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 am 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 (FDA) 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.”
Pharmaceutical Processing is a platinum sponsor of INTERPHEX.
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