How to Make the Correct Sampling in Cleaning Validation
There are two (2) most common and recognized types of sampling in cleaning validation.
Direct Surface Sampling
This method of sampling is the most desirable. This method can be implemented to determine the type of sampling material used and its impact on the test data.
The sampling material must not interfere with the test, either attenuating or magnifying the contamination or residues content.
For example, the adhesive used in swabs has been found to interfere with the analysis of samples.
Therefore, early in the validation program, it is important to assure that the sampling medium and solvent (used for extraction from the medium) are satisfactory and can be readily used during sampling in cleaning validation.
The advantages of direct sampling are that areas hardest to clean and which are reasonably accessible can be evaluated, leading to establishing a level of contamination or residue per given surface area.
Additionally, residues that are “dried out” or are insoluble can be sampled by physical removal.
A simpler method is the use of rinse solutions. Two advantages of using rinse samples are that a larger surface area may be sampled, and inaccessible systems or ones that cannot be routinely disassembled can be sampled and evaluated during sampling in cleaning validation.
A disadvantage of rinse samples is that the residue or contaminant may not be soluble or maybe physically occluded in the equipment.
The biggest disadvantage is the recovery determination of residues and contaminants not soluble in the rinse solution.
An analogy that can be used is the “dirty pot.”
In the evaluation of cleaning of a dirty pot, particularly with dried out residue, one does not look at the rinse water to see that it is clean; one looks at the pot.
Check to see that a direct measurement of the residue or contaminant has been made for the rinse water when it is used to validate the cleaning process.
For example, it is not acceptable to simply test rinse water for water quality (does it meet the compendia tests) rather than test it for potential contaminates.
Routine Production In-Process Control once Validated
Post Validation Monitoring – The conductivity testing is an indirect method with some value for routine monitoring once a cleaning process has been validated.
Conductivity testing can be useful in many situations as the bulk drug substance where reactors and centrifuges and piping between large equipment that can be sampled only using rinse solution samples.
Any other indirect test method can be validated and used to correlate with the cleaning condition of the equipment.
During validation, the firm should document that testing the uncleaned equipment gives a not acceptable result for the indirect test.
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HOW TO WRITE A CLEANING PROCEDURES IN 6 STEPS.
CONSIDERATIONS TO SELECT THE CORRECT TEST METHOD
TOP CLEANING VALIDATION FACTORS AND LEVELS
ESTABLISHMENT OF ACCEPTABLE CRITERIA
STATUTORY AND REGULATORY REQUIREMENTS
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References: Sampling in Cleaning Validation
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