UNIT 2
PACKAGING MATERIALS: TYPES,
SELECTION CRITERIA, ADVANTAGES
AND DISADVANTAGES OF GLASS,
PLASTIC, METAL, RUBBER AS
PACKAGING MATERIALS
INTRODUCTION
o Packaging is the science, art and technology of enclosing or
protecting products for distribution, storage, sale and use.
o Packaging also refers to the process of design, evaluation and
production of packages.
o Pharmaceutical packaging can be defined as the economical
means of providing presentation, protection, identification,
information, convenience, compliance, integrity and stability of
the product.
o Packaging is important in material handling, storage and
transportation.
FUNCTIONS OF PACKAGING
1. Product identification: Packaging greatly helps in identification
of products.
2. Product protection: Packaging protects the contents of a product
from spoilage, breakage, leakage etc.
3. Facilitating the use of product: Packaging should be
convenience to open, handle, and use for the consumers
4. Production promotion: Packaging is also used for promotion and
attracting the attention of the people while purchasing.
The materials selected must have the following
characteristics:
They must protect the preparation from environmental
condition.
They must not be reactive with the product
They must not impart to the product tests or odour.
They must be non-toxic
Must be FDA approved.
TYPES OF PACKAGING
1. Primary packaging
2. Secondary packaging
3. Tertiary packaging
Primary packaging:
It is the material that first envelops the product and hold it.
This is usually is the smallest unit of distribution or use.
Ex. Aerosol spray can, blister packs, bottle
Secondary packaging:
It is outside the primary packaging perhaps used to group primary
package together.
Ex. Boxes
Tertiary packaging:
It is used to bulk handling and shipping.
Contain many units of secondary packaging.
Ex. Barrel, container, edge protector.
Package Testing
Drop test
Vibration test
Shock test
Inclined impact test
Revolving drum test
SELECTION CRITERIA OF THE PACKAGING MATERIAL
The selection of packaging material depends on the requirement such
as protection from environmental factors and degree of protection
required:
Criteria for selection:
Physical properties of the product
Economy
Stability of formulation
Formulation components
Facilities available for packaging
Government regulation
Environmental criteria : light, temperature
Convenience: size, weight of dosage form
TYPES OF PACKAGING MATERIALS USED FOR
PHARMACEUTICAL PACKAGING
Glass
Plastics
Rubbers
Paper/ card boards
Metals
GLASS
Glass is generally used in pharmaceutical packaging because it
possesses greater protection quality.
Glass has been widely used as a drug packaging material.
Glass is composed of sand, soda ash, limestone and cullet (Cullet is
broken glass which acts as a fusion agent)Si, Al, Na, K, Ca, Mg, Zn,
and Ba are generally used into preparation of glass.
Advantages
Economical
They are quite strong and rigid.
Easily available in various shapes and sizes
They are chemically inert
They are hygienic and suitable for sterilization
They are relatively non- reactive
They are transparent which allows the visual inspection of the
contents; especially in ampoules and vials.
Photosensitive drugs may be saved from UV-rays by using amber
colour glass.
They are cheaper than other packaging materials.
Disadvantages
They are brittle and break easily.
They may crack when subject to sudden changes of temperatures.
They are heavier in comparison to plastic containers.
Transparent glasses gives passage to UV-light which may damage
the photosensitive drugs inside the container.
TYPES OF GLASS
Type I – Borosilicate Glass.
Type II – Treated Soda-Lime Glass.
Type III – Regular Soda-Lime Glass.
Type NP – General Purpose Soda-Lime Glass.
Some other types of glass are:
Silicon treated glass
Sulphured glass
Neutral glass
Amber coloured glass
Type I – Borosilicate Glass
It is highly resistant glass.
Alkalinity is removed by using boric oxide to neutralzsed the oxide
of potassium and sodium.
It has high melting point so can withstand high temperatures.
It is more chemically inert than the soda-lime glass.
It is used to contain strong acids & alkalies as well as all types of
solvents.
The addition of approx 6% boron to form type I glass reduces the
leaching action.
Uses: laboratory glass apparatus, for injection and water for
injection.
Type II: Treated Soda-Lime Glass
When glassware is stored for several months, especially in a damp
atmosphere or with extreme temperature variations, the wetting of
the surface by condensed moisture (condensation) results in salts
being dissolved out of the glass. This is called blooming or
weathering & it gives the appearance of fine crystals on the glass.
Type II containers are made of commercial soda-lime glass that has
been de-alkalized or treated to remove surface alkali.
The de-alkalizing process is known as sulphur treatment. Sulphur
treatment neutralizes the alkaline oxides on the surface, rendering
the glass more chemically resistant.
Uses: Used for alkali sensitive products.
Infusion fluids, blood and plasma.
Large volume container.
Type III and Type NP Glass
Both have similar composition and are distinguished from each
from each other on the basis of their hydraulic resistance.
Type III has average or slight better than average resistance and is
suitable for non-aqueous parenteral and non- parenteral products.
Type III glass containers are normally dry sterilized before being
filled.
Type IV has lowest hydraulic resistance and is suitable for solid
products, some liquids and semisolids and not for parenteral.
Types of Description Type of test Size(ml)
glass
I Highly resistant Powdered glass All
borosilicate
glass
II Treated soda Water attack 100 ml or less
lime glass
III Soda-lime glass Powdered glass All
IV(NP) General purpose Powdered glass All
soda- lime glass
PLASTIC
o Plastics may be defined as any group of substances, of natural or
synthetic origins, consisting chiefly of polymers of high molecular
weight that can be moulded into a shape or form by heat and
pressure.
o Plastic is made from one or more polymers together with certain
additives.
o Plastic used for packaging pharmaceutical product. These packages
are extremely resistance to breakage and leakage.
o The polymers used for making of plastic container are as follows:
Polyethylene
PVC
Polymethyl metho acrylate (PMMA)
Polystyrene
Advantages
1. Low in cost.
2. It is unbreakable.
3. It is available in various size and shape.
4. It has good protection power.
5. Ease for transportation.
6. It is light in weight.
Disadvantages
1. Plastic contain certain disadvantages like interaction, adsorption,
absorption, lightness so it has poor physical stability.
2. Main disadvantages is permeation. The atmospheric gases,
vapours or liquid from environment easily migrate into plastic
container.
Types of Plastics
There are two types plastic material:
1- Thermoplastic type
2- Thermosetting type
Thermoplastic type-
This plastic can be softened by heating and harden by cooling.
On heating they are soften to viscous fluid which harden again on
cooling.
Resistant to breakage and cheap to produce
e.g: Polyethylene, Polypropylene, PVC, Polystyrene,
Nylon etc.
Thermosetting type –
They need heat for processing into a permanent shape.
When heated they become flexible But, they do not become liquid.
During heating such materials form permanent crosslinks between
the linear chains, resulting in solidification and loss of plastic flow.
e.g: Urea formaldehyde, Phenol formaldehyde, Melamine
formaldehyde.
METALS
Metals are used for construction of container. The metals used for this
purpose are aluminium, tin plated steel, stainless steel, tin and lead.
Advantages
1. Metal holders are solid, generally unbreakable opaque
2. Resistance to chemical attack.
3. Labels can printed directly on their surface
4. They are impermeable to light, moisture, and gases.
5. They are strong.
Disadvantages
1. They are expensive
2. They react with certain drug or chemicals and produce toxic
product.
RUBBER
Elastomers are a group of polymers usually referred to as rubber.
Rubber is used mainly for the construction of closure used for
vials, transfusion bottles, dropping bottles and as washers in many
other types of product.
Common rubbers used in pharmaceutical packaging are as follows
Butyl rubber
Chlorobutyl rubber
Natural rubber
Silicone rubber
Types of rubber:
1. Natural : It consist of latex from
2. Synthetic: Synthetic rubber are silicon, neoprene, nitrite or butyl
rubber. They are expensive.
Advantages:
It does not deteriorate with age
Good quality rubber is resistant to sterilization conditions.
They are unbreakable, tough and easily transported.
Disadvantages:
Manufacturing process is complicated.
They are very expensive.