BT60-3 DRY-EO-STEAM

BT60-3 DRY-EO-STEAM

Hospital Pack Spore Test Kit. Dual Spore Strips Biological Indicator
For Ethylene Oxide (EO), Steam, Dry Heat or Chemiclave® sterilization processes

Usage

For in-house testing of sterilizer efficacy.

Applicable Regulation

ISO 11138-1:2006, ISO 11138-2:2006, ISO 11138-3:2006 and ISO 11138-4:2006; IRAM 37102-1:1999, IRAM 37102-2:1999 and IRAM 37102-3:1999.

Classification

Class 1, according to risk.

Authorization

Designed under Quality Management System standards ISO 13485:2003/NS-EN ISO 13485:2012. ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-1.

Characteristics

The kit contains 1 Control Strip and 2 Test Strips.
25 mm x 70 mm non-absorbent material package, Violet code
5.0 x 25.0 mm filter paper strips.
10h6 Geobacillus stearothermophilus ATCC 7953 spores and 10h6 Bacillus atrophaeus ATCC 9372 spores per strip.
Upon completion of the sterilization cycle, the spore strip should be tested in a suitable culture medium at 37 ºC or at 60 ºC. We suggest the use of BIONOVA® MC1020 or MC1030 culture media to final reading in 48 hours at 37 ºC for Ethylene Oxide and Dry Heat sterilization process control, or BIONOVA® MC20 or MC1020 culture media to final reading in 24 hours at 60 ºC for Steam sterilization process control. For conventional culture media like TSB, incubation for 7 days is recommended.
D-Value STEAM : Not lower than 1.5 minutes. Conditions: 121 ºC.
Z-Value STEAM : Not lower than 6 ºC.
D-Value EO : Not lower than 2.5 minutes. Conditions: 600 mg/l EO, 60 % RH, 54 ºC.
D-Value DRY HEAT : Not lower than 2.5 minutes. Conditions: 160 ºC.
Z-Value DRY HEAT : Not lower than 20 ºC.

Environmental conditions during manufacture

Room temperature 15-30 ºC, RH 30-80 %. Sterility conditions are necessary only during the inoculation process performed in laminar flow.

Storage conditions

T = 10-30 ºC, RH 30-80 %.

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

24 months.

Packing

3 spore strips per envelope, 25 envelopes per box.
Packing information: product code and description, process for intended use, classification according to regulation, manufacturer information and data on box´s label.
Information on envelope: product code and description, process for intended use, batch number, expiration date, strains.
Weight per box: 153.5 g.