Harmonized Manufacturing Network For Sterility Assurance

This presentation will provide an understanding related to Global Guidance related to holistic Contamination Control Strategies.  The importance of cross-functional collaboration to ensure all aspects of the Contamination Control Strategies are properly applied and modified based upon appropriate feedback, including CAPA from deviations.  This presentation will also discuss how to identify and drive innovation within the manufacturing space to improve Sterility Assurance processes and the development of the future facility and process design.  Finally, this presentation will discuss how to manage regulatory interactions, which can lead to successful audits.

Presented by Frederic Ayers, Advisor, Global Quality Systems at Eli Lilly and Company

Fred was a student-athlete at Franklin College of Indiana and participated in the college’s Leadership Program while graduating in 1999 with a Batchelor of Arts (B.A.) in Biology.  After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001.  Mr Ayers has held various roles within the Quality and Technical Services organizations.  In each position, Fred has helped advance Lilly’s state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert.  For Lilly’s Indianapolis Parenteral Manufacturing site, he had the responsibility for the development, implementation, and continuous improvement of the site’s sterility assurance programs.  Currently, as a Global Advisor, Fred is responsible for ensuring the Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations.  He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations.  Fred has been a strong supporter and contributor to local and national PDA events along with being a PDA Midwest Chapter Board Member since 2014 serving as the President from 2020-2021.

Why is the sterility of your drug product much more than just a test of sterility?

A lack of sterility and sterility assurance continue to be a significant reason for drug recalls and regulatory citations and can pose a very real risk to patient safety and public health. Sterilization is a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained. In this presentation we will:

• Examine the goal and science of sterility assurance including the revision of AAMI ST67
• Introduce and contrast Terminal Sterilization and Aseptic Processing of drug products through a regulatory lens as well as that of a manufacturer
• Discuss modification strategies to consider in order to use Terminal Sterilization

This information is meant to provide manufacturers with a better understanding of sterility to help them make the best decisions in regards to their specific drug product and relative patient safety.

Presented by Martell Winters, Director of Scientific Competence at Nelson Labs

John Schlecht, Vice President Technical Services, Sterigenics

Sponsored by Sterigenics and Nelson Labs

About Sterigenics:  
Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical/biopharma, food safety and advanced applications markets. With our industry recognized scientific and technological expertise we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 48 global facilities that span 13 countries, we offer our customers a complete range of outsourced terminal sterilization services, primarily using the three major sterilization technologies: gamma irradiation, ethylene oxide processing and electron beam irradiation as well as nitrogen dioxide sterilization and x-ray irradiation. We are committed to addressing the growing need for sterilization in many parts of the world and partnering with our customers to eliminate threats to human health.

About 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 4,000 customers across 15 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 800 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.

Safeguarding Global Health® – with every test we complete.