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New England Precision Stability Storage Facility Validated

ICH-specified environmental conditions available for products in all industries

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By: Tim Wright

Editor-in-Chief, Contract Pharma

A new Precision Stability Storage facility serving the Northeast has been fully validated and is ready for immediate occupancy.

The facility, located in Hopedale, MA, 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.

Precision Stability Storage provides off-site stability storage for products that require International Council for Harmonization (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% redundant controls and conditioners, as well as automatic electrical generator back up, in the unlikely event of a power loss.

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