Clean, Disinfect, and Validate
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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Pharmaceutical Technology’s 2017 Biologics and Sterile Drug Manufacturing eBook.
Prokaryotics Licenses Gram-Negative Antibiotic Potentiator from Northern Antibiotics
June 26th 2025Prokaryotics will gain worldwide rights to develop, manufacture, and commercialize NAB741, a non-bioactive polymyxin designed to increase permeability of the outer membrane of Gram-negative bacteria.
