Based on the selection of specific products for all production equipment, three consecutive lots are to be studied during a cleaning validation. All three lots must pass the acceptance criteria for chemical residue and microbial burden for the cleaning method to be validated.

Equipments in the Manufacturing and Filling areas are subjected to cleaning (manual and/or CIP/SIP (steam in place)) immediately following any production use in which they come into direct contact with the product. The following factors were considered in the design of the cleaning validation program:

• To avoid the potential for localized contamination, selection of "hardest to clean" sample sites for the equipment and development of the respective cleaning procedure will be done.

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