Blow fill-seal technology for parentral

1. Parenteral Plant Layout
BFS & FFS Technology
SUBJECT:- STERILE PRODUCTS FORMULATION & TECHNOLOGY
DEPARTMENT:- PHARMACEUTICS
M.PHARM (1ST SEM)
YEAR:- 2015-16
Presented By:
Mr. Pawara Dinesh C.
Roll No-6
supervised by
Mr. Jagdale Sachin K
MARATHWADA MITRA MANDAL COLLEGE OF PHARMACY
PUNE-33
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2.  Basic plant requirement
 Energy
 Water
 Air quality
 Waste disposal
 Non –technical factor
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3.  Type of production
 Batch operations:
 Continuous operations:
 Container size
 Environment control needs
 Product characteristics
 Space requirements
 Personnel Movement
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4. Function Area
Square meter percentage
Production 11,094 45.1
Warehouse 7,606 30.9
utility 1,716 4.1
Quality control 1,716 7.0
administration 1,018 4.1
Space requirements
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5. Filling Line
Filling Area
Weighing, Mixing,t Transfer
Clean Area
General production Area
Ware House
Exterior
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6
5
3
2
1
4
1st. Zones as per the cGMP:-
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6. S
T
O
C
K
R
O
O
M
COMPOUNDING
AREA
CLEAN UP
AREA
ASEPTIC
AREA
QUARANTINE
AREA
STERILIZATION
STORAGE
AND
TRANSPORT
PACKING
AND
LABELLING
LAY OUT OF PARENTERAL MANUFACTURING AREA
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7. 7

8. 8

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10.  The room should undergo 15-20 air changes per hour.
 A warning system should be provided to indicate failure in the air supply.
 Adjacent rooms of different grades should have a pressure differential of 10 - 15
Pascals.
 Counters in the clean room should be made of stainless steel or other non-porous,
easily cleaned material.
 Walls and floors should be free from cracks or crevices and have rounded corners. If
the walls or floors are to be painted, epoxy paint is used.
 Providing temp. & humidity controls appropriate to the product bein

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11. 11

12.  Blow-Fill-Seal (BFS) technique used to produce small, (0.1-
99mL) and large volume, (100mL +) liquid-filled containers.
 used to manufacture sterile pharmaceutical products as
parenteral (LVP & SVP), infusions, ophthalmic and inhalation
products.
 These are automated techniques to prepare sterile products.
 Europe in the 1930s, United States in the 1960s,
 Blow-fill-seal is a specialised packaging technology using in-
line forming and sealing a polymeric material to a container of
choice.
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13. 1. The basic concept of the FFS and BFS is to reduce the contamination by
forming the container, filling and sealing in a closed sterile chamber of the
machine.
2. There is no personnel intervention to reduce the chances of the
contamination during the manufacturing of sterile products.
3. It gives more production in very low operational cost with high assurance
of sterility
4. Thus this technology can be used to aseptically manufacture
sterile pharmaceutical liquid dosage forms.
5. BFS is used for the filling of vials for parenteral preparations
and infusions, eye drops, and inhalation products 13

14.  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 parenteral
 Blow fill seal technology is widely used and accepted by the
various pharmaceutical regulatory authorities as US-FDA and
MHRA.
 System is reported to achieve contamination rate below 0.1%.
 BFS and FFS techniques are more popular in United Kingdom
than United States.
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15.  The basic concept is formation, filling and sealing of plastic container in
aseptic environment. The BFS cycle can be divided into following main
steps:-
 Step 1: Parison extrusion
 Step 2: Container moulding
 Step 3: Container filling
 Step 4: Container sealing
 Step 5: Discharge of container
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16.  first of all polypropylene
granules (pharmaceutical
plastic resin ) are vertically
heat (at 200 ±30°C) through a
circular throat to form the tube
shaped known as parison.
Parison reaches to the mould
forming the container by the
pressure of sterile compressed
air.
Step 1: Parison
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17.  container moulding the extruded tube is
then enclosed within a two part mould
and then the tube is cut above the mould.
Moulding of container
 Blow molding (moulding) is a
manufacturing process by which hollow
plastic parts are formed.
• The blow molding process begins with melting down the plastic and forming
it into a parison or in the case of injection and injection stretch blow
moulding (ISB) a preform.
• The parison is a tube-like piece of plastic with a hole in one end through
which compressed air can pass.
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18.  The parison is then clamped into a mold and air is blown into
it.
 The air pressure then pushes the plastic out to match the
mold. Once the plastic has cooled and hardened the mold
opens up and the part is ejected.
 There are three main types of blow molding:
1. extrusion blow molding,
2. injection blow molding,
3. injection stretch blow molding.
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19.  In Extrusion Blow Moulding
(EBM), plastic is melted and
extruded into a hollow tube (a
parison).
 This parison is then captured by
closing it into a cooled metal
mold.
 Air is then blown into the
parison, inflating it into the
shape of the hollow bottle,
container, or part.
1. Extrusion blow molding
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20.  After the plastic has cooled sufficiently, the mold is opened and the part is
ejected.
 In Continuous Extrusion Blow Molding the parison is extruded continuously
and the individual parts are cut off by a suitable knife.
 EBM processes may be either continuous (constant extrusion of the parison) or
intermittent.
Types of EBM equipment may be categorized as follows:
1. Continuous extrusion equipment
2. Intermittent extrusion machinery
 Examples of container by EBM process include most polyethylene hollow
products, Milk bottles, shampoo bottles, watering cans and hollow industrial
parts such as drums. 20

21. Advantages :
 low tool and die cost;
 fast production rates;
 ability to mold complex part;
Disadvantages :-
 limited to hollow parts,
 To make wide neck jars spin trimming is necessary
2. Injection blow molding
 The process of injection blow molding (IBM) is used for the production of
hollow glass and plastic objects in large quantities.
 In the IBM process, the polymer is injection molded onto a core pin; then the core
pin is rotated to a blow molding station to be inflated and cooled
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22.  The process is divided into three steps:
 injection, blowing and ejection.
 The injection blow molding machine is based on an extruder barrel and screw
assembly which melts the polymer.
 The molten polymer is fed into a hot runner manifold where it is injected
through nozzles into a heated cavity and core pin.
 The cavity mold forms the external shape and is clamped around a core rod
which forms the internal shape of the preform.
 Advantages: It produces an injection moulded neck for accuracy.
 Disadvantages: only suits small capacity bottles as it is difficult to control the
base centre during blowing.
 No increase in barrier strength as the material is not biaxially stretched. Handles
can't be incorporated.
Injection blow molding cont…
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23.  This has two main different methods, namely
1) Single-stage 2)Two-stage process
Single-stage :
 Single-stage process is again broken down into 3-station and 4-station machines
 In the single-stage process both preform manufacture and bottle blowing are
performed in the same machine.
 The older 4-station method of injection, reheat, stretch blow and ejection is more
costly than the 3-station machine which eliminates the reheat stage and uses latent
heat in the preform, thus saving costs of energy to reheat and 25% reduction in
tooling.
 The process explained: Imagine the molecules are small round balls, when together
they have large air gaps and small surface contact, by first stretching the molecules
vertically then blowing to stretch
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24.  Advantages: Highly suitable for low volumes and short runs.
 Disadvantages: - Restrictions on bottle design.
Two-stage process:-
 In the two-stage injection stretch blow molding (ISB) process, the
plastic is first molded into a "preform" using the injection molding
process.
 These preforms are produced with the necks of the bottles,
including threads (the "finish") on one end. These preforms are
packaged, and fed later (after cooling) into a reheat stretch blow
molding machine. 24

25.  The preform is always stretched with a core rod as part of the
process.
Advantages:
 Very high volumes are produced.
 Little restriction on bottle design.
 Is suitable for cylindrical, rectangular or oval bottles.
Disadvantages:
 High capital cost.
 Floor space required is high, although compact systems are
available since a few years.
Two-stage process:-
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26. Step 4: Container Sealing
container sealing the mandrel is used to fill
the container with solution, following
filling, mandrels are removed and
secondary top mould seals the container.
Sealing of container
Step 3: Container filling
container filling the mould is transferred to
sterile filling zone where filling needles
called mandrels are lowered and used to
inflate the flat to form container within the
filling of container mold.
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27. Step5:- container discharge
container discharge filled and
sealed containers are then
conveyed to labelling and
packing sections.
Container discharge rommelag’s
BFS bottle-pack 321 machine.
Produces around 3000 bottles
(1000ml) in one hour with six
moulds
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28.  Produce sterile products.
 Reduced human intervention.
 The code numbers and variable data such as batch number and
expiry date can be embedded on to the container itself.
 Cleaning and sterilization of prefabricated containers and closures
is not required.
 No need to purchase and stock a range of prefabricated containers
and their closures.
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29.  Respiratory preparations,
 Oral solutions,
 Disinfectant liquids Different types of ointments and gels,
 Liquids for rectal or vaginal applications Packaging of certain
special food products such as soft drinks or milk products
Large volume Parenterals (normal saline, dextrose solution
etc) and small volume parenterals (eye drops, ear drops and
nasal drops).
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30.  www.slideshare.net/SudheerNunna/blowfill-technology
 www.pharmaguideline.com › Production › Sterile
 https://en.wikipedia.org/wiki/Blow_fill_seal
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