Maximum Batch size for Terminal Sterilized Vial fill Injectable product

Considering the Vial filling activity, How may hour of filling run should be considered for filling TS product in vial. Based on number of hours batch size needs to be decided?

That depends on the batch size that you validated in your process validation and media fill. The extent of your validation/media fill is determined using risk assessment of your filling process including for instance intermediate product hold time during filling etc. Also, marketing might request a certain batch size due to demand for the product.

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Dear Batch size depends upon:

  1. Manufacturing capacity of the site.
  2. Market forecast.
  3. Media fill - maximum filling duration covering routine and non routine intervention.
  4. Registered batch size
  5. Fill volume