Product Overview

PRO1 VT Validation Kit System for efficacy validation of the PRO1 MICRO Hygiene Monitoring System.

Product Details

Size (mm): Length: 88 x Width: 88 x Height: 55

Weight: 85kg

Key Benefits

Easy to use with Mini Pro Incubator.
The Positive Control consists of a vial with a defined amount of standard protein (blue cap).

The Negative Control consists of a vial with a protein-free solution (green cap).

Provides a quantitative analysis.

Incubation time 10 minutes within MINI Pro Incubator.

Product Code: PRO1VT.

Shipping Information

Thank you for visiting and shopping at Sychem. The following are the terms and conditions that constitute our Shipping Policy.

Shipment processing time

All orders are processed within 2-3 business days. Orders are not shipped or delivered on weekends or holidays. If we are experiencing a high volume of orders, shipments may be delayed by a few days. Please allow additional days in transit for delivery. If there will be a significant delay in shipment of your order, we will contact you via email or telephone.

Contact us for international shipping

For all enquiries regarding international shipping, please call directly and we’ll be happy to help.

Christmas shipping

Over the festive period, please note you may experience time delays when waiting for receipt of your order. However, we will endeavour to get all orders out as soon as possible.

Additional Information

Usage
Designed for efficacy validation of Chemdye® PRO1 MICRO Hygiene Monitoring System when use with Bionova® MiniPro, IC10/20FR or IC10/20FRLCD Auto-Reader Incubators. The PRO1 MICRO allows to quantify with high sensitivity proteins, allergens and reducing agents on different surfaces and difficult access areas after the cleaning process.
Applicable Regulation
Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.
ISO 15883-1: 2006 / HTM 01-01: 2016 / HTM 01-05: 2013.
Characteristics
The system has a Negative and a Positive Control.
The Negative Control consists of a vial with a protein-free solution (green cap).
The Positive Control consists of a vial with a defined amount of standard protein (blue cap).
Vial´s diameter: 12.0 mm; Vial´s length: 47.0 mm.
Quantitative analysis: Using Bionova® IC10/20FR, IC10/20FRLCD or MiniPro Auto-reader incubators. Read the instructions for use of the device previously.
Incubation time: using Bionova® IC10/20FR or Bionova® IC10/20FRLCD: 15 minutes. Using Bionova® MiniPro: 10 minutes.
Incubation range: (60± 2) ºC.
Environmental conditions during manufacture
15-30 ºC (room temperature), RH 30-80 %.
Storage conditions
T = 2-30 ºC, RH 30-80 %, store in dark place.
Transportation conditions
Storage conditions should be strictly followed.
Transport in closed and strengthened boxes in order to avoid damages. Transportation of this product does not represent a risk for health. Product can be kept at temperature below 30 ºC for up to 25 days during transportation without modifying its shelf-life (provided that the subsequent storage conditions are respected).
Shelf-life
2 years when stored refrigerated (2-8°C) and 6 months when stored at room temperature (up to 30°C).
Packing
Box with 10 Negative Controls (green cap) and 10 Positive Controls (blue cap).
Packing information: product code and description, process for intended use, presentation, storage conditions, manufacturer information and data on label.
EN
Rev.2 / 03.2019 Infection Control Division | Hygiene Indicators Page 4 de 4
Labeling
On product´s pack: product code and description, batch number, manufacture date and expiration date, barcode and datamatrix.
Possible target markets
Healthcare, Food, Pharmaceutical and Medical industries.
Other important information
Read product’s instructions for use thoroughly before using.
Description of identified and/or predictable risks which could represent a risk for the product
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.
EN


PRO1 VT

Positive negative calibration control kit

£330.00

Easy to use with Mini Pro Incubator.
The Positive Control consists of a vial with a defined amount of standard protein (blue cap).

The Negative Control consists of a vial with a protein-free solution (green cap).

Provides a quantitative analysis.

Incubation time 10 minutes within MINI Pro Incubator.

Product Code: PRO1VT.