Pharmaceutical Technology Explanation about Packaging and its Processing.

1. Package Material Properties
Packaging Media
Package Testing
By:
Girish Kumar K
IV MSc.
Biomedical Science

2. Package Material Properties
To afford necessary protection, the
materials from which container is to be
made must show certain basic principle as
following groups.
Mechanical Properties
Physical Properties
Chemical Properties
Biological Properties

3. Mechanical Properties
• Material must give container sufficient
mechanical strength to:
Withstand handling empty, when filling
and while closing.
Processing
Transport
Storage
Supply to and Use by consumer

4. Physical Properties
• The material should be impervious to any possible
contaminants. (e.g., solid, liquid, gases, vapors or micro-
organisms)
• The container must able to withstand heat if the
processing includes sterilization.
• The surface must be capable of clear labeling, often
difficult. (e.g., plastics).
• The package must have suitable life.
• The materials must be protected from light if necessary
i.e., it must be UV absorbent.
• The container must not obstruct substance from product
(e.g., absorption of water from creams into cardboard.)

5. Chemical Properties
• The container and the closure should not react
together, either alone or in the presence of
product.
• The product should not react with container or
closure, as might happen in case of alkaline
substances in aluminum container.
• Substance must not be abstracted from product,
such as loss of bactericides from injection
solution in rubber.
• The container or the closure must not yield
substances to the product.

6. Biological Properties
The materials of the container should be
able to withstand attacks by insects.
The package should not support mould
growth.
In both the above cases the risk is
greatest with cellulosic substances and if
the use of such material is unavoidable,
the attack may be minimized by
impregnation.

7. Closures
Suitable closing of container is necessary to-
Prevent loss of material by spilling or
volatilisation.
Avoid contamination of product by entry of
dirt, microorganism or insects.
Prevent deterioration due to effect of
moisture, oxygen or carbon dioxide.
Minimise the effect of changes of
surroundings, such as relative humidity,
temperature or pressure.

8. • Closure methods may be only once or
renewable.
Once only closure
Here the container is used only once, the
package the being closed by folding, as
with paper and plastic bags.
Closing is effected by fusion of package
material such as fusion of glass to seal an
ampoule or of plastic to close a polythene
bag.

9. Renewable Closure
• Renewable closure principally apply to
bottles, jars, tubes and smaller
containers.
• They may be of following types
Plug Type
Cap Type
i. Push fit cap
ii. Screw closure

10. Packaging Media
• Apart from economic aspects, selection of
materials for the manufacture of package is
governed by chemical and physical properties
of the materials and product.
• Packaging media includes:
1. Metals
2.Plastics
3.Paper and Bound
4.Glass
5.Rubber

11. Metals
• Metal containers are used for dry products due
to effect of trace metal contamination
introduced by corrosion, especially of iron.
• Aluminium containers are commonest, including
extruded tubes for tablets and collapsible
tubes for creams and ointments.
• Tins is also used for collapsible tubes.
• Metal foils especially aluminium are used for
sachets and unit packs of tablets etc.
• Thus each tablet is enclosed in a separate
compartment which is open only when required
for administration.

12. Plastics
Coming into increasing uses are:
•Phenol-, urea-, and melamine-formaldehyde
resins as screw closures.
•Polystyrene tubes for tablets etc.
•Polyethylene is widely used for flexible
containers, closures, bags etc.
•This type is more important depending upon
crystallinity of the polymer. Low density forms
soften at 100 to 110 degree Celsius.
•Polypropylene is similar to polyethylene but has
greater transparency and better heat resistance.

13. • Cellulose acetate is used as films of units packs of
tablets in same way as foils, but it has lower
strength and moisture resistance.
Paper and Board
• These have variety of uses for external packages
but use for primary packs limited usually
impregnated (e.g., with wax or plastic)
Glass
Glass is dealt in detail by Gunn and Carter but the
principal forms used in packaging are
• Soda Glass
• Neutral Glass
• Borosilicate Glass
• Treated Glass

14. Rubber
•Rubber is needed in a specialized form of
closure for injection containers.
Packaging examples
To illustrate the range of pharmaceutical
packaging the following summary indicates
the general group of products with typical
method of packaging.
It is noted that the glass is widely used as it
posses important properties of protection,
convenience and presentation.

15. • Injections (single dose, small volume, in
ampoules, cartridges or disposables
syringe)
• Liquid or other Injections(Oral in screw cap
bottles, Nasal sprays and Inhalations,
Powders, Tablets, Pills, Capsules,
Suppositories, Ointments, Creams, Pastes,
Surgical Dressings, Surgical ligatures and
Sutures)

16. Package Testing
• Testing procedures may be divided into
two groups according to whether the test
is applied to packaging material in isolation
or to the entire package.
Testing Material – Test applied to packaging
materials may be-
Chemical – The pH value of material, chloride
and sulphide in paper or board, alkalinity
of glass, compatibility test with chemicals
or medicaments are typical of chemical
test.

17. Mechanical – Standard test are available
for properties such as bursting strength
and tensile strength of papers, films and
foils foe the effect of creasing folding and
so on.
Environmental – materials may be tested by
standard methods for absorption of water,
permeability to water vapour, gases, oils,
odours. Etc. and for characteristics such as
light transmissions.
Packages are also tested both Mechanically
and Environmentally.

18. Introduction to Industrial Processing
• Anyone who has visited a large
pharmaceutical factory will know that it
can seem to both complex and confusing,
but the full manufacturing process can be
broken down to a number of stages, each
of which can be individually understand.

19. Need for Large Scale
Manufacture
• Economic Reasons – It is the scale of
manufacturing batches increases so,
proportionally, does the cost of
production decreases. However, manual
methods are employed and efficiency
increases with the use of mechanical
equipment for handling and processing
materials.

20. Accuracy
• Larger the quantities of materials
involved so proportionally, is the accuracy
of measurements increased. Further
more, larger organisation can supports
analytical laboratories for control during
manufacture and for testing the final
product.

21. Creater Scope
• The increasing complexity of modern
therapy has made it virtually impossible
to prepare many medicaments on a small
scale (e.g., antibiotic production is
feasible only on a large scale)
• Furthermore large organization can
maintain staff and facilities for research
work and the development of new
products.

22. Changed characters of Medicaments
• The product of research by a
pharmaceutical manufacturer is marketed
in a proprietary from in order to recover
the expenditure involved in its discovery
and development.
• These properties are then prescribed by
medical practitioners instead of
traditional prescriptions which have to be
prepared extemporaneously.