AIR MONITORING RANGING FROM ANAEROBIC TO GROWTH-HOSTILE PEROXIDIC CONDITIONS

摘要

Despite all the progress towards manufacturing or performing sterility QC-testing under nearly sterile conditions inrnisolators, we are occasionally able to isolate microorganisms in isolators. Isolators are gassed with Hydrogenperoxide andrnresidual low Hydrogenperoxide concentrations are accumulating to inhibitory levels during air sampling. Therefore accordingrnto ISO 14698 appropriate additives shall be included in culture media to overcome the effect, when anti-microbial activity isrnpresent at the sampling point. TCI-gamma, the supplemented medium for the centrifugal air samplers has been shown to bernhighly effective to neutralize Hydrogenperoxide, as is the case with anti-Peroxide cassettes for a sieve sampler. With directrninoculation of USP test strains TCI and anti-Peroxide cassettes perform well. When the operational performance of TCI in arncentrifugal sampler is tested against anti-Peroxide cassettes in a sieve sampler with environmental air, much higher recoveriesrnare obtained with the TCI-/centrifugal air sampler combination. This was repeated under different meteorological conditionsrnover the year. Some of these environmental micro organism will finally be found in cleanrooms therefore Systems with a yearrnround capability of reliable detection of airborne microorganisms are preferred. Gelatine disposables did not perform wellrnunder conditions with residual Hydrogenperoxide due to lack of additives to overcome Peroxidic conditions as mandated byrnISO 14698.rnSurprisingly the system TCI-gamma/centrifugal air sampler performed very well, too in anaerobic conditions underrnNitrogen gas and is therefore suitable for monitoring filling operations under nitrogen as well.rnThe system TCI-gamma/centrifugal air sampler was the only one with excellent operational results as well as inrngrowth-hostile Peroxidic environments, in anaerobic environments and in normal conditions in regulated cleanrooms andrnunregulated environmental conditions. This is very practical, as only one system has to be on stock for all purposes.