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.

In order to provide the proper conditions for chemical and microbiological testing, stability testing chambers need to maintain prolonged humidity, light, and temperature conditions for clinical and testing protocols. Precision Stability Storage is dedicated to partnering with pharmaceutical companies to produce the best 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 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.

Off Site ICH Storage Testing

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

ACCELERATED CONDITIONS

40°C/75% RH Chambers
40°C/25% RH Chambers

REFRIGERATED AND FREEZER CONDITIONS

5°C Chambers
-80°C AND -20°C Chambers

Ambient Storage

15°C – 30°C

ICH STABILITY GUIDELINES

We offer storage solutions that satisfy the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) storage condition guidelines.

WE STORE REFERENCE SAMPLES

Precision Stability and storage recognizes the importance of reference samples.

Reference samples – starting material samples kept safe for testing and analysis

We provide space specifically validated to accept retains for products requiring storage between 15° and 30° and that follows FDA guidelines regarding the storage of reference standards.