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TEM-015 Cleaning Validation – Swab Test
TEM-015
Issue date
Cleaning Validation – Swab Test
(Ref. VAL-020)
Project number:
Protocol Number:
Product/Active:
Process Line:
SWABBING RECOVERY STUDIES
1. Test Description
This test is to be conducted to document the validation of a TOC analysis method for use
in measuring samples for cleaning validation. A parallel analysis of swab samples will be
carried out and compared using TOC and HPLC analysis. Standard solutions will be
applied to stainless steel plates, dried and the residue removed by swabbing using the
Texwipe TX761 swab. Assessment of Linearity, Accuracy (recovery), LOQ, LOD and
precision of the swabbing method will be determined.
2. Test Objective
1. Determine the linearity and precision of a series of standards swabbed from a
stainless steel plate and measured by TOC and HPLC over a known concentration
range.
2. Determine the accuracy (recovery) of a series of standards swabbed from a stainless
steel plate and measured by TOC and HPLC over a known concentration range.
3. Determine the Limit of quantitation and limit of detection of a series of standards
measured by TOC and HPLC over a known concentration range.
4. Determine correlation between HPLC and TOC analysis.
5. Determine the visually clean limit.
6. Determine the final HPLC and TOC swabbing limits based on recovery studies.
3.
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