WHEATON® has hosted a Learning Lounge session at the American Association of Pharmaceutical Scientists annual meeting (AAPS), Tuesday, November 15th, in the Exhibit Hall of the Colorado Convention Center, Denver. The session, entitled “Selecting the Best Primary Packaging Container Based on its Extractables Profile,” offers an ideal introduction to the important topic of extractables and leachables and the problems they pose in packaging drug products. The Learning Lounge presentation will feature information on the extractables profiles of different commonly used packaging materials and will highlight the new FUSION material used to produce WHEATON’s innovative DualFUSION Vials.
Attendees of WHEATON’s Learning Lounge have gained a better understanding of the risks posed by chemicals that can leach out of conventional packaging materials manufactured from medical grade polymers and compromise the safety and efficacy of drug products. The session will describe the need to test packaging materials to identify potential leachables and establish an extractables profile. Relevant USP guidelines and testing protocols will be discussed.
The AAPS meeting has taken place November 13-17 in the Colorado Convention Center, Denver, CO. The Learning Lounge is located in the Exhibit Hall.
Medical grade polymers such as Cyclic Olefin Polymer (COP) and Cyclic Olefin Copolymer (COC) are often the basic components used to manufacture drug packaging materials. However, a broad range of chemicals may be added to these resins for manufacturing purposes. Leachables and extractables testing is critical to determine which of these chemicals might be able to leach into the drug product.
Session participants have learned about WHEATON’s new purpose-built FUSION material, which combines the best properties of both plastic and glass — a strong, lightweight, and crack-resistant plastic outer surface combined with an inert, protective glass-like inner surface that has outstanding barrier performance. WHEATON used Plasma Enhanced Chemical Vapor Deposition (PECVD) Technology to fuse an organosilicate protective layer with a silica-like (SiO2) barrier layer and to fuse that glass-like layer to a Cyclic Olefin Polymer shell to form a robust covalently bonded material.
FUSION solves several key problems in pharmaceutical packaging:
- Protects against delamination (flaking of the silicon layer) to prevent leaching of metal ions into solution
- Provides a robust gas permeation barrier
- Eliminates problems of potential leachables associated with plastic-lined containers
The plastic exterior provides lightweight mechanical strength to minimize the risk of breakage, protect valuable contents, and maximize the safety of handlers.
WHEATON’s new DualFUSION Vial can withstand a temperature range of -196oC to 121oC without cracking. The vials are uniquely bar-coded to facilitate product lot traceability.
DualFUSION vials offer significant benefits for manufacturers of biopharmaceuticals such as proteins, peptides, enzymes, DNA and RNA; of complex formulations that may be sensitive to oxygen or metal ion exposure; and of high potency and radioactive substances.