Cleaning (Reprocessing) Validations
Eurofins is well versed in performing effective cleaning validations to assure that a cleaning process is removing residues of the API of the product, the cleaning aids used in the cleaning process and the microbial contamination. Cleaning validations are critical part of your production process ensuring that the quality of your next product manufactured in the same clean/aseptic area is not compromised by waste from previous products and prevent cross-contamination. Eurofins can help you perform a cleaning validation but we can also assist you in:
- Evaluation of critical risks for cross-contamination during manufacturing
- Calculation of allowed residue levels on manufacturing equipment
- Development and validation of analytical methods to detect cross-contaminants
- Design of cleaning programs
- Sampling according to predetermined sampling plans
- Analysis of samples taken before and after cleaning
- Design of validation protocols and reports
Medical device industry (Reprocessing validations)
Single use and reusable Medical Device products require an effective and validated cleaning process to ensure patient safety. Eurofins not only performs reprocessing validations our consultancy team can also help you design/review your IFU and set up a testing strategy according to ISO 17664.
- Review IFU
- Set up testing strategy
- Perform Risk assessment
- Write expert statement
- Other needs?
Custom services are also available. Contact us to find out whether we can help. Our team will be happy to assist.
Why choose Eurofins BioPharma Product Testing
- Single-point-of-contact. Eurofins BioPharma Product Testing Netherlands has all expertise within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins BioPharma Product Testing Netherlands has several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.