STABILITY STORAGE

STABILITY STORAGE

Stability Storage

Boston Analytical has been performing pharmaceutical stability storage and testing studies since 1987. Our stability laboratory is located within our 30,000 square-foot facility with 3,197 cubic feet of storage space, ensuring stability storage capacity for years to come. Boston Analytical can help with all your stability storage needs and you can feel confident your products will be stored to your specifications.

Our Metrology department ensures that stability chambers remain constant and at the correct conditions every day. All of the stability chambers at Boston Analytical are installed, calibrated, validated, and RH-mapped by the Metrology department. We can easily accommodate custom settings.

Boston Analytical’s ICH-compliant chambers are guarded with fully-controlled monitoring and alert systems. Our stability chambers are supported by emergency back-up generators and on-site maintenance.

Storage Chamber Conditions
Condition Temperature and Relative Humidity
ICH Accelerated 40 °C / 75% R.H.
ICH Intermediate 30 °C / 65% R.H.
ICH Long Term 25 °C / 60% R.H.
ICH Zone IVb 30 °C / 75% R.H.
ICH Option II Photostability
ICH Refrigerated 5 °C
ICH Semi-Permeable 25 °C / 40% R.H.
ICH Semi-Permeable 40 °C NMT 25% R.H.
ICH CRT 20 °C to 25 °C/Ambient Humidity
ICH Frozen -20 °C
Ultra-Low Freezer -80 °C
Other conditions available upon request

Stability Storage Highlights

  • ICH-compliant stability chambers
  • Fully controlled monitoring and alert systems, supported by emergency back-up generators
  • On-site metrology personnel set up and monitor chambers
  • LIMS automatically identifies when pulls are due for testing
  • Trained personnel enter cGMP-compliant data in ELNs, which are available to clients
  • Storage for standard and semi-permeable stability testing
  • Accelerated Stability Services
Stability Storage and Testing