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Maintaining a Spore-Free Environment in the Cleanroom

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.

Control of Bacterial Spores

One of the most difficult requirements in a life science cleanroom is the control of bacterial spores. They can enter the cleanroom on people and on components at a surprisingly high rate. Research has shown that 40 per cent of consumables taken from stores are contaminated with bacterial spores (1). The study also showed that if the transfer disinfection procedure employed comprised of spraying solely with alcohol, only 27.6 per cent of the spores would be removed. The results of the different methods tested are shown in Table 1. Annexe 1 of GMP states that 'transfer of materials into and out of the unit is one of the greatest potential source of contamination' (2).


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By Suzanne Stubbs, Quality Manager at Shield Medicare Ltd

Suzanne Stubbs is Quality Manager at Shield Medicare Limited. She has 14 years' experience in the quality assurance of pharmaceuticals and medical devices. She is a Microbiologist and eligible for Qualified Person status. Suzanne presents on a number of topics in the area of contamination control at industrial seminars.

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