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Biological indicators

Overview

The biological indicators, provided by SAFE Sterilization ApS, are designed for control and validation of sterilization processes.

Moist heat sterilization (autoclaving) is carried out by use of dry saturated steam under pressure. In order to kill microorganisms, including bacterial spores, a temperature of at least 121°C is required for 15 minutes or 134°C for 3 minutes or equivalent combination of temperature and time, to achieve the specified kill effect.

Sterilisation med tør varme (tørsterilisation) foregår i en tørsterilisator, hvor der skal være effektiv cirkulation af den varme luft. Det kræver højere temperatur og længere tid at tørsterilisere end at autoklavere. Dette skyldes at tør luft har markant lavere varmekapacitet og dårligere varmeledningsevne, samt langsommere penetration af mikroorganismens cellevægge end tør mættet damp som i en autoklave. For at dræbe mikroorganismer, herunder bakteriesporer, kræves en temperatur på minimum: 160°C i 2 timer, 170°C i 1 time, eller 180°C i 30 minutter eller tilsvarende kombination af temperatur og tid.

Killing off microorganisms, including bacterial spores, is achieved in dry sterilisation by a minimum requirement of temperature against cycle time: 160°C for 2 hours, 170°C for 1 hour, or 180°C for 30 minutes, or equivalent combination in order to achieve the specified kill effect. It is important to measure the sterilization time from the moment the specified temperature is achieved in the autoclave/dry sterilizer.

Product description

De biologiske indikatorer er fremstillet i overensstemmelse med DS/EN ISO 11138-1, DS/EN ISO 11138-3 og DS/EN ISO 11138-4. SAFE Sterilization har valgt en kombineret indikator, som kan benyttes til test af sterilisationsprocesser med damp, såvel som tør varme.

The bacterial spores come from strains of standardized microorganisms from, for example, ATTC (American Type Culture Collection) or NRRL (ARS Culture Collection).

The biological indicators used to test steam sterilisation (autoclaves) are with bacterial spores from Geobacillus stearothermophilus,and to test dry heat (dry sterilizers), bacterial spores from Bacillus atrophaeus.These bacterial spores have high resistance (D-value) to the specific sterilization method and are therefore suitable for periodic monitoring and validating of these sterilization processes.

Overview

Biological indicators are used for periodic verification of sterilization processes

The biological indicators are also used for validations, post-repair verification, as well as for verifying sterilization processes of temporary equipment.

SAFE operates within the Danish “Nationale infektionshygiejniske retningslinjer” (NIR), which contains recommendations regarding procedures and handling of medical devices, as well as within specific guidelines set up by various industry organisations. Please consult your national guidelines as to ensure you comply with local legislation.

Please refer to our User guide and Recommendations for the healthcare sector on our website.

Validation

Always use a validated autoclave or dry sterilizer for sterilization of equipment.

Storage, durability and disposal

Biologiske indikatorer skal opbevares tørt ved 2-24°C og være beskyttet mod direkte sollys.

Expiration date is indicated on the biological indicator. Newer use an expired biological indicator.

Unused biological indicators must be sterilized and can be discarded as ordinary waste. If the biological indicators are not sterilized, you must dispose of them as clinical hazardous waste.

Subscription

SAFE Sterilization offers subscription plans, read more here to hear more.

Biological indicators are also sold individually, e.g. for the validation of equipment, additional checks after repairing the sterilizer or when using a loan sterilizer. Contact SAFE to learn more.

We use a product from

Steris Corp.

5960 Heisley Road
Mentor. OH 44060-1838
USA
www.steris.com