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In the first of three installments of our video tour of our Scottsdale, AZ, plant, Jeff Kyle, Sr. Director Operations and Supply Chain, speaks to what gets him excited about working at West: The knowledge that they are helping to improve the lives of patients by creating innovative drug packaging and delivery systems.
While compliance and standards are a very important part of the Scottsdale manufacturing philosophy, Jason Choi, Project Engineer, says—above all else—West employees keep in mind the patients who will eventually use the components and systems they’re making.
Creating a positive environment of like-minded employees starts with hiring the right people. At Scottsdale, employees dedicate themselves to serving the customer – and the patients impacted by their pharmaceutical products – to ensure products get out the door in time and are safely and effectively delivered to the patients.
Another aspect of that work culture, Kyle says, is the supportive environment in which employees work together, from top management to the technicians. It starts with mutual respect for everyone’s ideas in meetings – fostering a climate in which everyone feels, “we’re in it together” and a sense of ownership of the products they’re making as a team.
Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?<br />According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.
Bettine Boltres
PhD., Director, Scientific Affairs & Technical Solutions, Glass Systems
<p><em>Lloyd Waxman, Harold Murray and Vinod Vilivalam</em></p><div id="g_93cd4f5a_be87_417c_be5f_5391eae75b241"><div><div><em></em> </div><div><strong>ABSTRACT</strong></div><div><strong> </strong></div><div><strong>Purpose: </strong>The shipment and storage of biopharmaceuticals in prefilled syringes (PFS) places new demands on PFS performance. Studies compared package integrity of glass and plastic PFS: piston movement was evaluated under reduced pressures to simulate transport by air in non-pressurized holds, and container closure integrity was tested on PFS that had been frozen or frozen and thawed, since some biopharmaceuticals are stored and transported in the frozen state. Piston release and travel forces were also measured in plastic PFS since in order to be competitive with siliconized glass PFS, the functional characteristics of plastic PFS must meet or exceed the criteria established for glass PFS.</div></div></div>
<p>In <a href="/blog/2017/june/corporate-responsibility-for-2016">Part 1</a> of this blog series, we highlighted the Compliance and Ethics section of West’s inaugural Corporate Responsibility Report. </p><p>In Part 2, we will cover West’s commitment to serving the communities in which we live and work.</p>
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.
Regulatory agencies are driving the pharmaceutical industry to continuously improve the quality of drug products, but what is the reality for a drug developer who is expected to make parenteral preparations “practically free from particles”? Expectations of packaging are changing fast but how well prepared is the packaging to meet these needs?