Precision provides a variety of stability testing (shelf life) chambers that exceed the ICH guidelines for various temperature and humidity conditions including long-term, intermediate, accelerated, refrigerated and freezer storage conditions for pharmaceutical applications. Stability testing chambers provide cGMP storage according to FDA/ICH stability standards to help maintain ICH storage conditions.

In order to provide the proper ICH storage conditions for chemical and microbiological testing, stability chambers in the pharmaceutical industry 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.


  • 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 storage conditions of 2°C – 8°C
  • Freezer storage conditions of -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

ICH Stability Storage for Specific Temperature and Humidity Conditions

Stability Storage

25°C/60% RH Chambers
25°C/40% RH Chambers
30°C/65% RH Chambers
30°C/75% RH Chambers

Stability Storage

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


5°C Chambers
-80°C AND -20°C Chambers

Ambient Storage

15°C – 30°C


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

What are ICH Stability Guidelines?

ICH stability guidelines are policies that help determine and maintain the efficacy of drugs and pharmaceuticals. Established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), these guidelines ensure that the quality of a drug product keeps throughout its shelf life.

The ICH stability guidelines fall into different climatic zones to provide a comprehensive set of requirements for stability testing under various environmental conditions. Additionally, these guidelines cover areas such as the design of stability studies, storage conditions, testing frequency, and data analysis and help regulatory bodies and manufacturers align on scientific methodologies.

Pharmaceutical companies that adhere to the ICH stability guidelines can demonstrate that their products meet the necessary quality, efficacy, and safety criteria to keep patients safe.

ICH Storage and Stability Conditions for Testing

The ICH guidelines specify the ideal conditions for conducting stability testing according to different climatic zones to reflect the global nature of the pharmaceutical industry. Below are the storage and stability conditions defined by ICH:

  1. Long-term Testing Conditions: Long-term testing demonstrates the stability of a product during its proposed shelf life in the intended market. For Zone I (temperate) and Zone II (subtropical and with possible high humidity), this includes 25°C ± 2°C/60% RH ± 5% RH for 12 months or more and 30°C ± 2°C/65% RH ± 5% RH for 12 months or more, respectively.
  2. Intermediate Testing Conditions: Intermediate testing conditions are necessary when a significant change occurs at long-term conditions. In such cases, testing at an intermediate condition, such as 30°C ± 2°C/65% RH ± 5% RH for Zone I and Zone II, might be carried out for six months or longer.
  3. Accelerated Testing Conditions: Accelerated testing conditions can help predict the product’s stability profile in a shorter time frame. Typical conditions for this testing are 40°C ± 2°C/75% RH ± 5% RH or 40°C ± 2°C/not more than 25% RH over six months.
  4. Special Testing Conditions: Special testing conditions are for products that require specific requirements, such as refrigeration or freezing. For example, manufacturers might test products that require refrigeration at 5°C ± 3°C to determine their efficacy.


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.


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.
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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.