KS EAS 789 2013 - Kenya Bureau of Standards · EAS 789: 2013 Foreword Development of the East...

KENYA STANDARD KS EAS 789: 2013 ICS 77.100.40

Instant hand sanitizers — Specification

© KEBS 2014 First Edition 2014

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KS EAS 789: 2013

ii © KEBS 2014 — All rights reserved

TECHNICAL COMMITTEE REPRESENTATION The following organizations were represented on the Technical Committee: Reckitt Benckiser PZ Cussons E.A. Kapa Oil Refineries Unilever Kenya Ltd. Bidco Oil Refineries Haco Tiger Brands Kenya Industrial Research and Development Institute (KIRDI) Government Chemist’s Department Orbit Chemicals Pwani Oil Refineries Johnson Diversey E and C Africa Rumorth Group University of Nairobi Ecolab Ltd. MEP Chemical Industries Consumer Information Network Kenya Bureau of Standards — Secretariat

REVISION OF KENYA STANDARDS In order to keep abreast of progress in industry, Kenya Standards shall be regularly reviewed. Suggestions for improvements to published standards, addressed to the Managing Director, Kenya Bureau of Standards, are welcome.

© Kenya Bureau of Standards, 2014 Copyright. Users are reminded that by virtue of Section 25 of the Copyright Act, Cap. 12 of 2001 of the Laws of Kenya, copyright subsists in all Kenya Standards and except as provided under Section 26 of this Act, no Kenya Standard produced by Kenya Bureau of Standards may be reproduced, stored in a retrieval system in any form or transmitted by any means without prior permission in writing from the Managing Director.

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KENYA STANDARD KS EAS 789: 2013 ICS 77.100.40

© KEBS 2014 — All rights reserved iii


KENYA BUREAU OF STANDARDS (KEBS)

Head Office: P.O. Box 54974, Nairobi-00200, Tel.: (+254 020) 605490, 602350, Fax: (+254 020) 604031 E-Mail: [email protected], Web:http://www.kebs.org

Coast Region Lake Region Rift Valley Region

P.O. Box 99376, Mombasa-80100 P.O. Box 2949, Kisumu-40100 P.O. Box 2138, Nakuru-20100

Tel.: (+254 041) 229563, 230939/40 Tel.: (+254 057) 23549, 22396 Tel.: (+254 051) 210553, 210555 Fax: (+254 041) 229448 Fax: (+254 057) 21814

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KS EAS 789: 2013

iv © KEBS 2014 — All rights reserved

N A T I O N A L F O R E W O R D This Kenya Standard was prepared by the Technical Committee on Surface Active Agents under the guidance of the Standards Projects Committee, and it is in accordance with the procedures of the Kenya Bureau of Standards. This standard is identical with and has been reproduced from EAS 789, Instant hand sanitizers — Specification, published by East African Community (EAC). The National Standards Council has endorsed the adoption of the 2013 edition of this standard as a Kenya Standard. For the purposes of this standard, the text of the East African Standard should be modified as follows: a) Terminology The words 'this Kenya Standard' should replace the words ‘this East African Standard’, wherever they appear. b) References The references to East African Standards should be replaced by references to the appropriate Kenya Standards, where they have been declared. c) Normative and informative annexes A 'normative' annex is an integral part of a standard, whereas an 'informative' annex is only for information and guidance.

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EAS 789: 2013

ICS 77.100.40

EAST AFRICAN STANDARD


EAST AFRICAN COMMUNITY

© EAC 2013 First Edition 2013

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Copyright notice

This EAC document is copyright-protected by EAC. While the reproduction of this document byparticipants in the EAC standards development process is permitted without prior permission from EAC,neither this document nor any extract from it may be reproduced, stored or transmitted in any form forany other purpose without prior written permission from EAC.

Requests for permission to reproduce this document for the purpose of selling it should be addressedas shown below or to EAC’s member body in the country of the requester:

© East African Community 2013 — All rights reservedEast African CommunityP.O.Box 1096ArushaTanzaniaTel: 255 27 2504253/8Fax: 255 27 2504481/2504255E-mail: [email protected]

Web: www.eac-quality.net

Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.Violators may be persecuted

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EAS 789: 2013

ForewordDevelopment of the East African Standards has been necessitated by the need for harmonizing requirementsgoverning quality of products and services in the East African Community. It is envisaged that throughharmonized standardization, trade barriers that are encountered when goods and services are exchangedwithin the Community will be removed.

In order to achieve this objective, the Community established an East African Standards Committee mandatedto develop and issue East African Standards.

The Committee is composed of representatives of the National Standards Bodies in Partner States, togetherwith the representatives from the private sectors and consumer organizations. Draft East African Standardsare circulated to stakeholders through the National Standards Bodies in the Partner States. The commentsreceived are discussed and incorporated before finalization of standards, in accordance with the proceduresof the Community.

East African Standards are subject to review, to keep pace with technological advances. Users of the EastAfrican Standards are therefore expected to ensure that they always have the latest versions of the standardsthey are implementing.

EAS 789 was prepared by Technical Committee EAS/TC 074, Surface active agents.

© EAC 2013 – All rights reserved iii

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EAS 789: 2013Introduction

The alcohol contained within hand sanitizers, when rubbed on the surface of skin is effective in killing 99.9 %of dangerous germs on the skin. The type of alcohol used in most hand sanitizers is ethyl alcohol. Ethylalcohol is the active ingredient in most hand sanitizers. A concentration of 60 % to 95 % alcohol in handsanitizing product is recommended. However, there are also non-alcohol based hand sanitizers which can beeffective in killing germs. For instance, Benzalkonium Chloride (BAC) has been proven effective in killing 99.9% of germs. There are also several other non-active ingredients in hand sanitizer, the second mostconcentrated ingredient is water. Most hand sanitizers also have a form of moisturizer in their sanitizer suchas Vitamin E or Aloe. This is to help leave the skin soft after applying. Fragrances and dyes are among someof the other inactive ingredients.

iv © EAC 2013 – All rights reserved

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1 Scope

This East African standard specifies the requirements and methods of test for alcohol based instant handsanitizers. The standard does not cover non-alcohol based hand sanitizers.

2 Normative references

The following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.

EAS 104, Alcoholic beverages – Method of sampling and test

EAS 377-1, Cosmetics and cosmetics products — Part 1: List of substances prohibited in cosmetic products

EAS 377-2, Cosmetics and cosmetics products — Part 2: List of substances which cosmetic products mustnot contain except subject to restrictions laid down

EAS 377-3, Cosmetics and cosmetics products — Part 3: List of colourants allowed in cosmetic products

EAS 377-4, Cosmetics and cosmetics products — Part 4: List of preservatives allowed in cosmetic products

EAS 377-5, Cosmetics and cosmetics products — Part 5: Use of UV filters in cosmetic products

3 Terms and definitions

For the purposes of this standard terms and definitions given in ISO 862 and the following apply.

hand sanitizers antiseptic agents used to cleanse the hands when soap and water are unavailable. They are often used toprotect and prevent the passage of bacteria, virus and other pathogens that can cause infections.

4 Requirements

4.1 General requirements

4.1.1 The sanitizer shall have an acceptable odour.

4.1.2 The sanitizer shall be clear, colourless and in the form of liquid or gel.

4.1.3 The sanitizer shall not have any disagreeable odour or smell.

4.1.4 The substances used in the sanitizers shall conform to all the parts of EAS 377.

4.2 Specific quality requirements

The hand sanitizer shall also comply with the specific quality requirements given in Table 1 when tested inaccordance with the corresponding test method.

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EAST AFRICAN STANDARD EAS 789: 2013

Table 1 — Specific quality requirements for instant hand sanitizer

Sl. No Characteristic Requirement Test method

i) Alcohol content (ethanol and/or isopropanol, n-propanol), %, v/v, min.

60.0 EAS 104

ii) pH (neat) 6 - 8 —

iii) Bactericidal efficacy to pass test Annex A

5 Packaging and labelling

5.1 Packaging

5.1.1 The sanitizer shall be supplied in suitable well-closed containers/packages.

5.1.2 The containers/packages (including the closures) shall not interact chemically with the sanitizer andshall be strong enough to protect the sanitizer adequately during normal handling, transportation and storage.

5.1.3 Only containers/packages of the same size and bearing the same batch identification shall be packedtogether in a bulk container.

5.2 Marking

The container/package shall be securely closed and marked legibly and indelibly with the followinginformation:

a) name of the product as “hand sanitizer”

b) manufacturer’s name and physical address

NOTE The name, physical address of the distributor/supplier and trade mark may be added as required

c) batch or code number;

d) net content;

e) list of ingredients used;

f) general instructions for use (be in either English, Kiswahili or French or in combination as agreedbetween the manufacturer and supplier);

g) date of manufacture and expiry date;

h) country of origin/manufacture;

i) the following cautionary warnings:

i) “Do not allow the sanitizer to come into contact with eyes”;

ii) “Keep Out Reach of Children”;

iii) “If swallowed contact a doctor”; and

iv) “Highly flammable, keep away from fire or flame”.

© EAC 2013 – All rights reserved 2

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Annex A

(normative)

Determination of disinfecting efficacy

A.1 Outline of the method

A.1.1 The sanitizer is tested at the recommended ‘use’-dilution’ and concurrently at 0.5 and 1.5 times thatdilution. The test consists of challenging the diluted sanitizer with bacterial inoculum, withdrawing a sampleafter a given time and culturing the sample in a suitable recovery medium. After this sampling, the mixture isagain challenged by a second inoculum and after a second interval, is again sampled for culturing. Thisprocess is then repeated to provide a third challenge.

A.1.2 The sample is considered to have passed or failed the test according to the extent of growth shown inthe first two cultured samples.

A.2 Apparatus

A.2.1 Facility, for incubation at 37 °C ± 1 °C

A.2.2 Facility, for incubation at 2 °C ± 1 °C

A.2.3 Stop clock, indicating in seconds

A.2.4 Facility, for refrigeration at 4 °C ± 1 °C

A.2.5 Universal containers, made of glass and having metal tops with rubber liners. Plastic containers orglass containers with plastic tops shall not be used.

A.2.6 Test tubes, 19 mm X 150 mm

A.2.7 Filter paper, No. 4 Whatman (sterile) or equivalent

A.2.8 Facility, for autoclaving at 121 °C ± 1 °C

A.2.9 Pipette, capable of dispensing 0.02 mL ± 0.005 mL

A.2.10 pH meter

A.2.11 Facility, to sterilize by filtration

A.2.12 150 μm test sieve

A.2.13 Oven, capable of maintaining temperature at 100 °C ± 1 °C

A.3 Media

A.3.1 Growth media for test organisms

A.3.1.1 The growth media for test organisms shall be Wright and Mundy Broth with Dextrose (WMBD).

4 © EAC 2013 – All rights reserved

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A.3.1.2 Dispense 10 mL and 6 mL quantities of the Wright and Mundy Broth into universal bottles, andautoclave at 121 °C ± 1 °C for 12 min.

A.3.1.3 Add to this medium, 10 % (m/V) dextrose solution sterilized by filtration, to give a final dextroseconcentration of 0.1 % (m/v), (that is, to 10 mL broth add 0.1 mL dextrose solution and to 6.0 mL broth add0.06 mL dextrose solution).

A.3.2 Recovery medium

A.3.2.1 Composition

A nutrient broth prepared as follows:

a) beef extract, 10 g;

b) peptone, 10 g;

c) sodium chloride, 5 g; and

d) polyoxyethylene sorbitan mono-oleate, 30 g

A.3.2.2 Preparation

Add the ingredients to 1 000 mL of water. Mix well. Dispense 10 mL quantities into test tubes and autoclave at 121 °C ± 1 °C for 15 min.

A.3.3 Hard water

Standard hard water with 342 mg/L (ppm) hardness prepared as follows: dissolve 0.304 g of anhydrouscalcium chloride hexahydrate (MgCl2.6H20) in distilled water and make up the volume to one litre. Sterilize thestandard hard water by autoclaving at 121 °C ± 1 °C for 15 min. Allow this to reach room temperature beforeuse.

A.3.4 Yeast suspension

A.3.4.1 Weigh to the nearest gram about 65 g of active dry yeast. Cream by the gradual addition ofsterile hard water (A.3.3) using a heavy glass rod for stirring. Decant the creamed portion into a flask, addmore hard water to any lumpy residue remaining and repeat the creaming and decantation until no residueremains, and 500 mL of hard water has been used.

A.3.4.2 Shake the contents of the flask vigorously and strain-through a 150 μm sieve (A.2.12) breakingdown any remaining lumps.

A.3.4.3 Add 500 mL sterile hard water, shake vigorously.

A.3.4.4 Transfer 50 mL or 100 mL portions into screw-capped bottles, screw the caps tightly andautoclave at 121 °C ± 1 °C for 15 min. Allow the autoclave to cool without releasing the pressure. Store coldbut not freezing.

A.3.4.5 Dry two glass petri-dishes to constant mass. Into each of these dishes, pipette 25 mL of sterilizedyeast suspension and dry to constant mass at 100 °C. Calculate the average solids content of thesuspension.

A.3.4.6 Before use, pipette 25 mL of the sterilized yeast suspension into a beaker. Determine the pHusing a glass electrode, and determine the volume of 40 g/L sodium hydroxide solution needed to adjust thepH to 7.0 ± 0.1.

A.3.4.7 Immediately before use, add to each bottle of sterilized yeast suspension a volume of sterile hardwater and a volume of 40 g/L sodium hydroxide calculated to adjust the concentration of dry yeast to 5 %(m/v) and the pH to 7.0 ± 0.1. Discard prepared yeast, two weeks after preparation.


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A.3.5 Ringers solution, 25 % (v/v)

Dissolve 9.00 g of sodium chloride, 0.42 g of potassium chloride, 0.24 g of anhydrous calcium chloride and0.20 g of sodium bicarbonate in water and dilute to 1 000 mL. Add one volume of this solution to threevolumes of water to give a 25 % solution. Dispense into test tubes fitted with suitable closures and sterilizedby auto-claving at 121 °C ± 1 °C for 15 min.

A.4 Selection of the most resistant organism by the minimum inhibitory concentration test

A.4.1 The following organisms shall be used for the test:

a) Pseudomonas aeruginosa (NCTC 6749 or equivalent);

b) Proteus vulgaris (NCTC 4635 or equivalent); and

c) Staphyloccus aureus (NCTC 4163 or equivalent).

These organisms may be obtained as freeze dried cultures. Once sub-cultured, the organisms shall bemaintained on agar slopes of suitable nutrient medium at 4 °C ± 1 °C.

A.4.2 Subculture each organism daily into a universal bottle containing 6 mL of growth medium (see A.3.1)and incubate for 24 h ± 2 h at 37 °C ± 1 °C.

A.4.3 Dilute one part of freshly grown sub-culture of each organism, which is at least a fifth sub-culture andnot more than a fourteenth, with ten parts of the growth medium (see A.3.1) before dilution, the P. aeruginosa,culture shall be filtered using a Whatman No.4 filter paper.

A.4.4 Prepared three sets of ten, doubling dilutions of the sanitizer in universal containers (A.2.5). For thispurpose dilute the neat sanitizer in the growth medium (see A.3.1) or the recovery medium (A.3.2) to give afinal volume of 5 mL of the diluted sanitizer for each dilution.

A.4.5 Inoculate each dilution in one set with 0.02 mL of a diluted culture of one organism (see A.4.3).

A.4.6 Incubate all the three sets of inoculate dilutions at 37 °C ± 1 °C for 72 h, and examine to determinethe organism most resistant to the sanitizer, that is the organism for which the minimum inhibitoryconcentration is highest.

A.5 Preparation of inoculum

A.5.1 Daily sub-cultures of the test organism selected as in A.4.6 shall be grown in 6 mL quantities of thegrowth medium (A.3.1) and incubated at 37 °C ± 1 °C for 24 h ± 2 h.

A.5.2 The day before the test, inoculate 10 mL of the growth medium (A.3.1) with the test organism from adaily sub-culture and not more than a fourteenth. Incubate the inoculated, broth at 37 °C ± 1 °C for 24 h ± 2 h.

A.5.3 Add 6 mL of the test organism culture (A.5.1) and (A.5.2) to 4 mL of the yeast suspension (A.3.4) thusmaking a final concentration of 2 % (m/v) of yeast in the yeast/organism suspension. If a culture of P.aeruginosa is used, it shall be filtered using a Whatman No.4 filter paper before addition.

A.5.4 Shake the yeast/organism suspension for one minute with a few sterile glass beads. Immediatelybefore the test, count the number of viable organisms in the inoculum by decimal dilutions in 25 % Ringerssolution (see A.3.5) and by the drop plate method. The viable count shall be not less than 10 8 organisms/mLor more than 1010 organisms/mL or the test results are considered invalid.

6 © EAC 2013 – All rights reserved

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A.6 Preparation of the sanitizer dilutions

Prepare three dilutions of the sanitizer in hard water (A.3.3) based on the recommended ‘use dilution’ of thesanitizer, as follows:

• A = 0.5 times the recommended ‘use-dilution’;

• B = 1.0 times the recommended ‘use-dilution’; and

• C = 1.5 times the recommended ‘use-dilution’.

The sanitizer dilutions shall be prepared and tested on the same day.

A.7 Test procedure

A.7.1 The test shall be carried out at 27 °C ± 1 °C.

A.7.2 Dispense 3 mL of each dilution of sanitizer (A6) into separate universal bottles labelled A, B, and C,then allow to equilibrate to 27 °C ± 1°C.

A.7.3 Add 1 mL of the inoculum to A, B and C at 0, 1 and 5 min respectively and mix by swirling gently.

A.7.4 Eight minutes after the addition of the inoculum, remove a sample of the inoculum/sanitizer mixtureand put 0.02 mL into each of the first group of five tubes of recovery broths. Return the remainder of themixture in the pipette to the universal container.

A.7.5 Ten minutes after the first addition of the inoculum, add another 1 mL of the inoculum to each of thesanitizer dilutions and mix by swirling gently

A.7.6 After 8 min, remove a sample of the mixture as put before (A.7.4) and put 0.02 mL into each of thesecond group of five tubes of recovery broths.

A.7.7 Twenty minutes after the first addition of the inoculum, add a further 1 mL of inoculum to each of thesanitizer dilutions and mix by swirling gently.

A.7.8 After 8 min, remove a sample of the mixture as before and place 0.02 mL into each of the third groupof five tubes of recovery broths.

A.7.9 Swirl the recovery broths and incubate at 37 °C ± 1 °C for 48 h ± 2 h. Examine the growth and recordthe results.

A.8 Interpretation of results

A.8.1 The instant hand sanitizer, shall be regarded as having passed the test at the recommended ‘usedilution’ if there is no growth in at least two of the five recovery broths for the first and second additions of theinoculum.

A.8.2 To be acceptable, an instant hand sanitizer shall pass the test on three separate occasions usingfreshly prepared sanitizer and freshly prepared inoculum on each occasion.


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KENYA BUREAU OF STANDARDS (KEBS)

KEBS CERTIFICATION MARKS

1. Product Certification Marks

Diamond Mark of Quality

SYMBOL FOR PRODUCT QUALITY EXCELLENCE

Standardization Mark

SYMBOL FOR PRODUCT QUALITY

2. Systems Certification Marks

ISO 9001 REGISTERED FIRM

QUALITY MANAGEMENT SYSTEM


FOOD & SAFETY MANAGEMENT SYSTEM


ENVIRONMENTAL MANAGEMENT SYSTEM

KEBS is mandated to provide Standardization,

Metrology and Conformity Assessment Services

through:• Promotion of standardization in commerce and industry

• Provision of testing and calibration facilities

• Control of the use of standardization marks

• Undertaking educational work in standardization

• Facilitation of the implementation and practical application of standards

• Maintenance and dissemination of the International System of Units (SI) of measurements

KEBS offers the following services:• Standards development and harmonization

• Testing services

• Measurement services (Calibration)

• Enforcement of standards

• Product inspection services

• Education and Training in Standardization, Metrology and Conformity Assessment

• Product and Management Systems Certification Services

For further Information please contact

The Managing Director

Kenya Bureau of Standards

Popo Road, Off Mombasa Road

P.O. Box 54974 - 00200

NAIROBI, KENYA

Import Standardization Mark

SYMBOL FOR PRODUCT QUALITY

KEBS Standardization Mark (S-Mark) is issued

for use on products that comply with the minimum

quality requirements prescribed in Kenya

standards. It uses standards as a benchmark for

quality compliance and aims at giving

manufacturers improved market access and also

giving consumers an assurance of quality for the

products bearing the mark.

OCCUPATIONAL HEALTH AND SAFETY

OHSAS 18001

INFORMATION ON STANDARDS

Standards are documents that provide a common reference point for the assess-

ment of the quality of goods and services. Standards facilitate tranparency in the

exchange of products and enhance market access of Kenyan products into local,

regional and international markets.

Information on standards and related documents is available at the KEBS stan-

dards information centre.

KEBS houses the WTO-TBT National Enquiry Point (NEP) which disseminates

notification likely to affect international trade to the industry.

KEBS also provides technical advice on installation and improvement of quality

goods and services to the industry so as to facilitate efficient implementation of

standards. Some of the advantages of standards include: enhancement of quality

assurance, safety and environmental protection measures, minimization of wast-

age, reduction of costs and unecessary varieties and promotion of interchange-

ability and increased productivity in industry.

Tel.: +254 (0) 20 6948000

Fax: +254 (0) 20 604031

E-Mail: [email protected]

E-Mail: [email protected]

Website: http://www.kebs.org

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KS EAS 789 2013 - Kenya Bureau of Standards · EAS 789: 2013 Foreword Development of the East...

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