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Validation & Qualification | Aquatherm SWS Sterilizer (Syntegon) – PSC Biotech

About this Project

OBJECTIVE

CQV – Qualification of AQUATHERM SWS sterilizer (Syntegon)

SERVICES

The client engaged PSC™ to initiate the validation and qualification of a AQUATHERM SWS sterilizer (Syntegon) with a chamber of approximately 2500 ft3. Laboratory and Pharmaceutical Manufacturing equipment validations play a vital role to ensure the quality and effectiveness of the equipment being used for the development of manufactured products.

Our team of engineers efficiently completed the tasks of performing qualifications for the AQUATHERM SWS sterilizer (Syntegon). These tasks included writing and executing a Cycle Development Plan, an Installation and Operation Qualification (IOQ), and a Performance Qualification (PQ). PSC™ consultants performed these studies to cGMP standards. Our team worked closely with client engineers and equipment vendors to ensure that the equipment functioned properly. Equipment validations should be completed by professionals of life science services that offer a diverse team of highly qualified and experienced consultants.

PSC™ can provide on-site and off-site Pre-calibration and Post-calibration Verification of the Thermocouples or Wireless Data Loggers.

EQUIPMENT USED

  • iRTD-400 Probe
  • HTR-400 Bath
  • Ellab Probes (Wireless Data Loggers)

PROJECT SUCCESS

PSC™ engineers efficiently completed the task of performing qualifications for the AQUATHERM SWS sterilizer (Syntegon). PSC™ continues to remain engaged with the client for continued support, as well as any future equipment qualifications to establish GMP regulations throughout the entire manufacturing facility.