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Performance Validation has extensive experience with refrigerators, freezers, and sub-freezers 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 wireless Vaisala temperature and humidity data loggers and low-temperature loggers.
Performance Validation resources have expertise in determining logger placement for mapping, identifying locations for permanent monitoring sensors, and working with our clients to resolve hot/cold spot issues. For a more cost-effective solution, PV has developed standard temperature mapping templates and reports for almost any application. A summary of the types of recent projects completed are identified below:
- Completed several -80C sub-freezer qualifications (IQ/OQ/PQ) for a central cell bank lab at a large pharmaceutical manufacturer.
- Development and execution of a -80C ultra low freezer qualification (IQ/OQ/PQ) for a contract pharmaceutical packaging company.
- Completed a walk-in freezer qualification for a plasma processing/storage facility.
- Completed a raw material walk-in freezer qualification for a contract pharmaceutical manufacturer.
- Completed a new freezer qualification for a central cell bank lab at a large pharmaceutical manufacturer.
- Completed two reach-in freezer qualifications for a large pharmaceutical manufacturer.
- Completed mapping of two walk-in freezers and two walk-in coolers for a life sciences logistics provider.
- Completed mapping of a large clinical trials walk-in warehouse freezer and cooler for a large pharmaceutical manufacturer.
- Completed a reach-in freezer qualification for a large pharmaceutical manufacturer fermentation culture lab.
- Completed qualification of a new walk-in freezer and three existing reach-in freezers for a third party drug storage and distribution provider.
- Completed a reach-in refrigerator qualification for a pharmaceutical contract manufacturing company.
- Completed several walk-in chill room and two reach-in refrigerator qualifications for a large pharmaceutical manufacturer.
- Completed a walk-in cooler and a packaging room refrigerator qualification for a contract pharmaceutical packaging company.
- Completed a new reach-in refrigerator qualification for an animal health manufacturer cell culture lab.
- Completed a cold room mapping for a generic animal health manufacturer.
- Completed mapping of three walk-in coolers at two different sites for a specialty distribution and solutions provider.
- Completed mapping of four reach-in coolers for a pharmacy services company.
- Completed two new reach-in refrigerator qualifications for a large pharmaceutical manufacturer central cell bank facility.
- Completed qualification of a new walk-in cooler and seven existing reach-in coolers for a third party drug storage and distribution provider.
- Completed walk-in cooler and packaging room refrigerator qualifications for a contract pharmaceutical packaging company.
- Completed qualification of several rental walk-in cooler trailers for a small pharmaceutical manufacturer.
- Completed qualification of new reach-in refrigerators, a walk-in freezer, -80C sub freezers and requalification of relocated incubators and freezers for a new research laboratory at a diagnostics manufacturer.
For additional information , please schedule a call with one of our subject matter experts.
Principal Validation Engineer
