Development & Validation of Biodecontamination Processes

Process development and validation of isolators is a technical challenge

For Valicare's isolator experts these services are daily routine.

When developing a biodecontamination process, it is important to optimize the parameters for isolators and biodecontamination systems using physical, chemical and microbiological test methods so that microbiological indicators (BIs) are killed according to the given specifications.

 

As a wholly owned subsidiary of Syntegon Technology GmbH, the manufacturer of isolator and biodecontamination systems, Valicare GmbH consultants and engineers have detailed knowledge of process development and validation of isolators including sterility test and compounding isolators. Among other this includes the parameters to be set, the concentration and distribution of hydrogen peroxide, the gassing time, the temperature and humidity, the subsequent aeration time and the measurement of the residual hydrogen peroxide concentration. The initial qualification of the BIs we provide includes germ identification and quantification as well as a D-value determination in Valicare's own pharma-grade isolator.

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

Take advantage of our expert and professional support in the development of biodecontamination processes and GMP-compliant validation of your hydrogen peroxide-using isolator systems, regardless of the manufacturer.

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Contact us if you have any questions. We will gladly answer and advise you.

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