WILSON, N.C. – A new dual-zone freezer/cooler installed at Precision Stability Storage will deliver greater capacity and redundancy for clients, as well as maintain International Conference on Harmonisation (ICH) specifications for both rooms, even during defrost cycles.
This innovative system controls two stability rooms — one set at -20°C and the other at 5°C — with one single energy-efficient conditioner that maintains ICH specifications for both rooms,.
Precision Stability Storage’s new dual-zone room offers several important benefits to clients, including:
- Greater capacity. The new dual-zone room substantially increases Precision Stability Storage’s freezer and cooler capacity.
- Greater redundancy. All of the environmental chambers at Precision are 100-percent protected by a back-up conditioning unit. This new dual-zone room enhances the redundancy protection by automatically switching conditioners. If one unit goes out of service, the other unit will continue to maintain specified conditioners, even during defrost cycles, to ensure redundancy at all times.
- Tighter ICH compliance. With conventional, commercially available freezers, it is common for the freezer room to warm up as much as 8°C to 10°C during a necessary defrost cycle. The dual-zone operation of this system reduces the amplitude of that defrost spike, and maintains conditions in the room within 1-2°C during a defrost cycle — offering even tighter ICH compliance for those clients who need absolute precision for their stored products.
“Since temperature excursions due to defrost cycles are eliminated, the integrity of our clients’ samples remain uncompromised throughout the duration of their studies,” said Ken Edwards, Director of Quality Operations. “The dual units provide redundancy, and also allow us to perform periodic preventative maintenance without any downtime or room entry. The uniformity within the chamber allows Precision Stability Storage to maximize capacity since there are no hot or cold spots typically associated with -20°C and 5°C chambers. We’re excited to offer sample storage utilizing this cutting-edge technology to our clients requiring the most stringent levels of precision and consistency.”
The technology behind the dual-zone freezer/cooler was developed by Parameter Generation & Control, a strategic alliance partner of Precision Stability Storage. The alliance allows Precision Stability Storage to offer clients high-quality Parameter equipment needed to maintain rigorous temperature and humidity control and uniformity.
Precision Stability Storage provides off-site stability storage for products that require ICH environmental conditions. The facility is cGMP compliant and also provides sample management and monitoring at its state-of the-art facilities.
All Precision Stability Storage chambers meet or exceed ICH guidelines and 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 guidelines for the stability testing of new drug substances and products. Learn more at http://precisionstabilitystorage.com/