ASTM D5196-2006(2013) Standard Guide for Bio-Applications Grade Water《生物应用级水的标准指南》.pdf

1、Designation: D5196 06 (Reapproved 2013)Standard Guide forBio-Applications Grade Water1This standard is issued under the fixed designation D5196; 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

2、 parentheses indicates the year of last reapproval. Asuperscript epsilon () 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 us

3、e intended in laboratory 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

4、appropriate useof 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

5、be impor-tant.1.3 For all the other applications linked to anASTM methodand not bio-sensitive that require purified water, it is recom-mended that Specification D1193 or Test Method D5127 beconsulted.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its

6、 use. It is theresponsibility 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:2D1125 Test Methods for Electrical Conductivity and Resis-tivity of Water

7、D1129 Terminology Relating to WaterD1193 Specification for Reagent WaterD4453 Practice for Handling of High Purity Water SamplesD5127 Guide for Ultra-Pure Water Used in the Electronicsand Semiconductor IndustriesD5173 Test Method for On-Line Monitoring of CarbonCompounds in Water by Chemical Oxidati

8、on, by UVLight Oxidation, by Both, or by High Temperature Com-bustion Followed by Gas Phase NDIR or by ElectrolyticConductivityD5245 Practice for Cleaning Laboratory Glassware,Plasticware, and Equipment Used in MicrobiologicalAnalysesD5391 Test Method for Electrical Conductivity and Resis-tivity of

9、a Flowing High Purity Water SampleD5542 Test Methods for Trace Anions in High Purity Waterby Ion ChromatographyD5673 Test Method for Elements in Water by InductivelyCoupled PlasmaMass SpectrometryD5996 Test Method for Measuring Anionic Contaminants inHigh-Purity Water by On-Line Ion ChromatographyF1

10、094 Test Methods for Microbiological Monitoring ofWater Used for Processing Electron and MicroelectronicDevices by Direct Pressure Tap Sampling Valve and bythe Presterilized Plastic Bag Method3. Terminology3.1 DefinitionsFor definitions of terms used in this guide,refer to Terminology D1129.3.2 Defi

11、nitions 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 mL total numberof viable micro-organisms present in the 100-

12、mL sample,excluding anaerobic and microaerophilic bacteria.3.2.3 total organic carboncarbon in the form of organiccompounds.3.2.4 waterwater complying with compositions given inTable 1.4. Significance and Use4.1 The purity of water is relative and is usually character-ized by the limits of impuritie

13、s found in the water as well as bythe methods used to prepare and handle the water. Section 7mentions the suitable methods for water preparation.1This guide is under the jurisdiction of ASTM Committee D19 on Water and isthe direct responsibility of Subcommittee D19.02 on Quality Systems, Specificati

14、on,and Statistics.Current edition approved April 1, 2013. Published April 2013. Originallyapproved in 1991. Last previous edition approved in 2006 as D5196 06. DOI:10.1520/D5196-06R13.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm

15、.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15. Composition5.1 Water for Bio-Applications should be prepared

16、 (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 importa

17、nt 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 propertie

18、s 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 Standard

19、s, 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 wate

20、r 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 limits,s

21、ince 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-Applicat

22、ions 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 purificationtechno

23、logies such as distillation, deionization,electrodeionization, carbon adsorption, reverse osmosis,ultrafiltration, nanofiltration, UV photo-oxidation, and/orscreen membrane filtration, to meet the compositions given inTable 1.7.4 The water purification systems containing these tech-nologies should b

24、e 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 Trends8.1 The mo

25、nitoring 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 the best wa

26、y 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 AnalytesResistiv

27、ity 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 avoidcontamination (for

28、 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 thenanalyses of th

29、e 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 impact on so

30、me Bio-Applications. The user should addTABLE 1Analytes Maximum ConcentrationTotal Inorganic Analytes 1 g/L or resistivity of 18.2Mohm.cm 25C. See Note 1Total Organic Carbon (TOC on-linemeasurement)20 ppbHeterotrophic bacterial counts 100 cfu/100 mLEndotoxins (Endotoxin Unit)A0.01 EU/mLNucleasesBSee

31、 Note 2ProteasesCSee Note 2AIf application sensitive to endotoxins. Commercial kits and methods are availablefor such purpose.BIf applications are linked to DNA and/or RNA work.CIf applications involved proteins.TABLE 2 Ionic Suggested Contaminant ListCations AnionsAluminium ChlorideAmmonium Nitrate

32、Arsenic PhosphateCadmium SulfateCalcium FluorideChromiumCobaltCopperIronLeadMagnesiumNickelPotassiumSodiumTitaniumZincD5196 06 (2013)2any other ionic contaminants (not already indicated) to this listif the application being performed may be sensitive to thoseions.8.4 Heterotrophic Bacterial Count Th

33、e maximum con-centrations proposed in Table 1 is given for determination by aplate-count method. If this method is selected, Test MethodF1094 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

34、 the media selected willbe counted. If frequent verification with rapid results arenecessary, an epifluorescence method can also be used. In thiscase, viable and non-viable bacteria can be counted. Thereforethe maximum concentrations given in Table 1 should beadapted accordingly.8.5 NucleasesDetermi

35、nation 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. Sampling9.1 Samplings for the test methods specified in Section 13but also for the water that wil

36、l 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 airborne contamination tothe best of their ability, making note of possible sources ofcontamination due t

37、o the sampling procedure. It is recom-mended that the samples be handled in accordance withPractice D4453.9.2 Extreme care must be exercised in handling sampleswhen making analyses. Depending on the analyte to beanalyzed, experimental laboratory-ware should be selected.PFA or TFE fluorocarbon (excep

38、t 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,phthalates, and so forth). Several samplings should be per-formed according to the nature of the an

39、alyte.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 metals within the sample.9.2.2 The water sample should remain in storage a minimalperiod of time si

40、nce some analytes have a tendency to adhereto the container surface and others may leach from thecontainer.9.2.3 Practice D5245 should be used as a guide to clean theglassware or plasticware before microbiological analyses.9.2.4 When endotoxin monitoring or nuclease measure-ments are required, speci

41、al 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; howeverthe suggested maximum limits and the actual impuritiesconsidered, or both, may be modified by

42、 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 sampling technique, and cleanlinessof the working area.11. Summary of Method of Storage11.1 Storage of the f

43、inal 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 container used.12. Maintenance and Calibration12.1 Periodic preventive maintenance should be performedto e

44、nsure 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 performance of the installation and to be ableto anticipate any failures.12.2 Periodic calibration of th

45、e 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 ( Bacterial Endotoxins TestMethod.313.3 Heterotropic Bacterial CountTest Method F1094.13.4 Electrical Resist

46、ivityTest Method D1125 and TestMethod D5391.13.5 Total Inorganic AnalytesTest Methods D5391,D5542, D5673 and D5996. See Note 3.NOTE 1The resistivity value corresponds to the theoretical value ofthe water exempt of ions. As for a real, practical measurement, amaximum tolerance of 6 1 Mohm.cm should b

47、e accepted to take intoaccount the accuracy of the measurement device used.NOTE 2If Nucleases and/or Proteases are of concerns for theapplications, a purification technology that removes such contaminantsshould be used in the purification process (such as ultrafiltration ordistillation). Such purifi

48、cation step should be located as close as possibleto the point of use, avoiding recontamination of the water by downstreampurification stages.NOTE 3There is no current ASTM Standard Method for the determi-nation of all the anions and cations listed in Table 2 at the limits requiredby this guide. How

49、ever ICP/MS and ion chromatography methods areavailable to measure such elements at these levels. Manufacturersconsultation can be helpful.3Published in the U.S. Pharmacopeia twenty-seventh revision by The U.S.Pharmacopeial Convention, Inc.D5196 06 (2013)314. 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 selecti