campaign production

which is the maximum time of campaign production , before re-cleaning equipment?it is established?

Hi,

Very good question. Would like to explain as, there are two things to verify as a campaign production.

  1. Campaign in terms of Time (Contineuos process) or No. of batches (Batch processing) in equipment chain
  2. Campaign in terms of Time (Contineuos process) or No. of batches (Batch processing) in individual equipment

The time or no. of batches depend on the Nature/ process / chemistry of product you process in the Equipment (Chain). A evaluation report followed by the verification plan should be inplace before conducting such studies.

Any time line or No. of batches should be supported by proven data. You can go as long as you want provided your process & your data is supporting the facts.

Happy Reading !

Dear all
During the validation of Campaign batches you have to perform the validation of batche in respect to microbiological load, impurity profile for related substances and for las batch accerelated and log term stability study required e.g. if we are considering that 5 compaign batches for validation study then for 5th batch sability study required. after all this exercise you have establised the re-cleaning of equipments