SteriTech supply a complete service for Installation, Site Acceptance Tests (SAT) and Operational Qualification (IQ/OQ) for a newly installed units.  We can supply both the protocols and experienced validation personnel to complete the work.  The content of these documents is extensive and subject to customer approval. We supply all necessary test equipment to complete the work, including thermal mapping.
The qualification includes (but is not limited to):

  1.  Documentation checks.    - Drawing and configuration checks        
  2. Calibration checks (critical instruments).  - Load system and transfer checks
  3.  I/O (loop) and operational checks.  - Safety system checks.
  4.  Alarm checks.   - Operation and performance checks.

OQ performance checks that autoclaves are performed with empty chamber.  We recommend System Validation is followed by Cycle Development, using thermally mapped production loads, in readiness for Process Qualification.



Design