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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
