Autoclaves/SIP


Autoclaves/Sterilizers/Steam-in-place (SIP)

Performance Validation has extensive autoclave and steam-in-place experience from execution of qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of Kaye Validators, thermocouples, self-contained biological indicators (Bis), and BI incubator.

Performance Validation resources have expertise with identifying system sterile boundaries for SIP validations and developing/optimizing loads and cycles for autoclave validations.  A summary of the types of recent projects completed are identified below:

  • Developed and executed SIP Validation protocols for steam sterilization of upgraded fermenters for a large pharmaceutical manufacturer.
  • Developed and executed SIP Validation protocols for steam sterilization of new fermenters and existing fermenter support vessels for a large animal health manufacturer.
  • Developed and executed initial qualification (IQ, OQ, PQ) protocols for two new GMP steam autoclaves for a large animal health manufacturer cell culture lab.
  • Developed and executed annual revalidations of several different steam autoclave loads for multiple steam autoclaves for a central cell bank lab and a culture lab at a large pharmaceutical manufacturer.
  • Completed initial validation of several different steam autoclave loads for a new steam autoclave for a pharma contract research laboratory.
  • Developed and executed cycle development and qualification of a new dry cycle for a large animal health manufacturer cell culture lab.

 

For additional information regarding autoclave or SIP validation support, contact:

 

Neil Enlow

Principal Validation Engineer

Performance Validation, Inc.

Cell: (317) 341-2819