With the addition of the new space, the present obligated storage area is at 65% capacity.
PSS is a cGMP facility containing various chambers and rooms that have been mapped and validated for pharmaceutical stability storage and BioTech stability storage . These temperature and humidity controlled rooms and chambers are designed for FDA mandated shelf life studies, including intermediate testing and accelerated testing per ICH Q1A (R2).
PSS provides:
* Stability Storage at 25C/60% RH, 30C/60% RH, 30C/65% RH, 40C/75% RH, and 5 C. Additional chambers available for non-standard temperature and humidity conditions.
* Q1A (R2) compliant stability rooms and chambers that are fully validated to meet strict temperature, humidity and uniformity requirements.
* Stability rooms and chambers that are monitored 24 hours a day with part 11 compliant systems and are connected to automatic emergency generator power to ensure integrity of stored samples. If a system should go out of specification, an alarm will page PSS personnel for immediate repair.
* Back up conditioner and controls that will maintain any stability room or chamber if the primary conditioner goes down.
* A regulatory compliant facility within a cGMP environment.
PSS has designed this facility to meet the needs of companies that require off-site stability storage , redundant stability storage , short term growth needs, back-up storage, or long term stability storage conditioning.
Precision Stability Storage Increases Storage Capacity by 120