STABILITY CHAMBERS FOR PHARMACEUTICALS - OFF SITE ICH STABILITY STORAGE

Stability testing chambers provide storage according to FDA/ICH stability standards to help maintain ICH storage 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 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.

Off Site Stability Chamber ICH Storage for Pharmaceuticals

STABILITY CHAMBER 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 AND STORAGE CONDITIONS

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 IN OUR STABILITY CHAMBERS

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.

NUTRACEUTICALS, BIO-SCIENCES, GENETICS, COSMETICS, & TOBACCO

Precision can work with your Quality Assurance group to establish a proper storage protocol for your stability studies or follow your existing protocol. We maintain over 10 of the commonly recommended ICH stability storage conditions to provide the proper climatic zone for your study. Whether it be trial batches of a new product, API, or medical devices, we can accommodate your needs.

Precision upholds the highest sample management standards as we receive and inventory your pharmaceutical products. We’ll store your product in the pre-specified chamber at your desired product orientation, follow your protocol per pull dates, and confirm that the proper amount of samples are pulled per your selected dates and reserves.

Precision can ship your samples back to your facility or to a specified group for testing. Our stability storage facilities are equipped to provide shipping at specific temperatures from -20 to ambient temperatures and to log data during the shipment. If you are located near the storage facility, we can make pick-ups and deliveries. We also have many customers that use express shipping to destinations across the country.

 

SAMPLE TESTING STORAGE

Biological, pharmaeutical, cosmetic samples and more! Whether you’re storing with us for a 3 year study or 3 months, we can work with you to pull and ship products at the intervals you require. We take pride in our attention to detail and can also arrange for specialized shipping packages to ship at a specific temperature condition.

We provide full sample management services with our off-site stability storage services, including:

  • Receive and inventory product.
  • Place in required chamber at specified product orientation.
  • Follow your protocol per pull dates or help design proper pull dates.
  • Confirm proper amount of samples per pull dates and reserves.