Stability Testing and Storage
Automated continuous monitoring of environmental parameters
Reliable and consistent stability testing is a prerequisite to collect valuable data about drug product quality variations over time under a variety of environmental conditions including temperature, humidity, and light exposure.
At Bora, we use state-of-the-art ESI and Hsinron stability chambers equipped with an environmental monitoring system that continuously monitors the temperature and humidity, and automatically reports any deviations through visible and audible alarms. Our stability testing program, managed by a Labware LIMS or SAP system, is configured to avoid sampling errors at each time point and can easily trend temperature and humidity.
We have redundant chambers for our 25°C/60% RH, 30°C/65%RH and 40°C/75% RH conditions. All stability chambers are backed up with a diesel powdered generator.
We offer customized freeze/thaw temperature cycling with temperature ranging from 5°C to 40°C and humidity ranging from ambient to 75% RH. We also can support in-use stability and shipping studies.
We have a photo-stability chamber which provides visible and UV exposure, meeting the requirements for Option 1 per ICH Q1B.
All stability chambers have limited access by key card and are locked at all times. Stability chambers are monitored 24 hours a day and building is staffed 24/7.
Statistical analysis per ICH Q1E can be completed upon request.
Storage systems and capacity
Bora’s analytical laboratories are equipped with multiple stability chambers including walk-in and standalone chambers that maintain a range of ICH conditions as well as custom conditions. Our stability chambers have capacity to store routine and overage samples and can be set at different temperatures, humidity, and durations to meet varied customer stability program requirements.
Our stability storage capabilities include:
- 5˚C/Ambient humidity
- 25˚C/40% RH
- 25˚C/60% RH
- 30˚C/65% RH
- 30°C/75% RH
- 40˚C/25% RH
- 40˚C/75% RH
- 50˚C/ambient humidity