Process Equipment Related Leachable Compounds – 3 Case Studies

Process Equipment Related Leachable Compounds – 3 case studies

• Case 1: Over sterilized filter, 3 days instead of 3 hours – process leachable compounds in the parenteral drug product
• Case 2: Solid, white, 5 mm flakes in process equipment – effects on the parenteral drug products
• Case 3: What is wrong with the process equipment? – PERL investigation continued as a stopper related leachable analyses.

Presented by Dr. Tarja Nurmi, Senior Expert, Extractables & Leachables at Bayer

Dr Tarja runs the E&L Knowledge and Service Team at Bayer. She serves and supports globally her project teams, working with marketed products and in the development. Her 15 years of analytical experience in the academic research group of nutritionists, epidemiologists, public health experts and medical doctors is of great benefit in understanding the chemical behavior of drug products during a long-term contact with plastic and rubber components. Since starting at Bayer over 7 years ago, Tarja has created practical solutions in the laboratory to confirm the safety of plastic and rubber materials together with our toxicologists. She represents Bayer in the ELSIE consortium and is known at Bayer as a customer-focused E&L expert who can provide science-based solutions and answers.  

Potential Designs for Leachables Studies on Process Equipment

Leachables studies on equipment used in (bio)pharmaceutical production processes are somewhat less common and standardized than in the context of pharmaceutical containers. This presentation will elaborate on multiple case studies, in which a variety of study designs will be discussed. The presentation will focus on the practical aspects and pinpoint the diversity of practical study designs (and related challenges), which contrasts with the rather well known and rather standardized nature of leachables studies on container closure systems.

Presented by Pieter Van Wouwe, Scientific expert at Nelson Labs

Pieter Van Wouwe received his Master’s degree and PhD in Bioscience Engineering at the University of Leuven in 2011. In March 2016, he started working at Nelson Labs as a project manager, initially mainly involved in scientific interpretations and the reporting of analytical results. Over the years, he has expanded his role and became responsible for designing pharma-related extractable and leachable studies for both packaging materials and process materials. More recently, he has broadened his expertise to include medical devices and combination devices. Providing support for extractables and leachables studies to both biopharmaceutical and medical device companies is one of his current focus points, while knowledge sharing – internally and externally – is also part of his current role at Nelson Labs. 

Sponsored by Nelson Labs

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,000 customers across 13 facilities in the United States, Mexico, Asia, and Europe.  We provide our customers with mission-critical testing services, which assess the quality, effectiveness, and end-to-end sterility of products and, ultimately, the impact of the products on patient safety. These services are necessary for our customers’ regulatory approvals, product releases, and ongoing product performance evaluations.  We have over 900 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety, and quality assurance.  Pharmaceutical lab testing services include microbiology, biocompatibility and toxicology assessments, extractables and leachables evaluations of pharmaceutical containers, sterilization validation, sterility assurance, packaging validation and distribution simulation, and facility and process validation.  We also provide expert advisory services to help customers navigate the regulatory requirements applicable throughout their product’s lifecycle. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.