Rinse and Swabbing Procedures

The purpose of the HPLC analysis of cleaning samples is to prove with data that the equipment and cleaning procedures work, and that the surfaces of the equipment are indeed clean. The HPLC chromatographic finish is extremely reproducible and is the easiest part of the analytical 

The swabs present several problems. With swabs there are many steps that need to be validated to insure an accnrate result. The analyst must be able to quantitatively remove the analyte from the swab. The analyte is added to the swab as a solution, dried, and quantitatively extracted off for analysis. The preferable extraction solntion is the swabbing solvent. The HPLC mobile phase or a mobile phase component could be used, but would necessitate a dilution of the swabbing solution. Standard addition and recovery data of clarithromycin added to different lots of polyester fiber are present in Table 3.  

TABLE 3 Standard Addition and Recovery Data of Clarithromycin from Polyester Fiber 

Lot of polyester Clarithromycin added (pg) Clarithromycin found (pg) % recovery 

FIGURE 2 Typical chromatogram of washed and unwashed swab material showing the removal of chromatographic interferences. 

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