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 Russell Publishing Ltd
 Court Lodge
 Hogtrough Hill
 Brasted
 Kent TN16 1NU. UK
 Registered in England 
 No. 2709148
 Registered office as above.
 VAT No. GB 577 897847

 

Maintaining a spore-free environment in the cleanroom

publication date: Sep 21, 2007
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The manufacture of sterile pharmaceutical products is governed in the European Union by the requirements of EU Good Manufacturing Practice for Medicinal Products. The GMP guide gives very specific details on the environmental and microbial requirements for aseptic processing. However, little or no guidance is given on how to create and maintain the correct level of microbial contamination in the aseptic suite. This article focuses on two important issues – creating and maintaining a spore-free environment and preventing spore contamination that may result from the use of disinfectants.



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