Home - Blog - Parameter Generation & Control Builds 12,000CF Stability Storage Room

Large 12,000cf stability storage room to meet ICH guidelines for pharma client.


Parameter Generation & Control recently completed construction on a 12,000-cubic-foot stability storage facility for a Chicago-area pharmaceutical client.

The facility meets specialty climatic mapping and tolerances that include four International Conference on Harmonisation (ICH) stability zones for temperature and humidity.

Stefan Cazzonelli, sales and marketing manager, said Parameter constructs such stability storage units for clients all the time and takes pride in ensuring that facilities meet strict ICH guidelines and become fully validated and operational.

“Besides providing state-of-the-art temperature and humidity controls these facilities need, Parameter engineers also ensure structural integrity based on the client’s design,” he said. “Everyone at Parameter appreciates that when it comes to conditioned environments with regulatory oversight, there’s no room for monitoring or measurement error.”

Stability storage testing is a critical part of the drug approval process. To meet regulations established by the U.S. Food and Drug Administration (FDA), pharmaceutical companies must demonstrate how a particular drug product, including packaging, reacts over time under the influence of temperature, humidity and light.

The purpose of this testing is to determine whether any physical, chemical or microbiological changes affect the efficacy and integrity of the final product, thus ensuring that it is safe and effective, regardless of where it will be supplied.

Stability testing also establishes a finished drug product’s shelf life as well as recommended storage conditions.

For the purpose of stability storage testing, the ICH divides the world into four climatic zones based on a combination of temperature and relative humidity. The climatic zones are replicated in long-term stability studies to simulate conditions a drug product could be subjected to worldwide.

5500-7000 CFM Vertical Conditioner“Parameter products are engineered to optimally deliver tight uniformity by evenly dispersing air throughout a conditioned area,” Cazzonelli said.

For the purposes of the Chicago-area pharma client, Parameter employed one of its 5500-7000 CFM conditioners, which provides a humidity control constancy of ±0.5 percent, temperature control constancy of ±0.2°C, and relative humidity uniformity of ±1.0 percent.

Using proprietary environmental conditioning technologies, Parameter Generation & Control has supplied high-quality, FDA-compliant stability storage testing solutions to leading pharmaceutical companies worldwide for more than 40 years. Parameter’s reliable and cost-effective systems are customized for specific users and employ energy efficiency standards that top competing systems.