SANS 21148-2008 Cosmetics - Microbiology - General instructions for microbiological examination《化妆品 微生物学 微生物检查的一般说明》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-22064-8 SANS 21148:2008Edition 1ISO 21148:2005Edition 1SOUTH AFRICAN NATIONAL STANDARD Cosmetics Microbiology General instructions for mic

4、robiological examination This national standard is the identical implementation ISO 21148:2005 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 791

5、1 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 21148:2008 Edition 1 ISO 21148:2005 Edition 1 Table of changes Change No. Date Scope This South African standard was approved by National Committee SABS TC 217, Cosmetics, in accordance with procedures of the SABS Standards Division, in compliance with

6、 annex 3 of the WTO/TBT agreement. This SANS document was published in December 2008. Reference numberISO 21148:2005(E)ISO 2005INTERNATIONAL STANDARD ISO21148First edition2005-10-15Cosmetics Microbiology General instructions for microbiological examination Cosmtiques Microbiologie Instructions gnral

7、es pour les examens microbiologiques SANS 21148:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 21148:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be pr

8、inted or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no

9、liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file

10、is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or

11、 by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E

12、-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2005 All rights reservedSANS 21148:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 21148:2005(E) ISO 2005 All rights reserved iiiContents Page Foreword iv Introduc

13、tion v 1 Scope 1 2 Terms and definitions .1 3 Premises .1 4 Equipment 3 5 Strains of microorganisms .6 6 Personnel6 7 Preparation of the apparatus and glassware6 8 Preparation and sterilization of culture media and reagents8 9 Laboratory samples.10 10 Operating practices .12 11 Expression of results

14、 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 inoculums20 SANS 21148:2008This s tandard may only

15、be used and printed by approved subscription and freemailing clients of the SABS .ISO 21148:2005(E) iv ISO 2005 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Inter

16、national 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 wit

17、h 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 technica

18、l 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

19、 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. SANS 21148:2008This s tandard may only be used and pr

20、inted by approved subscription and freemailing clients of the SABS .ISO 21148:2005(E) ISO 2005 All rights reserved vIntroduction 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 la

21、boratories 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 especiall

22、y 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

23、, 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

24、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 t

25、echnique. 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 b

26、e 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 occu

27、rrence 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 o

28、f 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. SANS 21148:2008This s tandard may only be used and printed by approved subscri

29、ption and freemailing clients of the SABS .SANS 21148:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 21148:2005(E) ISO 2005 All rights reserved 1Cosmetics Microbiology General instructions for microbiological e

30、xamination 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). Be

31、cause 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 defin

32、itions 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 vol

33、ume 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 o

34、f 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. S

35、ANS 21148:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 21148:2005(E) 2 ISO 2005 All rights reserved3.2 Additional areas The areas included in this category are, for example: entrances, corridors, stairways, lifts; administrative ar

36、eas (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 premis

37、es 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 orde

38、rly. 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; manipulat

39、ion 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 cont

40、amination 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-prot

41、ection systems, when used, shall be installed on the outside of the windows, where practicable; SANS 21148:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 21148:2005(E) ISO 2005 All rights reserved 3 windows and doors shall be able to

42、 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

43、 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

44、 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

45、 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 t

46、ests. 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 apparat

47、us 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) safe

48、ty 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 vert

49、ical 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. SANS 21148:2008This s tandard may only be used and printed by approved