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Microbial Testing: Standards & Regulations


Regulatory Expertise Center in Microbial Testing

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As a worldwide leading provider of industrial microbiology solutions, Merck addresses the needs of customers in industries where consumer safety is a major concern. Pharmaceutical, food and beverage manufacturing are particularly sensitive due to the potentially grave consequences of product contamination. To minimize this risk, stringent standards regulate the production environments of pharmaceuticals and increasingly of food and beverages as well. Microbial testing standards in the food and beverage industry see quite some changes making it challenging to stay up-to-date.

The Merck Regulatory Expertise Center is a frequently updated resource of regulatory knowledge and expertise relevant to industry QC professionals. It is overseen by Barbara Gerten. As part of Merck’s ask-the-expert setup, she is available to take questions from customers on any of the white papers subjects.

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Barbara Gerten, Senior Scientist for Traditional Microbiology at Merck

Barbara Gerten, Senior Scientist for Traditional Microbiology at Merck, is a member of several ISO/CEN committees for microbiological standards. She is a microbiologist who can look back on many years of industry experience and developments in the regulatory environment.

Revised ISO 11133 and ISO 17410 Standards

ISO 11133:2014+Amd1:2018 is a mandatory standard for all ISO 17025-accredited labs for microbiological analysis of food, feed and water. It describes the preparation, production and performance testing of culture media from this whole area. Planned publication of amendment 2:2019 contains the control strains for the performance testing of confirmation and characterization media, reagents, dyes, stains and materials described in standards for the microbiological examination of samples from the food chain and water.

The technically revised edition of ISO 17410 specifies a horizontal method for the enumeration of psychrotrophic microorganisms that are able to grow at 6.5 °C. It replaces ISO 6730:2005 (IDF 101:2005), “Milk — Enumeration of colony forming units of psychrotrophic microorganisms — Colony-count technique at 6.5 °C” and ISO 8552:2004 (IDF 132:2004) “Milk — Estimation of psychrotrophic microorganisms — Colony count technique at 21 °C (Rapid method)”.

We summarized the latest changes in both these standards in a webinar for you.

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Short Talk: Detection of Listeria Monocytogenes according to International Standards

Listeria is a widespread microorganism in nature and Listeria monocytogenes is one of the most harmful pathogens which can cause serious foodborne illnesses and infections. It is therefore crucial to test food products and lab environments for Listeria monocytogenes. The testing workflow is regulated by international organizations to ensure consumer safety. But how can you stay compliant with these regulatory standards and ensure the most accurate results? In this 20-minute talk we will walk you through the Listeria monocytogenes testing workflow according to ISO 11290, FDA-BAM and USDA-FSIS, and show you our solutions which will help you to stay compliant.
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Spoilage and Sterility Tests in Beverages: New Revised IFU Method No. 12 for Detection of Alicyclobacillus in Fruit Juices, and Sterility Testing of Aseptic Filling Lines

Alicyclobacillus spp. can be difficult to control in fruit juice products as their spores survive juice pasteurization temperatures and may germinate and grow after processing if conditions are suitable. The economic impact of such incidents can be very high. The International Fruit and Vegetable Juice Association (IFU) Microbiological Working Group has revised, improved and validated their worldwide accepted method for the detection of Alicyclobacillus spp. in fruit juices with improved culture media formulations including performance criteria which are in agreement with ISO procedures.

Our on-demand webinar explains the new revised IFU Method No. 12 from 2019 for detection of Alicyclobacillus spp. in fruit juices and provides information about validation of aseptic filling lines in beverage production.

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Short Talk: Regulatory Compliance of Culture Media Based Detection of Pathogens Webinar

This 10-minute presentation focuses on ISO regulations for the detection of the most important pathogen, Salmonella spp., in the food chain and describes how the regulatory compliance for the required culture media can be made transparent for laboratories.
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Latest Amendments of the ISO 11133:2014 and the Revised ISO 16649 Part 1:2018 for Enumeration of Escherichia Coli in the Food Chain

ISO 11133:2014 is a mandatory standard for all ISO 17025-accredited labs for microbiological analysis of food, feed and water. It describes the preparation, production and performance testing of culture media from this whole area. Recently published amendment 1:2018 contains corrections and additional explanations whilst future amendment 2 will describe the performance testing of confirmation media and reagents.

ISO 16649-1, which specifies a horizontal method for the enumeration of β-glucuronidase-positive Escherichia coli, has also been revised. The method uses a colony-count technique after resuscitation using membranes and incubation at 44 °C on TBX agar. There are three horizontal methods (ISO 16649-1, ISO 16649-2 and ISO 16649-3) for the enumeration of β-glucuronidase-positive Escherichia coli, all parts are for general application. Parts 1 and 3 include a resuscitation step and should be used in preference for foodstuffs likely to contain sub-lethally injured cells.

Watch our on-demand webinar below to learn more about the latest amendments of the ISO 11133:2014 and the revised ISO 16649 part 1:2018.

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Revised ISO Food Microbiology Standards for Detection of Listeria, Enterobacteriaceae and Cronobacter

How can you stay ISO certified in the current environment of an ever-increasing, but necessary regulation? In 2017, the food microbiology ISO standards for ISO 11290, ISO 21528, and ISO 22964 were all updated. All food products and ingredients intended for human consumption and the feeding of animals are implicated, along with environmental samples in food production and handling areas. To help guide you through the most recent changes for handling the testing of Listeria (ISO 11290), Enterobacteriaceae (ISO 21528), and Cronobacter (ISO 22964), we have summarized the important points for you in our regulatory news flyers, available for download below. An on-demand webinar from our food microbiology expert—a member of the German ISO delegation—is also available.

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Download Regulatory News on revised ISO 22964

Download Regulatory News on revised ISO 21528

Download Regulatory News on revised ISO 11290

ISO 17025 Accreditation and ISO 11133:2014

How does ISO 17025 accreditation for quality control according to ISO 11133 standard lead to a quality increase in water and food microbiology testing? ISO 17025 accreditation specifies the quality management and technical requirements laboratories must meet to demonstrate technical competency and compliance with regulatory standards. The new EN ISO 11133:2014 describes the preparation, production and performance testing of culture media and applies for food, feed and water analysis. ISO 11133 is now mandatory for all accredited microbiology labs. This webinar explains the responsibilities of labs and media suppliers and the benefits of being ISO 17025 accredited for performance testing according ISO 11133.

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Salmonella Detection in the Food Chain: Revised EN ISO 6579-1 Promises Greater Flexibility for Testing Labs.

In early 2016, the International Organization for Standardization (ISO) published the EN ISO 6579-1 standard, which specifies a horizontal method for the detection of Salmonella spp. in the food production chain. Like the preceding version, EN ISO 6579:2002/Amd 1:2007, it covered products intended for human consumption, animal feeding and environmental samples in food production and handling as well as milk and milk products (previously described in ISO 6785 I IDF 93) and samples from the primary food production stage. It gave greater flexibility for testing labs, e.g. for the choice of some culture media, and for the range of incubation temperature.

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EN ISO 11133:2014 - A Mandatory Standard for Culture Media Used in Food and Water Testing

EN ISO 11133:2014 is a mandatory for all accredited laboratories that perform microbiological testing of food, animal feed or water using culture media. The standard clarifies procedures and draws a clear line between the responsibilities of the laboratories and the manufacturers/suppliers of culture media regarding media preparation, production, storage and performance testing.

This white paper focuses on the differences to ISO/TS 11133-1 and -2, which it has replaced, and discusses the implications of the new standard for food, beverages and water testing laboratories.

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Chromogenic Coliform Agar (CCA) to Replace Lactose TTC Agar in ISO 9308-1

A drastically revised ISO 9308 part 1 came into effect at the end of 2014. Lactose TTC agar has been replaced by chromogenic coliform agar (CCA) as the culture medium for enumerating coliform bacteria and Escherichia coli after the membrane filtration step. Using the fully validated Chromocult® Coliform Agar, the original culture medium from Merck Millipore on which the new standard is based, can make the transition easier for laboratories.

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