Cleanroom validation

Cleanroom validation

The FDA Guidance for Industry* and the United States Pharmacopeia** requires cleanroom operators to ensure that the disinfection regimen followed is validated.  The test method ASTM E2614-15 “Evaluation of Cleanroom Disinfectants” describes a suite of tests and acceptance criteria which a disinfectant should meet.

Disinfectants on the market will have already proved efficacy against reference organisms using standard methods, often shown on the back of pack. The cleanroom disinfectant efficacy testing goes one step further by performing these standard test methods, but instead uses organisms which have been specifically isolated from in-house environmental monitoring. This enhanced testing is also carried out on a range of surfaces and materials intended to be disinfected (such as PVC, latex, glass, silicone, stainless steel etc.).

Once a disinfectant has been validated against the in-house organisms, then this is not necessarily required to be repeated unless the disinfectants are changed, or if new in-house organisms are isolated during routine environmental monitoring.

We can offer this disinfectant efficacy validation package to meet your individual requirements.  We can also offer hygiene monitoring of cleanrooms to detect and isolate organisms which may become problematic.  Identification and retention of the isolates for further testing is included in this hygiene monitoring package.

For further information about our cleanroom validation services, please contact us.

*Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

**Chapter <1072> Disinfectants and Antiseptics