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Couple of dual-chamber containers have specifically created lyo stoppers put after the filling operation in a very semi-stoppered position allowing h2o to escape throughout lyophilization. In the course of drying, DCSs/DCCs are generally positioned within a “idea-up” configuration where the cakes sit on the top of the middle plunger. Just after
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12.0 Deviations: Any deviation within the protocol relevant to the production process, raw materials, equipment applied, sampling, in-process controls and analytical methods needs to be approved and documented inside the batch production record as well as the validation report.When process validation supports the establishment of generation process