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Quality Assurance INTERNATIONAL — ISO/FDIS

and Performance STANDARD 11133
Testing
of Culture Media

Implementation of
ISO Standard 11133
Part 1 and Part 2
Microbiology of food, animal feed and
water — Preparation, production,
storage and performance testing of
culture media
Microbiologie des aliments et de Teau — Préparation, production,
stockage et essais de performance des milieux de culture

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Contents of Quality Control Lecture

1. Introduction of new ISO Standard 11133-1

2. Practices for quality control of culture media

3. Introduction of new ISO Standard 11133-2

4. Summary T= International
Organization for
“ Standardization

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1

Why was ISO 11133 developed ?

No International Standard exist in —
which the Quality Control Specifications of —<
commercial Culture Media are described _“
-

Each Culture Media Manufacturer ha

it's own QC Specification i

User of Culture Media have no information whieh=

Growth limits are used by the Manufacturer

The new ISO 11133 describes now for the first time
which limits for Productivity and Selectivity each
Culture Medium MUST fulfil,
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ISO 1 1 133 I’@\ ::r):famqiio?at j

s‘ ' anization tor
part 1 and 2 NEZ Sill;!i¡durdizaiion

ISO 11133-1 (2000-06-01)

Microbiology of food and
animal feeding stuffs —
Guidelines on preparation and
production of culture media

This new standard describe for the first time in history of

Microbiology the definition of quality control for commercial
culture media.

Quantitative testing and reporting of results ( CoA )

with recovery rates is the new preferred testing method
CONFIDENTIAL
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g III

ISO 11133 — Part 1

Microbiology of food and animal feeding

stuffs — Guidelines on preparation and
production of culture media
Part 1:

General guidelines on quality assurance for

the preparation of culture media in the
laboratory

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Practices for quality control of culture media

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Documentation

Y Any performance evaluation and test organism used

Y Technical data sheet

Y Quality-control certificate

Y Safety and/or hazard data where needed

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MILLIPORE
1

Documentation - ISO 11133 part 1

» Check list by the laboratory Laboratory

checks upon receipt of the medium _

Y name of the.medium and batch code …

Y date of receipt
v expiry date
Y condition and integrity of packaging

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--
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Practices for Quality Control
Sterilisation a
Dehydrated media are not free of contaminants besides 7
heat-resistant microoganisms
Be sure that no residual media covers the wall of container
Autoclave only 15 min. at 121 %C
Sterilisation duration depends on the size of load and containers
Avoid excessive autoclaving to prevent Maillard reactions
degradation and breakdown of nutrient constituents
Sterilise heat labile substrates by filtration
Add heat labile supplements with aseptic precautions to the
cooled medium (45°C)
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MILLIPORE
Practices for Quality Control
The performance of the autoclave should be monitored

Sterikon® plus
Bioindicator for
checking steam
sterilization efficiency
acc. to USP
and Ph. EUR

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Practices for Quality Control

Preparation of heat sensitive media
Media for e.g. Enterobacteriaceae
containing:
Brilliant green
Bile salts
Iron salts XLD Agar is
most critical
should not be autoclaved

These media have the highest risk of overheating

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Melting of agar culture media

Wather bath versus Hot plate

Hot plate has the high risk that the

Culture Medium can be overheated
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MILLIPORE
1

Preparation of media in Petri dishes

> Pour the molten agar culture medium into Petri dishes so as
to obtain a thickness of at least 2 mm (e.g. for 90 mm
diameter dishes, 15 ml of agar are normally required) or as
specified in the International Standard.
> Allow the agar to cool and solidify by placing the plates with
lids in place on a cool, horizontal surface.
> During incubation, a loss of moisture of the agar media will
occur. A loss of water content can affect the growth of
microorganisms in some circumstances.

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MILLIPORE
1

Storage of media in Petri dishes

> Use the solidified medium immediately or store under conditions which
prevent its composition from being modified, i.e. in the dark and / or in the
refrigerator at 5°C + 3 “C in sealed bags
> Label the plates on the base with date of preparation and/or expiry date
and identity
> In general, for the surface inoculation of a solid culture medium, dry the
plates, preferably with the lids removed and with the agar surface facing
downwards ;

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Shelf life of prepared media O

»The shelf-life of media varies. Specific International or

National Standards may stipulate specific conditions and
shelf life.
>t is generally recommended not to exceed 2 to 4 weeks of
storage for plates and 3 to 6 months for bottles and tubes,
unless otherwise specified in specific standards or results of
the laboratory shelf life validation indicate a longer shelf life.
> A validated expiry date for stored media should be
established. Observe any colour change, sign of
evaporation/dehydration or microbial growth. Batches of
media showing such changes should not be used. CONFIDENTIAL
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Shelf life of prepared VRB — Agar (200 ml in a bottle)

Internal validation study (Recovery %)

VRB — Agar
Test strains
TSA 8 months + 2 weeks
at RT at 35C

Escherichia coli ATCC 8739 100 % 100 % 96 %

Escherichia coli ATCC 25922 100 % 97 % 97 %
Enterobacter cloacae ATCC 13047 | 100% 99 % 83 %
Salmonella typhimurium ATCC 14028 | 100 % 100 % 100 %
Staphylococcus aureus ATCC 6538 | 100 % 0 % 0%
Enterococcus faecalis ATCC 19433 | 100 % 0 % 0%
Bacillus cereus ATCC 11778 100 % 0% 0%
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MILLIPORE
ISO 11133 — Part 2

Microbiology of food and animal feeding stuffs —

Guidelines on preparation and production of culture media

Part 2:

Practical guidelines on performance testing of culture media

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MILLIPORE

General Quality Criteria

> The quality of culture media depends on the quality of the basic
ingredients, correct formulation, quality of preparation
procedures, elimination of contaminant microbial agents and
appropriate packaging and storage conditions.
> Quantitative, semi-quantitative or qualitative evaluations shall be
performed by the methods described in this Standard or by
another generally accepted technique.
> For interpretation of the results of testing, it is necessary to
compare the amount of growth on the test medium with that on a
reference medium. The use of a specific reference medium is
therefore mandatory for quantitative methods

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MILLIPORE
General Quality Criteria
Quality of Basic Media Components
Culture media described in the International Standards were judged
satisfactory; however, due to the variability of their quality, it may be
acceptable for media manufacturers to modify the concentration of
some basic biological ingredients, as listed below:

> peptones and meat or yeast extracts variable in their nutritive properties
»agar variable in its gelling properties
> buffering substances
>bile salts, bile extract and deoxycholate, antibacterial dyes, depending on their
selective properties
> antibiotics depending on their activity

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MILLIPORE
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General Quality Criteria

> Growth
- quantitative
- semi quantitative
- qualitative method

BAIRD-PARKER AGAR
> Productivity
S. aureus ATCC 6538
> Selectivity
> Biochemical Characteristics
> Performance Evaluation and Interpretation of Result

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MILLIPORE
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Productivity

> Solid, semi solid or liquid culture medias shall be

inoculated with an appropriate inoculum of the working
culture of each of the defined test microoganisms using
an appropriate device e.g. spiral plater

> Productivity has to reach a fixed limit

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Selectivity

> lo asses selectivity quantitatively, selective

culture media and a reference medium are
inoculated with an appropriate inoculum of
test trains.
> Selectivity has to reach defined values.

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MILLIPORE
General
> Forisolation and enumeration media, at least semi-
quantitative testing should be performed. For
characterization test media, qualitative testing may be
sufficient.
> Quantitative tests will give greater assurance of media
quality.
» For those media which contain no indicators or selective
agents the use of a single positive test strain is
appropriate. For those media which do contain indicators
or selective agents, strains which demonstrate the
function of the indicator(s) and selectivity must be
utilized.
> For complex media, i.e. with added supplements, each
batch should be verified with strains with characteristics.
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Methods for Solid Culture Media

Quantitative method

>ltis a general method suitable for most solid culture

media
- A spiral plater can be used
- The pour plate method for enumeration can also be used
in this way

> |t may not suitable for testing types of moulds

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Quantitative method — Procedure

Pre-culture the test strain in CASO Broth or Sab.-2%-Broth (Candida)

at 35% C for 24 h
Dilute the pre - culture with 1/4 Ringer - solution
Inoculate the test medium, an older reference lot and a reference
medium with the Spiral Plater
Count the colonies in comparison to an older reference batch and to a
reference medium
M ' MERCK

Quantitative method - Interpretation

BROLACIN (CLED) Agar

Ref.Medium (TSA) NEW batch

Calculation : 85 / 100 = 85 % recovery

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Quantitative method — Interpretation

CEREUS Selective Agar (MYP)

Ref.Medium (TSA) NEW batch

Calculation : 84 / 123 = 68 % recovery rate

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MILLIPORE
Methods for Solid Culture Media

Productivity > 70% for non selective media

> 50% for selective media

These values are generally achievable, however less rigorous criteria

can be accepted for certain combinations of media and test
microorganisms.

For media which are not specified in Annex B, e.g. those described
in local standards, these criteria may not be applicable.

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MILLIPORE
Performance criteria (Annex B)
‘ Enumeration Media — Selective Media ’
Media |Type | Microorganisms | Standard - Function | Incubation Strains of control Reference media| Methodof | — Criteria | Characteristlc reactions
—

VRBL | s | Colfoms | 1504832 Productivity | 24h/30°C E cOl ATCC 25022 0 8739 TSA Quantitative » Purplish colonles with or
without precipitation halo
Selectivty | 24h/30°C [E. fascalis ATCC 20212 or 19433 - Qualitative | Total inhibition -
Specifcity | 24h/30°C | Ps. aeruginosa ATCC 27853 - Qualitative . Colourless to beige
. — . l __colonies

Enumeration Media — Non Selective Media W

Media - [Type | Microorganisms | Standard | Function | Incubation Strains of control Characteristic reactions
—— — — Y — NUN——
PCA | & Totalflora — | 18O 4833 | Productivity | 72h/30°C | E, coll ATCC 25922 or 8739
S. aureus ATCC 6538 or 6538P
B, subtlis ATC_9_§_633‘

Enrichment Media — Non Selective Media N

of control
Media —| Type [Mieroorganisms | Standard | Function | Incubaflon | — Sirains

2737
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MILLIPORE
Culture Media in ISO Food Norms
with a recovery rate > 50%
> ISO 6888-1 Baird Parker Agar Staphylococcus aureus

> ISO 7954 OGY Agar Yeast 8: Moulds

> ISO 15214 MRS Agar Lactic acid bacteria

> ISO 7932 MYP Agar Bacillus cereus

> ISO 11290 Oxford Agar L. monocytogenes

> ISO 11290 PALCAM Agar L. monocytogenes

> ISO 7938 TSC Agar Clostridium perfringens

> ISO 7402

VRBD Agar Enterobacteriaceae
ISO 8523

ISO 4832 VRB Agar Coliforms

Y

ISO 16654 CT SMAC Agar E.coli 0157

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MILLIPORE
1

Certificate of Analysis Tryptic Soy — Agar

1.05458.5000 CASO agar Casein-peptone soymeal-peptone agar for
microbiology (40 g for 1 litre of culture medium) USP
Batch V273158

Baich Values

Appearance
clearness
colour
clear
yellowish-brown
all test strains
pH-value (25 "C)
Solidification point
7.3
35 “C must have > 70 %
Gel strength (Gelomal assay) 57 g
Solidification behaviour (2 hrs., 45 "C)
Siability test (Colour and hemolysis)
liquid
non-hemolytic
otherwise batch
is rejected
Balch Values

Recovery rale
Staphylococcus aureus ATCC 6538-P 130
ARDARA
Bacillus subtilis ATCC 6633 110
Escherichia coli ATCC 8739 85
Streptococcus pyogenes ATCC 21059 105
Candida albicans ATCC 10231 130
Candida albicans ATCC 2091 100

Incubation: 24 hrs.; 35 “C; aerobic

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 MILLIPORE
Certificate of Analysis VRB — Agar
1.01406.0500 VRE Agar Vialet red bile agar for microbialogy
Batch WMATEIDE

Earch Values
Appearance
clezmens clear
P diarkc pedl
pai-value (25 563 E
Solidificanon bebarionar
(2 s, 45 403 Eal

Recovey rotr nelafed $o colony comnt CASO agor d— 100 %ás

Baech Valoes
Becoveny rase (Escherickáa coli ATOC £739) 105 “
Coloey coloar CEschenchia coli ATOC 879 ed
Precipmane (Escherichia cols ATCC 5739 -
Recovery rase CEscherickaa coli ATOC 25922) 75 -
Colosy coloar (Eschenchia coli ATOC 551} ed
Precipaare (Escherichia cols ATCC 25921y -
Recowvery rase (Essercbacter cloacas ATOC 130473 - -
Crolomy coloar CEmerobacier cloacas AFPC 1 5047) med
Precupaare (Enmerobacier cloacas ATÓC 15047) -
Becovenr rase (Salmmonella Avpliimonen ATCC 14 sa “.
Coloeses (Salmonella rvphimacias ATCC 14028 passes nesr
Becoveny cate Y enmaa enserocolifica ATCC 96107 — -
Colomes MWenamia emerocolitica ATÉC S816) passes nest
= -

Becoveny wane
Staphylocoocus mercus ATCC 6535 -
Emterococcas faecakis ATCC 19435
Bacilbas cereuws ATCC 11778
Lactobacillus plamtanana ATCC 14917
drcrbarion: TT hrs.: 30 C aevolne.

Taar dere DD ALIF SY I5 0S 2005

E ae O MA IT o as ZNO

Dr Wolfeane Knichel
Eexponsible Laborarcoy mmamae gl < cmesol
Fs docimens has beern procivced ecoronrcalil ared &3 vl warfiowt a TT
NFIDENTIAL
 MILLIPORE
Certificate of Analysis Baird Parker — Agar
1-05406.0500 BAIRD-PARKER agar Staphylococcus selective agar
(base) acc. to BAIRD PARKER for microbiologay
Batch vMB14106

Batch Values

Appearance
cleamess opalescent
Colour yelowish-brovn
pR-value (23 70 a
Solidification behaviour (2 hrs., 45 “C) Tiequid

Recovery rate (Staphylococcus aureus ATC C 6538) 115

6538 black
+
Recovery rate (Staph: 25
Colony colour (Staphylococcus aureus ATCC black
5 +
ate (Enterococcus hirae £ 0.01 .
y rate (Proteus mirabilis ATCC 29906) 5
colour (Proteus mirabilis ATCC 28906 black
teus mirabilis ATCC 209063
Recovery rate (Staphylococcus epidermidis NCTC 110473 0.01 E
Growth (Staphylococcus epidermidis NCTG 11047 passes test
Recovery rate
Bacillus subtilis ATCC 6051
Pseudomenas aemginosa ATCC 9027
Escherichia coli ATCC £739
Salmenella syphinmrium ATCC 14028
Incubarion- 48 hrs.; 35 C- aerobic

Test date (DD MM FIYI). 21.07.2006

Expiry dare (DD. AL YYY 0305 2011

Dr. Wolfganz Knichel

respensible laboratory manager quality control
This document has been produced electronicaliy and is valid without a signature

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MILLIPORE
1

Recovery Rates — VRB Agar

120
110
100 = 2
90
% 80
70
60
50
40
30
643 806 541 906 476 306 370 506 291 306 Batch No

—— E.coli -=- S.typhimurium —— Enterob.cloaceae

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MILLIPORE
1

Qualitative streaking method

General

> The method is suitable for

S upplementary performance testing
of solid culture media.

The method is only qualitative

and scores are therefore only
indicative.
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MILLIPORE
1

Qualitative method — Interpretation

The growth on the plates after incubation is

assessed as:

> 0 corresponds to zero growth

» 1 corresponds to weak growth
» 2 corresponds to good growth

Target microorganisms shall score 2 and have typical appearance,

size and colony morphology. The growth of non-target microorganisms
shall be partly or completely inhibited (0 or 1).
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Methods for Liquid Media

Quantitative dilution method for target
and non — target microorganisms

> To determine the productivity of a liquid medium an

appropriate inoculum shall be used.

> The method is also appropriate for evaluation of new

culture media, broths or diluents.

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MILLIPORE
Methods for Liquid Media
Quantitative method — Procedure

> Select an appropriate number of tubes or 10 ml portions of each

batch of liquid medium to be tested.
> lInoculate test broth and reference broth for each test organism
with a small number (e.g. 10 cfu to 100 cfu).

> lInoculate test broth and reference broth for each test organism
with a higher number (>1000 cfu).
> Fortesting mixed cultures in selective media inoculate test broth
and reference broth with a small number of target
microorganisms and in the same tube with a higher number of
non-target microorganisms.
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MILLIPORE
Methods for Liquid Media
Quantitative method — Reading

Remove an aliquot volume or if necessary a dilution from

each broth after the incubation step and spread to a
non-inhibitory agar plate.
After incubation colonies of target and non-target
microorganisms are counted, in the case of mixed cultures
distinguishing the different types.
Calculation and interpretation shall be done with respect to
the aim of examination.

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Methods for Liquid Media

Quantitative method — Calculation / Interpretation

Ea 105 to 108 cfu per ml

m below 104 cfu per ml

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MILLIPORE
1

Certificate of Analysis FRASER - Broth

1.10398.0500 FRASER Listeria Selective Enrichment Broth (base) for
microbiology

Spec. values

Appenmnce
Elearmess Eleardo almosí clear
colour yellowish-brown
pH-value {25 2C) T= TA

Spec, Walues

Caolony count 1. Enrictment step

Lisicria monocybogenes ATCC 19111 =41-104 EFU-mi
Li=feria manacymapenes ATCC 35152 =41-10% [ T
Listeria momacylagenes ATCC 13952 =+1-104 CFU'mi
Listeria inmocua ATCC 33090 =+1-104 CFO ml
Enterococcus fascalis ATOC 19433 <+1-103 CFUml
Seaphylococcas aureas ATOC 6538 s+1-105 CFLYmil
Blackening 2. Enrichment steg
Cisteria monvcylogemes ATOC 19111
Cisteria monorytogenes ATOC 35152
Listeria monooytopenes ATOC 13932
Listerin innocua ATOC 33060

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MILLIPORE
Methods for Liquid Media
Quantitative method — Mixed Culture
RVS / TTn / Selenite Cystine broth
Quality control

Test strains Inoculum Growth after

24 hours
— , o
Escherichia coli Approx. 99 % <10%

ATCC 25922

Salmonella typhimurium Approx. 1 %

ATCC 14028
> 90 %

CONFIDENTIAL
Methods for Liquid Media

Results on CLED agar after selective enrichment in RVS broth

0 hr 24 hr

E. coli: Lactose (+) = yellow

Salmonella typhimurium: Lactose (-) = blue
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MILLIPORE
Methods for Liquid Media
Qualitative method - Interpretation
Qualitative evaluation shall be carried out visually
by allocating growth scores, e.g. from 0 to 2.

- 0 corresponds to zero turbidity

- 1 corresponds to very light turbidity
- 2 corresponds to good turbidity

The score of a target microorganism shall be 2. .

Other characteristics such as gas formation, colour

change, etc. can also be assessed by this method.
CONFIDENTIAL
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H

Documentation of Test Results

> The manufacturer or supplier shall provide, on

request, the specific microbiological characteristics
and general information relating to the specific batch
of culture medium.

> The use of control sheets for documenting and

evaluating the results of the routine performance
testing is recommended (see Annex A).

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MILLIPORE
1

Control Card (Annex A)

ºomml…forlnt.m-lg ity testing of culture media
culture medium quantity
of pouring: | pouring date: internal
lot number

dehydrated medium: supplier Tor amount date/signature

Supplement: supplior: ot amount: date/signature

| Physical quality control

expected pH-value: measured pH quality confirmed: | defects: date/signaturo
yes 9 no O
expected quaniity filed and/or observed: aquality confirmed: | defects: date/signaturo
layer thickness:
yes - no c
expected colour observed: Quality confirmed: | defects: date/signature
yos £ no o
expected clarity/presence of observed: Quality confirmed: | defects: date/signature:
optical artefacts:
yes O no ©
o:poel.d el siability 7 Sbserved: Quality confirmed: | defects: date/signature:
lency / moisturo:
yes 9 no o
Microbial contamination
| No. of tested plates or tubes: result Quality confirmed: | No. ef contaminated | date/signature;
plates or tubes:
Incubation: yes 9 no o
Microbiol ical - Productivity Method of control: Quantitative £ Qualitative 3
strains: : result Quality confirmed: date/signature:
incubation: yes o no El
m
Microbiol rowth - Method of con! Quantitative 5 Qualitative 5
3 critoria result: quality confirmed: date/signature:
Incubation: yes O no 0
reference medium
Microbiological growth - Matfiod of controk: Quantitative 1 Qualitative 5
strains: 3 Quality confirmed: date/signature
incubation yes O no 5
P et i
CONFIDENTIAL
 5

ISO 11133 — overview to actual parts l

H
z
E
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ISO TS 11133 Microbiology of food and animal feeding stuffs —

Guidelines on preparation and production of culture media

Part 2 Amd 1: 2011 Test microorganisms for commonly

used culture media
contains tables with the media used for food microbiology

contains WDCM numbers instead of ATCC numbers

for all strains of microorganisms used for quality control

Reason:
ATCC did not allowed for future publications of ISO
anY impression of equivalence of strains from different
culture collections compared to ATCC
(planned as a table for revised ISO 11133);
also only allowed to use ATCC numbers cited as ATCC™
using of ™is only possible in ISO standards, if equivalent substance /
material can also be used — but how can we show equivalence of the
strains from different culture collections ?

1SO 11133
for quality control of culture media B. Gerten Merck KGaA 09-2013 47
ISO 11133 — overview to actual parts M

ISO TS 11133 Microbiology of food and animal feeding stuffs —

Guidelines on preparation and production of culture media

WDCM numbers

are given as universal strain identifiers

by the World Data Centre for Microorganisms (WDCM)

WDCM is part of WFCC (World Federation of Culture Collections)

they have initiated a system that will help users find local sources
of the reference strains by citing all collections and
providing contact details and the collection’s unique reference

1SO 11133 for quality control of culture media B. Gerten Merck KGaA 09-2013 48
 REFERENCE STRAIN CATALOGUE PERTAINING TO
ORGANISMS FOR PERFORMANCE TESTING CULTURE
MEDIA
Staphylococcus aureus

WDCM 00032 ATCC™ 6538 ; CCM 4516 ; CCTM 2103 ; CCUG 1623 ; CCUG
10778 ; CECT 239 ; CIP 4.83 ; CNCTC Mau 29/58 ; DSM 799 ;
HMGB B865 ; IFO 13276 ; IMET 10761 ; LMG 8064 ; NCIB 9518 ;
NCTC
10788 ; FDA 209 ; FIRDI 941 ; IEM Mau 29/58

WDCM 00033 AHU 1142 ; ATCC™ 6538P ; BTCC 209P ; BU 395 ; CCM 2022 ;
CCTM 596 ; CCUG 1828 ; CECT 240 ; CIP 53.156 ; CN 3784 ;
CNCTC Mau 28/58 ; DSM 346 ; IAM 1011 ; IAM 12082 ; IFO 3061 ;
IFO 12732 ; IID 671 ; IMET 10904 ; LMG 8195 ; NCIB 8625 ; NCTC
7447 ; NRRL B-313 ; OUT 8232 ; RIMD 3109007 ; FDA 209P ; FIRDI
451 ; IEM Mau 28/58 ; PCI 1209 ; PZH 8/54 ; VNIIA 209P

WDCM 00034 < ATCC™ 2592§ XCCM 3953 ; CCTM 2816 ; CCUG 7738 ; CCUG
D 35 ; CIP 76.25 ; CNCTC Mau 80/73 ; DSM 1104 ;
JCM 2413 ; LMG 8224 ; NCIMB 12702 ; FDA strain Seatlle 1945

WDCM 00035 ATCC™ 9144 ; CCM 2107 ; CIP 53.154 ; DSM 683 ; LMG 10640 ;
NCIB 6571 ; NCTC 6571 ; NRRL B314 ; Merck Inc. 3R7089 ; strain
Oxford

WDCM 00130 | NCIMB 12820 ; NCIMB(QC) 50081

WDCM 00131 ATCC™ 29213 ; CCM 4223 ; CIP 103429 ; DSM 2569 ; LMG 10147 ;
NCTC 12973 ; JCM 2874

1SO 11133 for quality control of culture media B. Gerten Merck KGaA 09-2013 49
ISO 11133 — overview to actual parts

MERCK MILLIPORE
ISO TS 11133 Microbiology of food and animal feeding stuffs —

J
Guidelines on preparation and production of culture media

WDCM numbers @WDCM &R WDCM Reference Strain Catalogue

on the new WebSIte Of WDCM Browse Search Standards History Credit

(www.wfcc.info) ' á

itis also possible to search by

- species name
- WDCM strain number
Introduction: News & E
- . strain accession number Tm ctalogue was produced o enable broader and easier access to e refrence strans D220
m listed by the 180 TC 34 SC 9 Joint Working Group 5 and by the Working Party on Culture — PERTANNA
- n U m
ber er O
of standard
S an ar
e pblaton oo l ClieMeda Fd an ae
expressed by these bodies for a unique system of identifiers for

(ISO and other standards)

use in quality assurance.

WDCM Reference Strains cover: Te 19th v

1SO 11133 for quality control of culture media B. Gerten Merck KGaA 09-2013 50
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Summary Part 1 and Part 2
Demands to a reliable manufacturer of culture media:
Media manufacturer must be certified according to at least ISO 9001 standards
Media manufacturer should produce culture media in full compliance with
ISO 11133 Quality control methods

Merck as manufacturer of culture media:

Merck is certified as culture media manufacturer acc. various ISO norms.
Merck has available a clear documentation about the performance of their culture
media with values that exceeds ISO 11133

Customers:
Customers labs which are certified acc. ISO standards need:
To use validated culture media
To follow validated enrichment procedures

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ISO 11133 — overview to actual parts

MERCK MILLIPORE
Availability of ISO standards: ANSI web store (http://webstore.ansi.org/)

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11133
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[[O Electrotechnical
A Commission
ISO/TS 11133-1:2009

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Revises ISO/TR 11133-1:2000
Microbiology of food and animal feeding stuffs - Guidelines on preparation and production of
culture media - Part 1: General guidelines on quality assurance for the preparation of culture
Home media in the laboratory

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Account ISO/TS 11133-2/Amd1:2011

Other Information
Revises ISO/TS 11133-2:2003
- Amendment 1: Test microorganisms for commonly used culture media

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Microbiology of food and animal feeding stuffs - Guidelines on preparation and production of
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1SO 11133 for quality control of culture media B. Gerten Merck KGaA 09-2013 52
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