Thermal Validation

PharmaSys has provided world class thermal validation services to a number of international pharmaceutical and biotech companies and can deliver that same world class service to your company.


Services may be provided a-la-cart or as a turn-key solution including project management as required by the client.


PharmaSys uses industry standard Kaye Instruments [Validator® and ValProbe® (temperature and humidity)] for thermal validation projects. All thermal validation test equipment is fully certified and calibrated to NIST traceable standards.


The PharmaSys staff has performed sterility testing for autoclaves, lyophilizers, and sterilize-in-place cycles for various systems.


PharmaSys has also provided thermal mapping services for stability chambers, ovens, coolers, vacuum ovens and freezers from small laboratory units to larger walk-in units.

Capabilities

• Temperature and Humidity Room Qualifications
   

• Temperature and Humidity Warehouse Qualifications
   

• Temperature mapping experience includes:  

  autoclaves coolers cryogenic freezers depyrogenation ovens dry heat ovens freezers incubators

  lyophilizers ovens refrigerators stability chambers ultra low temperature (ULT) freezers vacuum ovens

   

• Kaye Validator (KL and 2000), Val Probe, and Digistrip
  experience
   

• Portable Storage Units
   

• Clean in place (CIP)
   

• Steam in place (SIP)