EN ISO 11133: 2014“Microbiology of food,

animal feed and water - Preparation, production, storage and performance

testing of culture media“MARCY L’ETOILE, DECEMBER 2014

Madam, Sir,

Recently, the ISO *** and the CEN ** published a revision of the standard XP CEN ISO / TS 11133: “Guidelines on preparation and production of culture media“

• XP CEN ISO / TS 11133-1: 2009 “General guidelines on quality assurance for the preparation of culture media in the laboratory“

• XP CEN ISO / TS 11133-2: 2004 “Practical guidelines on performance testing of culture media“ and its A1 amendment (2011)

This standard aims at enhancing reliability of microbiological analyses by standardizing the quality and performance testing of culture media dedicated to foodborne analyses. The standard was divided across 2 sub-parts and was only ever experimental in approach.

The new standard EN ISO 11133: 2014 is from now a full, self-contained standard, which includes culture media dedicated to the analysis of water and is thus recognized by accreditation bodies.

In addition to targeting professional culture media manu-facturers, this norm is also directed towards laboratories producing their own culture media in-house, from complete powders or from basic raw ingredients, or who use ready-to-use culture media, for periodical control of their suppliers.

bioMérieux, COMMITTED TO QUALITY

bioMérieux, a constant commitmentbioMérieux has previously informed you that since 2005, performance testing of culture media intended 2005, performance testing of culture media intended for foodborne analyses meet the requirements of this standard.

To maintain this compliance and to extend it to the media intended for water testing, bioMérieux has taken into account, for several months, the requirements of this new version of the standard, prior to its publication.

That is why we are pleased to inform you that the great majority of bioMérieux media described in the EN/ISO specific standards intended for foodborne and the water analyses, are already manufactured and tested in accordance with the requirements of the EN ISO 11133: 2014 standard. Our entire range will be soon in compliance.

Implementation of the standard and certificates of control After a thorough assessment of the new standard and its impacts, every new quality control protocol was evaluated on three batches of each media, certificates of control have been progressively updated since last July.

Certificates indicate from now on “Conformity with standard EN ISO 11133“ instead of “Conformity with standard XP CEN ISO / TS 11133-2 (Jan 2004) and A1“.

This compliance, as well as all the quality requirements we impose on our processes through:● the validation of stability under real conditions (transport, thermal shocks…), ● the concentration adjustments of the variable biological ingredients, as permitted by the standard, ● the performance testing at all stages of production of our media,● the use of very fertile reference media (bioMérieux TSA-ISO 11133 and SDA-ISO 11133, themselves controlled according to the new requirements of

this standard), to achieve the appropriate tests of productivity, ● the maintenance of additional controls if they were considered relevant,

guarantee you a high reliability of your analyses thanks to the excellent performance level of our culture media and excellent reproducibility between batches allow you to justify

the simplification of your controls of performance by avoiding the systematic checks of each batch of ready to use media at reception in your laboratory, especially as bioMérieux is ISO 9001 certified and has a Quality Management System in place, with particular procedures of design and quality control.

Simplifying the work of laboratories is our expertise To provide additional support to our customers, in particular to the accredited laboratories that manufacture media themselves from powder, and for which the standard becomes mandatory, we will soon provide:

● the reference media TSA and SDA already controlled according to the requirements of ISO 11133: 2014● a tool for understanding the standard with the major changes and important criteria to be aware of.

Our active and long-time participation in standardization bodies, in particular the ISO TC34 / SC9 (WG5) in charge of this standard, as well as our expertise as leader in microbiology for more than 50 years, allows us to provide insights on this very complete standard which can be difficult to implement at the laboratory level.

We hope that these measures will bring you complete satisfaction and will be an additional guarantee for the reliability of your microbiological analyses.

Our customer service is at your disposal to answer your questions

Yours faithfully,

Isabelle Desforges Hélène PerrigaudMarketing Scientific Manager - Food Global Products ManagerMember of Standardization Commissions Culture Media - FoodAFNOR*/CEN**/ISO***

* French association of Normalization • ** European Standardization Committee • *** International Standard Organization

bioMérieux S.A.69280 Marcy l’EtoileFranceTel.: +33 (0)4 78 87 20 00Fax: +33 (0)4 78 87 20 90

www.biomerieux-industry.com

Building quality every day

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This compliance, as well as all the quality requirements we impose on our processes through:●

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