Key Elements to Consider when Packaging Parenteral Products
WHEATON® recently announced that Global Market Manager, Jeffrey Reid, presented the education session “Key Elements to Consider when Packaging Parenteral Products” during INTERPHEX 2016 at the Javits Center in New York. The session provided 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. The session was recorded and can now be viewed on WHEATON® Industries YouTube page through the following link, https://www.youtube.com/watch?v=rTpqp79-JBI&feature=youtu.be.
In his presentation, Reid detailed the critical processes of particulate cleaning, depyrogenation, and sterilization necessary for the packaging containers of injectable drugs. He also described 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 focused 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.
Reid’s presentation also touched on the effects of sterilization when it comes to extractables and leachables. He noted that the sterilization of componentry and packaging/container closure system, especially elastomeric or polymer materials, can dramatically affect the extractable and leachable profile of a product. In addition, chemicals used to clean packaging components can also contribute to the leachable profile of the product.
In summary, it is paramount to fully understand specific standards and the testing methods that are associated with pharmaceutical packaging so good manufacturing practices are met at all times. Reid’s education session touched on the three topics below.
• Key processes primary packaging components undergo for finished injectable drugs
• Test methods for USP <788>, USP <85> and USP <71>
• Introduction of extractables and leachables along with the effects they have from sterilization