Eurofins Sinensis is well versed in performing effective cleaning validations to eliminate chemical cleaning agent residues on laboratory surfaces and equipment to ensure compliance with guidelines.
Contamination of starting materials, intermediates or finished products by another material or product must be avoided to obtain consistent quality medicinal products or medical devices. The risk of accidental cross-contamination usually arises from uncontrolled release of dust, gases, vapors, sprays from materials and products in process, from residues on equipment and from operators during manufacturing. The potential hazard for patients is determined by the level of hazardous contamination, such as highly-sensitizing compounds, hormones, cytotoxics or living microorganisms, and the administration route, such as injection. Besides a lack of knowledge and thus inappropriate understanding of the cross-contamination risks, is ineffective cleaning the most common source of cross-contamination.
Eurofins Sinensis can 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
Custom services are also available. Contact contact us to find out whether we can help. Our team will be happy to assist.
- Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Standard and custom solutions. If our standard solutions do not fullfil your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.