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• REFRIGERATION

• MEDICAL PRODUCTS

• FLUORINATED FEEDSTOCK

Support Analysis

The commissioning of propellant facilities at the customer's manufacturing site requires the generation of reliable analytical results as part of the qualification process. Appropriate analytical support can be provided during these activities, in addition to advice and on site guidance concerning the correct sampling procedure. Furthermore, advice can be given in the selection of meaningful acceptance criteria for the qualification of these facilities.

It is also possible to provide analytical support to meet exceptional needs during normal operation and use.

Method Transfer

It is appreciated that the implementation and operation of the analytical methods used to test ZEPHEX®134a and ZEPHEX®227ea is a major undertaking. In the event that customers wish to transfer some or all of these methods to their own laboratories assistance can be provided in a number of ways, such as specification of equipment, advice on operation and cross comparison of results with the ZEPHEX® QC laboratory during implementation.

Alternatively, as described below, an independent 'acceptance testing' service is available to avoid the need for individual customers to establish the full range of methods for this purpose.

Independent 'Acceptance Testing'

If required an additional confirmatory test result can be performed on ZEPHEX®134a conducted by an independent laboratory. This avoids the customer's need to implement a C of A (Certificate of Analysis) validation testing ('Acceptance Testing') as a means of authenticating the Mexichem Fluor C of A results. The additional results are confidential and held from Mexichem Fluor. The same analytical test methods are used; their operation in this laboratory demonstrating the methods' robustness to transfer into a separate corporate organisation. This unique service is available at the point of ordering ZEPHEX®134a propellant and can be provided on a 'universal' or 'skip lot' basis. This laboratory operates to cGMP standards and has been successfully inspected by the US FDA.