Introduction
Stability evaluation of products is a critical requirement in the determination of their safety, quality and efficacy.
FDA & ICH guidance include in the design of stability study the following considerations:
- Container/closure specification and its effect on product stability
- Storage conditions for products in general relative to various temperature and humidity requirements:
- Long term studies at 25 ± 2 șC and 60 ±5 % RH (for a period of 12 months)
- Intermediate studies at 30 ± 2 șC and 65 ±5 % RH (for a period of 6 months)
- Accelerated studies at 40 ± 2 șC and 75 ±5 % RH (for a period of 6 months)
- Stress studies may be conducted by increasing the temperature of the Accelerated test conditions at 10 șC intervals (e.g., 50 șC, 60 șC, ..) and 75 %RH.
- Storage conditions for products intended to be stored in refrigerators relative to various temperature and humidity requirements:
- Long term studies at 5 ± 3 șC (for a period of 12 months)
- Accelerated studies at 25 ± 2 șC and 60 ±5 % RH (for a period of 6 months)
- Storage conditions for products intended to be stored in freezers relative to various temperature and humidity requirements:
- Long term studies at 20 ± 5 șC (for a period of 12 months)
- Storage conditions for products intended to be stored semi-permeable containers relative to various temperature and humidity requirements:
- Long term studies at 25 ± 2 șC and 40 ±5 % RH (for a period of 12 months)
- Intermediate studies at 30 ± 2 șC and 35 ±5 % RH (for a period of 6 months)
- Accelerated studies at 40 ± 2 șC and 25 ±5 % RH (for a period of 6 months)
- Storage conditions for emulsions relative to various temperature and humidity requirements:
- Heating & cooling cycles should performed between 4 șC & 45 șC
Opulus provides various levels of solution products based on PyroButton Self-powered data-loggers, communication systems, and integrated software to meet the requirement for Temperature and Humidity Mapping of the Stability Chambers, Validation of the Storage Conditions, Temperature & Humidity Tracking of Products, Permeability Studies of Containers/Closures, Challenge Studies of Containers/Closures, Calibration of Stability Chambers, Maintenance, Qualification & Re-Qualification of Stability Chambers.
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