MCA Confirms cGMP at INEOS Fluor's ZEPHEX 227ea Plant
The UK Medicines Control Agency (MCA) has confirmed that the INEOS Fluor ZEPHEX 227ea manufacturing facility, operated by joint venture partner Great Lakes Chemical Corporation in Arkansas, USA, is in compliance with current Good Manufacturing Practice (cGMP) at the standard required for the manufacture of active pharmaceutical materials. Confirmation that ZEPHEX 227ea complies with the ICH Guide to Good Manufacturing Practice followed a recently successful audit of the medical propellant facility by the UK MCA.
INEOS Fluor, producer of ZEPHEX, is the world's leading manufacturer of medical HFA propellants typically used in metered dose inhalers for the treatment of asthma. The company has now had confirmation that both of its HFA propellant manufacturing facilities are in compliance, following a similar audit of the ZEPHEX 134a site at Runcorn, UK last year.
Confirmation of cGMP status for the 227ea site, comes as INEOS Fluor prepares to complete its first year of ownership of the ICI Klea business and serves as a useful reminder of the company's ongoing commitment to growing its medical propellants business and investing further in the expanding life sciences sector.
Dr. Tim Noakes, ZEPHEX product manager, INEOS Fluor commented: "The MCA audits have been extremely important for us, as far as we are aware we …2/MCA CONFIRMS cGMP AT ZEPHEX 227ea PLANT/2
are the world's first manufacturer of pharmaceutical propellants to receive confirmation of cGMP status from the MCA, for the manufacture of both HFA 227ea and HFA 134a."
"INEOS Fluor are totally committed to meeting our customers' requirements for the long term. We pioneered this technology and since launching HFA 134a nearly ten years ago, we have continued to work alongside our customers, to ensure that together our products and services meet, even drive, the exceptionally high standards of quality expected by the pharmaceutical sector. The purity and high quality of ZEPHEX results from our continued commitment to and ongoing investment in current Good Manufacturing Practice."
ZEPHEX 227ea is manufactured by INEOS Fluor's joint venture partner, Great Lakes Chemical Corporation in the USA, using a dedicated facility scaled to meet global pharmaceutical demand. Greg Leman, Specialty Fluorines Business Director , at Great Lakes said: "We are delighted to have received the confirmation of our cGMP status by the UK MCA. The importance of this third party acknowledgement can not be overstated and confirms the very high standard of operation that we run for the production of ZEPHEX 227ea.
"It is important to recognise that we are unique in many ways, not least because this plant, like the one in Runcorn, is a standalone production facility, dedicated to the manufacture of a single product, which avoids the potential for cross contamination of one propellant with another, an important factor in maintaining compliance with the extremely high specification that we provide to our customers."
Commercial manufacture of pharmaceutical HFA-227ea (heptafluoropropane) began at the INEOS Fluor joint venture facility in Arkansas in May 2000. Recently INEOS began shipments of bulk product into Europe to meet the demands of its customers for both HFA 134a and HFA 227ea, as they continue to replace CFCs traditionally used in metered dose inhalers.
§ ZEPHEX is the brand name for top quality, high purity hydrofluoroalkane (HFA) medical propellants from INEOS Fluor, one of the world's most long-standing and experienced medical propellant suppliers.
§ The ZEPHEX range includes ZEPHEX 134a (1,1,1,2 tetrafluoroethane) and ZEPHEX 227ea (1,1,1,2,3,3,3 heptafluoropropane).
§ ZEPHEX propelled metered dose inhalers account for approximately 90% of current worldwide HFA 134a MDI manufacturing. It is in widespread use in Europe, where it is already regarded as a vital component in enabling the move away from CFC-based inhalers without compromising patient welfare or confidence. It has also recently become available on the US market, with the completion of an FDA review and the approval of the first product to use it.
§ Worldwide, more than 50 million asthma and bronchitis sufferers rely on MDIs for their medical treatment. Traditionally, most MDIs have used CFC propellants, but these are being phased out as the pharmaceutical industry reformulates its products using CFC free propellants such as ZEPHEX 134a and the latest addition ZEPHEX 227ea.
§ INEOS Fluor is the world's leading producer of HFA 134a and a supplier of a range of fluorine based products and technologies to the pharmaceutical, automotive, insulation, air conditioning and refrigeration industries.
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