Where Cleaning Validation is Performed?

Cleaning Validations are performed by sampling the so called “critical points” of equipment, which are actually the “most difficult to clean” areas of the product contact surfaces. The critical points choice for Cleaning Validation purposes should result from an appropriate risk-assessment, conducted by a team made up of all the parties involved in Cleaning Validation, from the engineering responsible for installation and qualifications to the production staff that is in charge of the cleaning of the equipment. Typical aspects to consider for the selection of critical points are disassembly, dimensions, accessibility, shape and contact material surface.

Similarly to products, equipments can also share characteristics such as shape, size and cleaning procedure and therefore can be grouped using the bracketing approach. The execution of Cleaning Validation on a representative equipment of the group can be extended to all members of the group itself, leading to resources and time saving.

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