At every stage of your drug development programme, Exova can support you with advanced pharmaceutical stability storage and testing.

We offer a full range of monitored temperature, humidity, and light stability storage conditions meeting ICH Guidelines Q1A and Q1B, covering requirements for climate zones I to IV. Accelerated stress conditions, such as 50°C and 60°C, are available for degradation studies, low temperature storage is available for biological samples, and we have the flexibility to be able to set up additional non-standard temperature/humidity conditions upon request, as well as freeze/thaw cycle studies.

By working with you at every stage of your project we can also support you with protocol writing, final study reports and Certificates of Conformance, ensuring you can enter your markets with confidence.

Pharma stability storage

With chambers monitored and alarmed 24 hours a day, whether your project is a small one-off study or a major programme, we can provide you with a high quality stability service.

Our pharmaceutical stability storage solutions include:

  • Accelerated stress studies at high temperatures and humidities
  • Potent handling facilities
  • Regulated Substances License
  • Flexibility for additional temperature/humidity conditions – available on request
  • Multiple storage chambers available at each main ICH condition (for business continuity purposes)
  • 24-Hour continuous monitoring and recording of conditions
  • Alarms linked to 24 hour call-out
  • Back-up power to stability chambers and monitoring system
  • Strategic storage option for samples (storage within a separate stability chamber at the same condition for business continuity purposes)
  • Protocol writing and final study report
  • Deviation assessment and Mean Kinetic Temperature analysis
  • Home Office licensed facilities


ICH Conditions Offered

  • -20°C (± 5°C)
  • 5°C (± 3°C)
  • 25°C/40%RH, 25°C/ 60%RH (± 2°C/±5%RH)
  • 30°C/35%RH, 30°C/ 65% RH, 30°C/75%RH (± 2°C/±5%RH)
  • 40°C/ 75%RH (± 2°C/±5%RH)
  • Photostability
  • Additional non-ICH conditions available on request, such as 15°C/35%RH, 30°C/70%RH, 45°C/75%RH, 50°C, 60°C


Additional Storage Services


Development Project Reference Material Storage/Distribution

Exova offers storage, administration and distribution services for development project reference standards and related substances (chromatographic markers, impurities, degradation products):

  • Storage in continuously-monitored, controlled-environment chambers, qualified as for stability storage.
  • Dispensing of aliquots in GMP compliant laboratories
  • Dispatch to testing/manufacturing sites under controlled conditions
  • Management of re-validation schedules
  • Provision of a full characterisation/re-validation analysis service for reference materials

Available Storage Conditions:

  • <-70°C
  • -25°C to -15°C
  • 2°C to 8°C
  • 15°C to 25°C


GMP Retained Sample Storage

Exova provides a storage service for ‘retention samples’ as defined by EU Guidance on Good Manufacturing Practice.  Retained samples are stored in continuously-monitored, controlled-environment chambers, qualified as for stability storage.

Available Storage Conditions:

  • -25°C to -15°C
  • 2°C to 8°C
  • 15°C to 25°C
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Pharmaceutical testing facilities

2395 Speakman Dr.,
Mississauga, ON L5K 1B3

Contact: Larissa Hillar - Operations Manager
Tel: +1 905 822 4111

Fax: +1 905 823 1446

Email: americas@exova.com

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9240 Santa Fe Springs Road,
Santa Fe Springs, CA 90670

Contact: Eric Lindsay - General Manager
Tel: +1 562 948 2225

Fax: +1 562 948 5850

Email: americas@exova.com

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Plot 598-221, Dubai Investments Park 1, The Green Community, P.O. Box: 34924,
Dubai

Contact: Jason Dodds - Managing Director
Tel: +971 4 885 1001

Fax: +971 4 885 4004

Email: middle.east@exova.com

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