Products -> SterilAmp® II "5230" Biological Indicator

SterilAmp II "5230" is a compact, self-contained ampoule biological indicator for monitoring industrial low temperature (115°C) steam sterilization of liquids in small containers.

SterilAmp II "5230" contains a specially formulated culture medium that turns a dramatic yellow when spores grow, providing easy visual confirmation of sterilization within 72 hours, without the need for difficult and time-consuming laboratory work.

Availability

SterilAmp II "5230" Biological Indicators
Spore Incubation Units Population Reorder #

B. subtilis "5230"

72 Hours at
37°C

100

106 SASU/6

Use

Please follow instructions provided with each bag of SterilAmp biological indicators.

Sterilization
 
1. Place Sterilamp II inside representative liquid containers to be sterilized. Package or seal as usual. AAMI recommends a minimum of 10 BIs per cycle.
2. Locate test samples in areas of the load considered most difficult to sterilize or in convenient areas that have been validated. Identify test samples as to location in sterilizer.
3. After sterilizing, send SterilAmp II and products to sterility test laboratory along with at least one non-sterilized SterilAmp II marked POSITIVE CONTROL.
     
Sterility Test Laboratory
 
1. All SterilAmp II are fully self-contained BIs which do not require subculture.
2. Procedure:
    a. SterilAmp II may be left in the sterilized container or transferred to a rack or container which allows visual observation during incubation.
    b. Incubate Sterilamp II for three (3) days at 35-39° C.
   

c. Observe daily for growth.

Yellow = growth = non-sterile

Red = no growth = sterile

SterilAmp II should show "no growth" if sterilization has been achieved.

If color change to yellow occurs in SterilAmp II cultures, it indicates that the spores have survived the sterilization process and are non-sterile.
 
Controls:
 
  a. Positive: At least one positive control should be included in each test series. Incubate a non-sterilized SterilAmp II with test series. Color change from red to yellow indicates that the medium possesses suitable growth promoting qualities and that the SterilAmp II contains viable spores. If positive control does not grow, do not use the lot.

Storage

Refrigerate at 2-8°C.

Expiration

18 months from date of manufacture.

Certification

SterilAmp biological indicators are traceable to a recognized culture collection and certified for population, D-value, Z-value, Fo value, and performance.

Copyright 2005, SGM Biotech, Inc. All rights reserved.

SGM Biotech, Inc.
10 Evergreen Drive Suite E
Bozeman, MT 59718 USA
Phone: 406-585-9535
FAX: 406-585-9219
General Information: info@sgmbiotech.com
Customer Service: cust-service@sgmbiotech.com

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