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an overview of microbiology and strategies to ensure manufacturing operations protect against the potential for microorganism growth and contamination

Published: Tuesday, March 22, 2016

Current Good Manufacturing Practice (cGMP) rules require dietary supplement manufacturers to implement conditions and controls that protect against the potential for microorganism and contamination. Industry experts provide an overview of microbiology, discuss the importance of tracking microorganisms and toxins to ensure product integrity and strategies to protect products from microorganisms.

Presenters

  • Maria Mendres, Laboratory Supervisor, Quality Control Microbiology, NOW Foods, Inc
  • Maged Sharaf, Chief Science Officer, American Herbal Products Association (AHPA)
  • Tony Young, AHPA General Counsel and Partner at Kleinfeld, Kaplan & Becker

Topics

Bacteria, fungi and toxins: an overview

Experts will discuss the significance of the following microorganisms and toxins to product integrity.

  • Aerobic or viable bacteria
  • Enterobacteria and coliforms
  • Yeasts and molds
  • Pathogens:
    • Salmonella species
    • Escherichia coli
    • Listeria monocytogenes
    • Staphylococcus aureus
    • Pseudomonas aeruginosa
    • Bacillus species
    • Clostridium species
    • Shigella
  • Toxins produced by microorganisms and fungi:
  • Bacillus toxins
  • Enterotoxins
  • Mycotoxins (e.g. Aflatoxins)

Conditions that promote microbial growth and contamination

Physical and chemical factors will be discussed, including:

  • Water activity
  • Storage conditions and temperature
  • Nutritional content of product
  • Sanitary conditions and transfer of microorganisms in manufacturing
  • Biofilms

Control of microorganisms in raw materials and pre/post production

 

  • Methods of sterilization
  • Good Agricultural and Collection Practices/Good Manufacturing Practices/ Sanitation Practices/ Pest Control
  • Introduction to concepts of HACCP (Hazard Analysis Critical Control Points) and HARPC (Hazard Analysis and Risk Based Preventative Control)

Introduction to environmental monitoring

 

  • Water, surface and air microbiology
  • Introduction to ATP testing
  • Swabbing for pathogens
  • Testing for compressed air

Regulations for microbial contamination and testing

 

  • Discussion of microbiological topics related to 21 CFR Part 111
  • AHPA Microbiology & Mycotoxins Guidance
  • USP compendial methods
  • Introduction to alternative methods for rapid testing and validation/verification of these methods
  • Reporting positive pathogens to the FDA
  • How to set own specifications

Inside a microbiology laboratory

An overview of equipment, methods, certifications, and personnel qualifications/proficiency

  • Case study – microbiology laboratory of an AHPA member
  • Provide an idea about cost of outside versus in-house testing
  • When to test samples in-house and when to send outside

Answers to attendees' questions

Webinar Recording Details 

Presented: March 22, 2016

Duration: Two hours

Cost: $220 - AHPA Members
          $520 Non-members

Materials:

  1. Video Recording (MP4)
  2. Presenter Slides
  3. AHPA Microbial Level Chart
  4. Speaker Bios

The Botanical Safety Handbook, Second Edition includes:

  • Easily understood classification systems to indicate the safety of each listed species and the potential for drug interactions
  • Information on adverse events reported in clinical trials or case reports 
  • Safety-related pharmacology and pharmacokinetics of each herb
  • Additional information on the use of herbs by pregnant or lactating women 
  • Toxicological studies and data on toxic compounds 
  • Extensive references for each entry

The book is available in hardback print and online formats. Both versions contain the same information, but the online version, which is optimized for smartphones and tablets, has several additional attributes. Some of these relate to its operation, as it allows subscribers to search for keywords and botanical names and easily access the information they use most by saving personalized lists of entries. Perhaps more importantly, the online version will be updated regularly with new research, and subscribers will be notified of updates to provide immediate access to the most current information. The standard retail cost for either version is $119.95 (one-time cost in print; a renewable annual subscription online). We are discounting the cost for our members and would be happy to offer a discount to other organizations. A free preview of several entries are available online:

Subscribe to the online version or purchase a hardcover copy today. AHPA's Botanical Safety Handbook, Second Edition  Print Version: 1,042 pages, revised edition published in 2013 AHPA's Botanical Safety Handbook, Second Edition Online

Member annual subscription: $95.00 
Non-member annual subscription: $119.00 Discounts available for multiple user subscriptions.

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