Stability Testing and Storage

Pace Analytical Life Sciences (PLS) operates a 40,000 square foot state of the art contract analytical laboratory that provides stability testing and stability storage support to the pharmaceutical, biopharmaceutical and medical device industries requirements for stability studies, shelf life testing and shelf life determination. We conduct ICH stability studies following client supplied methods, compendial methods or methods that have been developed and validated by our own analysts. We provide stability testing for virtually all types of drug formulations including tablets, capsules, liquids, transdermals, aerosols and medical device combination products. We support long and short-term (accelerated) stability programs as well as photostability programs for Research & Development and commercial products.

Our stability storage chambers are fully mapped and continuously monitored by a validated computerized (Datatron) monitoring system. Our chambers and our monitoring system are supported by an external back-up power generator in case of power failure. Although our stability storage capabilities are geared toward providing pharmaceutical stability storage, we also provide stability storage on medical devices and other types of products. We offer the following ICH stability storage conditions and client specific storage conditions for your use:

  • ICH Storage Conditions ~ 8,000 cu. ft. Storage
  • -80°C, Reach-In
  • -20°C, Reach-In
  • 5°C, Walk-In
  • 25°C/60% RH, Walk-In
  • 30°C/65% RH, Walk-In
  • 30°C/75% RH
  • 30°C/70% RH
  • 40°C/75% RH, Walk-In
  • 40°C/10% RH
  • 50°C/10% RH
  • 37°C, 45°C and 50°C Accelerated Aging
  • Custom Conditions and Reach-In Chambers
  • Photo-Stability, ICH Q1b (Option 2)
  • Continuous Monitoring and Emergency Power Systems

Custom storage conditions are available and new storage conditions are added often. Contact your Project Manager or Account Executive to discuss your study and let us provide a storage proposal to address your needs.

Our staff will reconcile all stability samples that are sent to our facility prior to initiating any stability study. We then enter the protocol information into our stability tracking system. We can also develop stability protocols for our clients, if needed. Stability reports can be tailored to fit your needs.

Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on many drug substances and drug products. We maintain the highest level of quality and attention to detail to our clients to assure that their stability program will be successfully executed and that results will be delivered on time.

We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.

Note: The conditions maintained are subject to change based on the demands of client studies. Contact your Project Manager or Account Executive to confirm our current capacity for your studies.

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