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In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.
Selection of the appropriate primary packaging system is essential to delivering a high quality, safe, and stable drug product to patients. The primary packaging components which make up the containment system are selected on a range of factors, from chemical compatibility with the drug product ingredients to dimensional fit when mating packaging components. Optimized fit among mating packaging components is essential for flawless fill-finish processing.
As part of our West without Borders team member led giving program, West’s Korea team recently kicked off their first Food Drive event in Anseong, Gyeonggi in South Korea. All 15 West team members participated and collected over 170 kg (385 lbs) of food items for ten local families that have been impacted by the COVID-19 pandemic.
When choosing an elastomeric formulation for a stopper or plunger used to package parenteral drug products, there are several misconceptions related to the importance the elastomer class plays on the chemical and physical properties of the elastomer. Often we hear customers make general statements such as “chlorobutyl elastomers are better” or “bromobutyls have an advantage in property X.” In actuality, each elastomeric formulation is unique and has different properties that are independent of the class of elastomer.
The traditional way to package injectable drugs is to place them in a stoppered vial. The stopper is typically held in place with an aluminum ferrule that is called a seal. The vial seal is crimped onto the vial and not only serves to keep the stopper secured to the vial and the <a href="/pt-pt/blog/2018/february/minimize-microbial-contamination-with-flip-off-seals">vial contents sterile<sup>i</sup></a> but also protects the injection site on the stopper and provides a means of demonstrating lack of tampering.
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