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.
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Precision Stability Storage -
An ICH Validated Storage Facility
Multiple 900 cubic foot chambers
that are fully
mapped, validated,
and exceed ICH guidelines.
Download PDF 
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 compliant system
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
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