PHARMACEUTICAL STABILITY TEST CHAMBERS FOR OFF SITE ICH STABILITY STORAGE
Stability testing chambers provide storage according to FDA/ICH standards to help maintain ICH conditions for proper shelf life or accelerated testing of pharmaceutical products for pharmaceutical drug development.
In order to provide the proper conditions for chemical and microbiological testing, stability testing chambers need to maintain prolonged humidity and temperature conditions for clinical and testing protocols. Precision Stability Storage is dedicated to partnering with pharmaceutical companies to produce the best environmental conditions for stability testing storage possible.
Precision Stability Storage is a full storage service provider. We not only store your product at your specified temperature ranges and humidity levels but we can assist with proper pull protocols for your batches and can set up automated schedules to provide your drug substances and products for testing at the proper intervals.
We will also work with your group to schedule the type of shipment that will best fit your pharmaceutical stability testing requirements.
OUR FACILITY OFFERS THE FOLLOWING OFF SITE ICH STORAGE CONDITIONS:
- Long-Term and Intermediate conditions of 25°C/40%Rh, 25°C/60%Rh, 30°C/65%Rh, 30°C/ 75%Rh, 30°C/35%Rh
- Accelerated storage of 40°C/not more than (NMT) 25%Rh, 40°C/75%Rh
- Refrigerated and Freezer storage conditions of 2°C – 8°C (5°C), -20°C, and -80°C
Our facility is a validated cGMP (current good manufacturing practice) facility designed to meet Zones I – IV global submission requirements per ICH Harmonised Tripartite Guideline – Stability Testing of New Drug Substances and Products Q1A(R2). We provide precise, uniform temperature and humidity conditions for your pharmaceutical studies.