Since 2005, Aquabiliti has been a wholly American-owned manufacturer serving pharmaceutical, biotechnology, and medical-device customers from facilities in Pennsylvania and Tennessee. Known for keeping single-use system design and production in-house, the company develops tailored sterile water and process solutions for regulated life-sciences workflows. Its U.S. facilities are ISO 13485 certified, with the Pennsylvania operation also housing a 60,000-square-foot cGMP-compliant aqueous-solutions facility.
FDA-Registered Class II Medical Device Manufacturer
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ISO 13485:2016
certification
cGMP Compliance
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21 CFR Part 820 Quality System Compliance
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