Is EN 16615 suitable for cleanrooms?
Disinfectant Wipe Evaluation for Small and Large Surface Disinfection
Reinigung & Desinfektion
Abstract
Disinfectants that are used in an environment where good manufacturing practice (GMP) is employed are required to be validated to demonstrate that they can reduce typical and anticipated bioburden to an acceptable level.
EN 16615 provides the test method closest to the practical use of disinfectants because it incorporates the action of wiping the disinfectant onto a surface. As the method was initially intended to test disinfectant and antiseptic wipes in the medical area, this study has been conducted using EN 16615 methodology with modifications to include cleanroom-relevant surfaces (stainless steel and vinyl flooring) and organisms; Staphylococcus epidermidis (bacteria) and Bacillus subtilis (spore former).
Testing has been performed to represent small and large surface disinfection with wipes and mops and a variety of chemistries with varying modes of biocidal action.
The study results demonstrated that reductions of >3 log bacteria and >2 log spores were achieved, in compliance to USP <1072> Disinfectants and Antiseptics. These findings support the suitability of EN 16615, with relevant adaptations, for disinfectant validation in GMP-compliant cleanroom environments.
Correspondence:
Stefaan Vanhalle
Tunnelweg 20, 2845 Niel, Belgium
s.vanhalle@staxs.eu
 | David Collins is an accomplished microbiologist with a first class honors degree in Biology and over 15 years experience within pharmaceutical and cosmetic industry. He has held roles within microbiological quality assurance, R&D and consultancy. His expertise spans a variety of sterile manufacturing processes and their supporting activities. He is an expert in disinfectant efficacy testing and an IRCA qualified GMP auditor. He has been a Principal Global Technical consultant for Ecolab Life Sciences for the past |
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