PROCESSING OF CONTAINERS A. Glass container List of inorganic compounds used to impart color in glass Manufacturing Process of glass B. Plastics container Classification of plastics Manufacturing process of plastic container- Additives of plastics B. Metal 2. CLOSURES Materials used for closures Types of closures 3. CHILD RESISTANT PACKING 4. TAMPER EVIDENT PACKING *List of inorganic compounds used to impart color in glass *Manufacturing process of plastic container- Injection molding Extrusion Composite film manufacturing Blow molding Solvent casting Compression molding In 1992 FDA approves the following configurations as tamper evident packaging:- 1.Film wrappers 11. Metal/cans 2.Blister package 3.Strip package 4.Bubble pack 5.Shrink seals and bands 6.Foil, paper, plastic pouches 7.Bottle seals 8.Tape seals 9.Breakable caps 10.Aerosol containers

1. PROCESSING
CLOSURES
CHILD RESISTANT PACKING
TAMPER EVIDENT PACKING
PRESENTED BY-
Homendra Kumar Sahu
M. Pharm. 2nd Sem.
RCPSR BHILAI

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CONTENTS
1. PROCESSING OF CONTAINERS
A. Glass container
I. List of inorganic compounds used to impart color in glass
II. Manufacturing Process of glass
B. Plastics container
I. Classification of plastics
II. Manufacturing process of plastic container-
III. Additives of plastics
B. Metal
2. CLOSURES
I. Materials used for closures
II. Types of closures
3. CHILD RESISTANT PACKING
4. TAMPER EVIDENT PACKING

3. 1. PROCESSING OF CONTAINERS
A. Glass container :-
Generally Produced by mixture of sand (silica), Soda ash(Sodium
carbonate ), Lime soda(Calcium carbonate), Cullet(Broken glass)
Type Composition Use
a. Type 1 (Borosilicate) Silica (SiO2) 65-85%
Boric oxide (B2O3) 8-15%
Soda ash (NaO2) 3-9%
Alumina (AlO3) 1-5%
Calcium oxide (CaO) 0-
2.5%
• Packaging of strong
alkaline or acidic drug,
• Laboratory glass
apparatus.
• For injections and
• For water for injection.
3

4. 4

5. Type Composition Use
b. Type 2 (Treated soda
lime glass)
Silica (SiO2) 63-81%
Boric oxide (B2O3) 0-3%
Soda ash (NaO2) 9-12%
Alumina (AlO3) 0-2%
(CaO) 7-14%
(MgO2) 0-6%
(MnO2) 0.02%
(Cr2O3) 0.0.2%
(TiO3) 0.0.8%
(Se) 0.0.1%
• Used for alkali sensitive
products
• Infusion fluids, blood &
plasma.
• large volume container
5
• Sulfur di oxide treatment neutralizes the alkaline oxides on
the surface, thereby rendering the glass more chemically
resistant.
• The surface of the glass is fairly resistant to attack by water
for a period of time.

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7. Type Composition Uses
c. Type 3 (Regular soda
lime)
Silica (SiO2) 63-81%
Soda ash (NaO2) 9-15%
Alumina (AlO3) 0-2%
CaO) 7-14%
Boric oxide (B2O3) 0-3%
K2O 0-1.5%
• For all solid dosage
forms (e.g. tablets,
powders)
• For oily injections
• Not to be used for
aqueous injection
• Not to be used for
alkali-sensitive drugs.
• Freeze dried product
are stored
7
• The container made up of type3 glass have low
alkali content and high hydrolytic resistance.
• These can resist sudden change of
temperature.

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9. Type Composition Use
d. Type NP
Non-parenteral glass or
General purpose soda-
lime glass.
Sand, soda lime, soda ash,
cullet, color compound
Packaging of non
parenteral preparation
Generally used to pack
tablet, capsule , topical
products
9

10. I. List of inorganic compounds used to impart color in
glass
10
Compounds Color produced
Iron oxide
Manganese oxide
Cobalt oxide
Gold chloride
Selenium compound
Carbon oxide
Antimony oxide
Uranium compound
Sulfur compound
Lead with Antimony
Greens, Browns
Deep amber
Deep blue
Ruby red
Reds
Amber brown
White
Yellow green
Amber/brown
Yellow

11. ii. Manufacturing Process of glass
11
Primarily there are four process involved in
manufacturing of glass container-
1. Blowing:- In the blowing process compressed air is
used to make the molten glass in the cavity of a
mold of metal. Eg. Bottles and jars

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2. Drawing:- In drawing process the molten glass is
drawn through dies or roller to give shape to the soft
glass. Eg. Rods, tubes, sheet glass, ampoules and vial.
Advantage:- Thinner tubing, more uniform wall thickness,
Less distortion than blow moulded containers.

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3. Pressing:- The molten glass is pressed in
the process of pressing by a mechanical
force the side of mould.
4. Casting:- The molten glass is casted in
the cavity of mould using gravitational
and centrifugal force.

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B. Plastics container
Group of substances of natural/synthetic origin, mainly
polymers of high melting point, molded into shape or
designed as per requirement by application of heat &
pressure.
Plastics- formed when monomers undergo
polymerization.

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i. Plastics may be
1. Amorphous 2. Crystalline
Good clarity Opaque or translucent
Transparency Flexible
Hardness Less permeable
Less inert More inert
More permeable
ii. Classification of plastics
Depending on re-moldibility
1) Thermoplastic:- Normally rigid at operating temp. , but can
be remolded and reprocessed. E.g.,
• Polyethylene
• Polyvinylchloride

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• Polyvinylacetate
• Polystyrene
• Polypropylene
• Ionomer
• Dupont
• Polyurethane
• Polycarbonate
2. Thermosetting:- When subjected to heat , become
infusible or insoluble, and can’t be re-melted. E.g.,
• Melamineformaldehyde
• Phenol-formaldehyde
• Urea-formaldehyde

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iii.Manufacturing process of plastic
container-
a) Injection molding
b) Extrusion
c) Composite film manufacturing
d) Blow molding
e) Solvent casting
f) Compression molding

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a. Injection Molding
• Plastic is heated and melted
• Forced into cavity at high pressure
• Allow to cool in cavity
• Solidifies
• Mold opened
• Product removed
b. Extrusion
• Plastic heated and melted
• Forced under pressure through die
• Resulting in desired shape
• Extruded profile is cooled to solid using water or chilled
roll for film materials

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c. Composite film manufacturing
• Formed by coating, lamination & coextrusion
• Coating- applied to film as dispersion/soln /molten materials
• Lamination-preformed dissimilar films are joined together with
heat or adhesive
• Co-extrusion-Films are prepared
d. Blow molding
• Plastic is melted
• Formed in hollow cylinder(parison)
• Pinched off bottom of parison
• Air is blown into parison
• Lead to expanding of viscous plastic to walls of cavity
• Cooled and removed

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e. Solvent casting
• Liquid suspension of plastic prepared
• Deposited on endless belt
• Belt is passed through a heating chamber
• Dried film is stripped off, cooled
• Wound onto reels
f. Compress molding
• Thermosetting plastics are placed into mold
• Heated, melted and flowed to fill the cavity
• Mold is held under pressure until material cures
• Mold is open and product is removed

21. iv. ADDITIVES OF PLASTICS
It is usual to add other substances for improved
stability, or in-use performance.
a. Stabilizer: Side reactions during polymerization may
produce a proportion of unsaturated potentially
unstable compounds. so stabilizers are used to stop
those side reactions. e.g. octyl tin to stabilize PVC.
b. Antioxidants Plastics are vulnerable to oxidation. The
antioxidants binds with the free radicals and stops
the oxidation reaction. e.g. N,N’-di-b-napthyl-p-
phenylenediamine for stabilizing plastics and
rubbers.
21

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c. Pigments:- These are used for decorative purpose. They
may absorb electro-magnetic radiation in UV region and
thereby reducing photodegradation. For clear plastics
organic absorbers such as 4-biphenyl salicylate are used.
d. Fillers:- are often employed to make the product cheap
but in some cases may be essential for correct product
performance. e.g. Bakelite, a phenol-formaldehyde
resin, is brown brittle material, quite unsuitable for the
manufacture of screw caps unless mixed with a filler
such as wood flour. Examples of fillers: whiting, asbestos
and mica.

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e. Plasticizers:- are used to reduce Tg of a polymer. They
do it by directly reducing the attractive forces
between polymer chains.
f. Other agents: Cross-linked agents, curing agents,
activators and accelerators etc.

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v. Sterilization of plastics
Autoclaving(moist heat) 121oC for 15 min
1150C for 30 min
High density polyethylene
Polypropylene
Polycarbonate
Polytetraethylene
Teflon
Dry heat 160-1800C for 1-3 hr Tefzel
Teflon
tertrafluoroethylene
Gaseous sterlization 100%ethylene oxide under
negative pressure/10-15%
ethylene oxide with an
inert gas/formaldehyde
High density polyethylene
Polypropylene
Polycarbonate
Ethyle tetra fluoroethylene
Polyvinyle chloride
Polystrene

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C. Metal
a. Tin
• The popular name or term for the package “tin can”
and the use of the term “tinfoil” are both misnomers.
The material used to produce a can is properly called
tinplate and is a composite structure of steel and tin.
i. Manufacturing of tin container
• Steel is rolled into a thin sheet and then electrolytically
coated with tin.
• Originally, the steel was dipped in molten tin.

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• The layer of tin deposited on the surface of the steel
by electrolytic coating is extremely thin and
measures approximately 1/1000-in thick on each
side of a sheet or coil of can-producing metal.
• acrylic, polyester, vinyl, alkyd, and others, are used
to produce coatings for metal cans.

27. b. Aluminium
Aluminium are (capable of withstanding internal
pressure in aerosol containers), Shatterproof
Impermeable to gases, Light barrier (opaque,
this is both advantageous and disadvantageous)
Lightweight (due to the strength of the material
in thin cross sections).
27

28. i. Manufacturing Process of aluminum container:-
• Aluminum is produced by electrolysis to reduce
bauxite ore, which contains a high concentration of
aluminum in its oxide form, to the primary metal.
The ore undergoing electrolysis and reduction is in
its molten state.
• The material, rolled to a very thin cross section
(metal thickness), must undergo a secondary heat
treatment called “annealing” to adjust its hardness
properties for fabrication.
28

29. • Aluminum, alloyed and annealed to a softer more
ductile state and then rolled to extremely thin
thicknesses (e.g., 0.0002 in) is used as one layer in a
laminated material.
• Aluminum rolled into thin foils is a defect called
“pinholing” that appears as extremely small holes
invisible to the eye in what appears to be a solid sheet
of metal. When the metal is rolled and stretched into
extremely thin foils, the oxides and other impurities in
the metal move to the surface and tear, creating these
extremely small pinholes that are difficult, if not
impossible, to identify by visual inspection.
29

30. 2. CLOSURES:-
Closures are the devices by means of which containers can
be opened or closed. Proper closing of container is
necessary because:
 It prevents loss of material by spilling or volatilization
 Avoids contamination of product from dirt, micro-
organisms or insect
 Prevent deterioration of product from the effect of the
environment such as moisture, oxygen or carbon
dioxide.
30

31. i. Materials used for closures:-
The closures meant for storage of pharmaceutical product
generally made from:
A. Cork
B. Glass
C. Plastic
D. Metal
E. Rubber
31

32. ii. TYPES OF CLOSURES:-
A. Once only closure:-
• Fusion of glass to seal ampoule
B. Closure is found in five basic design:-
a. Screw on, Threaded screw cap:-
• Closure is threaded which matches with the
corresponding threads moulded on neck of the
bottle.
• Thread engagement is normally checked by
applying on the container at the recommended
torque.
32

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b. Lug cap: The lug cap is similar to the thread screw
cap and operates on the same principle but it is an
interrupted thread on the glass finish, instead of a
continuous thread.

34. c. Crown cap: This style of cap is commonly used
as crimped closure for beverage bottle and has
remained unchanged for more than 50 years.
34

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d. Roll-on- Aluminum roll on cap can be seal securely,
opened easily and resealed effectively. Resealable, non
resalable and pilfer proof types of roll on closures are
available for use on glass or plastic bottles.

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e. Pilfer proof closures:-
•It is similar to roll on closure but has a greater skirt length.
•This additional length extends below the threaded portion and
fastened to the basic cap by the series of narrow bridges.
•When the closure is removed the extra portion remains in the
space on neck of the container, this indicates that the package
has been opened.

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f. SNAP FIT CLOSURES
• Snap is any clasp or fastener that closes with a click.
• When the closure is in place, some resilient part of the
closure system that is in contact with the container
remains deformed, & provides a seal as it attempts to
return to its original dimensions.
• For opening, the top is designed to pry off or break off,
or have a built in dispenser.

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h. PRESS-ON VACUUM CAPS
Vacuum caps are a unique style of closure used to
protect oxygen-sensitive products.
• In pharmaceutical applications they are found on
metal containers for powdered infant formula.
• A vacuum is applied to a container, creating a partial
vacuum in the container headspace below the
closure.

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i. Rubber closure:
Rubber is used mainly for the construction of closure meant for
vials, transfusion fluid bottles, dropping bottles and as washers in
many other types of product.
a. Butyl rubber:- Vial sttoper
Advantages:
•Permeability to water vapor .
•Water absorption is very low.
•They are relatively cheaper compared to other synthetic rubbers.
Disadvantages:
 Slow decomposition takes place above 1300C.
 Oil and solvent resistance is not very good.

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 NITRILE RUBBER:
Advantages:
•Oil resistant due to polar nitrile
group.
•Heat resistant.
Disadvantages:
•Absorption of bactericide and leaching of extractives are
considerable.
b. Chloroprene rubbers:
Advantages:
•Oil resistant.
•heat stability is good.

41. 3. Child resistant packaging
41
Packaging that is difficult for a child to open
within a reasonable period but that presents no
difficulty for an adult to use properly with
flexible packages with hidden tears starts, push
blister pack.
DESIGN:- A child resistant package is usually
made of a difficult to open material or a trick is
needed to open the package. Eg. Press and turn
closure.

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The ISO [8317 (2003-4)] has published two standard test procedure
for child resistant packaging. One test with up to 200 infants aged
with 42 to 51 month. And second is 50 to 70 aged group.
TEST WITH INFANTS 42-51 MONTH :-
The children have to try and open in five minutes time in which ever
way they can think of. After five minutes they are shown how to
open the package once and without any further comment. Then
children try for another five minutes to open the package.
the package is to be regarded as child resistant if not more than 15
% of the children can manage to open the package within the first
five minutes. Considering the whole testing period of ten min. not
more than 20% of the child must be able to open the packaging

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Example of child resistant packing:-
Hidden tears starts indicator
Blister pack
Squeeze first & turn
Push & turn
Lug cap
Snap cap

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4. TAMPER EVIDENT PACKING:-
Tampering include three aspects, namely altering, pilfering, and
falsifying the pharmaceutical product. Manufacturer try to create
safe packing and govt. Continue to update regulations to include
new tamper evident technology. In 1975 USFDA issued a regulatory
requirement for tamper evident to be used for ophthalmic
preparations. Thus ensuring that such preparation remain sterile
until their use.
This regulation specified that the closure must be sealed in such a
manner that the content cannot be used without destroying the
seal.
In 1982 a further regulation on tamper evident packaging for OTC
human drug products described such packaging as “having indicator
or barrier to entry which, can provide visible evidence to consumers
that tampering has occurred”.

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In 1992 FDA approves the following configurations as tamper
evident packaging:-
1.Film wrappers 11. Metal/cans
2.Blister package
3.Strip package
4.Bubble pack
5.Shrink seals and bands
6.Foil, paper, plastic pouches
7.Bottle seals
8.Tape seals
9.Breakable caps
10.Aerosol containers

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1. Film wrapper
Film wrapping has been used extensively over the years for
products requiring package integrity or environmental protection.
It is categorizes into following types:
I. End folded wrapper:-
• The end folded wrapper is formed by passing the product into a
sheet of over wrapping film, which forms the film around the
product and folds the edges in a gift wrap fashion.
• The folded areas are sealed by pressing against a heated bar.
• The materials commonly used for this purpose are cellophane
and polypropylene.

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ii. Fin seal wrapper:-
• The seals are formed by crimping the film together and sealing
together the two inside surfaces of the film, producing a fin
seal.
• Fin sealing is superior than end folded wrapper
• With good seal integrity the over wrap can removed or opened
by tearing the wrapper.

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iii . Shrink wrapper:-
The shrink wrap concept involves the packaging of the product
in a thermoplastic film that has been stretched and oriented
During its manufacture.
• The major advantage of this type of wrapper are the
flexibility and low cost of packaging equipment

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2. Blister package:-
•It is a packaging configuration capable of providing excellent
environmental protection, coupled with an esthetically pleasing
an efficacious appearance .it also provides user functionality in
terms of convenience, child resistance, and now temper
resistance.

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3. Strip package
• A strip package is a form of unit dose packaging of tablet or
capsules. A strip package is formed by feeding two webs of heat
sealable flexible film through either a heated crimping roller or
a heated reciprocating platen. The product is dropped into the
pocket formed prior to forming the final set of seals. Since the
sealing is usually accomplished between pressure rollers, a high
degree of seal integrity is possible.

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4. Bubble packs
•The bubble pack can be made in several ways but is usually
formed by sandwiching the product between a thermoformable,
extensible, or heat-shrinkable plastic film and a rigid backing
material, this is passed through a heated tunnel, which shrinks the
film into bubble or skin over the product, firmly attaching it to the
backing card.
•The backing material cannot be readily separated from the bubble
or easily replaced without leaving evidence of tampering

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5. Heat shrink bands or wrappers
• The shrink band concept makes use of the heat-shrinking
characteristic of a stretch oriented polymer usually PVC. The
polymer is manufactured as an extruded, oriented tube in a
diameter slightly larger than the cap and neck ring of the bottle to
be sealed. Bands or wrappers with a distinctive design (e.g., a
pattern, name, registered trade mark, logo, or picture) are shrunk
by heat to seal the union of the cap and container. The seal must
be cut or torn to remove the product.
•Use of a perforated tear strip can enhance tamper evidence.

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6. Foil, paper, or plastic pouches
•The flexible pouch is packaging concept capable of providing not
only a package that is tamper resistant, but also, by the proper
selection of material, a package with a high degree of
environmental protection. A flexible pouch is usually formed
during the product filling operation by either vertical or horizontal
forming, filling, sealing (f/f/s) equipment.
•The product is enclosed in an individual pouch that must be torn
or broken to obtain the product. The pouch should have a
distinctive design (e.g., a pattern, name, registered trademark,
logo, or picture).

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7. Bottle mouth inner seals
•A bottle may be made tamper-resistant by bonding an inner seal to the rim of
the bottle in such a way that access to the product can only be attained by
irreparable destroying the seal.
Various inner seal compositions may be used like:
• Glassine and foil laminations.
• Glue mounted.
• Pressure sensitive adhesive.
• Heat sensitive adhesive.
•Paper, thermal plastic, polystyrene foam (except those applied with pressure
sensitive adhesive), plastic film, foil, or combinations there of, with a distinctive
design (e.g., a pattern, name, registered trademark, logo or picture) is sealed to
the mouth of a container under the cap.

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8. Tape seals
•Tape involves the application of a glued or pressure sensitive tape
or label around or over the closure of the package, which must be
destroyed to gain access to the packaged product. The paper used
most often is high density lightweight papers with poor tear
strength.
•Paper or foil with a distinctive design is sealed over all carton flaps
or a bottle cap.

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9. Breakable caps
Breakable closures come in many different designs. The roll on cap
design used in the past for carbonated beverages uses an
aluminum sheet, which placed over bottle neck during capping
operation. The cap blank is held on the bottle under pressure
while rollers crimp and contour the bottle tread into the cap blank.
The bottom portion of cap is rolled around and under the locking
ring on the bottle neck finish. This lower portion of the cap blank is
usually perforated so that it breaks away when the cap is
unscrewed, which serves as visible sign of prior opening.

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10. Ratchet-style plastic cap
A ratchet-style plastic cap is also commonly used for a number of
different products. In this design the bottom portion of closure
has a tear-away strip, which engages a ratchet on the bottle
neck. To remove the closure, the bottom portion of the closure
must be torn away to disengage the ratchet and allow the
removal of the cap.

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11. Metal Can

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Cork closure

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Questions
1. What is tamper evident packing? Write a detail account on types
of container and closure used in pharmaceutical industry.
2. Describe the various material for container and closure of
packaging. Explain tamper evident type packaging. What are the
safety requirement and packaging.
3. Discuss in detail about tamper evident and child resistant
packaging.

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