Regulatory literature abounds with restrictions that have been created with typical aseptic processes in mind — the pharmaceutical manufacturing industry is populated by responsible citizens baffled by these rules, and how they should be applied to their atypical processes.
Most, if not every, aseptic process is unique. Even in the same factory, two lines set up for the simplest process such as filling liquid products into ampoules could significantly differ.
The general principle of media fills is that the process should be simulated in a way that addresses every risk of microbiological contamination that could occur in practice, i.e., the process must be conducted exactly as in routine operation. In reality, usually some compromises are made specifically for media fills.
Although aqueous liquids are frequently portrayed as the typical product for generalizations on media fills as in Annex 1 of the E.U. Guide (CEC, 2002), they have their own complexities in terms of process simulation not shared by solid dosage forms or ophthalmics. In this treatment of process simulation, solid dosage forms are given as the initial example, followed by aqueous liquids, and then by consideration of more specialised applications, e.g., lyophilization, aseptic blending, and so on.
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