Clostridium botulinum Challenge Testing


Clostridium botulinum Challenge Testing


Introduction

Clostridium botulinum produces one of the most potent neurotoxins known, posing significant risks to food safety. QIB Extra offers specialised challenge testing services to assess and mitigate these risks, ensuring your products meet the highest safety standards.

Benefits 

  • Safety Assessment: Determines if a food product can support botulinum toxin production, ensuring consumer safety.
  • Shelf-Life Evaluation: Helps establish safe shelf-life durations for products by simulating storage conditions.
  • Regulatory Compliance: Provides evidence to meet food safety regulations and support risk managment decisions.
  • Risk Identification: Reveals potential risks in product formulations that may favour botulinum toxin production.
  • Informed Safety Measures: Guides the implementation of safety measures or reformulations based on test results.
  • Realistic Simulations: Conduct tests under typical conditions, offering a realistic assessment of product safety.

Background

Botulism is a rare but serious paralytic illness caused by a neurotoxin produced by the bacterium Clostridium botulinum. The toxin is the most potent toxin known to mankind with only 30 ng potentially being fatal to humans, therefore its potential presence in food products represents an incredibly serious risk to human health.

QIB Extra provides Clostridium botulinum challenge testing based on identifying the formation of the botulinum toxin in test products during defined storage conditions to help determine a products shelf-life. Our approach focuses on detecting the toxin rather than the presence of the bacteria, not least because there is evidence that toxin production can occur in the absence of any discernible increase in bacterial numbers i.e. growth. In addition, toxin detection at QIB Extra is achieved without animal testing; our results though are comparable in sensitivity with the mouse bioassay.
 
Challenge tests are tailored to the specific needs of the customer and QIB Extra is able to offer expert advice to help define the necessary experimental parameters required to provide sufficiently robust scientific data to support risk management decisions. Our expert on Clostridium botulinum challenge testing is Dr. Martin Webb, click here to find out more about his expertise and experience.
 

Our Testing Approach

Each challenge test is bespoke to your company, your product portfolio and the specific shelf-life requirement. A typical challenge test for Clostridium botulinum could be:
  1. A cocktail of spores from selected non-proteolytic Clostridium botulinum type B and type E strains are used to inoculate the product test packs;
  2. Uninoculated control test packs are also included as a control;
  3. The test packs are incubated at a defined incubation temperature and time (In the UK, this is typically 8 °C);
  4. A series of sampling time points during the incubation period are defined depending on the shelf-life of the product;  
  5. An agreed number of replicate packs at each sampling time are tested for botulinum toxin type B and type E (inoculated and uninoculated packs);
  6. Each test data point is also run as an analytical replicate;  
  7. Toxin concentrations calculated against a matrix matched standard curve.
QIB Extra tests for toxin types B and E as these are the common toxins associated with chilled food products however tests for other botulinum toxins are also available (for example if a shelf-stable food is to be tested requiring the detection of type A toxin).
 

Additional Resources

  • Guidelines: For information on the guidelines issued for chilled foods shelf-life concerning non-proteolytic Clostridium botulinum, click here.
  • Case Study: Learn how our research has been applied to the food industry in our case study: ‘New Improved Analysis Helps Industry Inform FSA’s 10-Day Policy’.
  • Publication: Read our publication in the journal Food Microbiology for an in-depth understanding of our methodologies.
  • Catalogue: Download our Clostridium botulinum catalogue for detailed information on our services.

Contact Us

For more information or to discuss how our Clostridium botulinum challenge testing services can support your product's safety and compliance, please contact us.


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Applied Contract Research and Analytical Services for Industry

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