Month: January 2017

503B, cGMP, FDA grade Compliance and Validation Services

Aseptic Enclosures, via it’s affiliation with Life Scientific, Inc. will now offer Mesa Laboratories’ Compliance and Validation Services to the 503B market segment. The agreement allows Aseptic Enclosures to provide FDA cGMP grade Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and services to outsourcing 503B facilities. Our validation Team has many …

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Hospira Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. In the unlikely event that the particulate is administered to a patient, …

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Case Study: Hospital Upgrades Cleanroom for a Fraction of the Anticipated Time and Cost

Here’s a case study about a customer that saved a lot of time and money by implementing Aseptic Enclosures’ HEPACirc™ for their facility. [pdf-embedder url=”https://jsclogisticsinc.com/asepticenclosures/wp-content/uploads/Aseptic-Enclosures-HEPAcirc-Case-Study-v1.pdf”] Aseptic Enclosures’ HEPACirc™ is a general purpose, “Plug-and-Play” Clean Room Grade, air purification upgrade system ideally suited to many types of clean mechanical or processing work. It is designed to …

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