Designation:D1193–06Federal Test Method
Standard No.7916
Standard Specification for
Reagent Water1
怎样给皮肤补水This standard is issued under thefixed designation D1193;the number immediately following the designation indicates the year of
original adoption or,in the ca of revision,the year of last revision.A number in parenthes indicates the year of last reapproval.A
权限翻译superscript epsilon(e)indicates an editorial change since the last revision or reapproval.
This standard has been approved for u by agencies of the Department of Defen.
1.Scope
1.1This specification describes the required characteristics of waters deemed suitable for u with the Standards under the jurisdiction of ASTM.
1.2The alphanumeric characters ascribed to water types and grades are specified in the ASTM Format and Style Manual. The have been assigned in order of historical precedence and should not be taken as an indication of a progression in water purity.
1.3Four types of waters have been specified,with three additional grades that can be applied to the four types.The grade specifications specifically address contaminants of mi-crobiological origin.
1.4All applicable ASTM Standards are expected to refer-ence one or more of the reagent water types where reagent water is needed as a component of an analytical measurement process.Where a different water type or grade is needed for an ASTM Standard,it may be added to this Specification through the ASTM Standard revision process.
1.5Although the water types and associated grades have been defined specifically for u with ASTM Standards,they may be appropriate for other applications.It is the responsi-bility of the urs of this standard to ensure that the lected water types or grades are suitable for their intended u. Historically,reagent water Types I,II,III,and IV have been linked to specific process for their production.Starting with this revision,the types of waters may be produced with alternate technologies as long as the appropriate constituent specifications are met and that water so produced has been shown to be appropriate for the application where the u of such water is specified.Therefore,the lection of an alternate technology in place of the technology specified in Table1 should be made taking into account the potential impact of other contaminants such as microorganism and pyrogens.Such contaminants were not necessarily considered by the perfor-mance characteristics of the technology previously specified.
1.6Guidance for applications,the preparation,u and monitoring,storage,handling,distribution,testing of the specified waters and validation of the water purification system is provided in Appendix X1of this document.
1.7This standard does not purport to address all of the safety concerns,if any,associated with its u.It is the responsibility of the ur of this standard to establish appro-priate safety and health prac
tices and determine the applica-bility of regulatory limitations prior to u.
2.Referenced Documents
2.1ASTM Standards:2
D1125Test Methods for Electrical Conductivity and Re-sistivity of Water
D1129Terminology Relating to Water
D1293Test Methods for pH of Water
D4453Practice for Handling of Ultra-Pure Water Samples D4517Test Method for Low-Level Total Silica in High-Purity Water by Flameless Atomic Absorption Spectros-copy3
D5128Test Method for On-Line pH Measurement of Water of Low Conductivity
D5173Test Method for On-Line Monitoring of Carbon Compounds in Water by Chemical Oxidation,by UV Light Oxidation,by Both,or by High Temperature Combustion Followed by Gas Pha NDIR or by Electrolytic Conduc-tivity
D5245Practice for Cleaning Laboratory Glassware,Plas-ticware,and Equipment Ud in Microbiological Analys D5391Test Method for Electrical Conductivity and Resis-tivity of a Flowing High Purity Water Sample
D5542Test Method for Trace Anions in High Purity Water by Ion Chromatography
D5997Test Method for On-Line Monitoring of Total Car-bon,Inorganic Carbon in Water by Ultraviolet,Persulfate
1This specification is under the jurisdiction of ASTM Committee D19on Water and is the responsibility of Subcommittee D19.02on General Specifications, Technical Resources,and Statistical Methods.
Current edition approved March1,2006.Published March2006.Originally approved in1951.Last previous edition approved in1999as D1193–99e1.
2For referenced ASTM standards,visit the ASTM website,,or contact ASTM Customer Service at For Annual Book of ASTM Standards volume information,refer to the standard’s Document Summary page on the ASTM website.
3Determination of Trace Silica in Industrial Process Waters by Flameless Atomic Absorption Spectrometry,Judith Rawa and Earl Henn,Analytical Chemistry,V ol51, No3,March1979.
Copyright©ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA19428-2959,United States.
Oxidation and Membrane Conductivity Detection
D 6071Test Method for Low Level Sodium in High Purity Water by Graphite Furnace Atom Absorption Spectroscopy D 6161Terminology Ud for Crossflow Microfiltration,Ultrafiltration,Nanofiltration and Rever Osmosis Mem-brane Process
D 6529Test Method for Operating Performance of Con-tinuous Electrodeionization Systems on Feeds from 50–1000µS/cm
F 1094Test Methods for Microbiological Monitoring of Water Ud for Processing Electron and Microelectronic Devices by Direct Pressure Tap Sampling Valve and by the Presterilized Plastic Bag Method
3.Terminology
3.1Definitions —For definitions ud in this specification refer to Terminology D 1129.
3.2Definitions of Terms Specific to This Standard:
3.2.1reagent water —water that is ud specifically as a component of an analytical measurement process and meets or exceeds the specifications for the waters.
3.2.2electrodeionization —a process that removes ionized and ionizable species from liquids using electrically active media and using an electrical potential to influence ion transport,where the ionic transport properties of the active media are a primary sizing parameter.Electrodeionization
TABLE 1Process for Reagent Water Production
Typeadrift
Grade
Production Process
A ,
B ,
C ,D
µS/cm E (max)M V ·cm F (min)pH
G
TOC µg/L H (max)Sodium µg/L I (max)Chloride µg/L J (max)Total Silica µg/L (max)HBC K cfu/mL (max)Endotoxin,EU/mL L (max)
I
Purify to 20µS/cm equiv.,followed by mixed bed DI,0.2µm filtration A
0.0555
18
50
1
1
3
I A
Purify to 20µS/cm equiv.,followed by mixed bed DI,0.2µm filtration A
0.0555185011310/10000.03
I B
Purify to 20µS/cm equiv.,followed by mixed bed DI,0.2µm filtration A
0.0555185011310/1000.25
I C
Purify to 20µS/cm equiv.,followed by mixed bed DI,0.2µm filtration A 0.05551850113100/10
II Distillation B 1.0 1.050553II A Distillation B 1.0 1.05055310/10000.03II B Distillation B 1.0 1.05055310/1000.25
II C
Distillation B
1.0 1.050553100/10knife的意思
III Distillation,DI,EDI,and/or RO,followed by 0.45µm filtration.C 0.25 4.020********III A Distillation,DI,EDI,and/or RO,followed by 0.45µm filtration.C 0.25 4.0200101050010/10000.03III B Distillation,DI,EDI,and/or RO,followed by 0.45µm filtration.C 0.25 4.0200101050010/1000.25
III C
Distillation,DI,EDI,and/or RO,followed by 0.45µm filtration.C 0.25 4.0200
1010500
1000/100
IV Distillation,DI,EDI,and/or RO.D 5.00.2 5.0to 8.05050IV A Distillation,DI,EDI,and/or RO.D 5.00.2 5.0to 8.0505010/10000.03IV B Distillation,DI,EDI,and/or RO.D 5.00.2 5.0to 8.0505010/1000.25
IV
C
Distillation,DI,EDI,and/or RO.D
5.0
0.2
5.0
to 8.0
50
50
100/10
A
Type I grade of reagent water shall be prepared by distillation or other equal process,followed by polishing with a mixed bed of ion-exchange materials and a 0.2-µm membrane filter.Feed water to the final polishing step must have a maximum conductivity of 20µS/cm at 298K (25°C).Type I reagent water may be produced with alternate technologies as long as the appropriate constituent specifications are met and that water so produced has been shown to be appropriate for the application where the u of such water is specified .B
Type II grade of reagent water shall be prepared by distillation using a still designed to produce a distillate having a conductivity of less than 1.0µS/cm at 298K (25°C).Ion exchange,distillation,or rever osmosis and organic adsorption may be required prior to distillation,if the purity cannot be attained by single distillation.Type II reagent water may be produced with alternate technologies as long as the appropriate constituent specifications are met and that water so produced has been shown to be appropriate for the application where the u of such water is specified .C
Type III grade of reagent water shall be prepared by distillation,ion exchange,continuous electrodeionization,rever osmosis,or a combination thereof,followed by polishing with a 0.45-µm membrane filter.Type III reagent water may be produced with alternate technologies as long as the appropriate constituent specifications are met and that water so produced has been shown to be app
ropriate for the application where the u of such water is specified.D
Type IV grade of reagent water may be prepared by distillation,ion exchange,continuous electrodeionization,rever osmosis,electrodialysis,or a combination thereof.Type IV reagent water may be produced with alternate technologies as long as the appropriate constituent specifications are met and that water so produced has been shown to be appropriate for the application where the u of such water is specified .E
Electrical conductivity at 25°C.F
Electrical resistivity at 25°C.G
pH at 25°C,not applicable to higher resistivity waters.H
Total organic carbon.I
Sodium.J
Chloride ion.K
Heterotrophic bacteria count.L
Endotoxin in endotoxin units per
mL.
devices typically compri mi-permeable ion-exchange membranes and permanently charged ion-exchange media(e Test Method D6529).
3.2.3rever osmosis(RO)—the paration process where one component of a solution is removed from another compo-nent byflowing the feed stream under pressure across a mipermeable membrane.RO removes ions bad on electro-chemical forces,colloids,and organics down to150molecular weight.May also be called hyperfiltration(e Terminology D6161)
4.Composition and Characteristics
4.1The types and grades of water specified in this Standard shall conform to the requirements in Table1.
5.Test Methods
5.1Electrical Conductivity and Resistivity—Refer to Test Methods D1125and D5391.
5.2pH—Refer to Test Methods D1293and D5128.
5.3Silica—Refer to Test Method D4517.
5.4Sodium—Refer to Test Methods D6071.
音乐英文怎么写5.5Chlorides—Refer to Test Method D5542.
5.6TOC—Refer to Test Methods D5173and D5997. 5.7Endotoxins—Refer to LAL Test Method.4
5.8Microbiological Contamination—Refer to Test Methods F1094.
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6.Keywords
6.1laboratory analysis;reagent;water
APPENDIX
(Nonmandatory Information)
X1.POTENTIAL REAGENT WATER ISSUES
INTRODUCTION
This Appendix is provided as a guide to various issues in the production,application,storage,and monitoring of Reagent Water.The issues are very complex and extensive.This guidance is not intended to be comprehensive or complete.Producers and urs of Reagent Water are encouraged to ek out additional sources of guidance in this area.
X1.1Preparation
white houX1.1.1Historically,reagent water Types I,II,III,and IV have been linked to specific process for their production. Starting with this revision,the types of waters may be produced with alternate technologies as long as the appropriate constituent specifications are met and that water so produced has been shown to be appropriate for the application where the u of such water is specified.
X1.1.2The preparation methods of the various grades of reagent water influences the limits of impuri
ties.Therefore,the lection of an alternate technology in place of the technology specified in the Table1should be made taking into account the potential impact of other contaminants such as micro-organism and pyrogens,even if a grade is not specified.Such contami-nants were not necessarily considered by the performance characteristics of the technology previously specified.
X1.2U and Application
X1.2.1Type I and Type III Water:
X1.2.1.1Contact with the ion-exchange materials may cau an addition of organic contaminants to the water.This will depend on the resin type/quality,quality of the regenera-tions(if regenerated),environmental conditions in which the water purification system is ud and actual system u(for example,duration of non-u periods).Practices may be put in place to decrea the risk or organic contamination:
(1)Periodic rinsing of the purification media to limit bacteriological(organic)contamination is recommended.
(2)After each period of non-usage,drawing off a quantity of water is necessary before u.Refer to the supplier speci-fications for the recommended volume.
(3)Synthetic activated carbon and/or UV(dual wave-lengths185nm and254nm)may be ud in the polishing stages to decrea the level of organic contaminants(to reach Type I water specifications),and/or to reach lower organic levels.
X1.2.1.2The quality of the water produced depends upon the type,age,and method of regeneration of the ion exchange materials(if regenerated).Likewi,theflow rate through the ion exchange resin bed will change the conductivity of the product water.The manufacturer’s instructions for resins or the resin cartridge bed should be followed.
X1.2.1.3The u of the membranefilter in the preparation of Type I and Type III water may add a small amount of organic components to the water initially produced.The amount of organic components relead differs depending on the type and brand of the membranefilter ud.Then the membrane should be rind according to the manufacturer’s 4Published in the U.S.Pharmacopeia by The U.S.Pharmacopeial Convention,
Inc.
instructions.The u of a qualified membranefilter on the organic relea is recommended.
X1.2.1.4Producing Type I water specifications is achieved utilizing a combination of purification technologies.The choice of technologies can vary depending on the feed water quality,system usage and cost considerations.Particular atten-tion should be taken regarding the location and quence of particular purification technologies in the process,as the can have an impact on thefinal water quality.
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X1.2.2Type II Water:
X1.2.2.1The description of Type II reagent water was intended to characterize product water from distillation pro-cess.Therefore,the lection of an alternate technology in place of the one specified should be made by taking into account the potential impact of other contaminants(such as micro-organism and pyrogen)than tho specified in Table1 for the Type II water.
X1.2.2.2Type II grade of reagent water is typically sterile and pyrogen-free as produced and generally may be ud whenever freedom from biological contaminants is desirable. However,the method of storage and handling of the water may itlf result in contamination.
X1.2.2.3Type II water is typically pyrogen-free as pro-duced,but should be tested in conformance with the require-ments of the referenced edition of United States Pharma-copeia,if proof is needed.
X1.2.3All Types of Water:
X1.2.3.1Biological contaminants may be important in the test procedure using any of the reagent waters specified.A classification of bacterial levels is included and should be specified if it is of significance to the test being performed. X1.2.3.2It should also be noted that the method ud to prepare the different types of reagent water may or may not remove non-ionized dissolved gas.If non-ionized dissolved gas are of concern for the application considered,the lection of a method to produce water appropriate for the purpo and compliant with the Table1specifications for the type and grade of water should be considered.
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X1.2.3.3To obtain sterile water,any of the types of reagent water listed in this ction may be produced,bottled,and heated to121°C for20min.This procedure is most easily carried out by autoclaving at103kPa(15psi)for20min. Alternatively,sterilizingfiltration of any types of the reagent water listed with a validatedfilter may also produce sterile water when performed in aptic conditions.The ur should choo the appropriate sterilization technique for the intended u.
X1.3Monitoring
X1.3.1The limits of Table1apply to the water sampled at the point of u or,when for practical reasons and/or to avoid contamination(for example connection of an equipment after a
0.2µmfilter),as clo as possible to the point of u and with
a regular verification of a low impact of the purification steps and/or equipment placed downstream of the monitoring sam-pling point.
X1.3.2Becau atmospheric gas and impurities rapidly recontaminate expod water,an on-line nsor should be employed for determining the electrical conductivity of reagent water Types I,II,and III.As atmospheric organic compounds and tho from sampling vials rapidly contaminate expod purified water,an on-line TOC monitor should be preferred for determining the TOC level of Type I and Type II water.
X1.3.3Quality and system performance parameters should be regularly reported and registered.Follow-up of trends in the quality and performance parameters should be performed regularly to check any variations in performance of the water purification installation and to be able to anticipate any failures.
X1.3.4The monitoring of different parameters should be performed at a frequency defined by the ur to ensure with a high degree of confidence that the water quality ud is always compliant with the specifications and the purpo.
X1.4Storage and Distribution
X1.4.1Generally speaking,storage of the purified water will cau a loss of the specified characteristics.The impact will be different depending on the water type and grade produced(resistivity characteristics for example,will be rap-idly impacted as soon as Type I water is be stored).Water types,other than Type I,can be stored if particular attention is taken regarding the materials,design of the storage system and time of storage.The material of the storage rervoir in contact with water should be lected to minimize the relea of extractables.
X1.4.1.1The design of the storage rervoir should be fully drainable,either opaque or placed in an environment which limit bacterial growth by the effects of light.
X1.4.1.2The storage container should be adequately pro-tected from air contaminants(particles and CO2,especially when water is drawn)and from bacteriological contamination. This should be achieved by airfiltration,inert gas blanketing, UV irradiation,chemical sanitization,heating above80de-
grees C,or a combination thereof.It should be recognized that the mere fact that the water is stored will likely reduce its purity despite attempts to prevent contamination.Storage should be sized to ensure a good turnover of water.
X1.4.1.3Manual or automatic draw-off and periodic saniti-zation should be performed in particular after long periods of non-u.The periodicity of such draw-offs and sanitization should be defined by the ur depending on the water purifi-cation system usage and water u.This periodicity can be defined during a qualification pha.After each sanitization, verification of the abnce of the sanitization agent should be performed.
X1.4.2If a distribution system is ud to transfer the water to a laboratory,it should be of special design to minimize contamination.Gravity feed is the preferred method(if pos-sible),since pumps are a potential source of contamination. X1.4.2.1If circulating systems are employed,the pumps should be designed to limit any contamination.
X1.4.2.2The piping materials,fittings,faucets,and joints should be designed to limit any contamination.
X1.4.2.3Outlets should be protected by UV or by micro-filtration(absolute0.22µmfilter)or other means
秃发是什么原因to prevent “back contamination”by airborne biological
impurities.
X1.4.2.4A loop distribution design is preferred to an antenna distribution,which can constitute a dead legs during periods of non-u.
X1.4.2.5Positive pressure should be maintained in the distribution systems to avoid any retro-contamination.
X1.4.2.6Microbiological proliferation should be minimized by suitable choice of periods of recirculation,flow rate,and/or temperature.
X1.5Handling
X1.5.1Extreme care should be taken in handling reagent water during analys.Depending on the water type required and the applications performed,container material and clean-ing procedures mus
t be chon appropriately.Practices D5245 and D4453should be consulted.
X1.5.2Laboratory-ware should be carefully lected ac-cording to the application.Low relea plastic-ware,such as PFA or TFEfluorocarbon(except for analysis offluoride)or HDPE laboratory-ware should be ud for ion-nsitive appli-cations and high purity glass containers may be preferable for organic-nsitive applications.
X1.6Maintenance and Calibration
X1.6.1Periodic calibration(if pertinent)of the different measuring instruments should be performed to ensure the validity of the values obtained.
X1.6.2Periodic preventive maintenance should be per-formed to ensure the long-term performance and reliability of the water purification system.Follow-up of trends in the quality and performance parameters should be performed regularly to check any variations in performance of the installation and to be able to anticipate any failures.
X1.6.3The frequency of system calibration and mainte-nance of the system should be defined by the ur depending on the importance of the water in applications,but should not be performed less than once a year.
X1.7Validation
X1.7.1Becau quality assurance is the key to ensure safety,efficiency and reliability,validation is becoming in-creasingly important.The validation process can be divided into4major qualification steps:
X1.7.1.1Design Qualification(DQ)—The Design Qualifi-cation is carried out before the lection of water purification system is made and consists of defining the water types required depending on the applications,and defining the technology(ies)to be ud,including the monitors to verify water quality.The design of the installation should also be defined according to requirements.All steps should be docu-mented.
X1.7.1.2Installation Qualification(IQ)—The Installation Qualification should take place after the installation of the system and consists of verifying and documenting that the installation was performed according to the predetermined specifications.This requires that the calibration of the various measuring instruments be verified.The actual installation should be compared with an installation drawing to ensure that no future installation modification be performed without suit-able control management.Verification of the availability of all documentation required to u and maintain
the system should also be done.Documented verification of the water purification system may be performed to ensure that the installation was performed according to specifications.
X1.7.1.3Operational Qualification(OQ)—The Operational Qualification is performed after installation of the system and consists of ensuring that the system is operating according to the predetermined specifications.Tests should be conducted to verify that the hydraulic,monitoring and electronic functions (including system alerts)of the systems are working according to the specifications.
X1.7.1.4Performance Qualification(PQ)—The Perfor-mance Qualification should be carried out after that the installation and operational qualification have been performed to document that the system is performing according to the predetermined specifications.During this qualification step verification of the appropriateness of the specifications,defined according to the applications,and verification of the water quality produced should be conducted.
X1.7.2Re-qualification should be conducted on a regular time-basis and also each time components are replaced which can affect the quality or the quantity of water.
X1.7.2.1The frequency of re-qualification depends on the importance of purified water in applications but cannot exceed one year.This ensures complete annual verification of the system alerts and calibr
ation of the measuring instrument.
X1.7.2.2A preventive maintenance(e Maintenance and Calibration ction)should be conducted regularly and all actions should be documented in a dedicated system logbook.
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