The document discusses the use of plastics in packaging materials, covering their classification, advantages, disadvantages, and considerations for drugs. Key points include the benefits of plastics such as lightweight and resistance to corrosion, as well as challenges like permeability and potential chemical reactions with drug products. It also outlines various moulding processes and testing requirements for ensuring quality in pharmaceutical applications.

1. PACKAGING MATERIALS
PLASTICS
DODDA DINESH KUMAR
IST YEAR M.PHARMACY
GITAM INSITUTE OF PHARMACY

2. CONTENTS:-
 Classification
 Advantages
 Disadvantages
 Drug plastics consideration
 Moulding processes
 Testing of plastics
 Application

3. Packaging:-
Packaging is best described as a coordinated system of
preparing goods for transport, distribution, storage,
retailing, and use of the goods.

4. PLASTICS
Plastics are group of substances either 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
Different Types of Plastics:
LDPE
HDPE
Polystyrene
Polycarbonate
Poly propylene
PVC
PET

6.  Advantages of Plastics
 Light weight.
 Reduced volume, (these two result in significant savings in warehousing
and distribution costs plus advantages to the consumer).
 No corrosion problems.
 Good resistance to mould and bacteria.
 Generally inert chemically, but be wary of ‘solvents’.
 Usually have good impact strength; difficult to break, if breakage
occurs fragments tend to be less hazardous than glass.
 Wide design and decorative possibilities.
 Offer a wide range of moulding processes.

7.  Disadvantages of Plastics
 No plastic is totally impermeable to moisture, gases, etc.
 May be permeable to, or subject to attack by, organic
substances, particularly solvents.
 Subject to adsorption and absorption according to formulation
ingredients.
 Fully effective closing systems are sometimes difficult to achieve.

8.  Guides offered by the FDA have identified the need for the following information when a
plastic is used for parenterals (now similarly covered by EN 9090/III).
1. Name of manufacturer.
2. Type of plastic.
3. Composition, method of manufacture of the resin and the finished container, plus a full description of
the analytical controls.
4. Physical characteristics (size, dimensions, whether flame treated, etc.).
5. Defect classifications (weight, seams, seals, wall thickness, pin holes, etc.).
6 .Light transmission test, USP (particularly if product is photosensitive).
7. Tests (USP):
• biological
• physico-chemical
• permeation.
8. Vapour transmission test (if appropriate).
9 .Toxicity studies not included in USP:
• sub-acute on extracts
• cell culture.
10 .Tests for leaching and migration.
11. Compatibility.
12. Sampling plan.
13. Acceptance specifications.

9. DRUG PLASTIC CONSIDERATIONS
 Permeation
 Leaching
 Sorption
 Chemical Reaction

10. PERMEATION
Transmission of gases, vapours or liquids
through packing material.
Permeation of oxygen and water vapour
may cause oxidation or hydrolysis of
sensitive drugs.
Increase in temperature and humidity will
make the condition still worst.

11. LEACHING
Migration of contents of the container to the
drug product.
Problems will be with colouring agents
used in plastics.

12. SORPTION
Removal of constituents of the drug product
by packing material.
This may cause serious problem like loss of
potency of drug.
A common problem is loss of preservatives.
Factors influencing: Chemical structure, pH.
Solvent system, temperature, length and area
of contact

13. CHEMICAL REACTION
Some ingredients of plastic containers may
chemically react with drug product or vise
versa.

14. MOULDING PROCESS:-
• EXTRUSION MOULDING

15. COMPRESSION MOULDING/COMPRESSION
TRANSFER MOULDING
•

16. • THERMOFORMING BY
PRESSURE, VACUUM, MECHANICAL
FORMING OR COMBINATIONS

17. ROTATIONAL MOULDING

18. REACTION INJECTION MOULDING (RIM)

19. SOFT MOULDING

20. DIP MOULDING

21. TESTING OF PLASTICS
General tests on plastics for pharmaceutical
purposes include
 Extractive and biological tests,
 Chemical tests,
 Physical tests and
 Toxicity tests.

22. STANDARD TEST PROCEDURES APPLIED TO
PLASTICS.
 Density
 Melt flow index (MFI)
Appearance—optical properties
 Gloss, Haze and transmittance (Clarity), Refractive index, Fastness to light
General physical properties
 Tensile properties
 Resistance to stress and flexing
 Compression, Torsion, Shear, Stress
 Impact strength
 Tear properties (tear propagation resistance)
 Hardness
 Abrasion resistance (wear resistance)
Temperature and heat sensitive evaluations (thermal properties)
 Heat distortion temperature (or heat deflection temperature)
 Melting point (Tm or crystalline melting point)
 Vicat softening point
 Brittleness temperature
 Thermal conductivity
 Flammability
Electrical properties

23. APPLICATIONS
Based on the utility of plastics they can be
categorized as
1. Rigid material plastics
2. Flexible material plastics
3. Metallic surface plastics
4. Plastic cements

24. Rigid material plastics
 These are the phenolic resines with various
inert filters these are used in the fabrication
of a number of items and it is light in weight
such as gears, pipes, valves, filter
press, pumps, etc…

25. Flexible material plastics
 These are thermo plastic materials these
materials can be rigid or flexible depending
upon the amount of plasticizer added these
are used in the fabrication of
tanks,funnels,buckets,etc…

26. Metallic surface plastics
 Plastics of polyethylene or poly vinyl chloride
types are used along with plasticizer for the
coating of metallic surface these are used to
protect the metals from corrosion. These
linings are applied on tanks, vessels, bottle
caps etc..

27. Plastic cements
 These are used for spaces between acid
resistance tiles and bricks.

28. References…
1. Packaging of pharmaceutical dosage forms
by. Thomas J Ambrosio
2. Pharmaceutical engineer
by. C.V.S. Subrahmanyam
3. www.google.com

29. THANK YOU