PRO1 MICRO, Pen System for Surface Protein Test

Packaging: Box contains 20 pieces

The PRO1 MICRO Hygiene Monitoring System is a high-sensitivity pen system engineered for the precise detection and quantification of residual proteins and reducing agents on surfaces. Designed for use on clinical surfaces and difficult-to-access areas after the cleaning process, it serves as a critical component in infection control by verifying cleaning efficacy. The system is specifically optimized for professional use in the healthcare, pharmaceutical, and medical industries.

Features:

• Exceptional Sensitivity: The system provides a limit of quantification (LOQ) of 1.0 µg of BSA and a detection sensitivity of 0.3 µg of BSA. 
  
• Advanced Sampling Technology: The system integrates a specialized reactive solution with a high-absorption swab, ensuring efficient sample collection across diverse surface types.
• Versatile Analytical Methods: Qualitative analysis is achieved via visual interpretation after a 7-minute incubation at 60±2°C. Quantitative analysis is supported by Bionova auto-reader incubators, with processing times of 7 minutes for IC10/20FR models or 4 minutes for the MiniPro model.
• Regulatory Alignment: The product is manufactured under ISO 13485:2016 Quality Management standards and complies with ISO 15883-1:2006, ISO 15883-5:2020, and HTM 01-01:2016.
• Stringent Storage Requirements: To maintain chemical integrity, the system must be stored vertically in a dark environment between 2-30°C with relative humidity (RH) between 30-80%.
• Shelf Life and Stability: The product remains viable for 24 months when refrigerated (2-8°C) or for a maximum of 6 months if stored at room temperature up to 30°C. 
  
• Operational Safety: The system is non-hazardous to health during transport but must be protected from freezing and high concentrations of alkaline sanitizers to avoid interference with results.

Documents:

• Brochure
• Instructions for Use
• Color Chart