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It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted. This comprises both knowing of proposed changes as soon as announced and being well prepared to accommodate them. USP Chapter <381> is changing, and Chapters <382>, <1382> and <1381> are being created. The Pharmacopeia Forum for final comments has been published.
The heavy metals tests section <381> (Elastomeric Closure for Injections, Heavy Metals) and Extractable Zinc have been removed. Testing to address extractable elements has been added to the guidance section under <1381> (Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems). The goal of the testing is based on risk, and therefore the requirement has been made a guidance – this is a significant change. West has developed extraction and analytical methods that are incorporated in <1381>. This work was performed on multiple elastomeric formulas. If support is needed, West can very well navigate through this guidance and perform required tests.
The functionality tests section of <381> (Elastomeric Closure for Injections, Functionality Tests) have not changed and is proposed to be omitted after 5 years to allow industry to adequately implement USP <382>. Greatly expanded functionality tests will be incorporated in <382> (projected title: Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems). Chapter <382> will address fitness-for-intended-use functionality requirements for the following packages and delivery systems: (a) vial and bottle systems, prefilled and single use syringe systems, blow-fill sealed containers, dental cartridges for local anesthesia, pen injectors, and plastic containers for IV’s; (b) corresponding elastomeric components; and (c) corresponding drug products. Functionality tests proposed are syringe plunger break force, glide force, and plunger seal integrity, as well as syringe tip cap and needle shield tests.
Note that <382> is not self-contained – it will incorporate elements of <1382> (projected title: Assessment of Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems).Chapter <1382> will include discussion of fitness-for-intended-use testing, with guidance for test sample preparation, test population, procedures, data interpretation, sample sizes, and reporting. <1382> also will contain many relevant ISO references and necessary details regarding functional testing specifications and general product knowledge expectations.
These changes are intended to enhance patient safety by reducing risk through more thorough product understanding – through increased focus on testing of packaging and delivery systems, including elastomeric component interactions with multiple interfacing components and with drug products.
West continues to focus on understanding the latest in the ever-changing regulatory landscape in its goals to be first-to-market with knowledge and advanced testing capabilities and methods to increase value to customers, but most importantly, reduce risk to the patient.
The Global Technical Customer Support (TCS) team has as its main focus engagement with customers – facilitating access to West’s expertise in pharmaceutical packaging components and delivery solutions, and providing assistance and technical information on West and Daikyo products and services.
<span style="color: black;">The final week of the Ambassador Internship program is coming to a close, and the 31 students who have been hard at work since June now have the opportunity to showcase what they have learned and reflect upon the entire experience during the program wrap-up. </span>
In 2004, Camp Victory, which is located in Millville, Pennsylvania, and operates camps for children who live with chronic health disadvantages including spina bifida, autism and cancer, added a wheel-chair friendly treehouse to their “Wish List” of needs. The tree house came with a hefty price tag and for several years, it sat on the list untouched. Just when Camp Victory was about to remove the treehouse from the wish list, it received a call from West’s CEO Don Morel and the campaign to build “Uncle Walt’s Treehouse” was born.
In the world of injection molding, experience, expertise, and a passion for sharing knowledge can transform careers and shape the future of the industry. Ron Barr, a seasoned Principal Process Engineer at West, is a testament to this philosophy. With a remarkable journey that began back in 1991 when he joined the workforce at the age of 19, Ron's story is an inspiration to aspiring professionals in the field.
In the final installment of our blog series on corporate responsibility, we are focusing on quality. This topic is at the forefront of all we do at West. After all, we are ultimately in business to serve the patients who use our products – and those patients are counting on us to deliver those products with the highest level of quality possible. We will not compromise on our commitment to quality. <br />
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