Stability

Stability studies are becoming increasingly important in the (bio)pharmaceutical development and registration process, and soon will be extended to the postmarketing period when the “On going Stability”-addition to the EU guide to Good Manufacturing Practice will be approved. For every (bio)pharmaceutical production facility the stability burden on the QC-department will become critical for the capacity of equipment, storage space and human resources. With our experience and facilities, PROXY is able to take care of your stability studies efficiently and cost-effectively.

Storage facilities

• -80 °C
• -20 ± 3 °C
• 5 ± 3 °C
• 15 ± 3 °C
• 25 ± 2 °C / 60 ± 5 % RH
• 30 ± 2 °C / 65 ± 5 % RH
• 40 ± 2 °C / 75 ± 5 % RH

Additional climate chambers are available for other temperature / humidity combinations.