Off-Site Pharmaceutical
Stability Storage Rooms
for the Bio-tech & Pharmaceutical
Industries
Precision Stability Storage (PSS), located in Wilson,
NC, provides modular offsite stability storage rooms
that are fully compliant with International Conference
on Harmonization (ICH) guidelines. We offer modular
pharmaceutical stability storage rooms for FDA-mandated
shelf-life studies, cold-testing chambers, environmental
control systems, and 21 CFR Part 11-compliant monitoring
systems.
Offsite
Stability Storage Rooms at an Affordable Price
One of the constant necessities in the pharmaceutical
industry is to develop information about the stability
of active pharmaceutical ingredients and drug products.
Our modular pharmaceutical stability
rooms offer precise
temperature control and precision humidity control
for materials that are in development, in the clinic,
or that are being commercially manufactured. Testing
chambers and pharmaceutical stability storage rooms
provide exact humidity and temperature control for
product testing.
Our modular off-site stability storage rooms and chambers
are rigidly designed, mapped, and validated to comply
with government-regulated pharmaceutical and biotechnology
storage requirements. Each of our stability rooms are
Q1A(R2) compliant and are is continuously monitored
with software that is 21 CFR Part 11 compliant, with
remote paging for immediate response to alarm conditions.
A complete back-up conditioning system is on site as
well as an automatic emergency generator provides redundant
facility power to ensure the integrity of stored material.
ICH Compliant Pharmaceutical Stability Storage Rooms
The FDA published the "Q1E Evaluation of Stability Data" guidance in 2004. Precision Stability Storage, LLC facilities are a cGMP solution for outsourcing your environmental test chamber needs and shelf-life rooms for pharmaceuticals, to meet both FDA requirements and the ICH stability storage guidelines.
Modular pharmaceutical stability rooms can be used for accelerated storage testing and intermediate storage conditions for pharmaceutical or biotech storage. All our chambers and rooms have been mapped and feature full pharmaceutical and biotech industry validation.
Rather than take on the operational costs of maintaining your own stability
storage chambers for pharmaceutical and biotech materials, let us show you how to be more efficiently compliant ICH and FDA guidelines.
Precision Stability Storage | Wilson, NC | Email Us
Off-Site Pharmaceutical
Stability Storage Rooms