2. Contents
Introduction
Types of packaging systems
Criteria for the selection of package type and package material
Packaging evaluation
Dosage forms and package forms
Containers: Glass, Plastic, Metal
Paper and board
Films, foils and laminates
Rubber components
Cotton
Adhesives and Inks
Closures
Special type of delivery devices: Aerosols, Transdermals
Packaging of Medical / Surgical Devices
Economic Aspects
Study Questions
References
3. Introduction
DEFINITION:
Packing: “Packing consists of enclosing an individual
item, or several items, in a container, usually for shipment
or delivery. This operation iiss mmoossttllyy ddoonnee bbyy hhaanndd aanndd
machine.”
Pharmaceutical Packaging: “Pharmaceutical packaging
means the combination of components necessary to
contain, preserve, protect deliver a safe, efficacious
drug product, such that at any time point before
expiration date of the drug product, a safe efficacious
dosage form is available.
4. Types of Packaging
Systems
Primary package system: Made
up of those package components
subcomponents that come into
direct contact wwiitthh tthhee pprroodduucctt,, oorr
those that may have a direct effect
on the product shelf life.
Secondary or tertiary package
system: Includes cartons,
corrugated shippers pallets.
21. Cotton
In solid preparations it is used to
prevent collision of individual units
As desiccant: To prevent
absorption of moisture ppaarrttiiccuullaarrllyy
by solid dosage forms like: tablets
and capsules.
26. Packaging of Medical / Surgical
Devices
Requirements ooff ppaacckkaaggiinngg
materials for Medical / Surgical
Devices
27. Evaluation Tests carried out for
medical devices
Sterility testing
Manual handling
VVeehhiiccllee ssttaacckkiinngg
Loose-load vibration
Drop test
Compression
Package seal strength testing
28. Economic Aspects and Outlook
Investigator should have a broad
background in various disciplines
New dosage forms, new materials,
new drug classes
29. Study questions
Define: Packing and Pharmaceutical
Packaging
What are the criteria for the selection of
materials for pharmaceutical ppaacckkaaggiinngg??
Give details of glass as the packaging
material
What are the specific criteria for the
packaging of Aerosols, Transdermals
and Medical Devices?
30. References
1. Donald C. Liebe, Packaging of Pharmaceutical Dosage Form, Modern
Pharmaceutics by G.S.Banker, Marcel Dekker, pp 681-725.
2. C.P.Croce, A.Fischer R.L.Thomas, Packaging material Science, The
theory Practice of Industrial Pharmacy by Leon Lachman, Third
eeddiittiioonn,, pppp 771111--773322
3. Autian. J., J.Pharm.Sci. , 52, 1963, pp 1, 105
4. D.C.Liebe, Pharmaceutical Packaging, Encyclopedia of
Pharmaceutical Technology, volume 12, Marcel Dekker, New
York,1993, pp 1-28
5. R.P.Abendroth, Glass as a packaging material for pharmaceuticals,
Encyclopedia of Pharmaceutical Technology, volume 7, Marcel
Dekker, New York, 1993, pp 79-99
31. 6. S.W.Shalaby B.L.Williams, Films and sheets for
packaging, Encyclopedia of Pharmaceutical
Technology, volume 6, Marcel Dekker, New York,1993,
pp 29-49
7. Elastomeric closures for Pharmaceutical packaging
8. USP 2244,, NNFF 1199,, 22000000.. ppgg 1100..
9. Plastic Packaging , Remington: The Science and
Practice of Pharmacy, 19th edition, Volume II, pp 1487.
10. M.E.Aulton, Pharmaceutics : The science of dosage
form design, D.A.Dean- packaging technology, pp. 712-
725
32. 11. Cooper and Gunn’s Tutorial Pharmacy, sixth edition, pp.
133-141.
12. WHO Technical Report Series, no. 902, 2002, Annex 9,
Guidelines on packaging for Pharmaceutical products, pp
120-137.
13. www.ffddaa..ggoovvppaacckkaaggiinngg..hhttmm
14. http://www.devicelink.com/pmpn/archive/98/08/002.html
15. Packaging engineering by Louis C. Barail, Reinhold
Publishing Corporation, U.S.A., 1994. Pages: 1-11, 357-
364.
33. 16. Medical device packaging handbook, edited by
Joseph D. O’Brien, 1990, published by Marcel
Dekker Inc. Pages: 51-220.
17. Packaging of Pharmaceuticals by C. F. Ross, first
edition 1975, by Newnes –Butterworths; London.