MidiMed has a production structure that is adapted to the manufacture of culture mediums. The production is done from "pharmaceutical quality" water and chemical products of pharmacopoeia grade. MidiMed culture mediums are prepared according to an aseptic manufacturing process and all steps of this process have been validated. Moreover, a final sterilisation is carried out by membrane filtration using 0.1µm membrane in order to guarantee the quality of product.
After distribution, the cultural mediums are placed in quarantine till their validation by the quality assurance department in order to check that they actually correspond to the strict product specifications:
Sterility
The norms applied for procedures of production of MidiMed are equivalent to those required for aseptic production of pharmaceutical products. The check is carried out by applying European pharmacopoeial standards.
Checking
of Physicochemical parameters
Osmolarity and pH are checked in order to meet the specifications of products.
Determination
of endotoxins ratio
Validation
of performances in cell culture
The validation of performances of culture mediums is done with cell lines adapted according to each product. The compliance of product with predefined specifications is tested by evaluating:
-Number of changeovers achieved;
-Cell multiplication;
-Observation of cell shapes under microscope.
In order to meet specific requirements of its clients, the culture mediums can be packaged in bottles of 100, 500 or 1000 ml or in packets of 5, 10, 20, 50 litres up to 500 litres.
Exemple de certificat d'analyse de milieu de culture au format
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