World Health Organization ; World Health Organization Offeset Publication No. 4, (Part 1): Plastic Containers for Phar and Laceuticals - Testing Jcid Control

By Jack Cooper

Book Id: WPLBN0000124113
Format Type: PDF eBook
File Size: 5.4 MB
Reproduction Date: 2005

Title:	World Health Organization ; World Health Organization Offeset Publication No. 4, (Part 1): Plastic Containers for Phar and Laceuticals - Testing Jcid Control
Author:	Jack Cooper
Volume:
Language:	English
Subject:	Health., Public health, Wellness programs
Collections:	Medical Library Collection, World Health Collection
Historic Publication Date:
Publisher:	World Health Organization


Citation APA MLA Chicago Cooper, J. (n.d.). World Health Organization ; World Health Organization Offeset Publication No. 4, (Part 1). Retrieved from http://www.gutenberg.cc/

Description
Medical Reference Publication

Excerpt
PREFACE In view of recent advances and new concepts i n pharmaceutical science, WHO has i n i t i a t e d the revision of the second e d i t i o n of the International pharmacopoeia.' Special a t t e n t i 0 n . i ~ being paid to the inclusion of general monographs on such subjects a s s t e r i l i z a t i o n methods, the microbial contamination of non-sterile drugs, the determination of foreign p a r t i c u l a t e matter i n solutions for i n j e c t i o n , and the composition and properties of p l a s t i c s i n r e l a t i o n t o t h e i r s u i t a b i l i t y a s containers f o r drugs. The l a s t mentioned subject is of p a r t i c u l a r i n t e r e s t since p l a s t i c s are now used t o manufacture containers not only for solid dosage forms but also for blood and injections generally, as well a s f o r l i q u i d s t h a t a r e not administered parenterally. They are also used t o manufacture syringes and other i n j e c t i o n devices. This comprehensive report on the subject has been prepared a t the request of WHO.

Table of Contents
CONTENTS .Page I . INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 I1 . GENERALPROPERTIESOFPLASTICS . . . . . . . . . . . . . . . . . . . . . . . . . 2 I I I . PLASTICS OF IMPORTANCE Polyethylene . . ; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Polypropylene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 P o l y v i n y l c h l o r i d e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Cellulosics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 . . . . . . . . . . . . I V PLASTICS FOR PHARMACEUTICAL PACKAGING ( CURRENT AND FUTURE ) 7 V . POTENTIAL PROBLEMS . PLASTIC CONTAINERS Sorption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Desorption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Permeation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Photodegradation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Polymermodification . . . . . . . . . . . . . . . . . . . . . : . . . . . . 13 V I . RELATIONSHIP OF PLASTIC CONTAINERS TO DOSAGE FORMS A . Parenteral preparations . . . . . . . . . . . . . . . . . . . . . . . . 16 B . Ophthalmic preparations . . . . . . . . . . . . . . . . . . . . . . . . 16 C . Topical preparations . . . . . . . . . . . . . . . . . . . . . . . . . 17 D . Solid dosage forms . . . . . . . . . . . . . . . . . . . . . . . . . . 17 E . Nonsterile o r a l l i q u i d s . . . . . . . . . . . . . . . . . . . . . . . . . 17 V I I . REGULATORY REQUIRENIENTS A. United S t a t e s PharmacopeialXVIIIthRevision~1 970 . . . . . . . . . . . 18 B . National Formulary. XIIIth e d i t i o n . 1970 . . . . . . . . . . . . . . . 18 C . Pharmacopoeia Helvetica. VIth e d i t i o n . 1971 . . . . . . . . . . . . . . 18 D . Pharmacopee frangaise. VIIIth e d i t i o n . 1965 . . . . . . . . . . . . . . 19 E . Nordic Pharmacopoeia Council . . . . . . . . . . . . . . . . . . . . . 19 F . B r i t i s h Pharmacopoeia. 1973 e d i t i o n . . . . . . . . . . . . . . . . . . . 19 . . . . . . G Pharmacopoeia of the German Democratic Republic. (DAB 7-1969) 20 H . Pharmacopoeia of Japan. VIIIth e d i t i o n . 1971 . . . . . . . . . . . . . . 20 V I I I . STANDARDS ISSUED BY STANDARDS INSTITUTIONS . A American Society f o r Testing and Materials (AsTM) . . . . . . . . . . . 20 B. Deutscher Normenausschuss . . . . . . . . . . . . . . . . . . . . . . . 21 . C B r i t i s h Standards I n s t i t u t i o n . . . . . . . . . . . . . . . . . . . . . 21 D . Standards Association of Australia . . . . . . . . . . . . . . . . . . 21 . I X INDUSTRY RECOMMENDATIONS FOR STANDARDS . . . . . . . . . . . . . . . . . . . . . 21 X . PROPOSALS FOR INTERNATIONAL STANDARDS . . . . . . . . . . . . . . . . . . . . . . 21 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XI . CONCLUS.IONS 24 X I 1 . REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26