Parameter provides off-site stability storage space for products that require ICH specified environmental conditions.
Our GMP facility in Wilson, N.C., contains rooms and chambers that have been mapped and validated for FDA-mandated long- and short-term shelf life studies under various temperature and humidity requirements. This includes intermediate testing and accelerated testing per ICH Q1A (R2). In addition, the Wilson facility is available for contingency management of your own on-site studies or excess storage needs. Our location is your ideal source for off-site stability storage rooms. View two cost comparison case studies that show your potential savings.
Why choose Parameter Storage?
Parameter offers an extremely cost-effective alternative to providing stability chambers in-house.
The expense of purchasing and owning a storage chamber represents a significant investment at the beginning of a study. Contracting your storage space needs with Parameter allows for significant cost reductions that can be spread across the duration of the study.
View this diagram of program options to help guide your decision.
So is it cheaper to rent or own? Learn more about the factors you should consider by reading our cases studies.
Parameter has designed the facility to meet the needs of companies that may also require short-term storage, back-up contingencies, and overflow capacity.
For your off-site storage needs, Parameter provides:
- Specific Humidity Conditions - Stability Storage 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. Additional chambers for custom temperature and humidity conditions are also 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) Compliant - Stability rooms and chambers that are fully validated to meet strict temperature, humidity and uniformity requirements.
- 24 Hour, Part 11 Compliant System - Stability rooms and chambers that 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 Parameter Chambers - Parameter’s humidity generating systems are unique. The sources for humidity, dehumidification, heating, cooling, and circulation are all packaged in 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 System – Parameter has a back up conditioner and controls in place that will maintain any stability 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.
View Photos of our Facility
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Contact
Request a quote for off-site storage by following this link.
For information about stability storage options and services, please email Ken Edwards, director of stability storage & validation, or call 252-243-2242.
Precision Stability Storage, LLC
3904 C Airport Drive
Wilson, NC 27896