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West is committed to the safe and efficient delivery of drug products to patients. Key to this is not only staying abreast of industry developments, but also being prepared to help customers address them. This is a focus of the Integrated Solutions platform.
For example, Dow Corning recently introduced a new product – Dow Corning® 366 35% Dimethicone NF Emulsion – an update of their 365 product. The difference between 365 and 366 is that the 366 product does not use a surfactant listed on the European Chemicals Agency REACh (Registration, Evaluation, Authorisation and Restriction of Chemicals) Authorisation List. These silicone-based products are used widely in the lubrication of glass syringes.
Switching to 366 presents a challenge of having to qualify new products; West is well-positioned to assist those customers facing this challenge through offerings that include filling syringes, evaluation of essential performance requirements (e.g., break loose and glide force, delivery volume, container closure integrity), identification of any incompatibility (e.g., drug product interaction with silicone product that alters syringe function or results in particulate formation), and evaluation of targeted leachables.
West has the staff, expertise and facility to design and execute the experiments needed to help reduce customer risk. For more information, contact an Account Manager, or Technical Customer Support (TCS) representative.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Dow Corning® is a registered trademark of Dow Corning Corporation.
The Tech Group’s Vice President and General Manager, Mike Treadaway, was recently honored with the Spirit of Philanthropy Award at the Association of Fundraising Professionals Greater Arizona Chapter’s 30<sup>th</sup> Annual Philanthropy Leadership Awards Dinner. The celebration honors those who advance philanthropy with awards including the Spirit Award, which recognizes outstanding philanthropic contributions to nonprofit organizations.
When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure. For the purposes of this discussion, the focus will be on the functional performance of the stopper and what key aspects should be considered during the assessment and selection process. Coring and fragmentation, container closure integrity, and machinability of the stoppers will be briefly reviewed.
<p>By Katrina Firlik, MD<br>Chief Medical Officer<br>HealthPrize Technologies</p><p>Although modern pharmaceuticals and advanced drug delivery systems save and improve the lives of millions of people around the world, there are countless others whose lives are not saved or improved—because they don’t take the medication at all, or often enough. Former Surgeon General C. Everett Koop summed it up best: “Drugs don’t work in patients who don’t take them.”</p>
Rubber components are essential for the safe containment and delivery of parenteral drug products. Many rubber formulations used in the pharmaceutical industry are based on halobutyl rubbers. Halobutyl rubbers, typically bromobutyl or chlorobutyl, are made by the halogenation of butyl rubber, which is a copolymer of isobutylene and isoprene (to a smaller extent). Key features of halobutyl rubbers that make them suitable for the pharmaceutical industry are that they typically have lower levels of extractables compared to other rubbers, and they have excellent resistance to permeation by water and oxygen.
The regulatory environment is moving to a more science-based approach to Container Closure Integrity (CCI). This is driven by the recent publication of United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products. Recently, West gave a webinar (377 registrants) titled <a href="https://www.youtube.com/watch?v=5K8R1jumXyU&feature=youtu.be">Container Closure Integrity: Six Keys to Simplify Your Strategy and Execution</a>, that addressed Chapter <1207> and other topics. The survey questions (over 100 responses) from this webinar are instructive.
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