Sterility Testing: Best Practices and Use of Isolator Technology

Oct 23, 2018

Register Free: http://www.pharmtech.com/pt_w/isolator

Sterility 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, experts 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

 

Who Should Attend:

 Bio/Pharmaceutical scientists and managers who are responsible for sterility testing, manufacturing, or regulatory submissions for sterile products.

 

Speakers:

Suzanne Williams, Manager, Bio/Pharmaceutical Microbiology, Eurofins Lancaster Laboratories, Inc.

Marcy Hibshman, Group Leader III, Principal Microbiologist, Bio/Pharmaceutical Microbiology, Eurofins Lancaster Laboratories, Inc.

 

Date and Time:

Live: Tuesday, 23 October, 2018 at 11 am EDT | 8 am PDT | 1600 BST | 1700 CEST

After the final airing of the webcast on 23 October, 2018 it will be available on demand until 23 October, 2019. 

Sponsor: Eurofins Lancaster Laboratories, Inc.

Register Free: http://www.pharmtech.com/pt_w/isolator

native1_300x100
lorem ipsum