In Sterile production, especially Vial filling and PFS filling, how you validate it is under sterile process and how you perform media fill? Thanks for your answering.
While I do not have much experience with PFS, you know that one of the tenets of the Media Fill is to simulate the aseptic process as much as it can to the actual process.
One recommendation that comes to my mind is that the PFS process would likely be an anaerobic process, which is relevant to the design of the media fill and select the type of growth medium and any process gasses or headspace in the syringes if any.
Do you have a more specific question about the PFS media fill where I could elaborate more?
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