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The 18F – FDG quality is related with the product's radiochemical and chemical purity characteristic. The level of control in the process of production is one of the key factors affecting quality. The 110 minute- half-life of the 18F agents makes it impossible to obtain the pre-injection sterility test result. Therefore, the sterilization method in the production process is the key element for 18F – FDG. The terminal sterilization (sterilization in the final packing) is a GMP gold standard. SteriPET is the first licensed 18F – FDG with Terminal Sterilization in the European Union Market. As mentioned in the European Pharmacopeia, Terminal Sterilization is the preferred preparation method for sterile products (EU Pharmacopoeia 5.1 General Texts on Sterility). Moreover, in annex 1 of European GMP manual, it is stated that "Filtration alone is not considered sufficient when sterilisation in the final container is possible" (Annex 1, European GMP). SteriPET is manufactured in 12 facilities in total in:
SteriPET is only manufactured by Medicheck in Turkey. The standards of high quality and safety are regularly audited by Quality Assurance, Regulatory Assurance and EHS PET and Supply Chain teams appointed by the GE Healthcare center.
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