Stability Storage and Testing

Our storage stability walk-in chambers, controlled to ICH guidelines, are monitored 24/7, 365 days of the year and have built-in safeguards to give you peace of mind. Additional stand-alone cabinets enable us to offer alternative parameters including refrigerated, frozen and client defined storage conditions.

Our stability storage and testing services offer:

  • testing to cGMP
  • testing for schedule I-V controlled drugs
  • temperature and humidity testing
  • testing for climatic zones I-IV
  • analytical support capabilities e.g. testing for leachables.

With safeguarding practices including:

  • a backup cabinet
  • emergency breakdown procedures
  • an out of hours response team
  • wireless monitoring systems.

The standard ICH conditions are:

  • 25°C/60%RH - Real time storage condition
  • 30°C/65%RH - Intermediate storage condition
  • 40°C/75%RH - Accelerated storage condition.

Our experienced staff can aid with study design, planning and management of stability storage testing, including stability storage methods, retest intervals and shelf lives. Our flexible storage conditions can be used for commercial stability studies and all tests can be performed under accelerated, real-time and forced degradation conditions.

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Resources

  • White paper

    Additive Manufacturing - A Metallurgical Perspective

    pdf 4 MB

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