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The session, to be held April 26, will detail critical practices and standards the FDA enforces for parenteral drug packaging
Millville, NJ – WHEATON® announces that Global Market Manager Jeffrey Reid will present the education session “Key Elements to Consider when Packaging Parenteral Products” on Tuesday, April 26 at 11:30 a.m. during INTERPHEX 2016 at the Javits Center in New York. The session will provide attendees with the information necessary to understand the specific USP standards and testing methods necessary to meet good manufacturing practices and to ensure the packaging is compliant with current Food and Drug Administration regulations.
In his presentation, Reid will detail the critical processes of particulate cleaning, depyrogenation and sterilization necessary for the packaging containers of injectable drugs. He will also describe the test methods related to these processes for finished injectable drugs as detailed by the United States Pharmacopeia (USP) and enforced by the FDA. Reid’s talk will focus on USP <788> “Particulate Matter in Injections”, USP <85> “Bacterial Endotoxins Test” and USP <71> “Sterility Test” and how each separate standard is met in order to maintain the integrity of the finished product.
In addition, the session will explore the issue of extractable and leachable components related to the use of elastomers and polymers for the packaging material, as well the role cleaning chemicals can play in the leachable profile as detailed in USP <1663> and <1664>.
“Preparing packaging for parenteral drugs is a time-consuming, multistep process that can add significant expense,” said Wayne Brinster, WHEATON® CEO. “Because of our experience producing purpose-built solutions for our customers, including ready-to-fill products for the parenteral drug industry that meet all of these standards, Jeff Reid is uniquely suited to provide this information to the attendees at INTERPHEX.”
Throughout its 126-year history, WHEATON has been dedicated to supporting scientific advances and discovery by providing innovative solutions for the laboratory research, diagnostic, and specialty pharmaceutical industries. The company’s expertise in designing and manufacturing plastic and glass containers with a wide selection of closure systems and custom solutions ensures the secure storage and delivery of sensitive materials and precious biomedical specimens around the globe. For more information, visit
WHEATON Contact:
Tracy Neri-Luciano
Global Director of Marketing
(856) 825-1100, x2655
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Brandwidth Solutions
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