Cleaning & Sterilization Validation
Dental devices require an effective and validated cleaning process to ensure customer safety. Lucideon helps you develop and validate your processes and products for regulatory authorities, including the FDA.
Regulatory Submission Support
We provide quality data and technical support with full documentation. In the heavily scrutinized area of medical device regulations, it is reassuring to have experts on your side who have prior experience of performing the tests.
With Lucideon's VALIDATA program you get a complete validation service for your medical devices to determine the effectiveness of your cleaning process and environment on an ongoing basis.
VALIDATA quantifies residual contamination using advanced surface analysis techniques, to detect what has not been removed by your cleaning processes. This is then compared to what is expected to be there and, by the application of a proprietary combinatorial algorithm, expresses the result as a single "Cleanliness Index" parameter in the form of a "% clean" figure.
Single Use Devices
- Implement a new cleaning procedure to gain regulatory approval
- Ensure continual cleanliness of your manufacturing and cleaning processes
- Identify the presence and source of contaminants
- Develop effective cleaning protocols for products (including ALM devices)
- Determine why residue limits are being exceeded, and set appropriate limits
- Verify and validate that a process change has not negatively affected cleanliness
- Perform residue analysis of detergents and manufacturing lubricants.
- Process design and development for the reprocessing of a dental device
- Validation of the effectiveness of a reprocessing method (cleaning, disinfection and sterilization)
- Validation of the compatibility of a device with the method
- Choice and identification of appropriate soils and detergents.
Cleaning Validation of Dental Device Manufacturing Equipment
Dental device manufacturing equipment requires thorough cleaning between batches and at timed intervals to ensure the cleanliness and safety of manufactured products, and to comply with current Good Manufacturing Practices (cGMP). Outsourcing the cleaning validation of your medical device manufacturing equipment can speed up the process, minimize disruption and provide a greater sense of security.
Lucideon offers specialist cleaning validation services for your ALM products. We develop cleaning methods and procedures to ensure that your ALM product is clean and safe for use.