COLLAGE OF HEALTH SCINCE ;

SECOND YEAR C. PHARMACY

DEPARTMENT
IPPP. PRESENTATION

Presented by; Group - 1

[Link]; 15/04/2011
1
 PACKAGING & STORAGE OF
PHARMACEUTICALS
TITLES TO BE COVERD ;
 Definition / introduction/ with their function
 Class /types/ of packaging
 Terminologies
 Packaging materials

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 Introduction

 What is packaging ?
 Packaging is defined as the collection of different
components which surround the pharmaceutical
product from the time of production until its use.

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 Functions of packaging

 Containment
 Strong enough to hold the contents during handling
 Protection
 Light
 Moisture
 Oxygen
 Biological contamination
 Mechanical damage
 Counterfeiting

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 Types of Packaging

1. Primary (Immediate) pack: 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.

Primary containers must NOT:

Chemically react with the product,
Release components
Retake product components.
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 Types of Packaging…

2. Secondary pack:
# 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 supply information about the product and its use.
# They should provide evidence of tampering with the medicine.

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 Types of Packaging…

3. Container Closure Pack

 The sum of packaging components that together contain and
protect the dosage form. This includes primary packaging
components and secondary packaging components, if the latter are
intended to provide additional protection (e.g. light barrier) to the
drug product.
4. Marketing Pack
 Combination of primary and secondary packaging, whether or not
the latter has any overt stability maintenance function
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 Terms of containers
 Single-dose containers hold the medicine that is intended for single use.
e.g. glass ampoule.

 Multi-dose 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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 Container
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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 qualities required for selection

 It must preserve the physical properties of all dosage forms and protect
them against damage or breakage.
 It must not alter the identity of the product.

 It must preserve the characteristics properties of the product to comply

specifications.
 It must protect product against undesirable or adulterating chemical,
biological or physical entities.

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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
• Plastic
• Metal

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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,

NB 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)

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.
.
Uses:
 Type II glass used to package aqueous preparations.
 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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 Packaging materials
Glass
Types of glass containers
Bottles:
These are either amber metric medical bottles or ribbed (fluted) oval bottles

Containers for Parenteral products:

Small-volume parenteral products, such as subcutaneous injections, are typically
packaged in various containers made of Type I glass.

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 Packaging materials
Glass
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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 PLAY EVERY BODY!!!!

PHARMACY IS BOTH
SCIENCE AND ART

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 Packaging materials
Plastics
A plastic is a material that contains an essential ingredient one or
more polymeric organic substances of large molecular weight.
The advantages of plastics for packaging
1. Flexible and not easily broken
2. Are of low density and thus light in weight
3. Are easily molded into various shapes
4. Suitable for use as container, closure and as secondary
packaging
5. 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 are very heat sensitive
3. They are not as impermeable to gas and vapor as glass

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 Packaging materials
Plastics
Classification of polymer types
1. Thermosets (Thermosetting plastics)
2. Thermoplastics

1. Thermosets (Thermosetting plastics)

• Consist of those plastics that, when subjected to heat, normally
will become infusible or insoluble, and as such cannot be remelted.
Example- phenol formaldehyde ,urea formaldehyde….
2. Thermoplastics
• Consist of those plastics that normally are rigid at operating
temperatures but can be remelted and reprocessed example –
polyethylene ,PVC…..
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 Packaging materials
Metals
• Aluminum
• Tin
• Tinplate

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 Closures

Container closure system

• The sum of packaging components that
together contain and protect the dosage form.
• This includes primary packaging components
& secondary packaging components, if the
latter are intended to provide additional
protection to the drug product.
Packaging system is equivalent to a container closure
system
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 Closures

The basis of closure systems

Closures may be achieved by a number of basic
means or a combination of two or more, as
follows.
– Pressure
– Temperature
– Adhesion

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 Closures

THERMOFORM BLISTERS
 plastic base web
 blister formed with aid
of heating
 low to high barrier

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 Closures

COLD FORM BLISTER

 blister formed mechanically (no heat)
 high barrier

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 THANK
NO GIFT, MORE THAN BEING A
YOU
PHARMACIST
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