Stability Testing and
Stability Storage Services
Cirrus provides ICH compliant stability
storage and testing services which include all method development
and validation for regulatory submission. Product release
testing as well as short- and long-term stability testing
are available. We support stability evaluations for products
intended for a variety of routes of administration including
inhaled, nasal, parenteral, oral, topical/transdermal products
(for small molecules, peptides and proteins). Submission-ready
documents will be generated.
Stability Storage
- About 4000 cubic feet of storage space with walk-in and
reach-in stability chambers including refrigerated and freezing
conditions as well as photostability
- ICH conditions
- Storage chambers are individually monitored by Veriteq
temperature and humidity monitoring systems and are supported
by back-up generators in case of power failure
- Temperature and humidity excursions outside set range
trigger an alert to the responsible personnel
Stability Samples
- Drug substance
- Drug product
- Devices and other appropriate product components
- Excipients
- Controlled drugs
Services
- Stability storage
- Method development and validation to support stability
studies
- Release testing
- Short-term, accelerated and long-term stability testing
- Device-drug product compatibility and excipient compatibility
testing
- Leachables testing as a function of stability storage
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