Boston Analytical has been performing pharmaceutical stability storage and semi permeable stability testing 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.
|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