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Cleaning validation documentation (example)


The following documentation example shows how the procedures in chapter 8.H Documentation (see figure 8.H-3) can be applied in practice.

It describes the cleaning validation of a high shear mixer. The fictitious validation study will draw on the examples in earlier chapters.

The validation scope is taken from the bracketing and matrixing described in chapter 8.D Establishing the scope of validation (see figure 8.D-4 and figure 8.D-5).

The limit calculation for the critical products A and E was given in chapter 8.E Acceptance criteria and limit calculation (see figure 3, figure 4 and figure 5).

The limit given for the cleansing agent cannot be traced to previous examples, but is in the order of magnitude in usual practice.

The documentation example includes both the validation protocol and the validation report and therefore represents a complete cleaning validation.

Figure 1 Cleaning validation protocol (example)  

Figure 8.J-2 Sampling plan (example)  

Figure 8.J-3 Validation report (example)  

 

Figure 8.J-4 Appendix to Validation report (example)  

 

Figure 8.J-5 Appendix to Validation report (example)  



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