Cleanrooms - Which Disinfectant is right for YOUR in-house microbes?
Cleanroom Operators are required by The FDA Guidance for Industry * and the United States Pharmacopeia ** to ensure 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, as in this example.
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.
At MSL 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 or to discuss any of our services please contact Carolyn Burney Carolyn.Burney@MSL.io
* Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
** Chapter <1072> Disinfectants and Antiseptics
|Japan (JP) Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing (2006)|
"Cleaning agents and disinfectants should be validated for their appropiateness and reliability in removing contminants prior to use. Cleaning and disinfection efficacy should be assessed and confirmed based on type and count of microorganisms characterized by periodic environmental monitoring"
|"If selected disinfectants might have inferior efficacy against microorganisms isolated from the environment, the efficacy should be reevaluated and the replacement with or alternate use of different disinfectants should be considered and implemented, as appropriate"|
|United States Food and Drug Administration (US FDA) Guidance on Aseptic Manufacturing (2004)|
"Routinely used disinfectants should be effective against the normal microbial vegetative flora recovered from the facility"
|"If indicated, microorganisms associated with adverse trends can be investigated as to their sensitivity to the disinfectants employed in the cleanroom in which the organisms were isolated"|
|European Medicines Agency (EMA) EudraLex Annex 1 - Draft|
"Disinectants should be cleaned and disinfected thoroughly in accordance with a written programme"
|"Disinfectancts should be shown to be effective for the duration of their in use shelf-life taking into consideration appropriate contact time and the manner in and surfaces on which they are utilized"|
|"Disinfectancts should be shown to be effective when used on the specific facilities, equipment and processes that they are used in"|
|PIC/S PI 007-6 - "Recommendation on the Validation of Aseptic Processes The effectiveness of disinfectants and the minimum contact time on different surfaces should be validated"|