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Acceptance Testing: Testing which is undertaken by or on behalf of the customer before 'accepting' a container of product for use. This testing provides an independent check of the results on Mexichem Fluor's Certificate of Analysis for the product. See also Confirmatory Testing.

BSI Drum: Term for the CODAP 95 upright stainless steel drums manufactured by BSI, and used for the supply of approximately one tonne quantities of ZEPHEX® propellants. Described in more detail in the Customer Zone. See also Van Hool’s Drum and Klaff Drum.

Certificate of Analysis: The document that accompanies each and every container of ZEPHEX® propellant. It lists analytical results from the release testing, container type, container identity, tag seal numbers, date of manufacture and date of analysis.

Confirmatory Testing: Testing undertaken by or on behalf of the customer to confirm the results provided by Mexichem Fluor on the Certificate of Analysis. See also Acceptance Testing.

Customer Zone: The section of this website (www.zephex.com) containing detailed specialist technical information of interest to ZEPHEX® customers. Click here to access.

Data Pack: This term is used within Mexichem Fluor to refer to the ‘Pack’ of technical data and information about ZEPHEX® propellants, which Mexichem Fluor supplies to customers for inclusion in their marketing authorisation applications. The ‘Data Pack’ is presented in the Common Technical Document format (section 3.2.P.4.6), and contains the same information as the Drug Master Files, which have been filed in the United States and Canada. See also Drug Master File (DMF).

Drug Master File (DMF): DMFs are documents containing technical data and information about ZEPHEX® propellants, which have been filed with the US FDA. A DMF will be reviewed in connection with a customer New Drug Application (NDA). DMFs for ZEPHEX® propellants have also been filed in Canada. See also Data Pack.

HFA 134a: 1,1,1,2-Tetrafluoroethane, also known as ZEPHEX®134a. The International Non Proprietary Name (INN) is Norflurane.

HFA 227ea: 1,1,1,2,3,3,3-Heptafluoropropane, also known as ZEPHEX®227ea. The International Non Proprietary Name (INN) is Apaflurane.

Hydrofluoroalkane (HFA): See also hydrofluorocarbon (HFC). The term used to describe those HFCs that have been further purified under GMP conditions to make them of suitable purity and quality to be used as medical propellants.

Hydrofluorocarbon (HFC): The term used to describe the technical (or industrial) grade purity chemicals consisting of partly fluorinated alkanes (e.g. 1,1,1,2-tetrafluoroethane; HFC 134a). This term is also used to describe chemicals consisting of partly fluorinated alkanes, even if they do not have large-scale applications, and are typically only available in laboratory scale quantities (e.g. 1,1,2,2-tetrafluoroethane; HFC 134). See also hydrofluoroalkanes (HFA).

ISO Tanker/ISO Container: The stainless steel road tank containers, of approximate capacity 20 metric tonnes, used for the supply of bulk quantities of ZEPHEX® propellants. Described in more detail in the Customer Zone.

Mexichem Fluor: The world’s largest HFA medical propellant supplier.

Klaff Drum: The TRG horizontal carbon steel drums used for the supply, to certain regions, of approximately one tonne quantities of ZEPHEX® propellants. Described in more detail in the Customer Zone. See also Van Hool’s Drum and BSI Drum.

Letter of Access: (see also Drug Master File). This is a letter written by Mexichem Fluor to the US FDA authorising the FDA to ‘access’ Mexichem Fluor’s Drug Master Files in conjunction with a customer’s New Drug Application. Letters of Access are also issued for the DMF filed in Canada.

Method Transfer: The series of practical steps which have to be undertaken, in accordance with a pre-defined protocol, to enable the implementation of an Mexichem Fluor analytical method within a customer or contract laboratory.

Method Validation: The series of practical tests which have to be undertaken, in accordance with a pre-defined protocol, to demonstrate that an analytical method fulfils its required function and is capable of generating the required information. In addition, the term can also refer to a series of practical tests to demonstrate that the operation of a method on particular equipment or in a particular laboratory is robust. See also Method Transfer.

Non-Volatile Residue (NVR)/Non Volatile Matter (NVM): Used interchangeably, these terms refer to any material that remains after the ambient evaporation of a known quantity of propellant, and the heating at 105 °C for two hours of any residues from this evaporation. Typically NVR/NVM are package related contaminants in the product, such as oil or grease, which are controlled to an unusually tight limit of 5ppm w/w in ZEPHEX® propellants.

Product Purity: This refers to the ‘organic’ purity of the product, and is determined by subtracting the sum of the related organic impurities present from 100%. For example, material that contained 100ppm w/w impurities would be considered to have a purity 99.99% w/w. See also Product Quality.

Product Quality: This refers to all aspects of the product that impact upon its suitability for use as a medical propellant. This encompasses inter alia product purity, manufacturing standards, laboratory standards, packaging standards, integrity of product during transit, supporting documentation and regulatory status. See also Product Purity.

Quality Assurance (QA): The independent function within Mexichem Fluor that has the responsibility for reviewing all data relating to production of ZEPHEX® propellants, for releasing product to the customer, and for conducting internal and external compliance audits.

Quality Control (QC): The Mexichem Fluor analytical services and facilities used for production and product sentencing purposes.

Related Organic Impurity: An organic impurity that could potentially be present in the propellant by it being ‘related’ to the manufacture of the product. The isomer of ZEPHEX®134a (HFC 134: 1,1,2,2-tetrafluoroethane) is a potential related organic impurity in ZEPHEX®134a, whereas ZEPHEX®227ea would be considered an organic contaminant in ZEPHEX®134a, since it is not related to its manufacture.

Release Testing: The testing that is undertaken by the Mexichem Fluor Quality laboratory as part of the process for releasing the product to the customer. The results will appear on the Certificate of Analysis.

Tag Seal: An individually numbered tamper-proof wire tag, which can be fixed to propellant container valves during transit to ensure that there has been no unauthorised tampering with the container or its contents. By including the traceable tag seal number on the Certificate of Analysis there is the added guarantee that the Certificate of Analysis only refers to the product currently within that container (and to which the tag seal is attached), and not to material previously within that container, which would have been fitted with a different tag seal.

Van Hool’s Drum: Term for the DOT 51 upright stainless steel drums manufactured by Van Hool’s, and used for the supply of approximately one tonne quantities of ZEPHEX® propellants. Described in more detail in the Customer Zone. See also BSI Drum and Klaff Drum.

ZEPHEX®: The brand name for Mexichem Fluor’s top quality, high purity hydrofluoroalkane (HFA) medical propellants. The ZEPHEX® range includes ZEPHEX®134a (1,1,1,2-tetrafluoroethane) and ZEPHEX®227ea (1,1,1,2,3,3,3-heptafluoropropane.