Cycle development and validation of high tech isolators is a challenge
Valicare’s specialists have strong technical expertise in this highly specific area via direct contact to one of the leading manufacturer (Syntegon Technology GmbH) of isolators including the relevant bio-decontamination-systems.
Valicare’s engineers have a long lasting hands-on experience in the development of bio-decontamination-cycles. They are well trained in optimizing the essential parameters for isolators and bio-decontamination-cycles like concentration and distribution of vaporized hydrogen peroxide, duration of gassing, temperature and air humidity by the use of physical, chemical and microbiological test methods.
They prove the required killing rate of microorganisms by the use of biological indicators (BIs) initially controlled by identification of bacteria and determination of the D-value at our internal laboratory.
With our strong technical expertise and practical knowledge we professionally support you in developing a bio-decontamination-cycle and GMP-compliant cycle validation for your special isolation system!