandrel Flexible Package Form Fill and Seal Machine
A packaging machine which forms packs from a reel of flexible material, on one or a number of mandrels, before filling the packs with
product and sealing their tops within the machine. Packs are formed using flexible packaging material on one or more mandrel to form
the pack which is then filled and sealed within the machine.
Uses: Traditionally used for flour and sugar.
Tubular Form Fill Seal (TFFS)
Tubular Form Fill Seal covers two main types that cover larger bags and sacks:
Tubular Bag Form Fill and Seal Machine
A packaging machine which forms a bag from a reel of lay flat tubular flexible packaging film. The bag is then filled with product and
sealed within the machine. Bags are formed from a tube of lay flat flexible packaging material and then filled and sealed within the
machine.
Tubular Sack Form Fill and Seal Machine
A packaging machine which forms a sack from a reel of lay flat tubular flexible packaging film. The sack is then filled with product and
sealed either within the machine or by separate machines.
Sachet Form Fill Seal
Packaging machines which use flexible packaging material, to form a package which is then filled and sealed in a sequence of operations to form
a three or four side sealed sachet.
There are 3 main types:
Edge Sealing Machine
Horizontally operated form fill seal machine in which the product is placed on a horizontal web of film before being sealed on 3 or 4
sides to an upper web of film. Machines may have one or two reels of material and can produce one or more lanes of packs. Uses:
Greeting cards and medical dressings.
Horizontal Sachet FFS
Packs are formed and sealed on 2 or 3 sides and filled vertically with the product before the remaining side is sealed whilst he film web
is moving horizontally but the pack remains vertical. Uses: liquids, free flowing powders and wipes such as hand cleaners, cosmetics
etc.
Vertical Sachet FFS
Uses one or more webs of film to form a pack which is filled vertically and sealed to produce a 3 or 4 sided sealed sachet. Can have
one or two webs of film and several lanes of packs. Uses: tea bags and pack liquids and free flowing powders and solids.
Strip Pack
Vertically operated FFS which produces strips of individually sealed packs joined together in predetermined lengths for a variety of uses
including soluble medicines.
Stick Pack
Horizontally or vertically operated FFS machine forming a thin 3 sided sachet from flexible packaging materials resembling a stick or pen.

Uses: sugar, tea, coffee, sauces, shampoos and toiletries.
Thermoform Fill Seal
A form, fill and seal machine in which a web of thermoformable material is heated and formed with pressure and/or vacuum, before being filled
vertically with product, sealed with a top film or magazine fed lid and finally cut to produce individual packs. Machines can produce one or more
lanes of packs and may incorporate equipment to evacuate packages before they are sealed.
Uses: cheese, bacon, fresh and cooked meats.
Blister Thermoform Fill Seal
The most common form of thermoform fill seal used almost exclusively pharma pills & capsules.
Deep Draw Form Fill and Seal Machine
Packaging machines which use deformable or thermoformable packaging material, to form a package which is then filled and sealed in
a sequence of operations to form a deep drawn pack.
Cold Form Fill and Seal Machine
A form, fill and seal machine in which a web of deformable material is formed under pressure in a die press, before being filled
vertically with product sealed, with a top film or magazine fed lid, and finally cut to produce individual packs. Machines can produce
one or more lanes of packs. Uses: single serve jam and preserves.
Blow Fill Seal
Blow mould Form Fill and Seal Machine: A Packaging machines in which plastic granules are melted, extruded, blow moulded to form a
container, filled with product and sealed within the machine.
Uses: pharmaceuticals and related products such as sterile unit doses e.g. eye drops.
Modified Atmosphere Packaging (MAP)
The objective is to extend shelf life by modifying, controlling or removing the atmosphere surrounding perishable products. Sophisticated
horizontal and vertical form fill seal systems are used.
FFS Pouch machine
Description
Definition
Importance
Scope and use of areas
Types of machines
Objectives
Dry Products
These are fully automatic FFS machines, controlled by Electro-Mechanical & equipped with Man
Machine Interface, for easy and user friendly operations. The FFS machines for Dry products aids in
packing Detergent Powder, Pan-masala, Henna, Talcum powder, ORS, Namkeen, Peanuts, Tea, Coffee,
Sugar Salt. etc.

SPECIFICATION:-
This machine can automatically measure, convey and feed, fill and form bags. It also performs date code
printing, bag sealing and cutting. It has a servo-motor control bag pulling system, high precision fiber
optic photo sensor control, plc control system, selected electrical and pneumatic components from a
reliable international manufacturer, preloaded operation menu on 5. 7" touch screen and can easily set and
change the packing parameter. It displays daily production output and self-diagnoses machine error. PID
temperature controller monitors heat sealing temperature to +I - 1ºc. Automatic edge position control
assures consistent film alignment during production to produce uniform bag quality.
Mechanism Electro-Mechanical
Filling Range 2 gms. to 200 gms. (Different Models)
Feeding System One line adjustable disc with telescopic
volumetric cup filler
Pouch Size Length : 45mm to 200mm Appx.
Width : 20mm to 150mm Appx.
Sealing Central Seal, 3 Side Seal, 4 Side Seal
Packing Material Any Continuous Heat Sealable Laminate in roll
form with eye marks.
Contact Parts SS 202
Temperature
Controller
Digital or Blind (as per Customer requirement)
Power Supply 1/2 HP, 220V, Single Phase, 50hz
Machine Weight 250 Kgs. Appx.
Salient Features
• Compact, Automatic, and Robust Machine.
• Entire Contact Parts are Fabricated of Stainless Steel.
• Easy operation, High Productivity, and Low Maintenance.
• Fast Change over to new Pouch Size and Different Filling Volume.
• Photoelectric Mark Registration system for Precision Cutting and Sealing of Sachet / Pouches.
• Machine. Mounted on Wheels for Easy Movement.
• Finest Quality Components and Excellent Workmanship.
Optional attachments:
Batch Coding.

Aseptic Form-Fill-Seal (FFS) Machine
Today, a growing number of pharmaceutical manufacturers are using advanced aseptic processing
technologies to minimize operator intervention and contamination risk in the filling and packaging of
liquid parenteral drugs. One of these technologies is form-fill-seal (FFS), in which a polymeric material is
formed and sealed inline to a container of choice, while the container is being filled.
FFS offers cost savings over conventional aseptic processing in glass. Traditional parenteral filling and
packaging requires 23 steps and individual machines for filling, stoppering and capping. In contrast, FFS
requires one piece of automated machinery, and takes place in six seconds or less.
The entire FFS process is performed under a class-100 laminar flow, preventing external contamination.
The fully automatic, computer-controlled technology allows for filling and packaging of up to 40,000
bottles of IV fluid per day. Nitrogen purging options are available for sensitive formulations such as
amino acids.
Get the latest analysis and commentary on manufacturing and the drug industry at our editors' blog. On
Pharma looks at the drug industry with a special focus on manufacturing, which is coming into its own as
a strategically important area.
Sterilization is achieved through an automatic, microprocessor controlled, circulating water-shower. The
water becomes sterile during the process without any hazard to the product. The pressure/temperature link
controls the whole process. The system uses a nylon filter medium to remove colloidal silica, pyrogens,
mycoplasma, viruses and other contaminants.
Outline of the F-F-S Process

A brief outline of a typical Form-Fill-Seal process to which this guide applies is as follows:
(a) A Form-Fill-Seal unit is specially built equipment which in one continuous operation forms containers
from a thermoplastic granulate, and then fills and seals them.
Originally developed for other purposes, they have for some years been suitably adapted and available for
use in the manufacture of pharmaceutical products, specifically sterile products.
(b) Bulk solution prepared under "microbiologically clean" or aseptic conditions (as appropriate) is
delivered to the machine through a bacteria-retaining filter. Pipework, filter housings and machine parts in
contact with the product are steam sterilized in place, where practicable.
(c) Filtered compressed air and granules of a plastic material conforming to a pre-determined specification
and known to be compatible with the product to be filled (usually polyethylene, poly-propylene or
polyethylene / polypropylene co-polymers) are supplied to the machine.
(d) Within the machine, the plastic granules are extruded downwards under pressure (up to 350 bar) as a
hot hollow mouldable plastics tube (or "parison") or tubes. As a result of the high pressure extrusion
process, the parison reaches a temperature of 170o
- 230o
C. The configuration and internal integrity of the
parison is maintained by an internal downward flow of filtered air under pressure.
(e) The two halves of a mould close around the parison and seal the base. Simultaneously, the top of the
parison is cut free by a hot knife-edge. The plastics material is now formed into a container(s) as
determined by the design of the mould by vacuum and/or sterile air pressure.
(f) The container(s) is/are immediately filled with a metered volume of the solution, displacing the sterile
air. Both the air and the solution are filtered through bacteria retaining filters immediately before entry
into the forming, or formed container(s).
(g) When the required volume is filled into the container(s) the filling unit is raised and the containers are
sealed automatically. The mould then opens, releasing a package formed, filled and sealed all in the one
continuous, automatic, cycle which takes a matter of seconds. Meanwhile, parison-extrusion continues,
and the cycle repeats. The filled and sealed units usually require "cropping" off excess plastic.

(h) In versions of these machines adapted for aseptic manufacture, the cycle is conducted automatically
within the machine's own internal sterile air flushed environment (or "air shower"). The machines can also
be used to fill suspensions, ointments, creams, and liquids other than aqueous solutions, although with
such products it is not always possible to employ the final aseptic product filtration prior to filling.
(i) A "multiblock" version of the machine permits the formation of a number (or set) of containers at each
pass from the parison by one mould.
When used for aseptic manufacturing, the cycle is conducted automatically within the machine’s own
internal sterile air flushed environment (or air shower). The range, accuracy, reproducibility and response
time of all controlling and recording instruments associated with the FFS machine and all supporting
equipment, must be adequate to ensure that defined process conditions will be consistent during routine
production. All instruments must be calibrated before any meaningful operational qualification can be
performed. Written calibration procedures should specify the methods to be used for each instrument.
Recalibration should be carried out after any maintenance, and all records maintained. New machine specs
should state requirements for:
• Materials of construction for all components, particularly all contact parts, such as machine pipe work;
internal components of purchased fittings like automatic valves including elastomeric and mechanical
seals; pipeline joint seals; welding materials; filters and filter housings including casing and substrate
layers of cartridges, as well as the main medium and all elastomeric seals; and polymer extrusion
equipment.
• Pipe work configuration, with attention to sterile fluid pathways — for example, the elimination of
“deadlegs”; position of thermocouples (“as installed” configuration, verified against the original design
configuration and confirmed by temperature mapping is typically part of the validation protocol); and
filter housing design.
• Porosity of the product and air filters. The validation data from the filter manufacturers should be
available.
• Mold design, considering fill volume range, wall thickness, opening characteristics and ease of use,
shape and other aesthetic considerations.
If FFS machines are used for the manufacture of non-sterile products, FDA’s current Good Manufacturing
Practices (cGMP) requirements should be followed. When used to manufacture products intended for
subsequent sterilization, these machines may be installed within an environment that would normally be
considered appropriate for the manufacture and filling of terminally sterilized products. If the machines
are to be used for the aseptic filling of sterile products they are usually provided with a localized
environment at the point of fill with Grade A air.
The Installation Qualification process for any FFS system should confirm and certify that the room
conforms to the specified Environmental Standard. A new cleanroom installation should include: room air
filter integrity tests; determination of air velocity at the face of each air inlet filter; room air change rate;
air particle counts, both viable and non-viable, in the rest condition; room pressure differentials; and
lighting, heating and humidity readings.
Blow-Fill-Seal Technology
Blow-Fill-Seal technology refers to the manufacturing technique used to produce small, (0.1mL) and large
volume, (500mL +) liquid filled containers. Blow-Fill-Seal technology was originally developed in
Europe in the 1930s and was introduced in the United States in the 1960s, but over the last 20 years it has
become more prevalent within the pharmaceutical industry, and it is now widely considered to be the
superior form of aseptic processing by various medicine regulatory agencies including the U.S. Food and
Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products.

The basic concept of blow fill seal (BFS) is that a container is formed, filled, and sealed in a continuous
process without human intervention, in a sterile enclosed area inside a machine. Thus this technology can
be used to Aseptically Manufacture sterile pharmaceutical liquid dosage forms.
The process is multi-stepped, firstly pharmaceutical-grade plastic resin is vertically heat extruded through
a circular throat, to form a hanging tube called the Parison. This extruded tube is then enclosed within a
two-part mould, and the tube is cut above the mould. The mould is transferred to the filling zone, or sterile
filling space where filling needles mandrels are lowered and used to inflate the plastic to form the
container within the mould. Following the formation of the container, the mandrel is used to fill the
container with liquid, following filling the mandrels are retracted and a secondary top mould seals the
container. All actions take place inside a sterile shrouded chamber inside the machine. The product is then
discharged to a non-sterile area for labelling, packaging and distribution.
Blow fill seal technology reduces personnel intervention making it a more robust method for the aseptic
preparation of sterile pharmaceuticals. BFS is used for the filling of vials for parenteral preparations and
infusions, optphalmic products and inhalation products for example Respules (TM). Generally the plastic
containers are made up of polyethylene and polypropylene. Polypropylene is more commonly used to
form containers which are further sterilised by autoclaving as Polypropylene has greater thermostability.
The versatility of the FFS technology is particularly demonstrated in the field of easy-to-use pre-portioned
consumer products. The practical and consumer-friendly FFS technology offer interesting applications
that enable sales figures to be increased for both newly created products and established branded products.
Effectiveness
The following effective quality can be maintained in form fill seal technique:
• Output performance
• High operating comfort
• Remote diagnosis and tele-service via an internet link
• HMI (Human Machine Interface)
• Operational data collection
• Automatic station positioning
• Dosing units with optimum filling accuracy
• From hygienic to fully aseptic configurations

Flexibility
• Customer- and product-specific design, adjusted to the product and production requirements
• Many different packs/moulds/designs are possible
• Size configuration in keeping with the production capacity required
• Flexible control concepts and integration with customer-specific systems
• All common packaging materials that are suitable for heat-sealing can be processed
Aseptic FFS Machines
Aseptic machines produce and sterilize the products on all sides. The packs are formed, filled and sealed
under aseptic conditions in a sterile tunnel.
This technology is mainly used for convenience products (puddings, snacks) and for dairy products
(desserts, cream cheese products etc.) to ensure longer shelf life and a better product quality.
FFS machines for rigid containers / Cups
Form Fill Seal technology is a combination of several processes; cups are thermoformed from plastic
sheet, filled with product, hermetically sealed with film and cut into singles or multi-packs – all on the
same machine.
Form Fill Seal has three principal economic an environmental assets: reduction in the use of plastic by
having wrap-around paper labeling, high levels of hygiene and minimum working space for a compact
machine.
It combines creativity with standard solutions. This is the adaption of technology to current market
demands and special requirements, focusing on individual, future-oriented solutions with the highest
economic efficiency and high product quality.
The following benefits are observed:
Cost reduction
• for the same cup capacity, the most economic use of raw materials,for the same production, the
most economic solution in terms of personnel, power consumption and maintenance

• for the same volume of production, lower cost of raw material storage (pre-formed containers can
use more than 6 times the space needed for materials on reels).
Flexibility
The combination of several functions on one machine provides the opportunity to have unique container
shapes and product formats with rapid change-overs in volumes and cutting in singles or multi-packs.
Marketing
The in-mould labeling facility provides the means to decorate the product and promote brand
identification, as well as displaying nutritional and other information. The paper also adds rigidity to the
side-wall of the cup, guaranteeing a reduction of 10 to 20% in the thickness of the plastic.
Hygiene
Thermoforming temperatures, in the range of 140 to 160°C, destroy much of any bacteria on the
packaging materials. A range of hygiene options enable an FFS machine to be built to suit our products
and environment.
General Technical Advantages
• Customer- and product-specific design in line with product and production requirements.
• Many cup designs are possible.
• Size configuration in keeping with the production capacity required.
• Flexible control concepts and integration with customer-specific systems.
• All common packaging materials can be processed.
Process Validation of pharmaceutical FFS Machines
1. Introduction
Form-Fill-Seal (F-F-S) technology is being used by pharmaceutical manufacturers, either to produce non-
sterile products or sterile products which are sterilized by filtration and not intended for further
sterilization, or to produce a very "clean" product for subsequent terminal sterilization.
Process Validation is defined as:
The action taken to demonstrate, and to provide documented evidence that a process will, with a high
degree of assurance, consistently achieve the desired and intended results.
Because of the relative complexity of the Form-Fill-Seal (F-F-S) machines used, what has been termed the
"prevalidation" or "Commissioning" phase (i.e. Installation Qualification and Equipment Qualification) is
of particular importance. These aspects are covered in this guide, and a brief outline of the basic operation
of the machines is given.
Installation Qualification, that is demonstrating and certifying that a piece of equipment is properly
installed, provided with all necessary services, subsidiary equipment and instruments, and is capable of
performing in accordance with its basic design parameters.
Operational Qualification consists of demonstrating that the equipment will perform consistently, and
within pre-defined limits, as specified and installed.
Validation has also been considered to have two aspects, or possible strategies - Prospective Validation
and Concurrent Validation.

Prospective Validation applies to new processes and new equipment, where studies are conducted and
evaluated, and the overall process/equipment system is confirmed as validated before the commencement
of routine production.
Concurrent Validation applies to existing processes and equipment. It consists of studies conducted
during normal routine production and can only be considered acceptable for processes which have a
manufacturing and test history indicating consistent quality production. Although lack of suitable records
relating to the Qualification phases may not necessarily compromise concurrent validation of some other
processes, evidence of proper machine installation is particularly important in the context of F-F-S.
Concluding Note on Validation Terminology.
While there is considerable variation in the understanding and use of the various terms discussed above,
there is general agreement that the critical validation concepts are the following:
1. The overall process is understood.
2. Equipment is appropriately specified and designed.
3. Equipment is properly installed and maintained and is demonstrably operating as specified and
designed.
4. The process is validated to ensure that it does achieve the desired and intended result.
2. Protocol Development and Control
Each stage of the evaluation of the effectiveness and reproducibility of an overall process should be based
on a pre-established and approved detailed written protocol, developed in accordance with the validation
approach. A written change control procedure should be established to prevent unauthorized change to the
protocol or process and restrict change during any phase of the studies until all relevant data are evaluated.
3. Personnel
Documented evidence of the relevant experience and training of all personnel involved in validation
studies should be maintained.Appropriately qualified personnel should ensure that the protocol and the
testing methodology are based on sound scientific and engineering principles and that all studies are
properly evaluated and certified.All personnel conducting tests and measurements should be trained and
experienced in the use of the equipment and measuring devices.
Engineering/mechanical personnel should be fully trained and competent in the operation and
maintenance of the F-F-S machines and any subsidiary equipment. They should also have basic training in
GMP requirements applicable to sterile production, such as gowning and manipulations.
4. Data Review and Study Certification
All information or data generated as a result of the study protocol should be evaluated by qualified
individuals against protocol criteria and judged as meeting or failing the requirements. Written evidence
supporting the evaluation and conclusions should be available.
5. Machine Design and Specification
Currently, F-F-S machine manufacturers produce machines with a range of modifications (or variations)
even within one specified model number. It is therefore essential that purchasers of these machines specify
their requirements precisely, and check that their specified requirements are met.
The original machine specification should include statements of requirements for the following:
(a) Materials of construction for all components, with special attention being paid to all contact parts, for
example;

1 Machine pipework.
2 Internal components of purchased fittings e.g. automatic valves, including elastomeric and mechanical
seals.
3 Pipeline joint seals.
4 Welding materials, particularly if any modifications to the manufacturer's specifications are required.
5 Filters and filter housings, including casing and substrate layers of cartridges, as well as the main
medium and all elastomeric seals.
6 Polymer extrusion equipment.
(b) Pipework configuration, with attention to sterile fluid pathways, for example;
1 Elimination of "deadlegs".
2 Position of thermocouples ("as installed" configuration, verified against the original design
configuration - to be confirmed by temperature mapping as part of validation protocol).
3 Design of filter housings.
(c) Porosity both of product and air filters. The validation data from the filter manufacturers should be
available.
(d) Design of moulds, considering fill volume range plus ullage, wall thickness, opening characteristics
and ease of use, as well as overall shape and other aesthetic considerations.
6. Equipment Qualification
6.1 Prior to the commencement of any Process Validation studies it is necessary to demonstrate and certify
that the F-F-S Machine and any supporting/subsidiary equipment, sub-systems and services are properly
installed and functioning in accordance with their basic design parameters.
6.2 For new equipment, qualification begins with the establishment of design, purchase and installation
requirements.
6.2.1 These requirements should be specified in writing and should include those matters relevant to the F-
F-S machine itself, in addition to design specifications for ancillary equipment, where relevant.
6.2.2 These design and installation requirements must be specific to the type and model of the equipment
required.
6.3 Installation Qualification of new equipment should be based on written procedures and the results
documented.
6.3.1 These written procedures should ensure that the pre-defined construction and installation
requirements are confirmed as being met, during the actual installation process.
6.3.2 All key installation parameters should be recorded, and certified as conforming to the pre-
determined requirements prior to operational qualification of the equipment.
6.4 For existing equipment, installation qualification may consist of defining existing equipment design
and installation parameters from records and from direct assessment.
6.4.1 This equipment should then be evaluated for its ability to meet the defined process specifications and
for the determination of any mechanical upgrading or procedural modifications needed to meet process
requirements.

6.4.2 Any modification should be documented as having been performed in accordance with
predetermined requirements, and certified as rendering the equipment suitable for Process Validation
Studies.
6.5 The Installation Qualification phase should be designed to ensure that the specified construction and
installation requirements are met, including correct provision of, and connection to, all services, power-
supplies, drainage systems and all ancillary equipment and instruments. In addition it should also cover all
basic functional checks, including:
6.5.1 Operation of all electric motors, pumps etc. (e.g. extruder drive motor, hydraulic vacuum pumps).
6.5.2 Operation of all automatic valves, switches etc.
6.5.3 Operation of automatic systems for each of the pre-defined stages of production. This includes all
computerized process control systems associated with the operation of the machine.
6.5.4 Operation of steam traps.
6.5.5 Operation of extruder heaters.
6.5.6 Operation and designation of thermocouples.
6.5.7 Setting and operation of alarm systems. (e.g. Air shower filter blockage, filter damaged switches).
6.5.8 Operation of hydraulic system. (e.g. Mould carriage, mould closing systems).
6.5.9 Positioning of main and head moulds (in relation to each other and to the platen).
6.5.10 Operation of the extruder including position of die and pin.
6.5.11 Fixing of timer settings for each stage of the process.
6.6 Operational Qualification consists of checking the equipment (as installed) over its defined operating
range in order to verify that it will perform consistently with the pre-determined limits.
6.6.1 Three or more test-runs should be performed in order to demonstrate through documented, certified
evidence that:
• operational parameters are maintained as pre-set for each test-run;
• all controls, alarms, indicators, and sensing, monitoring and recording devices function correctly;
• written procedures accurately reflect equipment operation.
6.6.2 Functions requiring attention in the specific context of F-F-S technology include:
• the equipment/pipe-line sterilization process (including steam supply temperature and pressure,
temperature mapping for "cold point" determinations; the overall profile of the sterilization cycle should
be monitored in order to minimize the use of excessive heating and/or time at elevated temperature to
bring the coldest part to the required temperature);
• fluid and air flows, including mould coolant temperature and flow-rate and air supply pressure for
each function;
• timer settings for each stage of the process;
• flushing and cleaning of all product and other fluid pathways (in respect of each product
manufactured);
• the filter drying process;

• extrusion of polymer and formation of product units to the required specification (e.g. appearance,
size, shape, wall thickness, fill volume, opening characteristics etc.; conformance to the specifications
should be assessed for each change in variable such as mould shape and size, type of polymer, product
formulation, product filter etc.);
• filter testing - to cover the testing of all filters, and to include the establishment of filter test
frequency for routine production.
6.7 Equipment must be certified as operationally qualified before any subsequent studies can be
considered valid.
7. Environmental Considerations & Maintenance
If F-F-S equipment is used for the manufacture of non-sterile products, then they should be installed in an
environment conforming to normal GMP requirements for non-sterile products, unless the nature/hazards
of the product requires special conditions or precautions. However, it is usually advisable to place the
machines in segregated air-conditioned areas, in view of the heat and particulate contamination which may
be generated.
Room Air Filter Test: Repeat at least annually, unless results of normal in-process monitoring indicate a
need for more frequent or additional testing.
Air Velocity: Repeat at least twice a year.
Air Particle Counts: Determine as part of regular in-process monitoring with formal certification by a
competent specialist agency twice a year.
Room pressure differentials should be monitored on a continuous, on-going basis.
Walls, floors and surfaces generally should be subject to a pre-determined program of cleaning and
disinfection.
Maintenance of FFS Machine subjected to process validation.
8. Routine In-process Control and Monitoring
All this in-process monitoring and control should be conducted in accordance with a written, pre-
determined program, which includes specified test limits and standards, and with all results formally
reported and evaluated against those limits.
9. Aseptic Process Validation - Media Fills
The usual, and generally acceptable, method of validating a sterile filtration and aseptic filling process is
the "Media Fill", - "Broth Fill", or "Process Simulation" technique, in which a liquid microbiological
nutrient growth medium is prepared and filled in a simulation of a normal filling operation. The nutrient
medium is processed and handled in a manner which precisely simulates the "normal" filling process, with
the same exposure to contamination-risk (from operators, environment, equipment and surfaces) as would
occur during routine manufacture. Sealed containers of the medium produced during the "media-fills" are
then incubated under prescribed conditions and examined for evidence of microbial growth, and thus of an
indication of the level of contamination in the units produced.

10. Incubation
Incubation of medium-filled units should take at least 14 days and may be at room temperature for 14 days
or may be at room temperature for the first 7 days, with the final 1 to 7 days at 30o
C to 35o
C. Alternate
suitable incubation schedules may be used as determined by the pharmacy to ensure enough growth of any
potential contaminating micro-organisms to be visually detectable.
11. Revalidation
Following initial aseptic process validation, media-fills should be repeated to an extent, and at a
frequency, which will depend on an occurrence of events or changes which may bear upon the potential
microbial hazard to the process and product. Significant modifications to equipment or facilities, changes
in personnel, undesirable trends in environmental monitoring results, and sterility test failures may all
indicate an immediate need to repeat a full process validation protocol (minimum of 3 consecutive
successful media-fill runs). During this time, the machine in question is taken out of service until any
problems have been resolved, and the results of the three media-fills have been evaluated and found
acceptable.
In the absence of any significant changes, or of any other events giving cause for concern, then a
minimum re-test frequency should be twice per year per machine, or where the machines are operated on a
continuous 24-hour operation basis, once per shift per year, that is, 3 times per year.
12. Documentation
A comprehensive outline of the protocol followed in the whole validation of the process should be
prepared. The overview should indicate the steps performed, in proper sequence, and should encompass:
a. the approach taken;
b. justification of the approach based on the product factors;
c. summation of any modifications to the equipment required; and
d. any modifications to the protocol resulting from the study.
Expert Evaluation
An evaluation of the entire study against the protocol requirements as outlined above should be prepared
and the conclusions drawn at each stage stated. The final conclusions should reflect whether the protocol
requirements were met.
The evaluation should include an assessment of the ability of the planned maintenance programs for the F-
F-S machine and ancillary equipment and instrumentation to maintain the validated conditions. In
addition, all process monitoring and control procedures required to routinely ensure that the validated
conditions are maintained should be reported.
The evaluation should be signed by duly authorized officers of the organization who were members of the
team establishing the protocol, and who have appropriate expertise in the area assigned to. Overall
approval of the study should be authorized by the head of the validation team and the head of the Quality
Control Department.

http://catalogs.indiamart.com/products/form-fill-seal-machines.html
Form Fill Seal Machines Displaying 1-50 of Total 474 Products Found
• Products
• Description
• Supplier Information
•
• Horizontal Form Fill Seal Machine For Soap (Finseal-11S)
We are one of the leading manufacturers of horizontal form fill seal machine, automatic form fill seal machine that offers a good mix of precision,
reliability and repeatability with low maintenance, FINSEAL 11 SOAP gives cost effective packaging solution. Built to the highest standards,
FINSEAL 11 SOAP maximizes process productivity for those companies seeking long term performance.
Horizontal Form Fill Seal Machine
Highlights
* Specially designed for wrapping toilet soap (Regular and guest size)
* Laundry soap and detergent bars
* Link up of machine to plodder/stampping machine possible
* Individual packs or chain packs
* Two or more soaps can also be inserted in one pack (depending on size)
* Autofeeder is an integral part of the machine
Principle of Operation
Soaps are placed on flat belt conveyor, either by link up conveyor (not more...
•
Khosla Machines Private Limited,
Mohali
Mohali
View Catalog

•
• Fully Automatic Vertical Form-Fill-Seal Machine for Packing Tablet (Model No. ARP-157)
Application:
The Machine operates on the principle filling of volumetric dish counting system. It is suitable for automatic packaging of medicine & food stuff
products such as Sugar Coat Tablet, Medicine Tablet, Chocolate Pill, Round Sugar Ball etc.
Sealing Type :
3 side sealing / 4 side sealing / centre sealing
Packing Size :
100mm - 280mm (film length)
200mm - 400mm (film width)
(Enlarged type can be made upon order)
Packing Range :
Depending on specific gravity of material to be packed
Speed :
20 - 22 pouches / min.
(Depending on flow rate & volume of the product)
Packing Material :
All heat sealable laminate PET/POLY, PET/FOIL/
POLY MET, PET/POLY/CPP/OPP etc. more...
• A. R. Enterprises (Alif Oven), Mumbai
Mumbai
About Us View
Catalog
•
• Automatic Card Packing Machine - Center Seal
Automatic Card Packing Machine - Center Seal more...
• Elegant Engineers, Noida
Noida
About Us View
Catalog
View Video
•

• Automatic Collar Type Form Fill Seal Machine With Auger Filler
Model No. BE/CF/500 (Auger Filler)
Application: Flour, Spices, Milk Powder, Cocoa, Coffee Powder, Besan, etc.
Packaging Range: 200 - 2Kg more...
• Budakoti Engineering Private Limited
Faridabad
About Us View
Catalog
•
• Form Fill Seal Machines
We offer quality range of single track form fill machines and form fill seal machines (FFS) which is manufactured using latest technology and is
used to fill the bags and pouches. In this machine, the bag length is adjusted by the photocell that traces the film mark. Our machines are
renowned for their compactness, simplicity in operation and low maintenance features.
The specifications of our machine are:
* Auger filler
* 3 side sealing
* Length of bag 40 mm. to 140 mm
* Film Size Width 40 mm. to 100 mm
* Packing Speed 40 bags/min
* Power Consumption Motor - HP, HP 220 V Single Phase
* Packing film laminated in roll
* Aluminum, PE, PP & BOPP combinations are used as supporting film
Besides the above said features, we also provide optional attachments which include:
* Mechanical and Electronic Data Code Imprinter
* Automatic Lubrication Pump
* Machine failure indicated by heater more...
• Harshika Industries
Thane
About Us View
Catalog

•
• Pick and Fill Sealing Machine
Intermediate Motion Rotary machine with 8 station
* Conveyor magazine for up to 2000 pouches
* Transfer to Grippers
* Pouch opening by filtered compressed air
* Pouch forming before filling
* 1st filling station to fill the product by valve and piston
* 2nd filling station to fill the product by valve and piston, if necessary
* Pouch stretching.
* 1st Sealing
* 2nd Sealing
* Cooler of seal imprint acting emboss coding same time
* Discharge Conveyor
Futures:
* Servo with P L C control with program storage
* Quick change over – bag , size change usually takes 10 min or less
* No pouch or failure of pouch opening – No fill
* Positive cutoff nozzles for no drip filling
Technical Specification:
Model P F S - 8 more...
• S. P. Automation & Packaging Machine
Coimbatore
About Us View
Catalog
•
• Servo / Electronic Auger Filler Machine
* Vertical Form Fill Seal Machine fitted with auger filler machine
* Micro Processor based Machine
* Electro-Pneumatically controlled
* Setting on HMI keypad
* Pillow (Centre) Sealed Pouches
* Positive Film unwinding
* Online Tracking
* Online Batch Coding & photo-mark position adjustment
* User Friendly Features
* No fill no pouch Logic
* Auto Diagnostic Mode

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