Trust

Through Compliance

Our Credo – «Trust Through Compliance»

In regulated environments of production, research, or healthcare, the qualification of equipment and processes is a fundamental component of quality. Processes where temeprature is a relevant parameter must be tested for compliance to assure and maximize safety and reliability. Trust means to fully understand and know your own processes – our experienced team for Thermal Process Qualification is glad to advise and support you in these matters.

We Measure and Qualify

As an independent service provider we measure and qualify thermal processes in the temperature range of -196°C to +400°C, based on your requirements and in accordance with current standards.

 

Our scope of service includes:

Qualification

Temperature-/ Humidity-Mapping

›      Autoclaves ›      Cooling units (refrigerators)
›      SIP-Processes ›      Freezers
›      Depyrogenation tunnels
›      Ultra-low freezers
›      Dry heat sterilizers
›      N2 storage tanks
›      Freeze dryers
›      Storage rooms
  ›      Incubators

 

Documentation

Measuring results and related measuring descriptions are supported by our GMP-compliant documentation. Data evaluation is carried out with the aid of 21 CFR Part 11-compliant software which offers full data integrity.

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