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Sterility Testing: Best Practices and Use of Isolator Technology

Tuesday, October 23, 2018 | 8 a.m. PDT | 10 a.m. CDT | 11 a.m. EDT

Sterility Testing WebinarSterility testing is a regulatory requirement for all preparations that according to the USP, EP, and JP Pharmacopeias are required to be sterile. Sterility testing is considered a referee test and is not intended as a sole product release test.  False negative and false positive results can occur if the proper process controls are not followed.

Many challenges are associated with achieving a suitable test environment to carry out sterility testing under the most ideal aseptic conditions; critical best practices should be followed to demonstrate an accurate, meaningful sterility test result.

Key Learning Objectives:

During this webcast, will discuss strategies and best practices for maximizing the conditions of the sterility test environment as well as reducing the risk of inaccurate results for sterility testing through the use of isolators and vaporized hydrogen peroxide (VHP). Topics will include:

  • Regulatory guidance and recommendations
  • Lab design and system overview
  • VHP decontamination cycles/load design and qualification
  • Package integrity verification for VHP
  • System monitoring and controls
  • Training
  • Method suitability
  • Sterility test methods and techniques
  • Pros and cons of isolator vs. cleanroom
  • Sterility test positive rate

Click here to register for this webinar

 

View our Past Webinars

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  • Practical Guidance for Successful Mammalian Cell Banking & Cell Line Characterization
  • Developing a Comprehensive Tool Kit for Microbial Identification
  • Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
  • Alternative Rapid Mycoplasma Testing Methods for Biopharma Products
  • UV-C Treatment—a New Procedure for Viral Inactivation
  • Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies
  • Best Practices for Extractables and Leachables Testing
  • Effective Strategies for Managing Comparator Product Testing
  • Outsourcing Cell Based Potency Assays: Perspectives from a Sponsor and a Contract Testing Laboratory
  • Critical Aspects of Antibody-Drug Conjugates: Structural Characterization and Analysis
  • Efficient and Effective Approaches to Managing Raw Material Methods
  • Risk Management of Adventitious Agent Contamination in Biopharmaceutical Products