For the duration of this phase, continual monitoring of process parameters and high quality characteristics at the level established in the process validation phase shall be carried out.Validation includes creating several batches underneath defined parameters to determine consistency. Typically, 3 consecutive batches inside appropriate limitations
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This indicator experienced a maximum incubation of 48 hrs but significant failures can be detected in £24 several hours. A speedy-readout biological indicator that detects the presence of enzymes of G. stearothermophilusThe central processing space(s) ideally should be divided into no less than three parts: decontamination, packaging, and steriliz
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