Conquering the challenges of developing and validating of isolators

Methods for parameter determination

Our capabilities include setting of parameters like concentration and distribution of hydrogen peroxide, gassing time, temperature and humidity, subsequent aeration time, and measurement of the residual hydrogen peroxide concentration. The initial qualification of the BIs includes germ identification and quantification as well as a D-value determination in Valicare's own pharma-grade isolator.

Service packages for sterility test isolators

Valicare developed a straightforward validation approach for biodecontamination processes using hydrogen peroxide for the sterility test isolators (STI) from Klenzaids, a leading manufacturer of aseptic, bioclean, and containment equipment in India and a joint venture partner of Syntegon. This concept includes protocols, advice on the loading scheme, provision of the necessary equipment and indicators, as well as on-site implementation. The concept can also be applied to sterility test isolators of other manufacturers.

Take advantage of our expert support in the development of biodecontamination processes and GMP-compliant validation of your isolator systems.