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Clean, Disinfect, and Validate
Axel Wehrmann is manager, customer service, SGS Life Sciences.
Effective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.
Facilities must demonstrate that a disinfection procedure efficiently reduces micro-organisms in a pharmaceutical cleanroom environment. Different guidelines emphasize the importance of validation studies for proper disinfection and several test methods allow for anti-microbial effectiveness testing.
This article describes how a disinfection validation study must be defined according to the specific conditions at the site and the variables within each method such as the type of disinfectant product, contact time, interaction with special surface materials, and special species of resident micro-organisms.
The role of the testing laboratory and the specialization of testing personnel will also be discussed, to ensure accurate, reproducible data is produced from anti-microbial effectiveness testing.
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