BioCold Environmental

FDA/ICH Stability Testing

The International Conference on Harmonisation (ICH) has established stability testing guidelines adopted by the FDA as mandatory for all new pharmaceutical products and dosage forms. The Q1A testing guidelines set parameters for long-term (real-time), intermediate and accelerated stability studies.

Study Storage Condition Time Period
Long-term 25°C ± 2°C
60% RH ± 5% RH
12 months
Intermediate 30°C ± 2°C
65% RH ± 5% RH
6 months
Accelerated 40°C ± 2°C
75% RH ± 5% RH
6 months
Refrigerated 5°C ± 3°C 12 months
Freezer -20°C ±5°C 12 months

BioCold stability test chambers and rooms have been specially designed for these controlled parameters, using microprocessor-based controls and ultrasonic humidification to achieve exceptional stability and uniformity. For regulated stability test applications, the key is to achieve the best possible control, avoiding the heightened scrutiny given to test results which barely satisfy the storage requirements. On all our stability chambers and rooms, we control temperature within 0.2°C, with uniformity of ± 1°C or better. Humidity is controlled within 0.5% RH, with uniformity of 2% RH or better.

BioCold's new BioLogic™ touchscreen interface offers user-friendly and validatable trending and communications features (USB/ethernet). The integrated data logging software is password-protected and 21 CFR part 11 compliant.

In addition to pharmaceutical products, cosmetics, veterinary products, and nutritional supplements also undergo rigorous stability testing. While the specific temperature and humidity settings may vary from one industry to the next, BioCold stability chambers are designed to satisfy both long-term and accelerated testing requirements across the stability testing market.

BioCold's stability refrigerators and freezers also offer reliable stability solutions for cold storage requirements.