Research project NM/A/22 (Research action NM)
CONTEXT
According to (inter)national norms (BIN, ISO, EN, Pharmacopoeia....) accredited and certified laboratories active in the field of microbiology should use (specific) well determined strains of micro-organisms as a (positive and negative) control.
In that context, there is a need for:
- guidelines for the preservation, check, distribution and use of those strains;
- alternative control strains (of better performance) or variations on test methods (more user-friendly and more adequate) to those mentioned in the norms.
THE PROJECT
Goals
- To establish a written document for preserving, checking, distributing and using of microbial reference strains intended for the distributor and end-user containing attainable, reliable and practical guidelines guaranteeing quality combined with userfriendliness;
- To improve the existing norms by formulating recommendations for the test methods outlined and by proposing the alternatives to the TCB strains actually quoted in the norms.
METHODOLOGY
The following activities are performed:
- Survey of the norms and the users’ needs
In collaboration with the Belgian Institute for Normalisation and based on a literature search, the relevant norms are collected. Based on the results of an inquiry sent to laboratories, the norms and control strains most commonly applied in Belgium are selected for this project.
- Working on the norms
Performance tests are carried out with the selected strains in relation to their norm(s). When during these tests one has concluded that certain recommendations to the test methods or alternative control strains in the existing norms need to be formulated, this information will be taken up in a document. The performance tests applied will be described in procedures.
- Working on the users’ needs
Procedures concerning the preservation and the distribution of the control strains are written down for the distributor. Quality plans are drawn up concerning the implementation of the procedures on the performance tests, preservation and distribution in the internal quality system of the distributor (next to other quality checks).
Guidelines for the preservation and use of the control strains by the end-user are formulated as well. The procedures/quality plans/guidelines made are finally tested in collaboration with some (accredited) laboratories.
- Establishing the documents and valorisation
A catalogue is made with the control strains tested during this project in relation to their norm(s). The procedures, quality plans, guidelines and catalogue are compiled in a document. The latter will be given to the authorities involved (BIN en BELTEST) and will be made available to the end-users of the control strains. The document with the recommendations formulated to the norms is deposited to the BIN as well.
THE PARTNERS
The partners of this project, BCCM/LMG, BCCM/IHEM and BCCM/MUCL, are members of BCCM TM (Belgian Co-ordinated Collections of Micro-organisms), a consortium of four complementary research based service culture collections which is supported by the Federal Offices for Scientific, Technical and Cultural Affairs (OSTC).
BCCM/IHEM (collection of filamentous and yeast-like fungi of public health interest), BCCM/MUCL (collection of filamentous and yeast-like fungi mainly of biotechnological or agro-industrial importance) and BCCM/LMG (bacterial strains, encompassing plant associated and phytopathogenic bacteria, bacteria of medical and veterinary importance, marine bacteria, food bacteria and various groups of biotechnological interest) are experts in the field of preservation, use and distribution of microbial cultures and play an important role in defining specific criteria to guarantee the quality of control strains and to formulate guidelines for the distributor and end-user of control strains.
EXPECTED PRODUCTS AND RESULTS
Based on the results of the inquiry, the following fields for each partner are defined as priority:
BCCM/IHEM:
- control of disinfectant and antiseptic products (NF T 72-281, EN 1275, EN 1650, EN 1657),
- sterility tests, microbial control of non-sterile products (Pharm. Eur.),
- control of media (ISO 11133: Microbiology of food and animal feeding stuffs / Guidelines on preparation and production of culture media);
BCCM/LMG:
- microbial food analyses (norms: EN, ISO, BIN, SP-VG, NF, FIL),
- control of media (ISO 11133: Microbiology of food and animal feeding stuffs / Guidelines on preparation and production of culture media);
BCCM/MUCL:
- biodegradation of wood (EN 113, ENV 839, ENV 807, EN 152, ENV 12038, EN 350).
See also ‘Establishing the documents and valorisation’ (in the description of the project).
SCIENTIFIC COLLABORATIONS
BCCM works in projects together with other European culture collections and organisations as the WFCC (World Federation for Culture Collections), ECCO (European Culture Collection Organisation), CABRI (Common Access to Biological Resources and Information) and EBRCN (European Biological Resource Centres Network).
USERS COMMITTEE
- H. Janssens (Belgian Institute for Normalisation)
- V. Merken (Ministerie van Economische Zaken, Dienst Accreditation, BELTEST)
PROMOTERS
Jean SWINGS
Universiteit Gent
Laboratorium voor Microbiologie
BCCM/LMG Bacteria Collection
K.L. Ledeganckstraat 35
B-9000 GENT
Tel: +32 9 264.51.08
Fax: +32 9 264.53.46
E-mail: BCCM.LMG@RUG.AC.BE
Henry MARAITE
Université catholique de Louvain
Mycothèque
BCCM/MUCL Fungi/Yeasts Collection
Place Croix du Sud 3
B-1348 LOUVAIN-LA-NEUVE
Tel: +32 10 43.37.42
Fax: +32 10 43.19.01
E-mail: BCCM.MUCL@MBLA.UCL.AC.BE
Nicole NOLARD
Institut de la Santé Publique - Louis Pasteur
Section de Mycologie
BCCM/IHEM Fungi/Yeasts Collection
Rue Juliette Wytsman 14
B-1050 BRUXELLES
Tel: +32 2 642.55.17
Fax: +32 2 642.55.19
E-mail: BCCM.IHEM@iph.fgov.be
Normalisation of the certification, distribution and use of microbial reference material : final report
Brussels : Federal Science Policy, 2005 (SP1479)
[To download]
Normalisation of the certification, distribution and use of microbial reference material : annexe
Brussels : Federal Science Policy, 2005 (SP1480)
[To download]
