Learn how to develop a cleaning method for cleaning of pharmaceutical manufacturing equipments.
A well-developed cleaning method is a primary requirement for the cleaning validation. Cleaning procedure should be developed before starting the cleaning validation. Following things should be considered during development of good cleaning procedure.
1. Select the cleaning procedure if it will be manual or automated.
3. Our strategy for the cleaning as a process, groups of equipment, the detergent used, equipment for cleaning, any risk included in cleaning etc.
4. Worst case should be selected that is hard to clean as residues on the equipment, corners of equipment and water-insoluble products.
5. Selection of cleaning agent and its concentration that can clean the residues properly.
6. Determination of temperature of water and cleaning agent, the volume of water to be used for cleaning, and contact time of the cleaning agent.
7. Recovery factor should be determined for the analysis of product and detergent residues.
9. Sampling locations should be selected considering the hard to clean place in the equipment.
11. The cleaning process should include the sequence of cleaning of the different parts of the equipment.
Nature of the product as solubility and insolubility should be studied in detail because it plays a great role in the cleaning activities.
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