Precision Stability Storage, LLC (PSS) has just increased its pharmaceutical stability storage capacity by 120% with the addition of new Parameter Generation and Control (PGC) rooms and conditioners. With the addition of the new space in Wilson, NC, 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 25°C/60% RH, 30°C/60% RH, 30°C/65% RH, 40°C/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.
