Storage in an environmental chamber

As part of the stability testing, we also store test samples. For ICH-compliant test sample storage, qualified climate-controlled facilities with the following controlled storage conditions are available:

  • 5°C
  • < –20°C
  • 25°C/ 60% RH
  • 30°C/ 65% RH
  • 30°C/ 75% RH
  • 40°C/ 75% RH
[Translate to English:] Wertschutzraum Betäubungsmittel

Special climatic conditions are also available on request, including the sample storage of narcotics.

All climate-controlled facilities for test sample storage are monitored by a central electronic system, which immediately warns the employees responsible in the event of any malfunction or if limits are exceeded.

We provide storage in an environmental chamber as part of the stability analysis, which we perform internally, but we also provide the service of stability storage for external testing.

We guarantee our clients timely removal from storage and GMP-compliant documentation of all activities associated with storage and removal. Test samples stored for external testing are sent to the client directly after removal, using controlled shipment if requested.

In this instance too, we advise our clients and provide support, e.g. when determining the test sample requirement per analytical test or the removal time according to the test protocol.