ASTM F1094-1987(2012) Standard Test Methods for Microbiological Monitoring of Water Used for Processing Electron and Microelectronic Devices by Direct Pressure Tap Sampling Valve a.pdf

1、Designation: F1094 87 (Reapproved 2012)Standard Test Methods forMicrobiological Monitoring of Water Used for ProcessingElectron and Microelectronic Devices by Direct PressureTap Sampling Valve and by the Presterilized Plastic BagMethod1This standard is issued under the fixed designation F1094; the n

2、umber immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Sco

3、pe1.1 These test methods cover sampling and analysis of highpurity water from water purification systems and water trans-mission systems by the direct sampling tap and filtration of thesample collected in the bag. These test methods cover both thesampling of water lines and the subsequent microbiolo

4、gicalanalysis of the sample by the culture technique. The microor-ganisms recovered from the water samples and counted on thefilters include both aerobes and facultative anaerobes.1.2 Three methods are described as follows:SectionsTest Method ASample TapDirect Filtration 6 to 8Test Method BPresteril

5、ized Plastic Bag Technique 9 to 12Test Method B2 Dip Strip Technique2/Presterilized PlasticBag1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health pra

6、ctices and determine the applica-bility of regulatory limitations prior to use2.2. Referenced Documents2.1 ASTM Standards:3D1129 Terminology Relating to WaterD1193 Specification for Reagent WaterF60 Test Method for Detection and Enumeration of Micro-biological Contaminants in Water Used for Processi

7、ngElectron and Microelectronic Devices (Withdrawn 1991)4F488 Test Method for On-Site Screening of HeterotrophicBacteria in Water (Withdrawn 2005)43. Terminology3.1 Definitions:3.1.1 total bacteria countnumber of viable heterotrophicbacteria capable of growing under test conditions specified.3.1.1.1

8、DiscussionTotal bacteria count is the general termfor heterotrophic plate count, now commonly used. Hetero-trophic bacteria are those microorganisms that cannot use CO2for food. They require more complex organic compounds foruse as growth nutrients. The majority of bacteria fall into thismajor group

9、ing.3.1.2 For definition of other terms used in this test method,refer to Terminology D1129.3.2 Definitions of Terms Specific to This Standard:3.2.1 presterilized plastic baga commercial presterilizedplastic bag of 200-mL capacity (or as appropriate to largersample sizes) to hold sample water. The b

10、ag should haveintegral fold over tabs to allow for resealing.3.2.2 bacteriological monitora commercial presterilizedplastic filter holder containing a 0.45-m membrane filter. (Noother filter pore size should be used.)NOTE 1If a larger pore size filter is used, organisms may pass throughthe filter; a

11、 smaller pore size filter does not wick up sufficient growthmedia, hence the level of recovery will be less than that of the 0.45-mfilter.3.2.3 total count testera paddle shaped plastic filter as-sembly containing a 0.45-m membrane filter and dehydratednutrient pad.4. Summary of Test Method4.1 Test

12、Method ASample TapDirect FiltrationAsam-pling valve as or similar to that shown in Fig. 1 is installed in1These test methods are under the jurisdiction of ASTM Committee F01 onElectronics and are the direct responsibility of Subcommittee F01.10 on Contami-nation Control.Current edition approved July

13、 1, 2012. Published August 2012. Originallyapproved in 1987. Last previous edition approved in 2005 as F109487(2005). DOI:10.1520/F1094-87R12.2The dip strip (Total Count Tester or SPC Sampler) method is permissible forwaters containing 10 microorganisms per millilitre.3For referenced ASTM standards,

14、 visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4The last approved version of this historical standard is referenced onwww.astm.org.Copyrigh

15、t ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1a pressurized line. The valve illustrated has a self closure anda male luer outlet fitting. This valve design minimized thechance of extraneous contamination. Any valve used forsampling should b

16、e constructed in a manner to reduce orprevent the retention of bacteria within its internal surfaces,and should be easily sanitized. The bacterial monitor isconnected to either the luer outlet of the illustrated samplingvalve, or in a suitable manner to an equivalent valve. The watersample is passed

17、 directly through the monitor, and the effluentvolume is measured after this filtration. Test Methods F60 arethen employed for bacteriological examination of the sample.4.2 Test Method BPresterilized Plastic BagThe sam-pling valve is installed as in Test Method A, then flushed cleanprior to taking t

18、he samples.The water sample is directly flowedinto a presterilized, precalibrated plastic disposable bag. Aftersampling, the plastic bag is sealed and stored briefly prior tobacteriological analysis of the sample. The sample may bestored at room temperature if analyzed within 2 h, otherwise, itshoul

19、d be stored from 4 to to 10C and analyzed within 6 h.4.2.1 Sample analysis is conducted by either Test MethodsF60 or Test Method F488 for bacterial content of the water.5. Significance and Use5.1 These test methods provide a field technique for thebacteriological analysis of electronic process water

20、s. Thesampling of these waters and subsequent bacteriological analy-sis may be critical to electronic product yields. Bacteria can bethe prime source of harmful contamination which can signifi-cantly reduce the yield of satisfactory microelectronic deviceproduction.5.2 The test methods described her

21、e may be used both tomonitor the bacteriological quality of water used in microelec-tronic product processing, and to locate the source of bacterialcontamination in a water purification system.5.3 These test methods are simple field methods, combiningsampling and bacteriological analysis techniques

22、that do notrequire bacteriological laboratory facilities.5.4 The test methods described employ culture techniquesfor bacteriological analysis. The user should be aware that suchtechniques cannot provide a complete count of the total viablebacteria present, since clumps and clusters of bacteria willa

23、ppear as one single colony when cultured, and since someviable bacteria will not grow under the test conditions used.However, a meaningful comparative bacteria count will beachieved by this method if the culturing of the sample is alwaysdone at the same temperature, and for the same period of time.T

24、he temperature of incubation should always be at 28 6 2C,and the period of incubation should be 48 h (or 72 h if timepermits). The period of incubation and temperature should bethe same for all comparative studies.TEST METHOD ADIRECT SAMPLE TAP6. Apparatus6.1 Sampling Tap,5see Fig. 1.6.2 Bacteriolog

25、ical Monitor6with 0.45-m membrane filter.6.3 Sanitarians Kit,6consisting of metal syringe, specialtwo way valve, and stainless steel graduated cup.6.4 Forceps6with blunt stainless, unserrated tips.6.5 Incubator , capable of holding temperature within 61Cin a range from 27 to 40C.6.6 Illuminator, 15

26、to 30-W incandescent or 8 to 10-Wfluorescent are generally acceptable. If incandescent light isconcentrated through or by a magnifying lens, a lower wattagemay suffice.5The sole source of supply of valves, YY2004000, and YY20E4010 (cataloguenumber), known to the committee at this time is Millipore C

27、orp., Bedford, MA. Ifyou are aware of alternative suppliers, please provide this information to ASTMHeadquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee,1which you may attend.6The sole source of supply of these products known to the commit

28、tee at this timeis Millipore Corp., Bedford, MA. If you are aware of alternative suppliers, pleaseprovide this information to ASTM Headquarters. Your comments will receivecareful consideration at a meeting of the responsible technical committee,1whichyou may attend.FIG. 1 Sampling Valve in Wall of P

29、ressurized LineF1094 87 (Reapproved 2012)26.7 Magnifier, 5 to 15 for counting colonies. An illumina-tor hand magnifier or a stereoscopic (dissection-type) micro-scope are satisfactory.6.8 Hypodermic Needle, No. 18, 2-in. blunt nose withplastic syringe.7. Reagents and Materials7.1 Isopropyl alcohol,

30、70 to 90 %, or 3 to 6 % semi-standardor reagent grade, hydrogen peroxide solution.7.2 Nutrient media6Supplied in double-tip scored am-poule or impervious plastic ampoule of either type listed:7.2.1 Membrane heterotrophic plate count, M-HPC Formu-lation:Peptone2.0 g.Gelatin2.5 g.Glycerol1.0 mL.Water

31、(Reagent Grade IV)100 mL (see SpecificationD1193).7.2.2 Membrane tryptose extract, M-TGE Formulation:Beef Extract0.3 g.Tryptone0.5 g.Glucose0.1 g.Water (Reagent Grade IV)100 mL.8. Procedure8.1 Sampling:8.1.1 Connect sampling valve to pressurized line as shownin Fig. 1.8.1.2 With water system operati

32、ng, open valve fully, flushfor 60 s at fast flow rate, and close the valve.8.1.3 Fill syringe with blunt nose No. 18 needle with 70 to90 % isopropyl alcohol, (or 3 to 6 % semi-standard or reagentgrade, hydrogen peroxide), and insert the 2-in. needle com-pletely into the sampling valve outlet port.8.

33、1.4 Inject 5 mL of the sanitizing agent chosen into thesampling port and allow to stand for 1 min. Remove the needlefrom the outlet port, and squirt some of the agent on the outsideof the male luer connector.8.1.5 Flush the valve again for 1 min and close the valve.8.1.6 Remove inlet and outlet caps

34、 from a bacteriologicalmonitor. Place caps aside on a clean surface, and avoidcontaminating the inner surfaces. Connect the monitor to themale luer outlet of the sampling valve, as shown in Fig. 2.Avoid finger contacts of inlet and outlets of monitor.8.1.7 Open sampling valve, by turning counter-clo

35、ckwisethe knurled outlet body, and allow 100 mL (Note 2) of sampleto pass through the monitor into a volumetric container. Closethe valve.NOTE 2To compensate for the natural bacterial growth variability indifferent water samples, the size of sample tested should be chosen inrelation to the expected

36、count level of organisms for that particularsample. Therefore, a sample size of at least 100 mL or greater should becollected for “polished” high purity water containing low bacterial counts(2 to 10 organisms per millilitre). For high count waters (10 organismsper millilitre), the sample size may be

37、 as little as 1 mL.8.1.8 Remove the monitor from the outlet luer and attach thesyringe pump to the outlet side of the monitor. Draw theresidual fluid from the monitor.8.1.9 One of the two nutrient media (7.2.1 and 7.2.2) may beused for culturing the microorganisms collected in the watersample. If th

38、e M-HPC medium is chosen, the use of the plasticampoule is described in 8.1.9.1. If the M-TGE medium isselected, the use of the double tip, scored glass ampoule isdescribed in 8.1.9.2. If the latter is used, the tip of the ampouleshould be flamed prior to use. The M-HPC medium has beenfound to be th

39、e preferred nutrient for analyzing high puritywaters where, due to a lack of sufficient nutrients, organismsmay be injured and consequently their growth could beinhibited by exposure to high nutrient media.8.1.9.1 Remove the monitor from the syringe and hold itwith membrane side up. Open plastic amp

40、oule by twisting capof container. Remove and discard. Align the opening at the tipof the ampoule to the inlet (top) of the monitor. Holding theampoule in a vertical position, and pressing firmly to the inletof the monitor, squeeze the contents drop by drop into themonitor, and onto the membrane surf

41、ace. Remove the ampoule,attach a luer-slip syringe to the bottom opening of the monitorand draw medium gently through the membrane. Maintain aslight vacuum until all the medium passes through the mem-brane surface. Remove the syringe and proceed to 8.1.10.8.1.9.2 Remove the monitor from syringe and

42、hold it withthe pad side (outlet side) up. Break or crunch the sleeve-covered tip of the ampoule between the inside of the forcepsnear the forceps handle. Holding the tip of a finger over thesleeve of the ampoule, break off the scored tip, insert it into theoutlet port of the monitor, and using the

43、ampoule in a pipet-likefashion, slowly release the 0.8-mL contents into the absorbentpad. Swirl the medium around the monitor until the pad isevenly covered. Remove the ampoule.8.1.10 Replace the caps (avoiding contamination of theirinner surfaces) on the monitor and place the monitor in theincubato

44、r at 28 6 2C, grid side down.8.1.11 Incubate for 48 h at 28 6 2C.8.2 Counting Colonies:8.2.1 Colonies appear as clear white, yellow, or gray roundspots 1 to 2 mm in diameter, and are counted under low powermagnification, 5 to 10 . If there are fewer than about twocolonies per grid square, count all

45、the colonies on ten randomlychosen grid squares and multiply this count by ten to arrive attotal number of colonies per filter.8.2.2 Express results as the number of colonies per millilitreof water sample.FIG. 2 Monitor on Luer Outlet of Sampling ValveF1094 87 (Reapproved 2012)3TEST METHOD BPRESTERI

46、LIZED PLASTICBAGSAMPLING9. Apparatus9.1 Commercial plastic bag,6presterilized, with volumecalibration template and storage rack.9.2 Same apparatus as in Test Method A, 6.1 through 6.8.9.3 Alternative analysis equipment (permissible for watercontaining 10 organisms/millilitre):9.3.1 Total Count Water

47、 Tester,7with M-TGE medium, or9.3.2 SPC Samples7(see Fig. 3).10. Reagents and Materials10.1 See 7.1 through 7.2.2.11. Procedure11.1 Sampling:11.1.1 Using the volume calibration template, premark theplastic bag at 100 mL (or as appropriate) prior to sampling.11.1.2 Follow 8.1.1 through 8.1.5 from Pro

48、cedure sectionsin Test Method A.11.1.3 Open the bag by pulling the tabs and place the bagunder the sample tap. Open the valve and allow the samplewater to fill to the 100-mL mark (or to level as appropriate).Exercise care not to contaminate the inside surfaces of thepresterilized bag while sampling.

49、11.1.4 Seal the plastic bag by pulling the tabs and wrappingthe top of the bag with several turns, then bending the tabstoward the center of the bag. Place the filled bag in the storagerack.11.2 AnalysisConduct an analysis of the sample within 2h if the sample is held at room temperature, or6hifsample isheld from 4 to 10C. Use either the monitor or the water testermethod.11.2.1 Monitor Method of Analysis :11.2.1.1 Remove the plug from the upper part of thebacteriological monitor and insert the sampling tube adapter.Attach the syringe and