Industry Insights: Stability Chambers in Pharmaceuticals

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What Are Pharmaceutical Stability Chambers?

Pharmaceutical stability chambers are used so that scientists may conduct stability testing. In order to get full FDA approval for new drug products, drug manufacturers must conduct extensive research on their product before it is released to the public. Stability testing aims to prove that the substance or performance of a drug product does not degrade prematurely under normal conditions. These are commonly referred to as shelf-life studies. Pharmaceutical stability chambers are used to control these conditions.

Why are Stability Chambers for Pharmaceuticals Important?

Pharmaceutical stability chambers are essential tools for ensuring the quality and safety of medications. They provide controlled environments that allow manufacturers to:   

• Predict shelf life by exposing drugs to various temperature and humidity conditions.   
• Identify potential degradation, safeguarding patient health.
• Meet FDA requirements for drug approval and ensure ongoing product quality.
• Optimize formulations, packaging, and storage conditions for maximum efficacy.
• Support the global distribution of safe and effective medications.

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ICH STABILITY CHAMBERS & SERVICES FOR THE PHARMACEUTICAL INDUSTRY

We have over 40 years of experience providing pharmaceutical stability chambers, validation, and compliance services. Our humidity control chambers enable you to test the stability and shelf life of your pharmaceutical products with precision. We accommodate moderate, long-term, and accelerated stability tests, allowing you the full range of conditions you may need to use to test the degradation of your pharmaceutical products via ICH stability chamber storage.

ICH Guidelines & Testing Pharmaceutical Stability Chambers

Any drug product or substance must undergo stability testing in order to be approved by the US FDA and other regulatory organizations. Stability testing allows us to verify how a pharmaceutical product will react in regards to changes in the surrounding environment. Subsequently, this enables those in the pharmaceutical field to identify a product’s shelf life and determine whether any physical, chemical or microbiological changes affect the efficiency and integrity of the final product, thereby ensuring that a pharmaceutical or regulated product is safe and effective, irrespective of where in the world it will be supplied. These stability guidelines are outlined by ICH Q1A(R2) standards. We understand that in FDA regulated environments there is no room for error in monitoring or measurement. Parameter offers humidity stability chambers and associated services that meet ICH storage conditions for moderate, long term, and accelerated stability studies. If you are interested in learning more about these standards in relation to temperature and humidity control, please read our overview of ICH Stability Guidelines for Pharmaceutical Stability.

ICH Conditions For Stability Storage

General ICH stability chamber storage conditions include, but are not limited to:

• 25°C/60% RH (Relative Humidity)
• 30°C/65% RH
• 40°C/75% RH

Our pharmaceutical stability chambers can also control custom ICH conditions such as: 30/75, 30/35, 25/40, 40/25, 5°C, and -20°C

Why Choose Parameter for Pharmaceutical Stability Storage Solutions?

Parameter provides precise control and distribution for stability chambers used in the pharmaceutical industry. This allows for problem-free mapping validations. Our stability storage equipment is reliable, cost effective, and has low energy requirements.

Precise Control Systems for Stability Chambers:

• Control Constancy – Parameter provides precise single point humidity and temperature control (±0.5% RH /±0.2°%C).
• Uniformity across the conditioned space – Parameter provides a tight uniformity by engineering optimal distribution systems that evenly disperse the air through a conditioned area.
• Sensor Accuracy – Parameter utilizes high-grade humidity and temperature sensors and maintains the calibration over the range of conditions required.

Stability Chambers for Pharmaceuticals 

Visit our catalog and search for the room or stability chambers that best fits your stability storage needs for pharmaceuticals.

• Conditioning Systems
  The same conditioning systems we provide for the walk-in rooms can also be applied to existing rooms, chambers or manufacturing processes.

Preservation Solutions for the Pharmaceutical Industry

Parameter offers a comprehensive range of preservation solutions for the pharmaceutical industry, with a focus on providing high-quality stability chambers for purchase. These include walk-in cold rooms and freezers ideal for bulk storage of temperature-sensitive pharmaceuticals.

Walk-in Cold Rooms

Our modular walk-in cold rooms provide precise temperature control and flexible storage for bulk pharmaceuticals, vaccines, and other sensitive materials. These ensure consistent temperatures and optimal storage conditions with the right configurations.

Walk-in Freezers

Preserve critical pharmaceuticals at ultra-low temperatures with our high-performance walk-in freezers. Engineered for reliability and efficiency, these freezers offer advanced temperature control, monitoring capabilities, and robust construction to safeguard your valuable products.

Explore our full range of cold rooms and freezers for the pharmaceutical industry.

ICH STABILITY CHAMBER VALIDATION AND COMPLIANCE SERVICES

Parameter’s validation services group can provide turn-key cost effective solutions to your validation and compliance challenges. Whether it is the challenge of setting up a validation, qualification program or an emergency response to a critical compliance situation, our team provides reliable solutions and support, ensuring your stability chambers consistently meet industry standards.

Read more about Parameter Validation & Compliance Solutions.

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