SIST EN ISO 21148:2009
(Main)Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005, including Cor 1:2006)
Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005, including Cor 1:2006)
This International Standard gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values). Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible products).
Kosmetik - Mikrobiologie - Allgemeine Anleitungen für mikrobiologische Untersuchungen (ISO 21148:2005 mit Cor 1:2006)
Diese Internationale Norm gibt allgemeine Anleitungen für die Durchführung von mikrobiologischen Unter-suchungen kosmetischer Mittel, damit deren Qualität und Sicherheit in Übereinstimmung mit einer entsprechenden Risikoanalyse [z. B. geringe Wasseraktivität (niedriger aw-Wert), hydroalkoholischer Anteil, extreme pH-Werte] sichergestellt ist.
Wegen der großen Vielfalt an kosmetischen Mitteln und potentiellen Anwendungsmöglichkeiten innerhalb dieses Anwendungsbereichs sind diese Anleitungen möglicherweise für einige Produkte nicht in allen Einzelheiten geeignet (z. B. bestimmte mit Wasser nicht mischbare Produkte).
Cosmétiques - Microbiologie - Instructions générales pour les examens microbiologiques (ISO 21148:2005, Cor 1:2006 inclus)
L'ISO 21148:2005 donne des règles générales pour la réalisation d'examens microbiologiques sur des produits cosmétiques afin de garantir leur qualité et leur innocuité, conformément à une analyse de risque appropriée (par exemple faible activité de l'eau, produit hydro-alcoolique, valeurs de pH extrêmes).
En raison de la grande variété de produits entrant dans le champ d'application de la présente norme et de leurs usages potentiels, ces règles peuvent ne pas être adaptées en tout point à certains produits (par exemple produits non miscibles à l'eau).
Kozmetika - Mikrobiologija - Splošna navodila za mikrobiološko preskušanje (ISO 21148:2005, vključno s popravkom Cor 1:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 21148:2009
01-oktober-2009
.R]PHWLND0LNURELRORJLMD6SORãQDQDYRGLOD]DPLNURELRORãNRSUHVNXãDQMH ,62
YNOMXþQRVSRSUDYNRP&RU
Cosmetics - Microbiology - General instructions for microbiological examination (ISO
21148:2005, including Cor 1:2006)
Kosmetik - Mikrobiologie - Allgemeine Anleitungen für mikrobiologische Untersuchungen
(ISO 21148:2005 mit Cor 1:2006)
Cosmétiques - Microbiologie - Instructions générales pour les examens microbiologiques
(ISO 21148:2005, Cor 1:2006 inclus)
Ta slovenski standard je istoveten z: EN ISO 21148:2009
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
SIST EN ISO 21148:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 21148:2009
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SIST EN ISO 21148:2009
EUROPEAN STANDARD
EN ISO 21148
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - General instructions for
microbiological examination (ISO 21148:2005)
Cosmétiques - Microbiologie - Instructions générales pour Kosmetik - Mikrobiologie - Allgemeine Anleitungen für
les examens microbiologiques (ISO 21148:2005, Cor mikrobiologische Untersuchungen (ISO 21148:2005)
1:2006 inclus)
This European Standard was approved by CEN on 23 May 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21148:2009: E
worldwide for CEN national Members.
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SIST EN ISO 21148:2009
EN ISO 21148:2009 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 21148:2009
EN ISO 21148:2009 (E)
Foreword
The text of ISO 21148:2005 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 21148:2009 by
Technical Committee CEN/SS H99 “Products for household and leisure use - Undetermined” the secretariat of
which is held by CMC.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by December 2009, and conflicting national standards shall be withdrawn
at the latest by December 2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 21148:2005 has been approved by CEN as a EN ISO 21148:2009 without any modification.
3
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SIST EN ISO 21148:2009
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SIST EN ISO 21148:2009
INTERNATIONAL ISO
STANDARD 21148
First edition
2005-10-15
Cosmetics — Microbiology — General
instructions for microbiological
examination
Cosmétiques — Microbiologie — Instructions générales pour les
examens microbiologiques
Reference number
ISO 21148:2005(E)
©
ISO 2005
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
PDF disclaimer
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© ISO 2005
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Published in Switzerland
ii © ISO 2005 – All rights reserved
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 Terms and definitions .1
3 Premises .1
4 Equipment .3
5 Strains of microorganisms .6
6 Personnel.6
7 Preparation of the apparatus and glassware.6
8 Preparation and sterilization of culture media and reagents.8
9 Laboratory samples.10
10 Operating practices .12
11 Expression of results .13
12 Neutralization of the antimicrobial properties of the product.13
Annex A (informative) Basic identification techniques.14
Annex B (informative) Basic techniques for counting and plating .19
Annex C (informative) Preparation and calibration of inoculums.20
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 21148 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2005 – All rights reserved
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
Introduction
The purpose of this International Standard is to help ensure that the general techniques used for conducting
cosmetic microbiological examinations are the same in other laboratories that adopt these standards, to help
achieve homogeneous results in different laboratories and to contribute towards the protection of the health of
the laboratory personnel by preventing risk of infection.
When conducting microbiological examinations for cosmetic products, it is especially important that:
⎯ only those microorganisms which are present in the samples be isolated or enumerated;
⎯ the microorganisms do not contaminate the environment.
In order to achieve this, it is necessary to pay attention to personal hygiene and to use working techniques
which ensure, as far as possible, exclusion of extraneous contamination.
Since, in this International Standard it is possible to give only a few examples of the precautions to be taken
during microbiological examinations, a thorough knowledge of the microbiological techniques and of the
microorganisms involved is essential. It is important that the analyses be conducted as accurately as possible,
including calculation of the number of microorganisms.
A large number of manipulations can, for example, unintentionally lead to cross-contamination and the analyst
should always verify the accuracy of the results given by his/her technique. It is necessary to take special
precautions, not only for reasons of hygiene, but also to ensure good reproducibility of the results. It is not
possible to specify all the precautions to be taken in all circumstances, but this International Standard at least
provides the main measures to be taken when preparing, sterilizing and storing the media and the equipment.
The given recommendations will allow enumeration and detection of mesophilic microorganisms which may
grow under aerobic conditions.
The recommendations are applicable to the determination of the absence of, or limited occurrence of specified
microorganisms that are of interest for cosmetic products.
The test methods are described in the individual standards. Alternative microbiological procedures can be
used provided that their equivalence has been demonstrated or the method has been otherwise validated.
The choice of a specific method, or combination of methods mentioned in these International Standards will
depend on the purpose for performing the test and it is for the user to decide which approach is best for
his/her application.
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SIST EN ISO 21148:2009
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SIST EN ISO 21148:2009
INTERNATIONAL STANDARD ISO 21148:2005(E)
Cosmetics — Microbiology — General instructions for
microbiological examination
1 Scope
This International Standard gives general instructions for carrying out microbiological examinations of
cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis
(e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these instructions
might not be appropriate for some products in every detail (e.g. certain water-immiscible products).
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
product
portion of an identified cosmetic product received in the laboratory for testing
2.2
sample
portion of the product (at least 1 g or 1 ml) which is used in the test to prepare the initial suspension
2.3
initial suspension
suspension (or solution) of a sample in a defined volume of an appropriate liquid (diluent, neutralizer, broth or
combination of them)
2.4
sample dilution
dilution of the initial suspension
3 Premises
3.1 Test areas
The areas required for the specific operation of a microbiology laboratory are as follows:
⎯ receipt, storage, preparation and processing of the samples;
⎯ preparation and sterilization of culture media, apparatus and glassware;
⎯ performance of analyses: weighing, dilutions, inoculations, subculturing, incubation, maintenance of the
strain, etc.;
⎯ decontamination and cleaning of apparatus, glassware, and processing of the analysis waste.
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
3.2 Additional areas
The areas included in this category are, for example:
⎯ entrances, corridors, stairways, lifts;
⎯ administrative areas (e.g. secretarial, offices, documentation rooms, etc.);
⎯ cloakrooms and toilets;
⎯ archive rooms;
⎯ stores.
3.3 Location of the premises
The environment within which the microbiological analyses are carried out shall not affect the reliability of the
analyses.
Care shall be taken to locate the premises so as to avoid risk of cross-contamination.
Care shall be taken to ensure protection against extreme conditions such as excess temperature, dust,
humidity, steam, noise, vibration, exposure to direct sunlight, etc.
The surface area shall be sufficiently large to keep the work areas clean and orderly.
During the course of the tests, care shall be taken to limit access to the test areas to only those persons
required to conduct the tests.
Separate rooms and/or separate areas and/or specific enclosures should be provided for the following:
⎯ receipt, storage and preparation of samples;
⎯ manipulation of microbial cultures;
⎯ preparation of culture media, apparatus and glassware;
⎯ decontamination and washing area;
⎯ sterilization;
⎯ incubators, refrigerators and freezers.
3.4 Equipping the premises
3.4.1 The test premises shall be fitted out in the following ways in order to reduce the risks of contamination
by dust and therefore by microorganisms:
⎯ walls, ceilings and floors should be smooth, non-porous, easy to clean, and resistant to detergents and
disinfectants used in laboratories;
⎯ overhead pipes conveying fluids should not cross the premises unless they are hermetically enclosed;
⎯ sun-protection systems, when used, shall be installed on the outside of the windows, where practicable;
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
⎯ windows and doors shall be able to be closed when conducting the test in order to minimize draughts.
Furthermore, they shall be designed so as to avoid the formation of dust traps and hence, to facilitate the
cleaning.
3.4.2 The ambient temperature and air quality (microorganism content, humidity, dust-spreading rate, etc.)
shall be compatible with carrying out the tests.
According to needs, a filter-ventilation and/or a microbiological cabinet are recommended for this purpose.
3.4.3 The laboratory bench tops and furniture shall be made of smooth, non-porous impermeable materials,
which are easy to clean and disinfect. Cabinet and equipment tops should be accessible for cleaning.
Non-fixed laboratory furniture shall be designed so as to facilitate cleaning the floors.
It is desirable that documents or books that are not frequently used be kept outside the test areas.
3.5 Maintenance
The floors, walls, ceiling, laboratory bench tops and furniture shall be maintained in good order to avoid cracks
where dirt might particularly accumulate and thus cause a source of contamination.
Regular cleaning and, when relevant, disinfection shall be carried out in order to keep the premises in a
condition suitable for conducting tests.
The ventilation systems and their filters shall be regularly maintained and filters changed when necessary.
4 Equipment
4.1 General
In general, all equipment shall be kept clean and in proper working condition.
Maintenance operations should be monitored. The measurement instruments and apparatus shall be regularly
verified according to an appropriate timetable and results recorded.
4.2 Microbiological cabinets
Cabinets are of two types:
a) clean-air cabinets, which are intended to protect the product from extraneous contamination and to
minimize contamination due to the operator;
b) safety cabinets, which are intended to protect the product from extraneous contamination, and also to
protect the operator and the environment.
Either cabinet can be used. Safety cabinets should be used for all work involving risk for the operator.
A cabinet is a dust-free workstation equipped with vertical laminar airflow. In microbiology, a safety cabinet is
used to retain the microorganisms on filters.
4.3 Balances
A microbiology laboratory for analyses of cosmetic products should be equipped with balances of the required
range and accuracy for the different products to be weighed. Generally, the accuracy required for weighing the
samples to be analysed and some components of the culture media and reagents, is ± 0,01 g.
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
4.4 Homogenizer
This equipment (e.g. blender, stomacher, etc.) may be used to prepare the initial suspension from the test
samples of non-liquid products.
4.5 pH–meter
The pH-meter should be capable of measuring to an accuracy of ± 0,1 pH units and its minimum measuring
threshold shall be 0,01 pH units.
4.6 Autoclave
The autoclave shall be kept in good operating condition and shall regularly be inspected by the competent
departments in accordance with the manufacturer’s instructions and proper documentation should be
recorded.
The autoclave shall not be used to sterilize both clean materials and also to decontaminate used materials at
the same time. Wherever possible, separate autoclaves for these two processes should be used.
4.7 Incubator
Incubators shall be equipped with a regulation system which allows the temperature to be kept even and
stable over their entire working volume.
If the ambient temperature is close to, or higher than, that of the incubator, use an incubator with a cooling
system.
Incubators should be protected from direct sunlight.
If possible, incubators should not be completely filled in one single operation because the culture media will
take a long time to equilibrate to temperature, whatever type of incubator is used (forced-air convection or
otherwise).
The temperature shall be checked and recorded at least every working day.
4.8 Water baths
Water baths are of two types:
⎯ thermostatically-controlled baths, suitable for incubation of inoculated culture media, for identification
tests, etc.;
⎯ temperature-controlled water baths for maintenance of sterile agar media in a molten state for later use in
specified procedures.
The required temperature and accuracy are stipulated in each method of application.
4.9 Refrigerator or cold-storage room
The temperature, unless otherwise specified, shall be 5 °C ± 3 °C.
4.10 Freezer
The temperature, unless otherwise specified, shall be below − 18 °C.
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
4.11 Sterilizing oven
A sterilizing oven is a chamber which allows the destruction of microorganisms by dry heat.
The temperature shall be evenly distributed within the chamber.
The oven shall be equipped with:
⎯ a thermostat;
⎯ a thermometer or a recording thermocouple;
⎯ a duration indicator or a programmer/timer.
4.12 Colony-counting device
A colony-counting device may be used.
4.13 Other equipment
WARNING — Volumetric glassware shall not be sterilized in a sterilizing oven.
Other equipment and apparatus for everyday use, include the following:
a) filtration apparatus (see below);
b) glass or plastic containers (test tubes, flasks, bottles);
c) glass or plastic Petri dishes (most commonly between 85 mm and 100 mm in diameter);
d) glass or plastic pipettes (10 ml, 2 ml, 1 ml), automatic pipettes;
e) sampling instruments;
f) wires and loops (of nickel/ chromium, platinum/ iridium or disposable plastic, etc.);
g) optical microscope;
h) gas burner or wire incinerator;
i) dispenser for culture media and reagents;
j) mechanical stirrer.
If the membrane filtration method is used, the equipment shall also include:
⎯ a membrane filtration system or filtration apparatus constructed of a suitable material, with a filter holder
of at least 50 ml, and suitable for use of filters with diameter 47 mm to 50 mm and not more than 0,45 µm
pore size;
⎯ the type of membrane material is chosen in such a way that the bacteria are not affected by the residual
components of the sample to be investigated;
⎯ a vacuum source able to give an even filtration flow rate (the device shall be set as to obtain the filtration
of 100 ml of liquid in less than 2 min).
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
5 Strains of microorganisms
The strains needed for the validation of the methodology are indicated in each method of application.
6 Personnel
6.1 Competence
All personnel working in a microbiology laboratory shall have received adequate training to enable them to
conduct properly the operations entrusted to them.
The personnel who perform the tests shall have a good knowledge and sufficient practical experience with
microbiological techniques and the microorganisms sought. The person in charge shall be able to interpret the
accuracy and precision required to yield acceptable results.
6.2 Hygiene
In the field of personal hygiene, the following precautions shall be taken not only in order to avoid
contaminating the samples and culture media, but also in order to avoid risk of personnel infection:
⎯ wear laboratory clothing that is light-coloured, clean and in good condition, manufactured from a fabric
which limits the risks of flammability; this clothing shall not be worn outside the work areas;
⎯ keep nails perfectly clean and well groomed, and preferably short;
⎯ wash hands, before and after microbiological examinations and immediately after visiting the toilets or
eating; for drying hands, use disposable paper or disposable cloth towels;
⎯ when inoculating, avoid speaking, coughing, etc;
⎯ do not smoke, drink or eat in the test areas;
⎯ do not put food for personal consumption in the laboratory refrigerators;
⎯ special precautions shall be taken by persons having infections or illnesses that are likely to contaminate
samples with microorganisms and may invalidate results.
7 Preparation of the apparatus and glassware
7.1 Preparation
The apparatus and glassware used in microbiology shall be prepared in such a manner as to guarantee its
cleanliness and/or sterility up until the time of use.
Stopper tubes and cap bottles by appropriate material prior to sterilization.
Stopper the pipettes with cotton or any other appropriate material.
If necessary, the apparatus and glassware to be sterilized should be placed in special containers or wrapped
in an appropriate material (e.g. special paper, aluminium, etc.).
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SIST EN ISO 21148:2009
ISO 21148:2005(E)
7.2 Sterilization
7.2.1 Sterilization by dry heat
Heat in sterilizing oven for at least 1 h at 170 °C to 180 °C or use any combination of time and temperature if
they are validated.
Indicators can be used in order to make certain that the sterilization has been achieved.
7.2.2 Sterilization by moist heat
Heat for at least 15 min at minimum of 121 °C in an autoclave. Indicators can be used in order to make certain
that the sterilization has been achieved.
7.3 Disposable apparatus
Disposable apparatus may be used in the same way as the re-usable glassware (Petri dishes, pipettes, tubes,
etc.) if the specifications are similar.
In this case, contact the manufacturer to determine that the proposed apparatus and glassware is suitable for
use in microbiology (in particular sterility) and that the material contains no substances that inhibit the growth
of microorganisms.
Disposable apparatus shall be decontaminated prior to its disposal. Other than the methods described in 7.6,
and depending upon national regulations, incineration may be used. If there is an incinerator on the premises,
decontamination and disposal may be achieved in a single operation.
7.4 Management of clean apparatus and glassware
Clean apparatus and glassware shall be protected against external contamination during storage, under
conditions which maintain their cleanliness.
7.5 Management of sterile apparatus and glassware
Prior to use, the apparatus and glassware shall be stored under conditions which allow them to remain sterile.
Disposable apparatus and glassware shall be stored in accordance to the manufacturer’s specifications,
without any damage to the packaging; laboratory-prepared apparatus and glassware shall be stored in clean
containers.
When sterilizing apparatus and glassware intended for microbiology, an expiry date (or a manufacturing date)
shall be put on each packaging. Hermetically sealed apparatus and glassware can be stored for up to
3 months prior to use unless otherwise specified.
7.6 Treatment of contaminated material
After use (culture of microorganisms or material in contact with microorganisms), the apparatus and glassware
and their contents shall be treated for destruction of microorganisms, prior to cleaning or disposal, whatever
the microorganism involved.
According to the nature of the materials, disinfection (10.1), sterilization (7.2) or incineration of disposable
material (7.3) may be used.
7.7 Washing
Wash apparatus and glassware after they have been treated (7.6).
Empty the containers of their contents.
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ISO 21148:2005(E)
Prior to washing, separate seals from stoppers or caps, as appropriate.
Rinse detergent residue from equipment with tap water. Rinse clean equipment with water 8.2.
In the absence of any commercial product, a sodium carbonate solution of 0,125 % (mass fraction) can be
[6]
used, followed by immersion in diluted acid [e.g. hydrochloric acid c(HCl) = 0,1 mol/l].
Specialized apparatus and glassware may be used in order to facilitate cleaning operations (e.g. pipette
washers, dishwashers, ultrasonic baths, etc.).
8 Preparation and sterilization of culture media and reagents
8.1 General
The accurate preparation of culture media is one of the fundamental steps in microbiological analysis and it
shall be given special care.
8.2 Water
WARNING — Water processed through an ion exchanger (de-ionized), may have a high
microorganism content; it is therefore advisable not to use such water without verifying that the
m
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