An ICH Validated Stability Storage Facility
Multiple 900 cubic foot chambers that are fully mapped, validated, and exceed ICH guidelines.
State-of-the-Art Offsite Stability Storage Rooms and Chambers
Precision Stability Storage (PSS) provides multiple pharmaceutical stability chambers for the storage of products that require environmental conditions that must adhere to ICH guidelines. Our cGMP facility contains various chambers and rooms that have been mapped and validated for pharmaceutical stability storage and BioTech stability storage.
Our stability rooms and chambers are designed for FDA mandated shelf life studies under various temperature and humidity requirements 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 compliantsystem and are connected to an 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.
Precise Control
Typical Room Layout
Elevation
Plan View
Learn more about the PSS "off-site" storage advantage. Expense of owning a chamber requires most of the investment at the beginning. Using PSS allows the expense to be spread across the duration of the study:
ICH Storage
Immediate Availability:
25°C / 60% RH
25°C / 40% RH
30°C / 65% RH
30°C / 75% RH
40°C / 75% RH
Features:
- ICH validated facility.
- Various temperature and RH conditions available.
- 100% redundant controls and conditioner.
- Electric generator back-up (automatically switches on power loss).
- Continuous monitoring of each chamber that is Part 11 compliant.
- Space and capacity to grow.
Benefits:
- Exceeds required specifications for temperature and humidity control.
- Validated storage available at various conditions including 25°C/60%, 30°C/65%, 40°C/75%, and 5°C.
- Reliable storage at specified conditions. Insurance against mechanical failure.
- Reliable storage at specified conditions. Insurance against utility service failure.
- Assurance that specification are continuously provided.
- Capable to meet future storage needs.
