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Bio decontamination of equipment by Vaporised Hydrogen Peroxide
(VPHP) is often implemented in the pharmaceutical industry. The use of isolators in pharmaceutical filling, and in active air lock systems of clean rooms, is closely linked to this technology and is well understood by
Valicare personnel.
Bio decontamination cycles have to
be adapted regarding VPHP concentration, duration,
temperature and humidity to achieve the required killing
rate of microorganisms to be demonstrated by the
inactivation of biological indicators (BI).
Based on our long experience in development of special bio decontamination cycles for our customers, Valicare offers the following support for GMP compliant use of your isolator system:
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Development of your specific bio decontamination cycle
- Documentation concerning development, validation, and operation
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Preparation of SOPs for use, maintenance and calibration of the isolator sensors
Valicare supplies you also with the complete validation of
your isolator system. Development and validation studies are
carried out by using qualified and calibrated test equipment (e.g.
NIR-sensors).
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