Cleaning Validation | Campaign Cleaning Validation (CCV)

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When the product demand does not allow for a complete clean up after each batch, a campaign cleaning validation must be conducted.  A back to back cleaning is performed between batches in a campaign, and a complete cleaning at the end of a campaign. Sampling of the equipment is performed after the last batch in a campaign, and all test results must meet predetermined acceptance criteria as per campaign cleaning validation protocol. 



Samples for residual active may be taken after back to back cleanings where possible, for information only. Microbiology samples may be taken after back to back cleanings in a campaign to ensure that there is no excessive microbial growth on the equipment.
 

If an extension of a campaign is necessary previously gathered data will be summarized, and a new protocol for extending the campaign length will be generated.  Upon completion of the number of batches for the campaign, cleaning validation of product contact surfaces is to be conducted.  Three consecutive successful cleaning verification's after campaign completion will validate the cleaning procedures for the manufacturing campaign.

A matrix approach may be used for campaign cleaning validation.  A successful campaign cleaning validation has been completed for campaigns of 20 batches of Solid dosage form and 5 batches of Liquid and Ointment dosage form.  The need for campaign cleaning validation for new products will be evaluated based on toxicity and active ingredient solubility.

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