Cleaning Validation – Swabbing. Swab Test Method.
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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.All cleaning validation sampling methods will normally include a visual check which will provide an immediate feedback on the cleaning process deficiencies. The sampling method will then be based on some or all of surface swabbing, sample fluid rinse, coupon sampling, placebo sampling.
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Swab sampling is a method of direct surface sampling, which is performed via wiping a surface with a swab, typically saturated with water or a sampling solvent, in order to remove residues from a surface. The swab is then desorbed, a chemical analysis is performed on the desorbed material. One of the major considerations associated with swabbing is the requirement of physical force in the sampling process, therefore, there is a necessity for operator training to ensure consistent physical force application during the swab sampling. As part of the swab sampling qualification the percent recovery must be determined. Additionally any extractables of the swab or protein binding to the swab head must not interfere with the sampling method. Swab sampling can be difficult to effectively apply in areas not easily accessed, for example pipes, the inner surfaces of hoses, small intricate equipment, reactor tanks with small ports, etc.. Swab sampling can provide an advantage where there are potentially dried out residues on a surface, or where residues are insoluble.
Other sampling methods:
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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