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. 1995 Sep-Oct;49(5):226-34.

Environmental microbial challenges to an aseptic Blow-Fill-Seal process--a practical study

D J Jones  1 , P Topping, J Sharp
Affiliations
  • PMID: 7489196

Environmental microbial challenges to an aseptic Blow-Fill-Seal process--a practical study

D J Jones et al. PDA J Pharm Sci Technol. 1995 Sep-Oct.

Abstract

A Blow-Fill-Seal machine, set to aseptically fill sterile liquid TSB medium into 20 ml plastic containers, was subjected to a series of environmental microbial challenges in order to evaluate the effects of the room environment, and of the actions of persons in the room, on the sterility of the product. Despite a series of relatively severe stresses to the system, none of the units filled (approximately 44,000) were found, following incubation, to display growth.

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