On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic ..read more

In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001, a standard intended to define the basic requirements, structure, responsibilities, and procedures required to implement an effective quality management system for manufacturing organizations in general. In 1996, the International Organization for Standardization issued the first version of ISO 13485, “Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001,” to specify, in conjunction with the application of ISO 9001, the Quality Management System (QMS) requir ..read more

Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market? 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 ..read more

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 ..read more

With employees’ students across the U.S. receiving $5,000 each year over four years, the Foundation fosters a culture of support for education and family at West ..read more

West and Dublin City University (DCU) in Ireland have formed a 4-year educational partnership that will provide 180 students from socio-economically disadvantaged backgrounds with scholarships and educational opportunities. The partnership with the DCU Access programme features the creation of a new annual €45,000 scholarship fund by West to run for four years ..read more

The global pen injector and auto-injector markets have witnessed significant growth due to the increasing demand for self-administration of injectable drugs. Pen injectors and auto-injectors provide a user-friendly and convenient solution for patients to administer medications, contributing to improved patient compliance and overall healthcare outcomes. There are well established traditional market segments that use cartridge-based delivery systems, including dental local anesthesia and diabetes care, as well as human growth hormone and allergy therapies. However, there have been significant d ..read more

In September 2023, Dr. Bettine Boltres, West’s contact for scientific affairs and technical solutions for glass, shared with us the most frequently asked questions that she encounters on glass-related topics. We are pleased to share Part 2 of the series where Dr. Boltres will share the remainder of the 10 most common questions she gets asked concerning glass vials. You can read Part 1 of the series ..read more

West and Dublin City University (DCU) in Ireland have formed a 4-year educational partnership that will provide 180 students from socio-economically disadvantaged backgrounds with scholarships and educational opportunities. The partnership with the DCU Access programme features the creation of a new annual €45,000 scholarship fund by West to run for four years ..read more

Overview of EU GMP Annex 1 EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use. It provides specific requirements for the manufacture of sterile medicinal products, including principles for cleanroom and clean zone design, personnel experience/qualification, and monitoring of manufacturing environments, just to name a few. The objective is to ensure product quality and potency, as well as patient safety, by minimizing risks of microbial, particulate and endotoxin/pyrogen contamination through manufac ..read more