Aseptic fill products, process flow

Process Flow, Variables, and Responses Aseptic Fill Products... 

PROCESS FLOW, VARIABLES, AND RESPONSES ASEPTIC FILL PRODUCTS... 

Process flow, variables, and responses aseptic fill products... 

Downstream processing is normally undertaken under clean room conditions, with the final steps (e.g. sterile filtration and aseptic filling into final product containers) being undertaken under Grade A laminar flow conditions (Figure 3.18). 

Within the filling room, all aseptic manipulations and process stages requiring exposure of the dosage form or product contact components should be protected by localized laminar flow drawing air from the Class 100 environment. The importance of this protection is not in the sterility of the air but in the sweeping effect of the air. 

Media Filling Trials Media fills are intended to simulate the risk of contamination that may arise from the aseptic assembly of sterile product elements by substitution of a sterilized placebo for the dosage form. The placebo should be chosen to be of similar flow/filling performance characteristics to the sterilized dosage form to mimic accurately the normal conditions of the production process. 

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