SANS 433-2008 Barrier creams《防护霜》.pdf

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 978-0-626-21398-5 SANS 433:2008Edition 2SOUTH AFRICAN NATIONAL STANDARD Barrier creams Published by Standards South Africa 1 dr lategan road groenkl

4、oof private bag x191 pretoria 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 433:2008 Edition 2 Table of changes Change No. Date Scope Foreword This South African standard was approved by National Committee StanSA SC 5140.01G, Deterge

5、nts, polishes and other chemicals Degreasers, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. This document was published in April 2008. This document supersedes SABS 433:1953 (edition 1). SANS 433:2008 Edition 2 1 Contents Page Foreword

6、1 Scope 3 2 Normative references . 3 3 Chemical and physical requirements . 3 4 Sampling and compliance with the standard . 4 5 Physical tests and chemical analysis . 5 5.1 Stability 5 5.2 Application . 5 5.3 pH value 5 5.4 Penetrability to challenging solutions 5 5.5 Washability test . 7 6 Fungal a

7、nd bacterial growth . 8 7 Packaging and labelling. 9 SANS 433:2008 Edition 2 2 This page is intentionally left blank. SANS 433:2008 Edition 2 3 Barrier creams 1 Scope This standard specifies requirements for barrier creams suitable for protection of the skin against acids, alkalis1), oils and solven

8、ts. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. Information on current

9、ly valid national and international standards can be obtained from Standards South Africa. British Pharmacopoeia (BP), 2007. 3 Chemical and physical requirements 3.1 General 3.1.1 All types of barrier creams shall be homogeneous and soft in texture, free from grit and substances known to be harmful

10、to the skin during long exposure. 3.1.2 All types of barrier creams shall be readily removable from the skin using detergent and water. 3.2 Odour Barrier creams complying with the requirements of this standard shall be free from objectionable odour during and after application to the skin. 3.3 Stabi

11、lity The barrier cream shall show no separation of liquid from the cream at 15 C and 30 C after standing for 48 h in accordance with 6.1. 3.4 Application When applied to the skin in accordance with 5.2, the barrier cream shall form a flexible adhering film at temperatures of 15 C to 30 C. 1)Suitable

12、 protective clothing should be used for protection against concentrated acids and alkalis. SANS 433:2008 Edition 2 4 3.5 pH value When determined in accordance with 5.3, the pH value of a water extract of the barrier cream shall be not less than 5,0 and not more than 8,5. 3.6 Penetrability to challe

13、nging solutions When tested in accordance with 5.4, the resistance of the barrier cream to the challenging solution mentioned on the container shall last for not less than 10 min at 30 C and 50 % relative humidity. 3.7 Washability When tested in accordance with 5.5, the barrier cream shall leave no

14、stains on a cotton duck. 3.8 Occurence of fungal and bacterial growth When tested in accordance with clause 6, the barrier cream shall show no fungal or bacterial growth. 4 Sampling and compliance with the standard 4.1 Sampling 4.1.1 General When no information concerning the implementation of quali

15、ty control or testing during manufacture is available, the following sampling procedure shall be applied to determine whether a lot submitted for inspection and testing complies with the requirements of the standard. The samples so taken shall be deemed to represent the lot for the respective proper

16、ties. The sampling procedure shall also be used for adjudication in cases of dispute. 4.1.2 Sampling from consignment Take the number of containers as stipulated in table 1. Table 1 Sampling requirements 1 2 Number of containers in consignment Number of containers to be taken 1 10 All 10 10 4.1.3 Sa

17、mpling for testing Take samples weighing not less than 250 g from original, unopened containers. These samples shall be taken as representative of the consignment. 4.2 Compliance with standard If the samples taken in accordance with 4.1 meet the requirements, the consignment represented by the sampl

18、e, shall be deemed to comply with this standard. SANS 433:2008 Edition 2 5 5 Physical tests and chemical analysis 5.1 Stability Maintain an original unopened container of barrier cream at 15 C for 48 h. Examine and note whether any liquid has separated from the paste. Repeat this procedure, except t

19、hat the barrier cream shall be maintained at a temperature of 30 C for 48 h. 5.2 Application Apply the barrier cream to the skin with the fingers at a temperature of 15 C to 30 C and 50 % relative humidity. Note smoothness, ease of spreading, continuity of the film and stickiness. 5.3 pH value 5.3.1

20、 Apparatus a) pH glass electrode. b) pH potentiometer. c) Heat-resistant glass beakers with a capacity of 200 mL. 5.3.2 Procedure Dissolve approximately 5 g of barrier cream in 50 mL of freshly boiled distilled water. Bring the water and barrier cream to boiling point and stir. Cool the extract to r

21、oom temperature and measure the pH of the solution with a glass electrode. 5.3.3 Reporting Report the pH value of the barrier cream to the first decimal place. 5.4 Penetrability to challenging solutions 5.4.1 Apparatus a) Confined spot test paper. A medium filter paper at the centre of which is set

22、off or “confined“ a circular area of 1 cm2by means of a ring of paraffin wax with which the paper is impregnated. To impregnate the filter paper use the following method: Immerse tissue paper in molten paraffin wax for a few seconds and allow the tissue paper to dry in a current of air or in front o

23、f an open window. Lay the tissue paper over a medium filter paper. Heat a circular steel disc 65 mm in diameter, 20 mm thick, and machined to a smooth flat finish with a 10 mm hole drilled in the centre of the machined surface on a hot-plate to about 90 C and press on the waxed tissue paper for a fe

24、w seconds. The wax in the tissue paper is impregnated in the filter paper leaving a 10 mm circular area in the centre. Cut the un-impregnated portion of the filter paper off so as to obtain a circular confined spot test paper of 65 mm diameter. Press the spot test papers in a laboratory press at 22

25、kN. b) A brass shim. A brass shim 65 mm in diameter and 50 m thick, with a 20 mm square cut from the centre of the shim. Press the shim in a laboratory press at 22 kN. SANS 433:2008 Edition 2 6 c) A Payne permeability cup, A Payne permeability cup or any other suitable cup which will prevent the eva

26、poration of a volatile solvent, and has a capacity of approximately 14 mL, a depth of 16 mm, an inside diameter of 38 mm, and a suitable device for securing the confined spot test papers over the cup. The securing device is necessary to prevent the challenging solution from leaking out of the cup wh

27、en the cup is turned upside down. d) A glass panel. A glass panel to support the paper disc for the duration of the test. e) A mirror. A mirror to observe the bottoms of the paper discs on the glass panel. f) Tripods. Two tripods for supporting the glass panel. g) A laboratory press. A laboratory pr

28、ess capable of exerting a total load of 22 kN. 5.4.2 Reagents a) Hydrochloric acid. 0,2N. b) Sodium hydroxide solution. 0,2N. c) Light liquid paraffin. Light liquid paraffin complying with the requirements of BP 2007. d) Carbon tetrachloride. (c.p). e) Sudan III red dye. Oil soluble. f) Phenolphthal

29、ein indicator. A 0,1 % solution. g) Bromophenol blue solution. Triturate 1 g of the indicator in a clean glass mortar with 7,5 mL of 0,2N sodium hydroxide solution and dilute with water to 1 L. 5.4.3 Procedure 5.4.3.1 General Place approximately 0,5 g of the cream on the centre of a confined spot te

30、st paper. Place the brass shim on top of the paper and around the cream, and put another circle of confined spot test paper on top of this. Carefully centre the confined spots on the confined area of the bottom sheet. Place the whole assembly in the laboratory press between two 102 mm square brass p

31、lates, approximately 5 mm thick, and subject it to a pressure of 22 kN. In this manner the maximum thickness of the barrier cream film becomes that of the shim metal standard. Place the cream “sandwich“on the glass panel and leave overnight. Observe the bottom of the test assembly by means of the mi

32、rror. All tests shall be performed at 30 C 1 C and 50 % 2 % relative humidity. 5.4.3.2 Penetrability to alkali Impregnate the confined area of the lower paper with the phenolphthalein indicator before the test is performed, and allow it to dry properly. Place 0,2 mL of the 0,2N sodium hydroxide solu

33、tion on the confined area of the upper test paper, after the assembly has been completed. Examine the bottom test paper for any red stains after the test assembly was left for 10 min at 30 C 1 C and a relative humidity of 50 % 2 %. SANS 433:2008 Edition 2 7 5.4.3.3 Penetrability to acid Impregnate t

34、he confined area of the lower paper with the bromophenol blue solution and use 0,2 mL of 0,2N hydrochloric acid as the challenging solution. Perform the test in accordance with 5.4.3.1 and 5.4.3.2. 5.4.3.4 Penetrability to oil Dissolve 0.5 g of Sudan III red in the light liquid paraffin and use this

35、 solution as the challenging solution. 5.4.3.5 Penetrability to chlorinated solvents Dissolve 0.5 g of Sudan III red in carbon tetrachloride and use this solution as the challenging solution. Proceed in accordance with 5.4.3.1 but use the Payne permeability cup for the penetrability test. Pour 10 mL

36、 of the red coloured carbon tetrachloride into the Payne permeability cup. Place the test paper assembly on the cup and secure it with the washer and clamps to the cup. Turn the cup upside down on the glass plate and observe the bottom paper in the mirror. 5.4.3.6 Penetrability to other liquids Use

37、the liquid mentioned on the container and proceed in accordance with 5.4.3.1 and 5.4.3.4 or 5.4.3.5 depending upon the volatility of the liquid. 5.4.4 Reporting Report whether or not the barrier cream is resistant to penetration by the challenging solution. 5.5 Washability test 5.5.1 Materials a) Ho

38、t water, of temperature approximately 50 C. b) Milled toilet soap. c) White cotton duck. 5.5.2 Procedure a) Take a square piece of cotton duck and place approximately 1 g of barrier cream in the centre of the cloth. Rub the cream into the cloth covering an area of approximately 50 mm diameter. Leave

39、 the cloth to dry overnight. b) Wash the impregnated cloth with soap and hot water. Scrubbing, wringing or any other conventional method of cleaning is allowed. Rinse the square of cotton thoroughly and compare the square of cotton with a similar untreated, washed square of cotton duck. 5.5.3 Report

40、ing Report whether or not the barrier cream leaves a stain on the cotton duck. SANS 433:2008 Edition 2 8 6 Fungal and bacterial growth 6.1 Test fungus cultures 6.1.1 Sporotrichum Buermanni SABS TCC 352 of the culture collection of the South African Bureau of Standards. 6.1.2 Candida albicans SABS TC

41、C 354 of the culture collection of the South African Bureau of Standards. 6.2 Preparation of cultures Prepare cultures of the test fungi by transferring small portions of the mycelium to freshly prepared glucose-nutrient agar slopes. Store the newly inoculated slopes at a temperature of 30 C + 1 C f

42、or 7 d. Observe the aseptic precautions practised in bacteriological technique. 6.3 Examination of cultures After 7 d the cultures should have spread over a large part of the slope and should show characteristic growth. Discard all culture tubes on which no characteristic growth of the test fungi ha

43、s occurred. 6.4 Preparation of the barrier cream for test Prepare plates of nutrient agar so that each plate contains 20 mL of agar. After the agar has cooled and set, heap about 5 g of barrier cream on top of the agar by means of a sterile spatula. Prepare a sufficient number of plates so that at l

44、east six plates are available for each sample of barrier cream. Not more than one sample of each cream shall be placed on each plate. 6.5 Procedure 6.5.1 Inoculation of the barrier cream Place by means of a sterile needle, a small portion of the mycelium of one of the test fungi directly on top of t

45、he barrier cream. Care shall be taken that no agar shall adhere to the inoculum. Incubate at least three samples of the barrier cream with each of the test fungi. 6.5.2 Incubation Incubate the inoculated plates at a temperature of 30 C 1 C for 7 d. Examine the plates. 6.5.3 Examination of plates Exa

46、mine the barrier creams for fresh growth of the test fungi immediately after incubation. No fresh growth shall be present. The agar immediately around the barrier cream shall also be free from bacterial growth. SANS 433:2008 Edition 2 9 7 Packaging and labelling 7.1 Packaging The barrier cream shall

47、 be packed in a container or dispenser which shall prevent the cream from drying, and no interaction shall occur between the container and its contents. 7.2 Labelling Each container shall be clearly and legibly marked with the following information: a) the words “Barrier Cream“; b) the types of subs

48、tances against which the barrier cream offers protection; c) the name or trade mark of the manufacturer or distributor, or both; d) the net mass of the contents; e) the methods of application and removal of the cream. (Mention should be made of whether hot or cold water is necessary for cleaning.) Standards South Africa