Precision Stability Storage provides off-site stability storage services for products that require ICH specified environmental conditions. In strategic alliance with Parameter Generation & Control, Precision offers the highest-quality equipment and facilities available for environmental and humidity control.
Stability chambers that exceed FDA/ICH standards to help you maintain ICH specifications for proper shelf life or accelerated aging testing of your product.
SPECIFIC HUMIDITY CONDITIONS
We provide the most commonly requested humidity conditions, from 25°C/60% RH to 40°C/75% RH and 25°C/40% RH.
FULLY VALIDATED Q1A (R2) COMPLIANT
COMPLETE BACKUP SYSTEM
Precision Stability Storage 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.
-80°C AND -20°C FREEZERS
The freezers provide tight overall chamber uniformity of ±0.85°C, remaining in ICH uniformity specification during defrost cycles.
UNIQUE PARAMETER CHAMBERS
Humidity generating systems from Parameter are unique. The sources for humidity, dehumidification, heating, cooling, and circulation are all packaged in one self contained unit.
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.
Why Choose Precision Stability Storage?
Precision Stability Storage offers an extremely cost-effective alternative to providing stability rooms 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 us allows for significant cost reductions that can be spread across the duration of the study, all while maintaining FDA/ICH stability requirements.
So is it more cost effective to rent or own? Learn more about the factors you should consider by reading our case study.
Precision Stability Storage has designed the facility to meet the needs of companies that may also require short-term storage, back-up contingencies, and overflow capacity.
Whether you’re storing with us for a 3 year study or 3 months, we can work with you to pull and ship products at the intervals you require. We take pride in our attention to detail and can also arrange for specialized shipping packages to ship at a specific temperature condition.
We provide full sample management services with our off-site stability storage services, including:
- Receive and inventory product
- Place in required chamber at specified product orientation
- Follow your protocol per pull dates or help design proper pull dates.
- Confirm proper amount of samples per pull dates and reserves.
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