White Paper: How Clean is Clean Enough?
The importance of developing, implementing, and validating a cleaning process and its potential impact on sterilization validation and...
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The Impact of the Cleaning Process on Sterilization Validation and Biocompatibility Activities
The achievement of a suitable level of cleanliness in the manufacturing of medical devices is an indispensable precondition to providing patients, users and third parties with safe and usable medical devices.
The scientific affairs team at Veranex is widely experienced in designing, implementing and validating cleaning processes of medical devices, while also validating sterilization processes and assessing biological safety. Combining the assessment of these processes enables a well-structured path to compliance that focuses on following a defensible approach, while making efficient use of the budget.
During this webinar, our experts Ramona Field and Adrien Marchand will guide you through:
- A basic understanding of how to develop, implement and validate a cleaning process.
- An introduction to the analytical methods used for detecting and quantifying different types of contaminants, and how to assess whether their presence is acceptable or not.
- An understanding of the link between the processes of cleaning, sterilization and biocompatibility and discussion on how to leverage the potential gains of considering these processes together when designing and executing a Verification and Validation Plan.
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Medical Device Vigilance: Important Considerations to Comply With the EU MDR
Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...