
The Bordon Facility, setup by Fresenius Kabi Oncology plc, has been designed, constructed and validated as per the requirements of the UK Medicine and Healthcare Product Regulatory Agency (MHRA).
The Bordon site is set up as the European importation, packaging, testing and release site for Fresenius Kabi Oncology. The site uses the "packaging postponement" model to meet customer demands at superior flexibility.
The facilities encompass a manufacturing area, a packaging area, a warehouse and QC laboratories equipped for both analytical and microbiological testing. The site includes a compounding area and wholesale activities for the UK market.
The manufacturing area has been designed to offer flexibility for easy and logical movement of people, materials and equipment. The production facility comprises of fully equipped clean rooms to ISO Class 6 containing a range of fixed and mobile isolators of Class 5. Positive pressure differentials ensure an adequate cascade between adjacent areas. The critical and the less critical areas are provided with separate air handling systems.
Currently the site imports, packs and supplies sterile products as well as oral dosage forms. The products are based on a wide range of technologies, like sterile concentrates, sterile liquids and freeze dried products.
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