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Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

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Risk of contamination

Extent of human manipulation of sterilised filtrate and lyophilisate during loading and unloading of the large number of trays typically used in these processes.

Extent of exposure of sterilised filtrate to controlled environmental conditions during filling, lyophilisation and unloading of lyophiliser compared to lyophilisation in the final container.

Extent of aseptic operations subsequent to the sterilisation step at both drug substance and finished product manufacturer in the ‘open tray’ process compared to lyophilisation in the final container.

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