Chemdye® PRO1 MICRO – High Sensitivity Pen System

Chemdye® PRO1 MICRO – High Sensitivity Pen System is an incubation-based system for quantitative or semi-quantitative detection of protein residues on surfaces after cleaning. Semi-quantitative detection can be performed visually, while quantitative detection requires theBionova® MiniPro auto-reader,whichis sold separately.The test is used in environments where objective measurement, documentation, and reproducible results are required rather than merely visual screening.

The method is based on a colorimetric reaction following incubation at 60 °C. The result can be read visually using a color scale (semi-quantitative) or through instrumental analysis (quantitative), which enables standardized assessment and monitoring of the cleaning process’s stability over time.

The system combines pen-style reagents with a highly absorbent swab, enabling effective sampling even on complex and hard-to-reach surfaces. This reduces sampling variability and improves the reliability of the results.

The test is designed to be integrated into validated workflows where protein is used as an indicator of residual contamination, with a focus on traceability, method control, and reproducibility. 

Supports work in accordance with established requirements for cleaning validation described in HTM 01-01, HTM 01-05, ISO 15883-1 and 15883-5 Standards.

Features

• Semi-quantitative or quantitative analysis (depending on the detection method) down to 1 μg
• Instrumental measurement usingthe Bionova® MiniProfor objective and reproducible assessment
• Capability for trend analysis and process monitoring
• Incubation-based method (time and temperature determine the level of analysis)
• Efficient sampling from complex and hard-to-reach surfaces
• Can be integrated into documentation and quality management systems