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We are excited to announce that thanks to the overwhelming support of our team members over the last 18 years, West’s donations to Camp Victory have now surpassed the $1 Million dollar mark!
Camp Victory, “a special place for special children,” is a camp located in Millville, PA (near West’s Jersey Shore and Williamsport sites) that serves as a fun camp retreat for children living with chronic health challenges. While at Camp Victory, a specialized staff ensures the children receive the greatest possible care, support and personal growth, while having much fun and making many friends.
Camp Victory hosted its first group of campers in 1994 and has grown steadily into the impressive facility and program it is today and has hosted over 30,000 overnight campers and counselors. Daily activities for campers include a variety of options, including archery, waterfront, challenge course, arts and crafts, and much more.
The complexity of bringing a combination product, such as an on-body delivery system (OBDS), to market cannot be overstated. Changing or unclear regulations are often cited by the industry as a major source of confusion which contributes to that complexity. However, continuous incorporation of updated standards and newly issued guidance documents during the development process can reduce risk, improve patient safety, save time and headaches when the submission date ultimately approaches.
USP General Chapter<382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems is slated to become official on December 1, 2025. This allows five years from the date of publication in December of 2020 for stakeholders to implement the new testing requirements for full compliance. While that date seems to be far off in the future, there has been interest in early adoption of the new chapter and implementation of the various tests it requires.
United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The original USP chapter for elastomeric components used in injectable drug packaging was <381> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems, which addressed characterizing for biological reactivity, physicochemical testing and functionality testing. The new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025 and will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. While under USP <381> compliance was typically a supplier responsibility, under the new chapter it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system, including the container closure system and the drug.