The combination of drugs, devices, and/or biological products creates a unique intersection of disciplines within the medical device and pharmaceutical industries. While combination products such as infusion pumps can innovate the delivery of drugs and/or biological agents, they may also pose a risk to patient safety. The storage and delivery of biologics through medical devices offers an opportunity for microbial ingress and subsequent microbial growth. To mitigate these risks, combination devices may require unique container closure designs or may incorporate antimicrobials directly within the drug or biologic.
This 60-minute webinar will provide an overview of validation testing, addressing both antimicrobial strategies and container closure systems used to control microbial ingress, proliferation, and colonization.
Topics include:
- Antimicrobial systems commonly employed in combination products and validation testing that applies to those systems
- The types of products and how they interact with their combined drug and/or biologic from a microbiologic perspective
- Validation testing for container closure systems and how to make test design decisions
An audience Q&A session will follow the technical presentations.
Speaker:
Aaron Zahne, Expert Consultant, Nelson Labs
Aaron Zahne is an Expert Consultant at Nelson Labs in Salt Lake City. He specializes in antimicrobial validations, in-use stability testing, and disinfectant efficacy testing. Aaron holds a bachelor’s degree in microbiology and molecular biology from the University.
Moderator:
Amanda Hosey, Editor, SAE Media Group
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