Cycle Development

a. Cleaning agent selection: Selection criteria for cleaning agents should be the suitability of removing product residues and low toxicity. Besides these, ingredients of the selected cleaning agent should also be known so that the cleaning of reagent itself can be proven.

b. Cleaning parameter selection: The most important cleaning parameters are time, temperature, cleaning agent concentration, and cleaning action, for example, impingement, sheeting, rinsing, and so on. By evaluating each cleaning step, the removal of residues can be determined and thus the need to add, delete, or modify a cleaning step can be decided as well.

c. Standard operating procedures: A draft-cleaning procedure should be in place prior to starting the cleaning validation. Once a successful validation is accomplished, the final standard operating procedure for cleaning must be completed with details such as time, temperature, concentration, and cleaning action.

d. Operator training: A formal training of operators includes reviewing and understanding the cleaning SOPs, qualified apprenticeship, and ensuring that training is successful. Operators must also understand the process of cleaning and the equipment they are cleaning.

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