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Bozeman Manufacturing Facility SterilAmp II Geobacillus stearothermophilus TECHNICAL REPORT Complies to USP, ISO 11138, and all appropriate subsections Technical Data and Use of SterilAmp II Part.

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This guide provides comprehensive instructions on how to complete the SterilAmp II - Biological Indicators form, ensuring accuracy and efficiency. By following these steps, users can confidently navigate the form's fields to meet the required standards for biological indicators.

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  2. Carefully read the introductory information provided on the form to understand the purpose of the SterilAmp II and its components.
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  4. Provide details about the SterilAmp II product, including the part number and specifications. Review any relevant safety information related to handling and storage.
  5. Follow the instructions for indicating the quantity of biological indicators being ordered or reported. Make sure to specify the desired ampoule size if applicable.
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Traditionally, ethylene oxide sterilization processes are routinely monitored with biological indicators that are composed of the microorganism Bacillus atrophaeus, usually inoculated onto a 1.5 X 0.25 inch paper carrier. A good example of a biological indicator is the Spordex® (STERIS) bacterial test strip.

The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobacillus stearothermophilus (formerly Bacillus stearothermophilus).

Microbial biomass, fungi, actinomycetes, lichens, as well as the population of earthworms, nematodes, termites, and ants can be used as bioindicators on account of their important role in nutrient cycling, specific soil fertility, soil development, and soil conservation (Anderson, 2003).

Biological indicators, or spore tests, are the most accepted means of monitoring sterilization because they assess the sterilization process directly by killing known highly resistant microorganisms (e.g., Geobacillus or Bacillus species).

sporogenes, B. subtilis, or B. atrophaeus are chosen as biological indicators. These spore-forming microorganisms are also preferred for verifying the sterilization of aqueous solutions due to their lower thermal resistance.

Biological indicator – Dry heat Sterilisation (Oven) Sterilisation with dry heat (dry sterilisation) takes place in an oven, in which the air must be able to circulate. It is the direct temperature effect, i.e. the irreversible denaturation of cell components, which destroys microorganisms present.

Biological indicators, or spore tests, are the most accepted means of monitoring sterilization because they assess the sterilization process directly by killing known highly resistant microorganisms (e.g., Geobacillus or Bacillus species).

Bionova® BT30 Biological Indicator is specially designed for monitoring Dry Heat sterilization processes at 160-180 ºC . If the sterilization process was not successful, the culture medium will change from blue to yellow after incubation at 37±2 °C, thus indicating the presence of living Bacillus atrophaeus spores.

STERIS biological indicators are available in two different species of spores, Bacillus atrophaeus for ethylene oxide (EO) and dry heat applications, and Geobacillus stearothermophilus for steam sterilization applications. STERIS also offers custom sterilization indicatorsmade to specifications.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232