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| MEDICAL PRODUCTS |
 Test Methods As part of the comprehensive quality control service, 11 different tests are performed to confirm the purity and quality of ZEPHEX®227ea and ZEPHEX®134a. In addition to using state of the art 'Related Impurities Methods' for both products, a wide range of tests is performed, aimed at confirming that ZEPHEX® propellants meet specification requirements. A number of these tests are unique to ZEPHEX® propellants and demonstrate Mexichem Fluor's commitment to a top quality propellant offering. These tests are applied as appropriate throughout the production processes. In addition, these tests include determinations specifically to assure the quality of the propellant in the final package (non-volatile residue). Full information on this, including downloadable test methods, is available to customers. If you have a password please click here. If you do not have a password, please click here to request one. Method Validation To ensure that the analytical techniques used to test ZEPHEX® propellants give reliable and consistent data, method validation studies have been performed in accordance with technically robust protocols. In addition to these initial studies, the transfer of methods into Quality Control laboratories is also validated. Future developments, and method implementations, would also be the subject of suitable validation programmes. This not only are ZEPHEX®134a and ZEPHEX®227ea manufactured to the standards required by the pharmaceutical industry but the test methods which are used are of an equivalent high standard. World leading related organic impurities method Confirmation of a product's purity is only as good as the methodologies which are used to assess this most important of attributes. The more searching the method, the greater the degree of confidence in the completeness of the result. To obtain this, methods are needed which have two critical capabilities. Firstly, they must they quantify the few impurities typically present in ZEPHEX® propellants. Secondly, they must demonstrate the absence of the broader range of halocarbon compounds associated with the manufacture of industrial grade HFAs and thus potential impurities in any HFA medical propellant. Sampling A true sample is crucial to the generation of an accurate analysis as an analytical result is only as good as the sample it was derived from, even when world-leading methodologies are being used. ZEPHEX® propellants are therefore sampled using robust procedures, which avoid all the usual problems associated with the sampling of liquefied gases, such as moisture ingress and non-representative sampling of bulk material. This sampling technique can be transferred to customers upon request, with on site training if required. Detailed descriptions of the sampling procedures are given in the Medical customer zone. If you have a password please click here. If you do not have a password, please click here to request one.  |
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