Product Details

Size (mm): Length: 66 x Width: 140 x Height: 70

Weight: 149.57kg

Key Benefits

Monitoring of airborne and surface disinfection by Hydrogen Peroxide (H2O2).

Super Rapid Readout of result when used with the IC1020FRLCD.

Self-contained and easy handling.

Direct contact with sterilizing agent.

Highly relibable results with very low possibility of cross contamination.

Final fluorescence reading is performed after2 hour-incubation at 60 ºC.

Polypropylene microfiber on spore carrier, 17.0 mm diameter, 60 g/m2. Spores carrier: polyethylene fibers: 5.0 x 40.0 mm.≥ 106Geobacillus stearothermophilus ATCC 7953spores per vial.Final fluorescence reading is performed after 2-hour incubation at 60 ºC (sensitivity≥ 97 %).

50 units per box.

Product Code: BT95.

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
Monitoring plasma or vaporized Hydrogen Peroxide sterilization processes (H2O2).
Applicable Regulation
Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.
ISO 11138-1:2017 and IRAM 37102-1:1999.
Classification
Class 1, according to risk.
Authorization
ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-1.
Characteristics
Polypropylene tube: 50.4 mm high x 8.5 mm external diameter. Wall thickness: 0.5 mm
Polypropylene cap: 10.5 mm external diameter, 16.4 mm high. Wall thickness: 0.9 mm
Cap filter: polyethylene fibers, 17.0 mm diameter.
Glass ampoule: 35.0 – 40.0 mm high. mm. External diameter: 6.8 mm. Wall thickness: 0.2 – 0.3 mm.
Culture medium 0.5 – 0.7 ml, purple color.
Polypropylene microfiber on spore carrier, 17.0 mm diameter, 60 g/m2.
Spores carrier: polyethylene fibers: 5.0 x 40.0 mm.
≥ 106 Geobacillus stearothermophilus ATCC 7953 spores per vial.
Final fluorescence reading is performed after 2-hour incubation at 60 ºC (sensitivity ≥ 97 %).
An optional visual pH color change confirmation could be performed after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 60 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain purple after the incubation process.
7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 2-hour reading. Fluorescence results may be compared to the 7-day visual reading.
NOTE: If 7-day readout is performed, a humidified environment will be required to prevent medium from drying out.
Environmental conditions during manufacture
Room temperature 15-30 ºC, RH 30-80 %. Sterility conditions are necessary only during inoculation process performed in laminar flow.
Storage conditions
T = 10-30 ºC, RH 30-80 %, keep in a dark place in its original box.
BT95
Self-Contained Biological Indicator.
Rapid Readout Fluorescence System.
EN
Rev. 10 / 03.2019 Infection Control Division | Biological Indicators Página 4 de 8
Transportation conditions
Storage conditions should be strictly followed.
Products should be transported in closed and reinforced boxes in order to avoid damages. Product transportation does not represent any risk for human health.
Shelf-life
2 years.
Packing
50 units per box.
Packing information: product code and description, process for intended use, presentation, regulation, bacterial strain, manufacturer information and data on pack´s label.
Labelling
On product: 17.0 mm x 33.0 mm polypropylene label. 1.5 mm chemical indicator line, printed with Hydrogen Peroxide reactive ink (color change to green). Graph showing final fluorescence reading time, product code, batch number, expiration date, process for intended use and bacterial strain printed in black.
On product’s pack: product code and description, batch number, bacterial strain and load, manufacture and expiration date, bar code and datamatrix code.
NOTE: manufacture date is calculated by subtracting 24 months to the expiration date.
Possible target markets
Healthcare and Industry.
Other important information
It is advisable to incubate at 60 ºC in Bionova® IC10/20FR, IC10/20FRLCD or MiniBio Auto-Reader incubator
Read product’s directions for use thoroughly before use.
Description of identified and/or predictable risks which could represent a risk for the product
Do not store the product near sterilizing agents.
Do not expose this product to EO, Dry heat, Radiation or any sterilization process other than Hydrogen Peroxide.
The positive biological indicator can be autoclaved at 121 ºC for at least 20 minutes, at 132 ºC for at least 15 minutes in gravity displacement steam sterilization, or at 134 ºC for at least 10 minutes in vacuum steam sterilizer
EN


BT95VH202 Rapid

Self-contained biological indicator. Super rapid readout fluorescence system

£538.80

Monitoring of airborne and surface disinfection by Hydrogen Peroxide (H2O2).

Super Rapid Readout of result when used with the IC1020FRLCD.

Self-contained and easy handling.

Direct contact with sterilizing agent.

Highly relibable results with very low possibility of cross contamination.

Final fluorescence reading is performed after2 hour-incubation at 60 ºC.

Polypropylene microfiber on spore carrier, 17.0 mm diameter, 60 g/m2. Spores carrier: polyethylene fibers: 5.0 x 40.0 mm.≥ 106Geobacillus stearothermophilus ATCC 7953spores per vial.Final fluorescence reading is performed after 2-hour incubation at 60 ºC (sensitivity≥ 97 %).

50 units per box.

Product Code: BT95.