Stability, Storage, and Testing

Since the establishment of pharmaceutical expiration dating requirements, Celsis Laboratory Group has provided appropriate storage conditions to meet regulatory and client requirements. Stability conditions are expanded and upgraded to remain current with the ICH (International Conference on Harmonization) Guidelines as well as the FDA Guidelines. Standard Operating Procedures are maintained for the following:

• General stability requirements and operations
• Labeling, handling and storage of stability samples
• Computerized sample entry
• Computerized reporting of stability tests
• Quality Control program for stability storage units/areas

The following storage conditions are currently available:

• Ultrafreezer NMT -70°C
• Freeze/thaw -20°C to 50°C programmable
• 20°C ±5°C
• 20°C ±3°C
• 23°C ± 2°C / 75% RH ± 3% RH*
• 25°C ± 2°C / Ambient Humidity
• 25°C ± 2°C / 40% RH ± 5% RH
• 25°C ± 2°C / 60% RH ± 5% RH
• 30°C ± 2°C / 60% RH ± 5% RH
• 30°C ± 2°C / 65% RH ± 5% RH
• 40° ± 2°C
• 40°C ± 2°C / NMT 25% RH
• 50°C ± 2°C

* Condition for container permeation testing

Additional temperature and humidity conditions available on request