Controlled Temperature Storage

To assure the quality of your medicinal product and support stability storage testing throughout your drug development programme Symbiosis offers facilities for controlled temperature and humidity storage. Operating to GMP and licensed by the MHRA we adhere to industry guidelines for recording storage temperatures of products within our facilities. Continuous, independent, recording including alarms linked to temperature monitoring devices means that we can demonstrate compliance through the records that are kept and provide evidence of compliance to your products’ storage specifications.

We can help to develop robust stability protocols, including accelerated stress studies assessing temperature, humidity and photostability and provide final study reporting to support your products shelf-life assignment.

CONTROLLED TEMPERATURE STORAGE

We understand how valuable your product and data are, hence precaution is taken at every step to minimise the effect of external conditions on the quality and stability of your product.

We work with qualified courier companies to deliver your product from our site to its destination, wherever in the world, under controlled conditions. If your raw materials/finished products require storage and shipment under controlled conditions we’ve got it covered.

WHICH TYPES OF STORAGE ARE AVAILABLE?

Our stability storage solutions include the full range of ICH storage conditions;

  • – 80°C ± 5°C
  • – 20°C ± 5°C
  • 5°C ± 3°C
  • Controlled ambient 15-25°C
  • 25°C ± 2°C/40% RH ± 5% RH
  • 25°C ± 2°C/60% RH ± 5% RH
  • 30°C ± 2°C/35% RH ± 5%RH
  • 30°C ± 2°C/65% RH ± 5% RH
  • 30°C ± 2°C/75% RH ± 5% RH
  • 40°C ± 2°C/75% RH ± 5% RH
  • 24 hour continuous monitoring and recording of conditions
  • Chambers are alarmed for out-of-range notification and call-out 24 hours a day
  • Accelerated stress studies assessing temperature, humidity and photostability
  • Protocol preparation and final study reporting
  • Facilities of potent handling/storage
  • Provision of Certificate of Conformance for storage

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