ASTM D5196-2006 Standard Guide for Bio-Applications Grade Water《应用生物学级水的标准指南》.pdf

1、Designation: D 5196 06Standard Guide forBio-Applications Grade Water1This standard is issued under the fixed designation D 5196; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses ind

2、icates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide is intended to describe the chemical andbiological characteristics of water to be used whenever criticalpurity is essential to the use intended in l

3、aboratory Bio-Applications, for example, clinical, pharmaceutical, and bio-medical. The importance of such a reagent is often underesti-mated despite the impact that it can have.1.2 This guide is not intended to be used as a reference inpreparing water for injectables. Generally, the appropriate use

4、of this guide may include experiments involving tissue culture,chromatography, mass spectrometry, Polymerase Chain Reac-tion (PCR), DeoxyriboNucleic Acid (DNA) sequencing, DNAhybridization, electrophoresis, molecular biology or analyseswhere molecular concentrations of impurities may be impor-tant.1

5、.3 For all the other applications linked to anASTM methodand not bio-sensitive that require purified water, it is recom-mended that Specification D 1193 or Test Method D 5127 beconsulted.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is t

6、heresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 1125 Test Methods for Electrical Conductivity and Re-sistivity of WaterD 1129 Termi

7、nology Relating to WaterD 1193 Specification for Reagent WaterD 4453 Practice for Handling of Ultra-Pure Water SamplesD 5127 Guide for Ultra Pure Water Used in the Electronicsand Semiconductor IndustryD 5173 Test Method for On-Line Monitoring of CarbonCompounds in Water by Chemical Oxidation, by UV

8、LightOxidation, by Both, or by High Temperature CombustionFollowed by Gas Phase NDIR or by Electrolytic Conduc-tivityD 5245 Practice for Cleaning Laboratory Glassware, Plas-ticware, and Equipment Used in Microbiological AnalysesD 5391 Test Method for Electrical Conductivity and Resis-tivity of a Flo

9、wing High Purity Water SampleD 5542 Test Methods for TraceAnions in High Purity Waterby Ion ChromatographyD 5673 Test Method for Elements in Water by InductivelyCoupled PlasmaMass SpectrometryD 5996 Test Method for Measuring Anionic Contaminantsin High-Purity Water by On-Line Ion ChromatographyF 109

10、4 Test Methods for Microbiological Monitoring ofWater Used for Processing Electron and MicroelectronicDevices by Direct Pressure Tap Sampling Valve and by thePresterilized Plastic Bag Method3. Terminology3.1 DefinitionsFor definitions of terms used in this guide,refer to Terminology D 1129.3.2 Defin

11、itions of Terms Specific to This Standard:3.2.1 endotoxinssubstances or by-products usually pro-duced by gram negative micro-organisms that give a positivetest for endotoxin in accordance with 13.2.3.2.2 heterotrophic bacterial counts/100 mLtotal numberof viable micro-organisms present in the 100-mL

12、 sample,excluding anaerobic and microaerophilic bacteria.1This guide is under the jurisdiction of ASTM Committee D19 on Water and isthe direct responsibility of Subcommittee D19.02 on General Specifications,Technical Resources, and Statistical Methods.Current edition approved April 1, 2006. Publishe

13、d April 2006. Originallyapproved in 1991. Last previous edition approved in 1999 as D 5196 91 (1999).2For referenced ASTM standards, 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 D

14、ocument Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.2.3 total organic carboncarbon in the form of organiccompounds.3.2.4 waterwater complying with compositions given inTable 1.4. Significance and

15、 Use4.1 The purity of water is relative and is usually character-ized by the limits of impurities found in the water as well as bythe methods used to prepare and handle the water. Section 7mentions the suitable methods for water preparation.5. Composition5.1 Water for Bio-Applications should be prep

16、ared (usingwater purification technologies) starting from water complyingwith the U.S. Environmental Protection Agency (EPA) Na-tional Primary Drinking Water Regulations, or from compa-rable regulations from the European Union or Japan. The use ofsuch a minimum standard quality for feed water is imp

17、ortant todecrease the risk of producing and using final purified waterthat would be compliant with the compositions given in Table1 but could contain certain specific contaminants in concen-trations that could affect the applications.5.2 Recommendations for purity of water should conform tothe prope

18、rties and chemical limits given in Table 1; however,the suggested maximum limits and the actual impuritiesconsidered, or both, may be modified by the user based uponthe intended use of the water.5.3 Although these water types and associated grades havebeen defined specifically for use with ASTM Stan

19、dards, theymay be appropriate for other applications. It is the responsi-bility of the users of this standard to ensure that the selectedwater types or grades are suitable for their intended use.6. Reagents6.1 Purity of WaterUnless otherwise indicated, referencesto water shall be understood to mean

20、water types as defined inthis guide.7. Summary of Preparation Methods7.1 The method of preparation used for the water must bedesigned to remove organic, inorganic, volatile, biologicalimpurities and particulates to provide water that meets theconcentration limits in Table 1. These are suggested limi

21、ts,since the actual maximum levels for the individual impuritieswill depend on the end use for which the water is required.More restrictive limits than those suggested in Table 1 may berequired by mutual consent of the parties concerned, provideda suitable test method is agreed upon.7.2 The Bio-Appl

22、ications grade water needs to be preparedfrom tap water complying with U.S. EPA National PrimaryDrinking Water regulations or comparable regulations of theEuropean Union or Japan.7.3 The purification of tap water shall be accomplished by asingle technology or a combination of suitable purificationte

23、chnologies such as distillation, deionization, electrodeioniza-tion, carbon adsorption, reverse osmosis, ultrafiltration, nano-filtration, UV photo-oxidation, and/or screen membrane filtra-tion, to meet the compositions given in Table 1.7.4 The water purification systems containing these tech-nologi

24、es should be constructed from materials shown tocontribute to low contamination to the final product water.7.5 Because quality assurance is key to ensure safety,efficiency and reliability, validation of the water purificationinstallation is highly recommended (see Section 14).8. Monitoring and Trend

25、s8.1 The monitoring of different parameters should be per-formed at a frequency defined by the user to ensure with a highdegree of confidence that the water quality used is alwayscompliant with the specifications and the purpose.8.2 Regular calibration and maintenance of the measuringinstruments is

26、the best way to ensure, with a high level ofconfidence, the validity of the values obtained to determine thecompliance with the specifications of the water used. Trendingparameters is the main reliable source of information to definemaintenance schedule and to anticipate failures.8.3 Inorganic Analy

27、tesResistivity is the most widely usedparameter to monitor the overall ionic purity. According totheir mobility, each ionic species will have a different effect onthe resistivity. The limit of Table 1 apply to the water sampledat the point of use or, when for practical reasons and/or to avoidcontami

28、nation (for example connection of an equipment after a0.2 m filter), as close as possible to the point of use and witha regular verification of a low impact of the purification stepsand/or equipment placed downstream of the monitoring sam-pling point. If in-line measurements are not possible thenana

29、lyses of the water produced should be conducted todetermine that the total ionic concentration of all the analytesdescribed in Table 2 does not exceed the compositions given inTable 1 (# 1 g/L total). Table 2 lists common cations andanions that have an impact on the resistivity value and mayhave an

30、impact on some Bio-Applications. The user should addany other ionic contaminants (not already indicated) to this listif the application being performed may be sensitive to thoseions.8.4 Heterotrophic Bacterial CountThe maximum concen-trations proposed in Table 1 is given for determination by aplate-

31、count method. If this method is selected, Test MethodF 1094 can be used as a reference. Such determination can beperformed at a periodicity that will be defined by the user. Onlyviable bacteria that are able to grow on the media selected willbe counted. If frequent verification with rapid results ar

32、enecessary, an epifluorescence method can also be used. In thisTABLE 1Analytes Maximum ConcentrationTotal Inorganic Analytes 1 g/L or resistivity of 18.2 Mohm.cm 25C. See Note 1Total Organic Carbon (TOC on-linemeasurement)20 ppbHeterotrophic bacterial counts 100 cfu/100 mLEndotoxins (Endotoxin Unit)

33、A0.01 EU/mLNucleasesBSee Note 2ProteasesCSee Note 2AIf application sensitive to endotoxins. Commercial kits and methods areavailable for such purpose.BIf applications are linked to DNA and/or RNA work.CIf applications involved proteins.D5196062case, viable and non-viable bacteria can be counted. The

34、reforethe maximum concentrations given in Table 1 should beadapted accordingly.8.5 NucleasesDetermination of nucleases should be per-formed when RNA and/or DNA are used in the applications.8.6 ProteasesDetermination of the proteases should beperformed when proteins are involved in the applications.9

35、. Sampling9.1 Samplings for the test methods specified in Section 13but also for the water that will be used for the Bio-Applicationsassume that great care and skill will be employed in obtainingthe water samples to be tested or used. It is assumed that theoperators will prevent container and airbor

36、ne contamination tothe best of their ability, making note of possible sources ofcontamination due to the sampling procedure. It is recom-mended that the samples be handled in accordance withPractice D 4453.9.2 Extreme care must be exercised in handling sampleswhen making analyses. Depending on the a

37、nalyte to beanalyzed, experimental laboratory-ware should be selected.PFA or TFE fluorocarbon (except for fluoride analysis) orHDPE laboratory-ware should be used for ion analysis andhigh purity glass containers should be preferred for organicmolecules analysis (TOC, volatile chlorinated hydrocarbon

38、,phthalates, and so forth). Several samplings should be per-formed according to the nature of the analyte.9.2.1 Storage of the sample may be required for the detec-tion of metals, in which case 1 mL of re-distilled HNO3(1:99)should be added per litre to reduce the pH and to preservesolubility of the

39、 metals within the sample.9.2.2 The water sample should remain in storage a minimalperiod of time since some analytes have a tendency to adhereto the container surface and others may leach from thecontainer.9.2.3 Practice D 5245 should be used as a guide to clean theglassware or plasticware before m

40、icrobiological analyses.9.2.4 When endotoxin monitoring or nuclease measure-ments are required, special endotoxin-free and/or nuclease-freeglassware is advised.10. Recommendations for Purity10.1 Recommendations for purity of water should conformto the properties and chemical limits given in Table 1;

41、 howeverthe suggested maximum limits and the actual impuritiesconsidered, or both, may be modified by the user based uponthe intended use of the water.10.2 The precision of detection will depend on the purity ofthe reagents used, equipment employed, experience of thelaboratory personnel, the samplin

42、g technique, and cleanlinessof the working area.11. Summary of Method of Storage11.1 Storage of the final purified water should be avoided orlimited to as short a time as possible. Final purified watershould be protected from any external contamination, as wellas contamination from the storage conta

43、iner used.12. Maintenance and Calibration12.1 Periodic preventive maintenance should be performedto ensure the long-term performance and reliability of the waterpurification system. Follow-up trends in the quality and per-formance parameters should be observed regularly to checkany variations in per

44、formance of the installation and to be ableto anticipate any failures.12.2 Periodic calibration of the different measuring instru-ments should be performed to ensure the validity of the valuesobtained. Due to the difficulties in calibrating conductivitymeters used for low conductivity ranges ( Bacte

45、rial Endotoxins TestMethod.313.3 Heterotropic Bacterial CountTest Method F 1094.13.4 Electrical ResistivityTest Method D 1125 and TestMethod D 5391.13.5 Total Inorganic AnalytesTest Methods D 5391,D 5542, D 5673 and D 5996. See Note 3.NOTE 1The resistivity value corresponds to the theoretical value

46、ofthe water exempt of ions. As for a real, practical measurement, amaximum tolerance of 6 1 Mohm.cm should be accepted to take intoaccount the accuracy of the measurement device used.NOTE 2If Nucleases and/or Proteases are of concerns for the appli-cations, a purification technology that removes suc

47、h contaminants shouldbe used in the purification process (such as ultrafiltration or distillation).Such purification step should be located as close as possible to the pointof use, avoiding recontamination of the water by downstream purificationstages.NOTE 3There is no current ASTM Standard Method f

48、or the determi-nation of all the anions and cations listed in Table 2 at the limits required3Published in the U.S. Pharmacopeia twenty-seventh revision by The U.S.Pharmacopeial Convention, Inc.TABLE 2 Ionic Suggested Contaminant ListCations AnionsAluminium ChlorideAmmonium NitrateArsenic PhosphateCa

49、dmium SulfateCalcium FluorideChromiumCobaltCopperIronLeadMagnesiumNickelPotassiumSodiumTitaniumZincD5196063by this guide. However ICP/MS and ion chromatography methods areavailable to measure such elements at these levels. Manufacturersconsultation can be helpful.14. Validation14.1 Because quality assurance is the key to ensure safety,efficiency and reliability, validation is becoming increasinglyimportant. The validation process can be divided into 4 majorqualification steps:14.2 Design Qualification (DQ)The Design Qualificationis carried out before the sel