Category: EN – newsitem

MicroVal has approved the renewal of the certificate for Compact Dry TC, manufactured by Nissui Pharmaceutical Co. Ltd and Supplied by HyServe GmbH. Compact Dry TC enumerates total viable organisms in a broad range of foods.

We are proud that the first ever MicroVal certificate to be issued will be valid for at least another four years. Compact Dry TC was first validated twelve years ago in 2007. The renewal study was performed by Campden BRI.

The method is also validated for AOAC PTM and NordVal.

The certificate has number 2007LR01 and can be found here on the MicroVal website, together with the supporting  summary report.

MicroVal has just issued the first certificate for Neogen’s Soleris Enterobacteriaceae, based on a semi-quantitative validation for detection of Enterobacteriaceae at a threshold of <10cfu/ml. The study was conducted by Campden BRI.

This novel approach was designed to meet a specific legislative requirement in EU 2073 for the presence of Enterobacteriaceae in dairy products at a level of <10cfu/ml. Historically, ISO 16140-2:2016 validation studies have either been quantitative i.e. based on enumeration of microorganisms in the test samples, or qualitative, i.e. based on detecting the presence or absence of a target microorganism in a test sample. This semi-quantitative study design compared the results from the enrichment of a test sample in the Neogen Soleris system using the S2-EBAC9 Enterobacteriaceae vial with the results from the reference method which uses a plating method. The unique part of this validation was the use of a single plate of the reference agar where the absence of any colonies was equivalent to detection of <10cfu/ml and the presence of one or more colonies was equivalent to detection of >10cfu/ml. Hence the approach used a plate count method as a qualitative result and not a quantitative result.

This semi-quantitative approach could have a wide application to many other microbiological test methods which use a dilute to specification approach to show compliance with a target threshold of,  for example,  <10cfu/ml  or  <100cfu/ml.

The certificate for Neogen’s Soleris Enterobacteriaceae can be found by the number 2018LR83.

In September 2019 MicroVal has approved the issuing of the certificate for HyServe’s Compact Dry PA, the ready to use plate for enumeration of total Pseudomonas aeruginosa (PA). This is the first MicroVal certificate for a enumeration method to be used within the field of water intended for human consumption. The certificate is based on the results of a validation study in accordance with ISO 17994:2014 and ISO 16140-2:2016, which has been performed by Campden BRI. The certificate can be found by the number 2017LR66. The Compact Dry plates are manufactured by Nissui Pharmaceutical CoLtd and supplied by HyServe.

Moreover, the certificate for HyServe’s CompactDry YM for the enumeration of yeasts and moulds in a broad range of foods, which was originally issued in 2011, has been successfully renewed, based on the validation study according to ISO 16140-2:2016 by Campden BRI. The certificate has number RQA2008LR10.

Two  SY-LAB certificates issued

In December MicroVal approved the issuing of two certificates for methods developed by SY-LAB Geräte GmbH. The RiboFlow® Listeria Twin Testkit for the detection of Listeria Monocytogenes and Listeria spp was certified based on the results of a validation study by RIVM. Campden BRI performed the validation study for AMP-6000® TMAC for the enumeration of Total Aerobic Mesophilic Count. The certificates have number 2015LR53 and 2015LR60.

On 29 October 2018, MicroVal organised a successful workshop on the validation and verification of alternative microbiological confirmation methods.

Recently MicroVal approved on the issuing of the first validation certificates for confirmation methods worldwide, for the Bruker Maldi-Tof. These have been issued based on the results of four parallel validation studies for four different target organisms (Cronobacter spp, Samonella spp, Campylobacter and Listeria spp. & Listeria Monocytogenes).

The objectives of the workshop were to inform and exchange on verification and validation of microbiological methods, especially focussing on alternative confirmation methods. The current developments of the relevant standards on validation of alternative microbiological confirmation methods (ISO/DIS 16140-6), on in-house method validation (ISO/DIS 16140- 4) and  verification (ISO/DIS 16140-3) were also discussed.

It was a successful workshop with a full auditorium and lively participation. MicroVal aims to organize more workshops in the future.

An important part of the MicroVal validation process is the presentation and discussion of study results in the MicroVal Technical Committee (MVTC).

The MVTC comprises of more than 15 members, including representatives of test kit manufactures, expert labs, end users and government. Decisions in the MVTC  regarding, for instance, validation are based on consensus amongst members, with the ISO 16140 and the MicroVal rules as a solid foundation. The combined knowledge and experience of the members allows for flexibility and innovation, at the same time providing trust and accountability.