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Removing API residues from processing tools in sterile areas is a serious validation issue especially for cyto-toxic compounds. The Sequence below highlights this issue as a user required three distinct wipe passes with a standard clean room grade polyester wiper in order to achieve a surface free of Arsenic residue. But validation testing showed instances when Arsenic was still present.
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High levels of Arsenic found after first polyester wiping pass |
The second motion with polyester wipers shows reduced Arsenic levels |
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The third polyester wiper indicates an Arsenic free surface |
More rigorous inspection techniques showed Arsenic contamination on the surface. MiraWIPE'S® unique fiber structure enables improved cleaning efficacy enabling the user to achieve validated cleanliness with only 2 wiper passes. |



