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Validation of cleaning and disinfection processes

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