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Stability

The Stability laboratory performs testing required to support package and bulk product stability programs. To ensure the complete accuracy of our results, stability chamber conditions are monitored 24 hours a day using the Kaye Labwatch system.

Designed to meet the critical needs of the pharmaceutical industry:

  • Full ICH chambers available
    • 30°C / 65% RH
    • 25°C / 60% RH
    • 30°C / 60% RH
    • 40°C / 75% RH
    • 30°C / 70% RH (Zone IV)
    • 30°C / ambient
  • Method development, transfer, and validation
  • Protocols, storage, testing, and report writing
  • Raw material and finished product testing
  • Microbial limits testing (for USP and EP requirements)
  • Cleaning validation and environmental monitoring
  • Autoturb, Biolog and Bioluminescence
  • Sterility testing
  • Identification and product screening
  • Routine monitoring of water systems
  • Method development, transfer, and validation
  • Controlled Substance capable
    • Fully licensed
    • Infrastructure in place
      • Vault for API
      • Video Monitors and Motion Detectors
      • Registered Pharmacist on staff
      • SOP's
      • Card Key Access