Product Overview

Self-Contained Biological Indicator with Rapid Readout Fluorescence System.

Product Details

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

Weight: 152.15kg

Key Benefits

Suitable for the steam sterilisation process within an autoclave / steriliser.

Rapid Readout of result when used with the IC1020FRLCD.

Spores carrier: Filter Paper: 16.0 mm, 160.0 g/m2≥ 106 Geobacillus stearothermophilus ATCC 7953 spores per vial.

Final fluorescence reading is performed after 3 hour-incubation at 60 ºC.

Positive biological indicators can be sterilized in a gravity-air displacement steam sterilizer at 121 ° C for 30 minutes, at 132 ° C for 15 minutes or 134 ° C for 10 minutes; or in a dynamic-air removal steam sterilizer at 132 ° C for 4 minutes or 135 ° C for 3 minutes.

Culture medium 0.5 – 0.7 ml, purple color.Polypropylene microfiber on spore carrier, 17.0 mm diameter, 80.0 g/m2. Spores carrier: Filter Paper: 16.0 mm, 160.0 g/m2. ≥ 106 Geobacillus stearothermophilus ATCC 7953spores per vial.

50 units per box.

Product Code:BT220.

Shipping Information

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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.

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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 Steam sterilization cycles.
Conditions: vacuum assisted and gravity air-displacement cycles at 121-135ºC.
Exclusive conditions for United States:
• Gravity cycles at 121 °C, 30 minutes.
• Gravity cycles at 132 °C, 15/25 minutes.
• Gravity cycles at 135 °C, 10 minutes.
• Vacuum assisted cycles at 132 °C, 4 minutes.
• Vacuum assisted cycles at 135 °C, 3 minutes.
Applicable Regulation
Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.
ISO 11138-1:2017 and ISO 11138-3:2017; IRAM 37102-1:1999 and IRAM 37102-3:1999.
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: medical grade paper, 60.0 g/m2, 17.0 mm diameter.
Glass ampoule: 35.0 - 40.0 mm high. 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, 80.0 g/m2.
Spores carrier: Filter Paper: 16.0 mm, 160.0 g/m2.
≥ 106 Geobacillus stearothermophilus ATCC 7953 spores per vial.
Final fluorescence reading is performed after 3-hour incubation at 60 ºC (sensitivity: ≥ 97 %).
An optional visual pH color change confirmation could be made 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 3-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 avoid medium to dry out.
D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value is informed at 132ºC and at 135ºC.
Z-Value is informed.
BT220
Self-Contained Biological Indicator.
Rapid Readout Fluorescence System.
Rev. 27 / Infection Control Division | Biological Indicators 06.2019 Página 4 de 6
Environmental conditions during manufacture
Room temperature 15-30ºC, RH 30-80%. Sterility conditions are only necessary during the inoculation and manufacturing process, which is performed in laminar flow.
Storage conditions
T = 10-30 ºC, RH 30-80 %, keep in a dark place in its original box.
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, storage conditions, manufacturer information and data on pack´s label.
Labelling
On product: 17.0 mm x 33.0 mm polypropylene label. 1.5 mm x 10.0 mm chemical indicator line, printed with Steam reactive ink (Color change to brown). 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 load, manufacture and expiration date, barcode 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
Incubation at 60 ºC must be performed in Bionova® Auto-Reader incubators.
Read product’s instructions 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 Steam.
Discard biological indicators after use according to your country’s healthcare and safety regulations. Positive biological indicators can be sterilized in a gravity-air displacement steam sterilizer at 121 ° C for 30 minutes, at 132 ° C for 15 minutes or 134 ° C for 10 minutes; or in a dynamic-air removal steam sterilizer at 132 ° C for 4 minutes or 135 ° C for 3 minutes.
EN


BT220Steam Rapid

Self-contained biological indicator. Super rapid readout fluorescence system

£354.00

Suitable for the steam sterilisation process within an autoclave / steriliser.

Rapid Readout of result when used with the IC1020FRLCD.

Spores carrier: Filter Paper: 16.0 mm, 160.0 g/m2≥ 106 Geobacillus stearothermophilus ATCC 7953 spores per vial.

Final fluorescence reading is performed after 3 hour-incubation at 60 ºC.

Positive biological indicators can be sterilized in a gravity-air displacement steam sterilizer at 121 ° C for 30 minutes, at 132 ° C for 15 minutes or 134 ° C for 10 minutes; or in a dynamic-air removal steam sterilizer at 132 ° C for 4 minutes or 135 ° C for 3 minutes.

Culture medium 0.5 – 0.7 ml, purple color.Polypropylene microfiber on spore carrier, 17.0 mm diameter, 80.0 g/m2. Spores carrier: Filter Paper: 16.0 mm, 160.0 g/m2. ≥ 106 Geobacillus stearothermophilus ATCC 7953spores per vial.

50 units per box.

Product Code:BT220.