PRO1 MICRO Hygiene Monitoring System

High sensitivity pen system for the detection and quantification of surface proteins

Usage

The PRO1 MICRO is designed for high-sensitivity detection and quantification of proteins and reducing agents on surfaces, particularly those difficult to access after cleaning. It targets hygiene verification in healthcare, pharmaceutical, and medical environments.

Applicable regulation

Designed under Quality Management System standards ISO 13485:2016/NS-EN, ISO 13485:2016.
ISO 15883-1: 2006, ISO 15883-5: 2020. HTM 01-01: 2016, HTM 01-05: 2013.

Regulatory and Technical Specifications

• Standards: Complies with ISO 13485:2016/NS-EN, ISO 15883-1:2006, ISO 15883-5:2020, HTM 01-01:2016, HTM 01-05:2013.
• System Components: Pen (12.4 mm diameter, 161 mm length), Swab (111.9 mm length), reactive solution.
• Sensitivity & Quantification: Detects as low as 0.3 µg BSA, with a quantification limit of 1.0 µg BSA.
• Qualitative Analysis: Requires incubation at 60 ± 2 °C for 7 minutes using the Bionova® IC10/20. Results are visually interpreted using a reference guide inside the box.
• Quantitative Analysis: Uses Bionova® IC10/20FR, IC10/20FRLCD, or MiniPro auto-reader incubators. Incubation: 7 minutes for IC10/20FR/IC10/20FRLCD, 4 minutes for MiniPro.

Environmental conditions during manufacture

T = 15-30 °C, RH = 30-80%.

Storage conditions

T = 2-30 °C, RH = 30-80%, keep in a dark place.
Store vertically as indicated on the package.

Transport conditions

Storage conditions should be strictly followed.
Transport in closed and strengthened boxes in order to avoid damages. The transport of this product does not represent a risk for health.

Shelf life

Shelf life of 24 months when stored refrigerated (between 2-8 °C). Maximum shelf life without refrigeration (up to 30 °C) is 6 months.

Packing

Box with 100 units (5 aluminum bags with 20 pens each + 1 swab moisturizer).
Box with 20 units (1 aluminum bag with 20 pens + 1 swab moisturizer).
Packing information: product code and description, presentation, storage conditions, manufacturer information and data on label.

Labelling

On product: product code and description, batch number, manufacture and expiration date and datamatrix code.
On product’s box: product code, batch number manufacture and expiration date, bar code and datamatrix code.

Possible target markets

Healthcare, Pharmaceutical and Medical industries.

Other important information

Read product’s instructions for use thoroughly before use.

Precautions

• Do not reuse.
• Do not open until its use.
• Do not touch the swab with your hands. Wear gloves, surgical mask and other hygiene measures.
• Do not freeze.

High concentrations of alkaline sanitizers may cause false negative results in some cases. Hydrogen peroxide based disinfectants may cause a false positive color change reaction.