In order to ensure the quality and reliability of medical products, pharmaceuticals and their raw materials, the product and its raw materials in all stages from production to consumption to TS EN ISO / IEC 17025 Laboratory management principles and national / internationally accepted American Pharmacopoeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (EP) We carry out microbiological, chemical, physical tests and analyzes according to BP) and ISO methods.
Accredited medical analyzes are bioburden test, sterility test, ethylene oxide residue test, cleaning validation test (detergent residue test, oil grease residue test), leakage test.
The microbiological air measurement in the clean rooms where medical products are produced and the analysis of the samples taken from the personnel hand and equipment surfaces are reported as accredited with Türkak.
Within SANİTER, CE marking works and T.C. All analyzes to be carried out within the scope of Annex-1 (Absolute requirements) of the Ministry of Health Medical Device Regulation are carried out in accordance with international standards and are presented in comprehensive reports
It is performed to determine whether the validation of your products is done correctly.Read More +
It is performed to determine that your products remain stable for the specified real-time shelf life...Read More +
After sterilization of your products with ethylene oxide, it is carried out to determine the residue...Read More +
Ürünleriniz üzerindeki biyolojik bakteri yükünü tespit amacıyla gerçekleştirilir.Read More +
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