Performance Validation has extensive experience with incubators and stability chambers 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.
Performance Validation resources have expertise with 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 qualification (IQ/OQ/PQ) of existing reach-in incubators/stability chambers sitewide for a large medical device manufacturer.
- Completed a new reach-in stability chamber qualification (IQ/OQ/PQ) for a pharma contract research laboratory.
- Completed several reach-in and walk-in stability chamber requalifications for a lab facility at a large animal health manufacturer.
- Completed several new shaker incubator qualifications (IQ/OQ/PQ) for a culture lab facility at a large pharmaceutical manufacturer.
- Completed several shaker incubator requalifications for a cell culture lab at a large animal health manufacturer.
- Completed several incubator/stability chamber qualifications for a large pharmaceutical manufacturer and a large combination device manufacturer.
- Completed several hot room mappings for a large pharmaceutical manufacturer.
- Completed two new shaker incubator qualifications (IQ/OQ) for a large pharmaceutical manufacturer’s central cell bank facility.
- Worked through a stability chamber manufacturer to complete three walk-in stability chamber qualifications (IQ/OQ/PQ) for a large medical device manufacturer engineering test lab.
For additional information regarding incubator and stability chamber qualification, please schedule a call with one of our subject matter experts.
Principal Validation Engineer