BACTERIOLOGY
Results and discussion For the three repeated experiments, the mean spore count ejected into the workstation during five minutes of nebulisation were in the range 2.0 × 108
to 2.4 × 108
cfu. Recovery of
B. atrophaeus colonies from the workstation interior (settle plates) was zero for all plates, and >300 colonies for all positive control plates at two minutes and four minutes. The consistent absence of colonies recovered after nebulisation of the spore suspension indicates that the filter in the workstation was highly effective in the removal of spores from the atmosphere. Thus, we demonstrated that the A135 GMP workstation substantially eliminates bacterial and particulate contamination from the work area (as determined using Bacillus spores) and meets the requirements of EN 12469:2000. The workstation provides EU GMP Grade A cleanroom conditions appropriate for the manufacture and manipulation of live biotherapeutic products containing fastidiously anaerobic bacteria, or other therapeutic products that require the absence of oxygen in their production.
References 1 BS EN 12469:2000 Biotechnology –
Performance criteria for microbiological
Fig 1. Whitley A135 workstation (plan view).
safety cabinets. The British Standards Institution 92000.
2 Brown KL. Spore studies in relation to heat processed food. Chipping Campden, United Kingdom: Campden and Chorleywood Food Research Association. 1984
Don Whitley Scientific (DWS) develops, manufactures and sells equipment and associated products for microbiology and cell culture applications worldwide. All products designed and developed by DWS are manufactured in its own premises in England.
www.dwscientific.com
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