Sunday, November 27, 2016
Saturday, November 26, 2016
Use of Nitrogen gas in lyophilizer during media fill
Process simulation studies (media fills) are simulating the
whole process in order to evaluate the sterility confidence of the process.
Process simulation studies include formulation (compounding), filtration and
filling with suitable media.
Simulations are made to ensure that the regular process for
commercial batches repeatedly and reliably produces the finished product of the
required quality. However, each process simulation trial is unique and so it is
not possible to extrapolate these results directly to actual production
contamination rates.
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