A multicentred investigation of clean air requirements for terminally sterilized pharmaceuticals

Whyte, W. (1983) A multicentred investigation of clean air requirements for terminally sterilized pharmaceuticals. Journal of Parenteral Science and Technology, 37(4), pp. 138-144. (PMID:6620047)

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Publisher's URL: https://journal.pda.org/content/37/4/138

Abstract

Experiments were carried out in four manufacturing pharmacies to assess the effect of ventilation and airborne contamination on terminally sterilized products. Each pharmacy manufactured containers of 0.9% sodium chloride and carried out experiments in widely differing conditions of airborne cleanliness. No correlation could be demonstrated between the cleanliness of the air and the quality of the product (as established by bacterial and dust particle counts) and it was concluded that the containers and closures (especially after autoclaving) were the main source of contamination. It is suggested that complex ventilation schemes for the production of terminally sterilized products are not necessary.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Whyte, Dr William
Authors: Whyte, W.
College/School:College of Science and Engineering
Journal Name:Journal of Parenteral Science and Technology
Publisher:Parenteral Drug Association
ISSN:0279-7976

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