Simulation of Processes Involving Aseptic Bulk Compounding Before Filling

Some sterile products need to be compounded aseptically, e.g., suspensions. Some antibiotic solid-dosage forms require blending with a carrier. Each particular case is likely to be different. There may be compounding of two liquid phases, both of which have been passed through bacteria-retentive filters; compounding of two solid phases both of which enter the filling room through pass-through hatches; or compounding of liquid and solid phases.

The general rule for media fills is that the aseptic compounding needs to be included in the simulation.

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