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.
- Developed and executed an initial autoclave validation for an organ recovery facility in response to an FDA audit.
- Developed and executed validation of a new tabletop sterilizer and revalidation of an existing tabletop sterilizer for a pharmaceutical testing laboratory utilizing wireless temperature probes.
For additional information regarding autoclave or SIP validation support, contact:
Principal Validation Engineer
Performance Validation, Inc.
Cell: (317) 341-2819