QUALITY CONTROL TESTING OF PACKAGING MATERIALS

 

6.(A)  PACKAGING MATERIAL SPECIFICATIONS:-

Specifications of packaging materials may contain below mentioned particulars:-
(i)  Printed strip rolls
*    Common name
*    Code number
*    Description
*    Colour scheme and design
*    Quality of printed matter
*    Seal quality
*    Effect of heat
*    Name of approved supplier
*    Frequency of re-inspection of stored material
*    Precaution
*    Date of issue of specification

(ii) Cartons
*    Name (name of the drug and strength)
*    Code number
*    Description
*    Dimensions (length, width, height)
*    Colour scheme
*    Quality of printed matter
*    Printed matter
*    Gram per square meter
*    Suitability
*    Name of approved supplier
*    Frequency of re-inspection of stored material
*    Date of issue of specification

(iii) Bottles
*    Common name
*    Code number
*    Description
*    Total height
*    Neck height
*    Body diameter
*    Type of glass
*    Overflow capacity
*    Suitability
*    Name of approved supplier
*    Date of issue of specification

(iv) Pilfer proof caps
*    Common name
*    Code number
*    Description( including design and monograph )
*    Uniformity of weight
*    If waded caps thickness of cap
*    Sealing quality
*    Date of issue of specification

(iv) Finished product specification
*    Generic name of the product
*    Trade name
*    Dosage form and strength
*    Description (colour, shape, dimension, taste, etc.)
*    Physical properties (pH, dissolution time, disintegration time etc.)
*    Name of pharmacopeia or other any other recognized book of standards in which the monograph appears.
*    date of expiry, precautions and safety aspects, date of issue of specification

6.(B)  PACKAGING OPERATION
It is of utmost importance to ensure that correct packaging materials are used for drug product.

The entire operation should be well defined via written procedure and followed in totality.

Particular attention should be given to ensure that different products are not packed in close proximity unless there is physical segregation. The written procedures should include following features, which will prevent mix-ups and cross contamination:
1.      Before packaging operations begin, steps should be taken to ensure that the work area, packaging lines, printing machines and other equipments are clean and free from any products, materials or documents previously used.
2.      Identification of drug product with lot or control number that permits determination of the history of the manufacture and control of the batch.
3.      The name and lot number of the product being handled should be displayed at each packaging station or line.
4.      All the products, labels, labeling and packaging material should be checked on delivery to the packaging department for quantity, identity, and conformity with the packaging instructions.
5.      Examination of the packaging and labeling materials for suitability and correctness before start up of packaging operations and documentation of such examination in the batch production record.
6.      Containers for filling should be clean before filling. Attention should be given for avoiding and removing contaminants if any, such as glass fragments and metal particles.
7.      Online control of the product during packaging should include at least checking the following:
·         General properties of the packages.
·         Whether the packages are complete and the count is as per specification.
·         Whether the correct products and packaging materials are used.
·         Correct functioning of line controls.
8.      Samples taken away from the packaging line should not be returned. They should where appropriate, be destroyed (e.g. leak tested strips)
9.      Product lots which have been involved in special events (rework or re inspection) should be reintroduced into the process only after additional inspection and approval is carried out by authorized personnel.

7. W.H.O GUIDELINES FOR QUALITY CONTROL OF PACKAGING MATERIALS
1.      All the containers and closures intended for use shall comply with the pharmacopoeial and other specified requirements.

2.      Suitable sample sizes, specifications, test methods, cleansing procedures and sterilization procedures shall be to suitability of packaging materials.

3.      Plastic granules should also comply with the pharmocopeial requirements including physio-chemical and biological tests.

4.      All the containers and closure shall be rinsed prior to sterilization with water for injection according to written procedure.

5.      The design of the closures, containers and stoppers shall be as such as to make an airtight seal when fitted to the bottles.

6.      It shall be ensured that containers and closures chosen for a particular product do not affect the product adversely.

7.      When the glass bottles are used, the written schedule of cleansing shall be laid down and followed.

8.      Individual containers of parenteral preparations, ophthalmic preparations shall be examined against black or white background fitted with diffused light after so as to ensure freedom from foreign matters.

9.      Glass bottles-
a)      Shape and design of the glass bottle shall be rational and standardized.
b)      Glass bottles made of USP Type-1 and USP Type-ll glass shall only be used.
c)      USP Type-lll glass containers may be used for non-parenteral sterile products.

10.  Plastic containers:-
a)      Preformed plastic containers intended to be used for the packing of large volume parenteral shall be moulded in-house by one-continuous operation through an automatic machine.
b)      Blowing, filling, and sealing operations shall be conducted in room conforming to requirements.

11.  Rubber stoppers:-
The rubber stoppers used for large volume parenterals shall comply with specifications prescribed in the Indian pharmacopeia.

CONCLUSION
The testing of packaging materials is almost requirement for any pharmaceutical industry. The material of a package affects quality, stability and efficacy of drug product.  Thecost of material of a package should be as low as possible without compromising the quality of product. It should pass the specifications of tests before it reached the local markets and made available to the consumers of product. The type of test followed should be according to requirements of regulatory agencies.

REFERENCES
1.    “INDIAN PHARMACOPOEIA 2007”, Volume-1, published by The Indian Pharmacopoeia Commission, Central Indian pharmacopoeia Laboratory Govt. Of India, Ministry of  Health & Family Welfare Sector-23, Raj Nagar, Ghaziabad-201 00 Page no. 363-371
2.    “UNITED STATES PHARMACOPOEIA 2007”,Volume-1,Page no.661
3.    Swarbrick James, “ENCYCLOPEDIA OF PHARMACEUTICAL TECHNOLOGY”, Volume -1,Third Edition, Page no.2526-2541
4.    Lachman leon, Lieberman H.A, Kanig J.L,“THE THEORY AND PRACTICE OF INDUSTRIAL PHARMACY”, Third Indian Edition  1990, Varghese Publishing House, Dadar Bombay Page no.711-732
5.    Organization Of Pharmaceutical  Producers Of India, “ QUALITY ASSURANCE GUIDE” Fourth Edition 2001, Chapter 11.5 Page no. 1-4
6.    Banker G.S, Rhodes C.S, “MODERN PHARMACEUTICS”, Fourth Edition , Published by Marcel Dekker, Page no.587-600
7.    “EUROPEAN PHARAMOCOPEIA”5.0, Vol-1,page no.303-317
8.    Jerkins W.A, Osborn K.J, “PACKAHING DRUGS AND PHARMACEUTICALS”, edition 1993, Technomic Publishing Co.Inc., Page no. 1372-1389
9.    Dean D.A, Evans E.R, and Hall I.H, “PHARMACEUTICAL PACKAGING TECHNOLOGY”

NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.

SUBMIT YOUR ARTICLE/PROJECT AT articles@pharmatutor.org

Subscribe to Pharmatutor Alerts by Email

FIND OUT MORE ARTICLES AT OUR DATABASE


Pages

FIND MORE ARTICLES