Professional Documents
Culture Documents
Prepared By:-Guided By:-: Hemant Rathod Miss Natasha Sharma
Prepared By:-Guided By:-: Hemant Rathod Miss Natasha Sharma
Prepared By:-Guided By:-: Hemant Rathod Miss Natasha Sharma
Hemant Rathod
Guided by:-
Miss Natasha Sharma
Contents
Characteristics of Packaging materials
Role of Packaging
Selection of the Packaging materials
Containers
o Ideal requirements of container
o Types of containers
o Materials for making of containers
Closures
o Types of closures
o Materials for making of closures
Packaging is the process by which the pharmaceuticals
are suitably packed so that they should retain their
therapeutic effectiveness from the time of their
packaging till they are consumed. Packaging may be
defined as the art and science which involves
preparing the articles for transport, storage, display
and use.
Types of Pharmaceutical Packaging Materials:-
Glass
Plastic
Metal
Paper and board
Characteristics of Packaging Materials:-
They must protect the preparation from
environmental conditions.
They must not be reactive with the product.
They must not impart to the product tastes or odors.
They must be nontoxic.
They must be FDA approved.
They must meet applicable tamper-resistance
requirements.
They must be adaptable to commonly employed high
speed packaging equipment.
Role of Packaging:-
Protection-against light
-against reactive gases
-against moisture
-against microbes
-against physical damage
-against pilferage and adulteration
Presentation
Identification
Information
Compatible
Convenience
Selection of the Packaging Materials:-
1. On the facilities available, for example, pressurized
dispenser requires special filling equipment.
2. On the ultimate use of product. The product may be
used by skilled person in hospital or may need to be
suitable for use in the home by a patient.
3. On the physical form of the product. For example,
solid, semi-solid, liquids or gaseous dosage form.
4. On the route of administration. For example, oral,
parenteral, external, etc.
5. On the stability of the material. For example,
moisture, oxygen, carbon dioxide, light, trace metals,
temperature or pressure or fluctuation of these may
have a deleterious effect on the product.
6. On the contents. The product may react with the
package such as the release of alkali from the glass or
the corrosion of the metals and inturn the product is
affected.
7. On the cost of the product. Expensive products
usually justify expensive packaging
Factors affecting selection of Packaging
Materials:-
1.Mechanical Factors:-
• Shock
• Compression
• Puncture
• Vibration
2. Environmental Factors:-
• Temperature
• Pressure
• Moisture
• Gases
• Light
• Infestation
• Contamination
Containers:-
Container is one in which the product is placed.
A pharmaceutical container is defined as a device that
holds the drugs and is or may be in direct contact with
the preparation.
Ideal Requirements of Container:-
Types of Glass:-
Type 1:-Neutral or Borosilicate glass
Type 2:-Treated Sodalime glass
Type 3:-Regular Sodalime glass
Type 4:-General Purpose Sodalime glass
Evaluation of Glass Containers:-
U.S.P. and I.P. provides two testes to determine the
chemical resistance of glass containers:
Table: Limits of alkalinity for glass containers
Testes Containers Limits, ml of 0.02 N
H2SO4
1.Powder glass test Type 1 1
Type 3 8.5
Type NP 15
Advantages:-
Composition of Plastic:-
• Plastics are synthetic polymers of high molecular weight.
Plastic is made from one or more polymers together with
certain additives. The polymers commonly used are
polyethylene, polypropylene, polyvinyl chloride,
polystyrene, etc.
Classification of Plastics:-
1. Thermoplastic type
2. Thermosetting type
Evaluation of Plastic:-
• Leakage test
• Collapsibility test
• Clarity of aqueous extract
• Water vapour permeability test
Metals
• The metals commonly used are aluminium, tin plated steel,
stainless steel, tin and lead.
Advantages:-
They are sturdy.
They are impermeable to light, moisture and gases.
They can be made into rigid unbreakable containers by
impact extrusion.
They are light in weight as compared to glass containers.
Disadvantages:-
They are expensive.
They may shed metal particles into the pharmaceutical
product.
Closures:-
Evaluation of closures:-
1. Sterilization test
2. Fragmentation test
3. Self sealibility test
Reference:-