PACKAGING

TECHNOLOGY
HUDAN TAUFIQ
FARMASI-FK UNISSULA
PACKAGING

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 INTRODUCTION
The container must:
Maintain the quality, safety and stability of the medicine.

Protect the product against:

physical damage,
chemical and microbial contamination,
light, moisture and oxygen as appropriate

Be user friendly, easy to open and reclose.

Other factors such as cost and the need for both child
resistant closures and tamper –evident seals.
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Each container is labeled with the :
Identity and quantity of the medicine.
Batch no.
Appropriate storage instructions.
Product expiry date
Requirements for handling and storage.

Limitation of repackaging: e.g.

glyceryl trinitrate tablets…… volatile drug.
Sterile products; not always possible.

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 PRIMARY AND SECONDARY PACKAGING
1. Primary packaging: Which are in direct contact with the
product (bottle, closure, blister…..).

Primary containers must:

Protect the medicine from damage and from extraneous
chemical and microbial contamination.
Support use of the product by the patient.

Primary containers must NOT:

allow product leakage,
chemically react with the product,
release components
uptake product components.
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 PRIMARY AND SECONDARY PACKAGING
2. Secondary packages:

Are additional packaging materials that improve the

appearance of the product and include outer wrappers or
labels that do not make direct contact with the product.
Also can also supply information about the product and
its use. They should provide evidence of tampering with
the medicine.

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TERMS OF CONTAINERS
Single-dose containers hold the medicine that is
intended for single use. e.g. glass ampoule.

Multidose containers hold a quantity of the material

that will be used as two or more doses. e.g. multiple
dose vial or the plastic tablet bottle.

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TERMS OF CONTAINERS
Well-closed containers protect the product from
contamination with unwanted foreign materials and
from loss of contents during use.

Airtight containers are impermeable to solids, liquids

and gases during normal storage and use. If the
container is to be opened on more than one occasion it
must remain airtight after re-closure.

Sealed containers such as glass ampoules are closed

by fusion of the container material.

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TERMS OF CONTAINERS

Tamper-evident containers are closed containers fitted with

a device that irreversibly indicates if the container has been
opened.

Light-resistant containers protect the contents from the

effect of radiation at a wavelength between 290 nm and 450
nm.

Child-resistant containers, commonly referred to as CRCs,

are designed to prevent children accessing the potentially
hazardous product.
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TERMS OF CONTAINERS
Blister packs are composed of a base layer, with cavities
that contain the pharmaceutical product, and a lid. This lid
is sealed to the base layer by heat, pressure or both. They
are more rigid than strip packs and are not used for
powders or semi-solids. Blister packs can be printed with,
day and week identifiers to produce calendar packs. These
identifiers will support patient compliance.

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TERMS OF CONTAINERS
Tropicalized packs are blister packs with an additional
aluminum membrane to provide greater protection against
high humidity.

Strip packs have at least one sealed pocket of material

with each pocket containing a single dose of the product.
The pack is made of two layers of film or laminate material.
The nature and the level of protection that is required by
the contained product will affect the composition of these
layers.

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TERMS OF CONTAINERS
Original packs are pharmaceutical packs that are
commercially produced and intended for finite treatment
periods.

Pressurized packs expel the product through a valve. The

pressure for the expulsion of the product is provided by
the positive pressure of the propellant that is often a
compressed or liquefied gas.

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The selection of packaging for a pharmaceutical
product is dependent on the following factors:

The nature of the product itself: its chemical

activity, sensitivity to moisture and oxygen,
compatibility with packaging materials
The type of patient: is it to be used by an elderly
or arthritic patient or by a child?
The dosage form
Method of administering the medication
Required shelf life
Product use, such as for dispensing or for an
over-the counter product.
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 PACKAGING MATERIALS
GLASS
Glass is the preferred packaging material. Glass
does have several advantages:
It is inert to most medicinal products,
Impervious to air and moisture,
It allows easy inspection of the container contents,
It can be colored to protect contents from harmful
wavelengths of light,
Easy to clean and sterilize by heat,
It is available in variously shaped containers.

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PACKAGING MATERIALS
GLASS
Disadvantages of glass:
Fragile: glass fragments and cracks
Expensive in comparison to plastic.
Heavy (transport cost)
Certain types of glass release alkali into the container
contents,

The chemical stability of glass for pharmaceutical use is

given by the resistance of the glass to the release of soluble
minerals into water contacting the glass. This is known as
hydrolytic resistance.

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 PACKAGING MATERIALS
GLASS
Type I glass:
Composition: Neutral glass, borosilicate glass (silica (silicon dioxide, SiO2) and
boron oxide).
Advantages:
It possesses a high hydrolytic resistance.
It is the most inert type of pharmaceutical glass.
It has the lowest coefficient of thermal expansion (and hence suitable for
sterilization by heat…..for ampoules and vials).
Disadvantages:
It has very high glass transition temperature so needs complicated processing.
And therefore expensive.
Uses:
Type I glass is suitable for packing all pharmaceutical preparations.
It is widely used as glass ampoules and vials to package fluids for injection.
In contrast to the other types of glass (type II and III), this type has no/little
amounts of basic oxides, so It is used to package solutions that could dissolve
basic oxides in the glass.

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 PACKAGING MATERIALS
GLASS
Type II glass
Composition: soda-lime-silica glass.
Soda (Na2CO3) is used to decrease the glass transition
temperature of silica. However, soda would increase water solubility
of silica, so lime (CaO) is used to increase the hydrolytic resistance.
This type would also contain other oxides.
Advantages:
This glass has a lower melting point than Type I glass. It is thus
easier to produce and consequently cheaper.
High hydrolytic resistance due to surface treatment of the glass.
Uses:
Type II glass used to package aqueous preparations.
However, as it contains basic oxides, it is not used to package
parenteral formulations with a pH <7 (i.e. acidic); this would increase
the pH of the formulation and could affect the drug stability and
potency.
It is the glass used to produce containers for eye preparations and
other dropper bottles.

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PACKAGING MATERIALS
GLASS

Type III glass

Composition: soda-lime-silica glass: It has a similar composition

to Type II glass but contains more leachable oxides.

Properties and uses: Type III glass offers only moderate

resistance to leaching and is commonly used to produce
dispensary metric medical bottles. It is also suitable for packaging
non-aqueous parenteral products and powders for injection.

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 GLASS

Types of glass containers

Bottles:
These are either amber metric medical bottles or ribbed (fluted) oval
bottles. Both types is supplied with a screw closure.

Amber metric medical bottle are used for packaging a wide range of oral
medicines.

Ribbed oval bottles are used to package various products that should not
be taken orally; this includes liniments, lotions, inhalations and antiseptic
solutions.

Containers for Parenteral products:

Small-volume parenteral products, such as subcutaneous injections, are
typically packaged in various containers made of Type I glass. Glass
ampoules for single use, Multiple-dose vials for more than one use.
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 GLASS

Types of glass containers

Jars:
Powders and semi-solid preparations are generally packed in wide-
mouthed cylindrical jars made of clear or amber glass.

Dropper bottles:
Eye drop and dropper bottles for ear and nasal use are hexagonal-shaped
amber glass containers fluted on three sides. They are fitted with a cap,
rubber teat and dropper as the closure.

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 PACKAGING MATERIALS
PLASTICS

Two classes of plastics:

Thermosets ( screw caps ) and Thermoplastics.

The advantages of plastics for packaging:

1. Release few particles into the product
2. Flexible and not easily broken
3. Are of low density and thus light in weight
4.Can be heat sealed.
5. Are easily moulded into various shapes
6. Suitable for use as container, closure and as secondary
packaging
7. Cheap.
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 PACKAGING MATERIALS
PLASTICS

The disadvantages of plastics are :

1. They are not as chemically inert as Type I glass
2. Some plastics undergo stress cracking and distortion from
contact with some chemicals
3. Some plastics are very heat sensitive
4. They are not as impermeable to gas and vapor as glass
5. They may possess an electrostatic charge which will attract
particles
6. Additives in the plastic are easily leached into the product
7. Substances such as the active drug and preservatives may be
taken up from the product.

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THE PRINCIPAL PLASTIC MATERIALS USED IN PHARMACEUTICAL PACKAGING
Plastic polymer Properties Uses Notes
Low-density Soft, flexible and Squeeze bottles as eye Disadvantages. of PE (LDPE and
polyethylene easily stretched. drop bottles. HDPE):
•Softened by flavoring agent and
(LDPE) aromatic oils,
High-density Strong, stiff, less Bottles for solid •Unsuitable for packaging oxygen
sensitive products,
polyethylene permeable to dosage forms •Adsorb antimicrobial preservative
(HDPE) gases than LDPE. agents,
•Crack on contact with organic
solvents.

Polypropylene Strong and stiff, Used for closures with

good resistance to hinges. Used also for
cracking when tablet containers and
flexed IV bottles

Polyvinyl Rigid Laminate (for blisters)

chloride (PVC) and the main
constituent of IV bags.

Polystyrene (PS) Clear, hard, brittle Used for tubes and Its use in drug packaging is limited
with low impact amber- tinted bottles. due to its high permeability to
resistance. It is also used for jars water vapor
for ointments and
creams with low water
content.
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FILLING AND PACKAGING
OPERATION
The following critical aspects must be evaluated and controlled
during large-scale validation and manufacturing runs
Proper control of product temperature to aid product flow and
maintain product
consistency before and during filling and packaging operations
Proper agitation in holding tanks and filling order to main
product uniformity and homogeneity during filling and packaging
operation
The use of air pressure and inert atmosphere to achieve
product performance and stability in the primary container
TOPICAL SEMI-SOLID
DOSAGE FORMS
Containers
The container material should not adversely
affect the quality of the preparation or allow
diffusion of any kind into or across the material
of the container into the preparation. The
container should be fitted with a closure that
minimizes microbial contamination and is
equipped with a device that reveals whether
the container has ever been opened.

The International Pharmacopoeia - Sixth Edition, 2016

TOPICAL SEMI-SOLID
DOSAGE FORMS:
Containers should be made from a material that does not
adversely affect the quality of the preparation
Containers should be of a design that minimizes microbial
contamination.
Use of suitable metal or plastic flexible tubes is preferred.
The preparation should maintain its pharmaceutical integrity
throughout the shelf life when stored at the temperature indicated
on the label