Validation and Quality Assurance of Medical Device Cleaning Processes
Presented by Dr Chris Pickles and Stuart Watson, the webinar covered current regulatory guidance, residues and sources of contamination, and how to identify contaminants and their source via surface, gravimetric and residue analysis.
With the surfaces of medical devices becoming more complex, in terms of their geometries and chemistry, and with the rise in combination devices, effective device cleaning can be challenging.
Ensuring the cleanliness of devices to below acceptable residue limits is a regulatory requirement, necessary to introduce devices into global markets. What's more, contamination doesn't just flout regulations, it can also lead to implant failure and poor device performance.
Having a cleanliness verification and validation procedure in place is vital to ensure manufacturers' peace of mind.
In this webinar, the presenters discussed:
- Current regulatory guidance
- Residues and sources of contamination
- Residue limits
How to identify contaminants and their source via:
- Surface analysis
- Gravimetric analysis
- Residue analysis.
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