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Raleigh, NC, United States, 2013/08/19 - Parameter provides off-site stability storage space for products that require International Conference on Harmonisation (ICH)-specified environmental conditions - HumidityControl.com.
The company’s stability storage rooms and chambers are fully validated to meet strict temperature, humidity and uniformity controls. Chambers and rooms are monitored 24/7 and are current Good Manufacturing Practices (cGMP) compliant.
Parameter Stability Storage rooms and chambers have been mapped and validated for FDA-mandated long- and short-term shelf life studies under various temperature and humidity requirements.
In addition, Parameter offers back-up contingency storage to businesses whose own stability storage facilities prove inadequate because of space constraints, disastrous weather conditions or electrical failures.
“Our expanded capacity puts us in a great position to offer clients all the space and conditions they require,” said Clay Hile, president and CEO. “Our stability storage assures clients that the integrity of their study or product never will be compromised.”
Parameter Stability Storage provides:
• Specific humidity conditions. Conditions are set at 25°C/60% RH, 30°C/60% RH, 30°C/65% RH, 40°C/75% RH, 30°C/75% RH, 25°C/40% RH and 5°C, with custom temperature and humidity conditions available.
• -20°C freezers. The freezers provide tight overall chamber uniformity of ±0.85°C, remaining in ICH uniformity specification during defrost cycles.
• Fully validated Q1A (R2) compliance. Rooms and chambers are fully validated to meet strict temperature, humidity and uniformity requirements.
• 24 Hour, Part 11 compliant system. Rooms and chambers are monitored 24 hours a day with part 11 compliant system and are connected to an automatic emergency generator power to ensure integrity of stored samples. If a system should go out of specification, an alarm will page Parameter personnel for immediate repair.
• Unique chambers. Sources for humidity, dehumidification, heating, cooling and circulation are packaged within one self-contained unit. This unit is specifically designed to provide 250-400 CFM of conditioned air to small rooms and reach-in chambers. The conditioner is designed to produce very precise humidity and temperature control.
• Complete backup. Parameter has controls in place to maintain any room or chamber if the primary conditioner goes down, plus a back-up generator to power the entire facility in the case of an electrical outage.
Headquartered in Black Mountain, N.C., with stability storage facilities close to the Research Triangle Park, Parameter Generation & Control (humiditycontrol.com) is an internationally respected innovator and manufacturer of precise stability storage products.
Known for their dependability, Parameter products continually surpass industry expectations with their technologically advanced energy conservation.
Currently, Parameter products protect items such as the Gutenberg Bible and the Gettysburg Address, both at the Library of Congress in Washington, D.C.