Stability Testing
Chambers designed to meet ICH, FDA, GMP, and GLP guidelines
Stability testing provides evidence to a regulatory body that the quality of the product or raw material doesn’t vary with time, under the influence of a range of different factors including temperature, humidity and light. ESPEC Stability Chambers meet or exceed current regulations of the Medicines and Health Regulatory Authority (MHRA), Food and Drug Administration (FDA) or other competent regulatory organisations.
ESPEC stability chambers test:
- Shelf life
- Ingredient degradation
- Packaging
- Expiration Dating
Summarized below are the recommended environmental conditions per Q1A(R2): (Stability Testing of New Drug Substances and Products).
An increasing number of pharmaceutical companies are requesting the calibration of data loggers to cover these requirements.
| Study | Storage condition | Minimum time period |
|---|---|---|
| Long Term | 25°C ± 2°C / 60% RH ± 5% RH | 12 months |
| 30°C ± 2°C / 65% 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 |
Pharmaceutical Applications
Related Links
Stability Testing Model Comparison
| Model / Link | Interior Dimensions (W x D x H) |
Interior Volume | Temperature Range | Humidity Control | Notes | |
|---|---|---|---|---|---|---|
| EZO30-EA | 27.5" x 27.8" x 63.5" | 28.1 cu. ft. | 10 to 65°C | Yes | ||
| EZO60-EA | 55" x 27.8" x 63.5" | 56 cu. ft. | 10 to 65°C | Yes | ||
| BTZ-475 | 19.6" x 15" x 23.6" | 4 cu. ft. | -70 to 180°C | No | up to 2.75°C/min. | Also available with humidity control |
| ESPB364 | 62" x 108" x 94" | 364 cu. ft. | (-10 or 10) to 85°C | Optional | up to <1°C/min. | Galvanized or stainless steel interior |
| ESPB499 | 85" x 108" x 94" | 499 cu. ft. | (-10 or 10) to 85°C | Optional | up to <1°C/min. | Galvanized or stainless steel interior |
| ESPB634 | 108" x 108" x 94" | 634 cu. ft. | (-10 or 10) to 85°C | Optional | up to <1°C/min. | Galvanized or stainless steel interior |
| ESPB770 | 131" x 108" x 94" | 770 cu. ft. | (-10 or 10) to 85°C | Optional | up to <1°C/min. | Galvanized or stainless steel interior |
| ESPB904 | 154" x 108" x 94" | 904 cu. ft. | (-10 or 10) to 85°C | Optional | up to <1°C/min. | Galvanized or stainless steel interior |
| ESPB1040 | 177" x 108" x 94" | 1040 cu. ft. | (-10 or 10) to 85°C | Optional | up to <1°C/min. | Galvanized or stainless steel interior |
| Click model number for details, including metric & english units. | ||||||
