Chemical Test Sporal "A" 1 pc.

Biological indicator for the control of the steam-formaldehyde sterilization process DS-100

COMPOSITION AND PROPERTIES:

The indicator has the form of a strip paper saturated with a suspension of spores of the type Bacillus stearothemophilus ATCC 7953 (for Form) and Bacillus

Atrophaeus ATCC 9372 in one special paper package to protect against contamination Each indicator

contains not less than 1 x lOs units capable of transforming into vegetative forms (CFU).

Spores contained in indicators exposed to saturated steam under pressure at a temperature of 121° C (1st arm.) survive 100% for

5 minutes, spores exposed to the same conditions for 15 minutes are completely inactivated

(0% growth). D value for temperature 121° C is not less than 1.5 minutes (this is the decimal reduction coefficient, i.e. the time expressed in minutes necessary for the test microorganisms to be reduced by an order of magnitude at a given temperature).

In the case of formaldehyde sterilization, the test should be exposed to 1-2% formalin for 60-90 minutes.

HOW TO USE:

• Place the test indicators in at least two of the largest representative packages for a given load and place them in

places that are most difficult to access for the sterilizing agent.

• Carry out the established sterilization program

• After completing the sterilization process, remove the test indicators from the load and inoculate within 5 hours after exposure.

If the indicators cannot be incubated within the specified time, they should be placed at room temperature for up to 24 hours,

• Food control of microorganisms is an indicator that has not been subjected to the sterilization process.

• Sterilize tests after use and expired tests in an autoclave or incinerate

• For Formaldehyde or E0 sterilization, a biological test is performed on each HODOLVVA

• Maintaining aseptic conditions, remove the strips of tissue paper from the paper and foil bags and place each in a separate bacteriological test tube with TSB (Soy Broth mode) the bag can be cut anywhere.

Make sure that the strip of tissue paper is completely immersed in the broth

• Incubate for 5 days at 55 +/- 2°C

Growth should not occur in test tubes containing paper strips from sterilized indicators. The appearance of

growth indicates an incorrect sterilization process.

• The tubes should be observed daily to detect any growth. In the case of ineffective sterilization, in 90%

of cases, growth will occur within 48 hours. However, you should always observe the tubes for 5 days.

• In a tube containing an unsterilized indicator, growth should occur within 48 hours.

STANDARDS

- Products meet the EN 866 standard for biological control and ISO 11138

MANUFACTURER

SPS Medical NY USA, Henrietta Road