Validation of cleaning and disinfection of
Microbiological contaminants - CCS
Preparatory stage
STRATEGY FOR A VALIDATION PLAN AND ESTABLISHMENT OF THE METHOD ACCORDING TO THE 5MS
Provision of a template for a General Validation Plan
Provision of a template for a C/D Matrix
Step 1 :
CONFIRMATION OF THE EFFECTIVENESS OF THE C/D METHOD
Provision of a Risk Assessment template to define the location of microbiological sampling
Visual checks and Microbiological sampling of surfaces before and after C/D
Step 2 :
IOQ QUALIFICATION OF C/D PROCESSES
Provision of a template for an IOQ Protocol for the Qualification of C/D
Processes Documentary verification and completion of the IOQ Protocol
Step 2 :
PQ QUALIFICATION OF C/D PROCESSES
Provision of a template for a PQ protocol for the Qualification of C/D processes
FMECA Risk Assessment rating for the choice of which “wild” strains to use
PQ tests (With or without mechanical actions, EN 16615 or EN 13697)
Completion of the PQ protocol and interim signature of the validation plan
Step 3 :
MONITORING OF CLEANING AND DISINFECTION
Provision of a Risk Assessment template to define the locations for extra monitoring
Visual checks and microbiological sampling of surfaces
Closing phase :
VALIDATION SUMMARY REPORT
Provision of a Validation Summary Report template
Completion of the Validation Summary Report
Validation of cleaning: Chemical contaminants - CCCS
Preliminary Worst Case study to establish the method according to the 5Ms
Master Plan for validating cleaning processes applicable to the surfaces of the equipment in contact with products
Risk assessment : Selection of the product, selection of the surfaces, selection of the sampling plan
Qualification of processes
Tests
Monitoring
