Environmental Chamber Qualification / Validation Services
Environmental chambers are highly accurate and stable enclosures used to store and/or test products and materials in pharmaceutical, biotechnology, medical device and healthcare industries. Environmental test chambers are also known as climatic chambers or climate chambers. In highly regulated environments that need to comply with current Good Manufacturing Practices (cGMP) or current Good Laboratory Practices (cGLP) it is often required to map your environmental chambers to ensure that your product or sample is in the desired environmental conditions.
Common types of environmental chambers validated and qualifed to cGMP/cGLP standards:
- Freezers ( Crygenic, Liquid Nitrogen, Ultra low, Laboratory, Blast, Controlled Rate )
- Laboratory Refrigerator and Explosion Proof Refrigerator
- Laboratory Incubator, Shaking Incubator, Bacterial Incubator, Co2 Incubator
- Temperature Chamber
- ICH Stability Chamber
- Humidity Chamber
- Photostability Chamber
- ICH Alcohol Aqueous Stability Chamber
- Climatic Chamber
- Bead Bath and Water Bath
For new environmental chambers it is often requested to generate validation protocols and perform a full IQ/OQ/PQ, which includes temperature mapping. After the IQ/OQ/PQ qualification, the data can either be handed over for report generation or Ellab can generate the final reports including summary. Validations for existing environmental chambers are often more limited due to the unit being in use. For existing chambers more companies are moving to periodic revalidations anywhere from one to five years in frequency. In revalidation circumstances Ellab can either generate the validation protocol or use the companies current protocol. Ellab can always be flexible based on your particular needs.
Options when validating your controlled storage environment: