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BT40-6 EO-DRY

CHF 150.00

BT40-6 EO-DRY

Spore Strips Biological Indicator
For Ethylene Oxide and Dry Heat sterilization processes.
Spore: Bacillus atrophaeus (ATCC 9372). in a 106 population.

Art.-Nr.: BT40/6-100 Kategorien: ,
Beschreibung
BT40-6 EO-DRY

Spore Strips Biological Indicator
For Ethylene Oxide and Dry Heat sterilization processes.
Spore: Bacillus atrophaeus (ATCC 9372). in a 106 population.

Usage

Monitoring Ethylene Oxide (EO) and Dry Heat Sterilization Processes.

Applicable Regulation

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

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

25 mm x 70 mm non-absorbent material package. Green code.
5 mm x 25 mm filter paper strip.
10 6 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. We suggest the use of BIONOVA® MC1030 or MC1020 culture media to final reading in 48 hours. For conventional culture medium like TSB, incubation for 7 days at 37 ºC is recommended.
D-Value DRY : Not lower than 2.5 min. Conditions: 160 ºC.
Z-Value DRY : Not lower than 20 ºC.
D-Value EO : Not lower than 2.5 min. Conditions: 600 mg/l EO, 60 % RH, 54 ºC for EO.

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

100 units per aluminium foil bag. Weight: 36.2 g.

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