ICH-specified environmental conditions available for products in all industries
HOPEDALE, MASS. — A new Precision Stability Storage facility serving the Northeast has been fully validated and is ready for immediate occupancy.
The facility — located in Hopedale, Mass., just west of Boston — offers a full suite of conditioning options, including walk-in rooms and –80-degree freezers.
Precision Stability Storage’s latest expansion into the Northeast follows the company’s recent launch of a new corporate brand and website — www.precisionstabilitystorage.com — intended to better communicate its identity, vision and scope of work.
Precision Stability Storage provides off-site stability storage for products that require International Council for Harmonisation (ICH)-specified environmental conditions using proprietary high-quality and validated equipment compliant with the U.S. Food and Drug Administration’s (FDA) Part 11 regulations. The company also provides sample management and monitoring within all of its state-of the-art facilities.
All rooms and chambers have been fully 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. In addition, rooms and chambers incorporate 100-percent redundant controls and conditioners, as well as automatic electrical generator back up, in the unlikely event of a power loss.
Precision Stability Storage has a strategic alliance partnership with Parameter Generation & Control that allows the company to offer high-quality Parameter equipment needed to maintain the rigorous temperature and humidity control and uniformity customers need and expect. Parameter provides stability storage chambers and rooms to pharmaceutical companies in more than 30 countries worldwide.