Disinfectants used in pharmaceutical facilities for sterile production
Michele Cavalleri, Eurofins Biolab, Italy
Eurofins proposes four phases to validate the use of disinfectants applied in clean rooms and microbiologically classified environments as well as to verify the efficacy of cleaning and disinfection procedures. Each phase can be independently performed according to regulatory requirements.
Phase1: Characterisation of the endogenous microbial contamination:
Identifies endogenous microbial strains that are considered to be most critical and representative of the environment where disinfectants are to be used, which helps to determine the microorganisms that will be subjected to efficacy testing.
Phase 2: Experimental evaluation of the disinfectant efficacy under practical conditions of use:
Quantifies the efficacy of the disinfectants vs. the strains chosen in phase 1 using quantitative carrier test (reference method: EN13697:2001) and surfaces that are representative of the ones to be treated (e.g. glass, stainless steel, PVC, PMMA, etc).
Phase 3: Validation of the disinfection process:
Validates the whole disinfection process through a field trial at the manufacturer’s site. In this phase, the aspects related to application mode, real bioburden and structural features of the site will be taken into consideration to establish a validation plan, including evaluation of the sampling points, sampling frequency, duration of the validation, specific SOPs of cleaning and disinfection, validity criteria, etc.
Phase 4: Microbial monitoring:
Detects deviations from the required conditions, for example, incorrect use or rotation of the disinfectants, the appearance of more resistant strains or a modification of the characteristic bioburden.
Surface microbiological monitoring is performed to detect the presence of Bacillus pumilus contamination inside a clean room. The site cleaning and disinfection SOPs do not include a highly effective sporicidal disinfectant.
A chlorine releasing agent, such as a ready-to-use disinfectant based on ClO2, is chosen after evaluating its suitability for the relevant surfaces. The efficacy of the disinfectant is assessed via EN13697 carrier test method under simulated practical conditions in order to define the effective contact time against Bacillus pumilus spores.
Once the effective condition has been found, a validation plan is proposed in order to monitor in situ the efficacy of the updated disinfection process, i.e. elimination of Bacillus pumilus spores contamination.
Contact: GMP_EU@eurofins.com