BT50-5 FORM-STEAM

BT50-5 FORM-STEAM

Spore Strip Biological Indicator.
For Steam and Formaldehyde sterilization processes.
Spore: Geobacillus stearothermophilus (ATCC 7953). in a 10h5 population.

Usage

Monitoring 121 ºC – 134 ºC Steam and Formaldehyde Sterilization Processes.

Applicable Regulation

ISO 11138-1:2006, ISO 11138-3:2006 and ISO 11138-5:2006; IRAM 37102-1:1999 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

25 mm x 70 mm non-absorbent material package. Brown code.
5 mm x 25 mm filter paper strip.
10 6 Geobacillus stearothermophilus ATCC 7953 spores per strip.
Upon completion of the sterilization cycle, the spore strip should be tested in a suitable culture medium at 60 ºC. We suggest the use of BIONOVA® MC20 or MC1020 culture media to final reading in 24 hours for Steam sterilization and 48 hours for Formaldehyde sterilization. For conventional culture media like TSB, incubation for 7 days at 60 ºC is recommended.
D-Value STEAM : not lower than 1.5 minutes. Conditions: 121 ºC.
Z-Value STEAM : not lower than 6 ºC.
D-Value FORM : not lower than 6 min. Conditions: 60 ºC, 1 mol/l formaldehyde.

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: 36.3 g.