Company provides ICH-specified environmental conditions for products in all industries
Precision Stability Storage is expanding its geographic presence with the opening of a new facility in Hopedale, Mass. Located just west of Boston, the facility is strategically placed to serve the entire Northeast.
This expansion is coupled with the company’s 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 U.S. Food and Drug Administration’s Part 11 regulations. The company also provides sample management and monitoring within its state-of the-art facilities.
All Precision Stability Storage rooms and 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.
“Precision Stability Storage has built significant relationships with clients throughout the Northeast corridor that make now the ideal time to expand our presence and reinforce our continued support to them,” said Clay Hile, managing director. “Our new site puts us in a great place geographically to offer existing and prospective clients the space and conditions needed to ensure the short- and long-term storage integrity of their products.”
Managing the New England facility will be Jeff Plugis, who has more than 25 years of experience managing humidity instrumentation, as well as meteorology-based humidity calibration companies. Having Plugis on board is a perfect situation for Precision Stability Storage’s Northeast facility, Hile said.
“Jeff is ideal for this position. His unique background brings to our growing team tremendous knowledge about global regulatory requirements as well as first-hand experience when it comes to maintaining a cGMP facility,” Hile said. “He will do a great job and I’m excited about the opportunities he and our new facility will create for our company.”
Precision Stability Storage has a strategic alliance with Parameter Generation & Control (Parameter) 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 to pharmaceutical companies in more than 30 countries.