POLYMERS IN

PHARMACEAUTICAL
PACKAGING.
PRESENTED BY PRASHANT SONAWANE
TRAINEE ENGINEER PSDC - TS

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 CONTENTS-
INTRODUCTION

ROLE OF PACKAGING

PACKAGING MATERIAL

REQUIRMENTS

SELECTION OF PACKAGING

PLASTICS IN PACKAGING

EXAMPLES OF PLASTICS USED IN PACKAGING

TESTING & ANALYSIS OF PLASTICS

QUALITY CONTROL

SCOPE AND FUTURE

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 INTRODUCTION -
The plastic packaging system refers to the sum of packaging components that
together contain the pharmaceutical product, including closures.

This sum of packaging components includes primary & secondary components,

which are those components that directly contact the pharmaceutical product at
some time during the product's manufacturing, distribution, storage, or use.

Plastic packaging systems for pharmaceutical use include bags, bottles, cartridges,
dry powder and metered-dose inhalers, nebulizers, refillable syringes, vials, and bottles
as packaging systems for capsules and tablets.

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 ROLE OF PACKAGING -
PROTECTION Containment The containment of the product is the most
fundamental function of packaging for medicinal products

IDENTIFICATION - Identification of the medicine including strength.

INFORMATION - Safe preparation of the medicine if required e.g. dilution

Storage and shelf-life of in-use product.
Appropriate disposal of unused medicine and the packaging.

COMPATIBILITY - Compatible for handling drugs.

PRESENTATION - Spoons, cups or syringes for oral dose measurement & delivery

CONVENIENCE - For transportation and handling Should be safe with Children

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 PACKAGING MATERIAL -
Different types of materials used in pharmaceuticals packaging include,

> GLASS > METALS

> PLASTICS > PAPER & BOARD
> ELASTOMERS > COTTONS

GLASS Glass is one of the old and cheapest materials used for the packing of
various types of pharmaceutical formulations, especially for the parenteral formulations
Glass is composed of sand, soda ash, lime stone, cullet, Silicon, aluminum, born, sodium,
potassium, calcium, magnesium, zinc and barium.
TYPES - Neutral or Borosilicate glass
Treated soda lime glass
Regular soda lime glass
General purpose soda lime glass

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 METALS Metals are commonly used for
sealing of vials used for ear drops. Generally used
metals are aluminum, tin plated steel, stainless steel,
tin and lead. The collapsible metal tube, used for
pharmaceutical ointments and creams,

PAPERS - Kraft paper used as outer facing far corrugated, spirally wound kegs and
fiberboard drums.
Uncoated paper usually from highly-grade chemical pulp source , used in
the calipers far small labels and leaflets.
White wood-free paper for laminates is usually one-side coated paper
which is used to make the outside coated surface less permeable.
Vegetable parchment paper is the most water-resistant paper of all. It is
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 COTTON Cotton is used to ensure product stability and prevent product
degradation during shipping.
Cotton is a natural fiber bleached and absorbent that
creates a dry environment inside the package.
Cotton is used in packages containing various types
of tablets and capsules. Its moisture content is NMT 8.0%.

ELASTOMERS Elastomers are used to seal the

openings of cartridge, vials and bottles. Providing
material soft and elastic enough to permit entry and
withdraw of a hypodermic needle without the loss of
indignity of sealed containers.

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 REQUIRMENTS FOR PACKAGING MATERIAL
-
Packaging systems for pharmaceutical use must be suitable for their intended use.
The packaging system should adequately protect, be compatible with, and be
composed of materials that are safe for use with the pharmaceutical product.

From a chemical perspective, a plastic packaging system used in pharmaceutical

applications should be such that the ingredients of the pharmaceutical product are not
adsorbed on the surface of the packaging system, are not absorbed into the body of
the packaging system, and do not migrate through the packaging system.

The packaging system should not release substances that accumulate in the
pharmaceutical product in quantities sufficient to affect its stability.

The packaging system should be adaptable to employed high speed of packaging

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equipment.
SELECTION OF PACKEGING -
Target Patient Population Dosing regimen
Route of administration
Need for dosing device
Nature of disease

Product Stability Barrier requirements

product compatibility

Commercial Market requirements/trends

Dosing patient compliance
Security evidence
Manufacturing issues
Economics, Cost of Goods

Regulatory considerations Global & Local

Presentation Dosage form preferences, E.g. Local pack preferences: e.g. for
oral solid dose bottles vs. blister packs

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RANGE OF PHARMA PRODUCTS -
Pharmaceuticals can be classified in many ways i.e. either by the therapeutically action
or by the mode of administration or sources from which they are derived.

Classification is the one according to dosage forms. On this basis, pharmaceuticals can
be classified into the following major groups:

Solid dosage forms - tablets, granules, capsules and powder.

Liquid oral forms - syrups, suspensions, elixirs, dry syrups and oral drops.
Oral hygiene products - mouth wash, mouth gel, mouth paint.
Semi solid forms - creams, gel, lotion etc.
Parenterals - eye, ear, nose drops, injectables, intravenous solutions
and transfusion solutions e.g. External sprays and
inhalers
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 PLASTIC IN PHARMA PACKAGING
- In the pharmaceutical industry, following are the most common types of plastic based
packages currently used for marketing the different product forms.

TAMPER RESISTANT PACKAGINGS -

A tamper resistant package is provided with an indicator or barrier before entering
the package, so that if this indicator or barrier is broken, the buyer immediately gets
the evidence that the product has been opened or tampered. Especially over the
counter products require tamper resistant packaging. The following packages are
approved by FDA as tamper resistant packaging systems:
> Film wrappers > Blister package
> Strip package > Bubble pack
> Shrink seals > Plastic pouches
> Aerosol containers > Sealed cartons.

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 BLISTER PACKING
Three different forms of blister packs are used for packaging tablets and capsules.
Thermoformed blisters.
Cold formed blisters.
Tropical blisters
The thickness of Al foil ranges from 0.020 mm
to 0.35mm, whereas the PVC film used is of
thickness range of 200 micron to 300 micron.

The PVDC coating may also be replaced by Surlyn.

Polyvinylchloride, PVC / polyethylene combinations, For moisture protection PVC may
be laminated with polyvinylidene chloride or PTFE films. Under extremely humid
condition coated PVC is preferred.

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 STRIP PACKAGING -
A strip package is a form of unit dose packaging that is commonly used for package
is formed by feeding two webs of a heat-sealable flexible film through either a
heated crimping roller or a heated reciprocating plates. The product is dropped
into the pocket formed prior to forming the final set of seals. The strip packets are
cut to the desired number of packets in length. The product usually has a seal
around each tablet.
Aluminum foil/LDPE.
Aluminum foil/HSL.
Glassine/LDPE
The aluminum foil used is 0.03mm or 0.04mm
thick and the LDPE is generally of 37.5 micron.
The LDPE film may be at times replaced with LLDPE. Most often the heat seal
lacquer used Ethyl Vinyl Acetate Ethylene Acrylic Acid.
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 AEROSOL CONTAINER

The aerosol container is a metered dose . A hydrocarbon propellant in its cooled

liquid phase is added to the container along with the product, and a spray nozzle
contained in a gasket metal ferrule is crimped over the opening of the aerosol
container.
A length of polyethylene tube, called a dip-tube,
is attached to the inside of the spray nozzle
and dips into the product, drawing product into
the spray nozzle when the sprayer is activated.

The spray nozzles are usually metered to allow

a specific dose to be dispersed with each spray.

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PLASTIC SQUZEED TUBE

For packaging of ointments and creams which are a semi-solid form, plastic collapsible
tubes, are used. Printed plastic collapsible tubes of multi layered structure are used.

Aluminum foil laminated barrier layer tubes of 280

total thickness (PE layer/12 Al. foil layer /PE).
Aluminum foil laminated barrier layer tube of 180
total thickness (PE layer/20 Al. foil layer /PE).

The shoulder material of the tubes is generally HDPE with special barrier compound.
The mouth opening can also be nozzle type with nozzle shaped closure. The orifice
may also be closed by induction seal with aluminum foil.

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 AMPOULES & VIALS -

Powder and liquid injectables are packed in ampoules, vials, cartridges and prefilled
syringes.
Plastic Ampoules - Blow-fill-seal form-fillseal plastic ampoules generally made from PP
or LLDPE as clear are used. These are available in capacities of 1 ml
to 25 ml

Plastic Vials - Blow-fill-seal/form-fill-seal plastic vials generally made from PP or

LLDPE are used. These are generally used for packing sterile water
for injectables.

Insulin Pen - An insulin pen is an insulin delivery device which just looks like an
ordinary pen, It uses insulin cartridge and disposable needles. They
are available as single dose or multiple dose.
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 PACKAGING WITH SPECIAL FEATURES -

Some of the special features in plastic packages are highlighted below:

Innovative In-built Desiccant Container

For highly moisture sensitive products, inbuilt desiccant
is provided in the plastic cap of a plastic container.

Unique Shaped Blister Pack

PVC-Al Foil blister packs have a unique shape
PVC Al foil blister is used for packing of capsules.

Holographic Labels/Seals -
Holographic labels/seals are used as tamper evident devices in package.

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 PLASTIC
CONTAINER -
CONTAINERS -

The container is the device that holds the drug. The immediate container is that which
is in direct contact with the drug at all times.

Air tight container -

Air tight containers are used to protect the

container from atmospheric contamination

of liquids, solids or vapors.

They prevent loss of drugs due to

efflorescence, deliquescence or evaporation or oxidation.

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 Hermetically sealed containers -

Hermetically sealed containers is that which

does not allow the air and other gases to pass

through it.

Light resistant containers -

They are used to protect the drugs which undergo

decomposition in the presence of light. Such drugs

may be enclosed in amber colored bottle or opaque container.

Well closed container

A well closed container is used to protect the preparation from contamination,

by extraneous solids, to prevent the loss of contents during transport, storage and handling.
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 CLOSURE AND CLOSURE LINERS -
A closure is that part of a package which prevent the contents from escaping and allow
no substance to enter the container. Closures are available in five basic designs:

> Screw-on, threaded > lug caps

> Crimp-on > Pilfer-proof closures
> Press-on snap > Non-reusable Roll-on Closures
> Roll-on > Friction

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 Pilfer-proof closures:

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snap
 TEST METHODE -
PHYSICAL PROPERTIES -
Protection from impact - ASTM D 5276
ASTM D 3060
ASTM D 3071
Protection from vibration - ASTM D 4278
ASTM D 4169
ASTM D 2497

Protection from temp. & humidity extreme - ASTM D 4322

Utility test for stacking and pressure - ASTM D 642, ASTM D 6653
Peel test of sealed area - ASTM F 1929, ASTM F 2096
ASTM F 2054

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TEST FOR FILMS
Burst strength per 0.001 inch - ASTM D 882, 774
Tear strength - ASTM D 1004
Folding endurance - ASTM D 2176
Oxygen permeability - ASTM D 543
Resistance to acid alkali - ASTM D 1434, DIN3380, BS 2782

TEST FOR CONTAINER

Screw neck finish - BS 5789
Collapsible tube - BS 2006
Printing inks resistance - BS 432

CHEMICAL TESTS -
Permeation, Leaching, Sorption, Chemical reaction, and alteration in the Physical
properties of plastics or products.
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 PACKAGING PRACTICE
REPACKAGING A SINGLE SOLID ORAL DRUG PRODUCT INTO A UNIT-DOSE

Blister packages offer a wide array of designs both in functionality and in appearance.
Various packaging materials are used to create blisters that are tailored to provide
optimum performance.

The blister container consists of two components:

the blister, which is the formed cavity that holds the

product, and the lid stock, which is the material that

seals to the blister.

The choice of lid stock depends on how the blister is to be used, but generally the lid
stock is made of aluminum foil. The material used to form the cavity is typically a
plastic, which can be designed to protect the dosage form from moisture
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 PHARMA WASTE DISPOSIBLE
SYSTEM -
Waste disposable polices

Recycling packaging - The use of environmental friendly packaging needs to be

considered, i.e. recyclable or degradable packaging.Valuable packaging materials,

Incineration - Eliminating and incinerating packaging. Some plastic materials

cannot be recycled and are therefore incinerated. The burning of polyvinyl
chloride is controversial since, if combustion is not complete, it causes a
potential increase in the levels of dioxin in the environment. Incineration can be
recommended if the combustion heat produced by it can also be used for other
purposes.

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 REFFERENCES -

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 STORED
PLUTO > PSDC > TEAM > PRASHANT > PACKAGIND.
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