We provide reliable validated stability test chambers that exceed FDA/ICH standards to help you maintain ICH specifications for proper shelf life or accelerated aging testing of your product.
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 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 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.
Storage for Specific Humidity Conditions
Long-Term and Intermediate conditions
25°C/60% RH Chambers
25°C/40% RH Chambers
30°C/65% RH Chambers
30°C/75% RH Chambers
40°C/75% RH Chambers
40°C/25% RH Chambers
Refrigerated and Freezer Conditions
-80°C AND -20°C Chambers
ICH Stability Guidelines
We offer storage solutions that satisfy the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines.