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  • Sterility Failure Investigation

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Ons found 5. Possible causes 6. Corrective action 7. Preventative action 8. Disposition of filling room 9. Documentation Approval of Investigation DR 1 Purpose of report The purpose of this document is to provide a summary report of the incident investigation conducted into: 2 Batch Details Product Name Date of Manufacturing Product Code Container and size Terminally sterilized Y/N Batch # Filling Room # Filling Machine Autoclave Cycle Sterility Test Details Date Technician Num.

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The three methods of Sterility Testing are membrane filtration, Direct Transfer (Product Immersion) and Product Flush.

Direct Inoculation and Membrane Filtration Methods. Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and can be performed in an isolator or cleanroom environment.

An investigation is performed to determine if a sterility failure is invalid due to laboratory error. Once a sterility test is initiated, trained microbiologists periodically observe growth media for turbidity or fogginess indicating microbial growth.

The test is valid if the growth of each of the added microorganisms observed within 3 days for bacteria and 5 days for fungi. 2. If growth is not observed within 3 days for bacteria and 5 days for fungi the test is considered invalid.

There are two recommended methods of sterility testing for pharmaceuticals: membrane filtration and direct inoculation.

Failing the sterility test results in quarantining the entire affected batch. An investigation to determine how the sterility test failure occurred will follow. This will mean suspension of production while every stage of your manufacturing and testing process is examined for potential areas of risk.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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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
Content Takedown Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
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 workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
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