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 products.
ICH Stability Testing & Guidelines for Pharmaceuticals
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 page on issues to consider when complying with ICH guidelines.
ICH Stability Storage Conditions
General ICH storage conditions include, but are not limited to:
25°C/60% RH (Relative Humidity)
Our chambers can also control custom ICH conditions such as: 30/75, 30/35, 25/40, 40/25, 5°C, and -20°C
The Parameter Advantage for Moderate, Long Term, & Accelerated Stability Studies
Parameter provides precise control and distribution for stability chambers. This allows for problem-free mapping validations. Our equipment is reliable, cost effective, and has low energy requirements.
Parameter Precisely Controls:
- 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.
- Reach-in Chambers
Various sizes of reach-in chambers that provide relative humidity control to ±0.5% RH and temperature control to ±0.2° C.
- Walk-in Rooms
Versatile modular rooms that can be configured to a specific application or size requirement. These rooms will also maintain ±0.5% relative humidity control and ±0.2° C temperature control.
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 or qualification program or an emergency response to a critical compliance situation, our validation services team will respond to your needs with proven resolution, expertise and confidence.