12 Mistakes to Avoid during Cleaning Validation

This article describes the most common mistakes to avoid during the cleaning validation study.

If you are assigned to make a cleaning validation, pay attention to these 12 Mistakes to Avoid during Cleaning Validation.

The design of the cleaning equipment is fundamental to obtain acceptable results.

The design of equipment is the most important element to consider in cleaning process efficacy, specifically in large systems that may employ semi-automatic or fully automatic clean-in-place (CIP) systems since they represent a significant concern.

1. A good design includes sanitary type piping with sanitary ball valves.  Since when non-sanitary ball valves are used, the cleaning process is more difficult.

2. Consider the knowledge of the cleaning operators in these systems and the level of training and experience in cleaning these systems.

3. Also, check the written and validated cleaning process to determine if these systems have been properly identified and validated previously.

4. Check the flow charts and piping diagrams for the identification of valves and written cleaning procedures (with special attention in larger systems), such as those employing long transfer lines or piping.

5. Inadequately identified valves, both on prints and physically, may lead to incorrect cleaning practices. Therefore, piping and valves should be tagged and easily identifiable by the operator performing the cleaning function.

6. Make sure all critical elements are considered in the documentation of the cleaning processes. For example, identify and control the length of time between the end of processing and each cleaning step.

7. The drying of residues will directly affect the efficiency of a cleaning process in particular during topicals, suspensions, and bulk drug operations.

8. Microbiological issues in the equipment cleaning should be considered in the design whether or not CIP systems are used for the cleaning of processing equipment.

9. The cleaning process design must consider preventive measures rather than removal of contamination once it has occurred.

10. Establish a good design in the routine cleaning and storage of equipment to prevent microbial proliferation. For example, equipment should be dried before storage, and under no circumstances should stagnant water be allowed to remain in equipment subsequent to cleaning operations.

11. Consider equipment sterilization or sanitization procedures after the cleaning process, where such equipment is used for sterile processing.

12. The control of the bioburden through adequate cleaning and storage of equipment is important to ensure that subsequent sterilization or sanitization procedures achieve the necessary assurance of sterility. This is also particularly important from the standpoint of the control of pyrogens in sterile processing since equipment sterilization processes may not be adequate to achieve significant inactivation or removal of pyrogens.

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ERRORS AND MISTAKES TO AVOID DURING CLEANING VALIDATION.

HOW TO WRITE A CLEANING PROCESS PROCEDURES IN 6 STEPS.

THE TOP ANALYTICAL METHODS USED

PREFERRED TEST METHODS

CONSIDERATIONS TO SELECT THE CORRECT TEST METHOD

SAMPLING

TOP CLEANING VALIDATION FACTORS AND LEVELS 

ESTABLISHMENT OF ACCEPTABLE CRITERIA

STATUTORY AND REGULATORY REQUIREMENTS

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Prevent the most common mistakes to avoid during cleaning validation.

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References

PIC/S Guideline to Validation – PI -006-3 (2007)

ICH Guideline Q7 “GMP for APIs

Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/validation-cleaning-processes-793

httpss://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment

httpss://www.gmp-compliance.org/gmp-news/what-does-the-fda-expect-from-cleaning-validation-today

httpss://gmpnews.net/2019/06/fda-requirements-for-cleaning-validation/

httpss://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/contamination-control-cleaning-validation.pdf?sfvrsn=4