MC1020-2

MC1020-2

Culture medium with pH-indicator.
For growth of Geobacillus stearothermophilus ATCC 7953, Bacillus subtilis DSM 5230 y Bacillus atrophaeus ATCC 9372 bacterial spores.

Usage

To test growth of Geobacillus stearothermophilus ATCC 7953 used for monitoring Steam, Formaldehyde and VH 2 O 2 sterilization processes, Bacillus subtilis DSM 5230 used for monitoring Steam at low temperature sterilization processes and Bacillus atrophaeus ATCC 9372 bacterial spores used for monitoring Dry Heat and EO sterilization processes.

Applicable Regulation

ISO11138-1:2006, ISO11138-2:2006, ISO11138-3:2006, ISO11138-4:2006 and ISO11138-5:2006; IRAM 37102-1, 2 and 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 Technology) PM 1614-1

Characteristics

Sterile growth medium is specially formulated for use with our BIONOVA® products (also suitable for other brand products).
Growth medium color: red
Plastic tube: 68 mm high, 10 mm diameter
Medium volume: 2 ml
For germination and growth of Geobacillus stearothermophilus ATCC 7953, Bacillus subtilis DSM 5230 and Bacillus atrophaeus ATCC 9372 bacterial spores.

Incubation conditions:
24 hours for Geobacillus stearothermophilus ATCC 7953 spores subjected to Steam/VH 2 O 2 processes and 48 hours for Formadehyde processes (maximum). 60 ± 2 ºC.
48 hours for Bacillus atrophaeus ATCC 9372 spores subjected to Dry Heat and EO processes and Bacillus subtilis DSM 5230 subjected to Steam at low temperature; (maximum). 37± 2 ºC
Medium turns to yellow when spores grow.

Environmental conditions during manufacture

15-30 ºC room temperatures, RH 30-80 %. Sterility conditions are necessary during plastic tube filling with sterile medium, performed in laminar flow.

Storage conditions

T = 4-20 ºC, RH 30-80 %, keep out of direct light.

Transportation conditions

Storage conditions should be strictly followed.
Transport in closed and reinforced boxes in order to avoid damages. Transportation of this product does not represent a risk for health.

Shelf-life

24 months.

Packing

50 units per box.