Cleaning Validation – Solvents

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Where any aqueous or organic solvents are used in the cleaning procedure, the quantity utilized should be sufficient so as to remove residues, but equally should not create a potential for any reaction with or damage to the equipment, or the over-dilution of the residue and the resultant loss of analytical sensitivity.

Samples should be collected in clean or sterile containers. All validation samples must be properly labelled with complete information regarding the source of the sample, sampler’s name, sampling date, reference number, product name, and the part of equipment from which the sample has been collected.

A sample of the rinse or swabbing solvent should always be included with the actual test samples to serve as a reagent blank for any chemical or microbiological determination when required.

All types of samples, physical, chemical, or microbiological, should be collected according to a written procedure and using techniques, reagents, equipment, and containers appropriate to the type of testing to be performed. Only trained personnel should perform the collection of these samples.

The environmental effectiveness of cleaning procedures should be assessed by surface sampling of non-product contact surfaces (for example floors, walls, air ducts, exterior equipment surfaces, etc.). Samples should be collected and analyzed for potential contamination.

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Other sampling methods:

Swabbing involves using a wipe or swab that is moistened with high purity water (WFI – water for injection) that is typically wiped over a defined area in a systematic multi-pass way always going from clean to dirty areas to avoid recontamination – i.e. 10 side by side strokes vertically, 10 horizontally and 10 each with the flip side of the swab in each diagonal direction. For TOC analysis very clean low background swabs or wipes and sample vials should be used.

Rinse water sampling involves taking a sample of an equilibrated post-final rinse that has been re-circulated over all surfaces. Rinse samples should be correlated to a direct measuring technique such as swabbing

Coupon sampling involves the use of a coupons or an actual removable piece of pipe that is dipped into high purity water to extract residues for analysis.

Placebo testing involves using placebo product and analyzing for residues from the previous batch.

Information & Training.

Product and Process Validation.

The Validation Master Plan. Performing a Gap Analysis. Validation in the Design Process. Etc..
How to ensure Validation efforts are aligned with potential Risks.
How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
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Reference:
FDA. Validation of Cleaning Processes.