Blogs

Technical Guideline for Study of Nitrosamine Impurities in Chemical Drugs (Trial) was issued by the China National Medical Products Administration on 8 May 2020. This guideline discusses nitrosamine impurities in drug products, including the sources of nitrosamine impurities and the control strategy. The control strategy is given from the perspectives of the basic concept of control, control limits, establishment of analytical methods, and control of risk throughout the drug product lifecycle.

For injectable drug products, coring and fragmentation of elastomer stoppers is a critical concern. This is caused by tearing or shearing a fragment of the stopper in a vial during insertion of a needle or a spike. The cores/fragments that enter the drug product may lead to harmful patient outcomes. Testing of stoppers is a must for many pharmacopeias. Coring and fragmentation is complex and influenced by many factors, in particular the stopper and the needle.

West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma^® 1mL long piston, substantially raising the standard for product acceptance. The D Sigma piston combines Daikyo best practices with a known formulation (D21-7H), Daikyo Flurotec^® film, RB2 Coating, RSV^® and RUV^® processing with key innovation improvements of automated dimensional measurements, tight Acceptable Quality Levels (AQLs), particulate testing per ISO 8871-3, and enhanced vision inspection to achieve high levels of performance and consistency.

Historically, finding suitable containers for complex protein drug products has been difficult, since interaction with elastomeric closures can result in particle formation. These particles indicate an underlying change within the drug product, undermining integrity and risking patient safety. The correlation of silicone coatings with protein aggregation has made some wary of their use; however, an elastomeric closure with no coating or film can be difficult to process. Another concern is that leachables originating from the elastomeric closure can induce particle formation.

With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).¹ The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.

As the need for higher quality drug delivery and packaging components increases, customers are challenged to meet new standards and comply with additional regulatory requirements. To help our pharmaceutical and biopharmaceutical partners meet these challenges and reduce risk, West has developed next-generation quality for ready-to-sterilize and ready-to-use components.