1:00PM –1:25PM

Abstract:
Most medical device manufacturers know the importance of sending their product through rigorous cleaning and testing before they release to market. Standard sterility and biocompatibility tests are already an essential part of many manufacturers' protocols. What may not be as commonly understood, however, are the different ways a product can be contaminated during the manufacturing and production, cleaning processes, and packaging of medical devices. To avoid detrimental contamination, manufacturers should test their devices to examine the surface residues remaining on the device after these processes. This presentation on cleaning validations for newly manufactured and single use implants is a useful guide to help develop a successful test plan to provide cleanliness data. In addition, this presentation gives guidance on industry trends to justify residue limits.

We will discuss:

• Cleaning validation background and history: including current standards and working documents
• Determine a sampling plan and the potential contaminants
• Choose test methods (outline each recommended option)
• Justify residue limits

Intended audience: QA/QC, Regulatory Affairs, Product Engineers, Medical Device R&D, a must for anyone in the medical device industry

About the speaker:
Alexa Tatarian Project Coordinator

Alexa Tatarian is currently a Project Coordinator in the Service Center at Nelson Laboratories working primarily with cleaning validations and non-routine special projects. She earned a B.S. degree in Microbiology from Brigham Young University in 2009. Before becoming a Project Coordinator, she worked in the analytical chemistry department at Nelson. Alexa specializes in consulting on cleaning validations for newly manufactured and single use implants.