Cleanliness of Newly Manufactured Medical Devices

Schedule (all times EST)

• Day 1: 9:00am - 5:00pm
• Day 2: 9:00am - 1:00pm 

About the training 

Cleaning is often a critical step in the manufacturing process of single-use medical devices as contaminants could cause serious safety problems as well as impact device biocompatibility and sterilization effectiveness. It is the responsibility of the medical device manufacturer to ensure physical, chemical and microbiological contaminants (as applicable) are reduced to a safe level and to provide objective evidence of the verification of the cleaning process effectiveness.   

Implementing an effective cleaning process on medical devices requires knowledge on the cleaning technologies available, process design, risk management, test methods, cleanliness requirements, process validation, and process verification. These topics will be covered in this 1.5-day comprehensive course with a focus on NF ISO 19227:2018.   

REQUIRED LEVEL

• Some familiarity with process validation (such as OQ/PQs) and general knowledge of medical devices manufacturing. 

To learn more about the program, click here.

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