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.
May 15, 2017
Volume 2017 eBook, Issue 1, pg s51-s54

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.

Read this article from Pharmaceutical Technology’s 2017 Biologics and Sterile Drug Manufacturing eBook.

View other articles in the 2017 Biologics and Sterile Drug Manufacturing eBook.

 

native1_300x100
lorem ipsum