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Cleaning methods differ greatly in various factors and following parameters must be included as per GMP guidance.

1.An adequate standard operating procedure (SOP), written in detail and listing a precise procedure for cleaning all individual parts of the system.

2.A procedure to determine cleaning efficiency by means of sampling, tests and inspections.

3.Sufficiently sensitive analysis methods to test the level of residue to be removed from the equipment

4.An adequate personnel training program.


To evaluate an efficient cleaning procedure, following parameters need to be considered:

- volume of each washing and rinse solutions

- temperature on input and output of the washing and rinse solution

- flow rate and pressure levels

- detergent concentration

- quality of washing and rise solutions

- time and sequences to define the order and duration of single stages

- gas for purification, evacuation and draining must be checked

- mixers and pump, rotation speed and etc.

- system coverage inspection

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