Quality Management Systems
Fluorochem is registered to standard ISO9001:2008 with BSI certificate number FS26123. We can supply a copy of the certificate on request.
Product Specifications & Certificate of Analysis
Certificates of Analysis (CofA) report batch specific information and are available for all of our products. A CofA for your product may be available at your request from our Technical Service group, and/or included with your shipment.
Analytical Test Methods
A number of the analytical methods used by the Quality Control department to test Fluorochem products are available for your review. Specific analytical methods can be requested from our Technical Service groups. Depending on the request, Fluorochem reserves the right to disclose certain information under a Confidentiality Disclosure Agreement. Fluorochem is able to develop custom analytical methods and to integrate additional testing for custom-made or customized products in order to tailor the testing to best fit your needs.
Quality Control Facilites
- Thermo-Scientific Trace DSQ-II GC-MS
- Jasco 4100 FT-IR
- Mettler Toledo autotitration
- Mettler Toledo Karl Fischer water content titration system
- MP70 Metler Toledo melting point determination
- Jasco P-2000 Polarimeter
- 1H, 19F and 13C nmr
- Chiral LC-MS
- Qualification and validation activities
- Control of documents
- Batch record review
- Product release
- Investigation of non-conformances
- Risk assessment
- Implementation of corrective and preventive actions
- Change control and customer notifications
- Internal, customer and regulatory audits
- Supplier qualification and audits
- Review and approval of final and raw material product specifications
- Review and approval of all manufacturing and packaging documents and operating procedures
- Method development and method validation of assays
- Writing and approving quality control procedures and protocols
- Sampling and testing of raw materials and final products
- Chemical, and physical testing of final products.