Regulatory Expertise Center in Microbial Testing
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.
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.
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.
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.
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.
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.
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.
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.