Cleanliness of newly manufactured medical devices
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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.
Charlotte Negrón-Morales Product Reviewer, GMED North America
Charlotte is a Product Reviewer at GMED North America. She carries out evaluations as part of the CE marking conformity assessment in the field of medical devices with focus on topics related to sterilization, packaging, and cleaning.
She has a technical background in Chemistry & Engineering. She worked in the Orthopedics Medical Device industry for 7 years in manufacturing, R&D and Quality Department as a Cleaning Validation Engineer, Packaging Development Engineer, and Sterilization Engineer; among other roles. Over the course of these years, she developed a unique set of experiences within the medical device regulatory and quality science topics.
Charlotte currently works at GMED NA as a product reviewer and provides regulatory support for the transition to the European Regulation EU 2017/745.
Who Should Attend
- Medical Device Manufacturers: Regulatory Affairs Managers, Quality Managers, R&D Manager, R&D Engineer, Quality Specialist/Engineers, Regulatory Affairs Specialist, Process Validation Specialist/Engineer, Manufacturing Engineers, Microbiologist and/or Scientist. Persons responsible for preparation of technical documentation and validation of cleaning processes. and Marketing Managers
- Auditors and Product Reviewers for Medical Devices
Learning Objectives
- Obtain knowledge related to cleaning validation requirements before final packaging
- Define the methodology for implementation, validation, and control of medical devices cleaning processes
- List the associated documentation when single-use medical devices are cleaned during manufacturing
Educational Resources
- Theoretical presentations
- Practical workshop
- Course evaluation
Check out the Program
- Introduction & Context
- Design of Cleaning Process
- Risk Management
- Test Methods
- Cleanliness Specifications
- Process Validation
- Process Verification
- Workshop
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