ASTM D5196-06(2013)
(Guide)Standard Guide for Bio-Applications Grade Water
Standard Guide for Bio-Applications Grade Water
SIGNIFICANCE AND USE
4.1 The purity of water is relative and is usually characterized by the limits of impurities found in the water as well as by the methods used to prepare and handle the water. Section 7 mentions the suitable methods for water preparation.
SCOPE
1.1 This guide is intended to describe the chemical and biological characteristics of water to be used whenever critical purity is essential to the use intended in laboratory Bio-Applications, for example, clinical, pharmaceutical, and biomedical. The importance of such a reagent is often underestimated despite the impact that it can have.
1.2 This guide is not intended to be used as a reference in preparing water for injectables. Generally, the appropriate use of this guide may include experiments involving tissue culture, chromatography, mass spectrometry, Polymerase Chain Reaction (PCR), DeoxyriboNucleic Acid (DNA) sequencing, DNA hybridization, electrophoresis, molecular biology or analyses where molecular concentrations of impurities may be important.
1.3 For all the other applications linked to an ASTM method and not bio-sensitive that require purified water, it is recommended that Specification D1193 or Test Method D5127 be consulted.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
General Information
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: D5196 − 06 (Reapproved 2013)
Standard Guide for
Bio-Applications Grade Water
This standard is issued under the fixed designation D5196; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope and Semiconductor Industries
D5173 Guide for On-Line Monitoring of Total Organic
1.1 This guide is intended to describe the chemical and
Carbon in Water by Oxidation and Detection of Resulting
biological characteristics of water to be used whenever critical
Carbon Dioxide
purity is essential to the use intended in laboratory Bio-
D5245 Practice for Cleaning Laboratory Glassware,
Applications, for example, clinical, pharmaceutical, and bio-
Plasticware, and Equipment Used in Microbiological
medical. The importance of such a reagent is often underesti-
Analyses
mated despite the impact that it can have.
D5391 Test Method for Electrical Conductivity and Resis-
1.2 This guide is not intended to be used as a reference in
tivity of a Flowing High Purity Water Sample
preparing water for injectables. Generally, the appropriate use
D5542 Test Methods for TraceAnions in High Purity Water
of this guide may include experiments involving tissue culture,
by Ion Chromatography
chromatography, mass spectrometry, Polymerase Chain Reac-
D5673 Test Method for Elements in Water by Inductively
tion (PCR), DeoxyriboNucleic Acid (DNA) sequencing, DNA
Coupled Plasma—Mass Spectrometry
hybridization, electrophoresis, molecular biology or analyses
D5996 Test Method for MeasuringAnionic Contaminants in
where molecular concentrations of impurities may be impor-
High-Purity Water by On-Line Ion Chromatography
tant.
F1094 Test Methods for Microbiological Monitoring of
1.3 ForalltheotherapplicationslinkedtoanASTMmethod Water Used for Processing Electron and Microelectronic
Devices by Direct Pressure Tap Sampling Valve and by
and not bio-sensitive that require purified water, it is recom-
mended that Specification D1193 or Test Method D5127 be the Presterilized Plastic Bag Method
consulted.
3. Terminology
1.4 This standard does not purport to address all of the
3.1 Definitions—For definitions of terms used in this guide,
safety concerns, if any, associated with its use. It is the
refer to Terminology D1129.
responsibility of the user of this standard to establish appro-
3.2 Definitions of Terms Specific to This Standard:
priate safety and health practices and determine the applica-
3.2.1 endotoxins—substances or by-products usually pro-
bility of regulatory limitations prior to use.
duced by gram negative micro-organisms that give a positive
2. Referenced Documents test for endotoxin in accordance with 13.2.
3.2.2 heterotrophic bacterial counts/100 mL— total number
2.1 ASTM Standards:
of viable micro-organisms present in the 100-mL sample,
D1125 Test Methods for Electrical Conductivity and Resis-
excluding anaerobic and microaerophilic bacteria.
tivity of Water
D1129 Terminology Relating to Water
3.2.3 total organic carbon—carbon in the form of organic
D1193 Specification for Reagent Water
compounds.
D4453 Practice for Handling of High Purity Water Samples
3.2.4 water—water complying with compositions given in
D5127 Guide for Ultra-Pure Water Used in the Electronics
Table 1.
4. Significance and Use
This guide is under the jurisdiction of ASTM Committee D19 on Water and is
4.1 The purity of water is relative and is usually character-
thedirectresponsibilityofSubcommitteeD19.02onQualitySystems,Specification,
ized by the limits of impurities found in the water as well as by
and Statistics.
the methods used to prepare and handle the water. Section 7
Current edition approved April 1, 2013. Published April 2013. Originally
approved in 1991. Last previous edition approved in 2006 as D5196 – 06. DOI:
mentions the suitable methods for water preparation.
10.1520/D5196-06R13.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5. Composition
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
5.1 Water for Bio-Applications should be prepared (using
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. water purification technologies) starting from water complying
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D5196 − 06 (2013)
TABLE 1
ultrafiltration, nanofiltration, UV photo-oxidation, and/or
Analytes Maximum Concentration screen membrane filtration, to meet the compositions given in
Total Inorganic Analytes 1 µg/L or resistivity of 18.2 Table 1.
Mohm.cm
7.4 The water purification systems containing these tech-
@ 25°C. See Note 1
Total Organic Carbon (TOC – on- 20 ppb
nologies should be constructed from materials shown to
line
contribute to low contamination to the final product water.
measurement)
Heterotrophic bacterial counts 100 cfu/100 mL
7.5 Because quality assurance is key to ensure safety,
A
Endotoxins (Endotoxin Unit) 0.01 EU/mL
B efficiency and reliability, validation of the water purification
Nucleases See Note 2
C
Proteases See Note 2 installation is highly recommended (see Section 14).
A
Ifapplicationsensitivetoendotoxins.Commercialkitsandmethodsareavailable
for such purpose.
8. Monitoring and Trends
B
If applications are linked to DNA and/or RNA work.
C
8.1 The monitoring of different parameters should be per-
If applications involved proteins.
formed at a frequency defined by the user to ensure with a high
degree of confidence that the water quality used is always
compliant with the specifications and the purpose.
with the U.S. Environmental Protection Agency (EPA) Na-
tional Primary Drinking Water Regulations, or from compa- 8.2 Regular calibration and maintenance of the measuring
rableregulationsfromtheEuropeanUnionorJapan.Theuseof instruments is the best way to ensure, with a high level of
such a minimum standard quality for feed water is important to confidence, the validity of the values obtained to determine the
decrease the risk of producing and using final purified water compliance with the specifications of the water used. Trending
that would be compliant with the compositions given in Table parameters is the main reliable source of information to define
1 but could contain certain specific contaminants in concen- maintenance schedule and to anticipate failures.
trations that could affect the applications.
8.3 Inorganic Analytes—Resistivity is the most widely used
5.2 Recommendationsforpurityofwatershouldconformto parameter to monitor the overall ionic purity. According to
the properties and chemical limits given in Table 1; however, their mobility, each ionic species will have a different effect on
the suggested maximum limits and the actual impurities the resistivity. The limit of Table 1 apply to the water sampled
considered, or both, may be modified by the user based upon atthepointofuseor,whenforpracticalreasonsand/ortoavoid
the intended use of the water. contamination (for example connection of an equipment after a
0.2 µm filter), as close as possible to the point of use and with
5.3 Although these water types and associated grades have
a regular verification of a low impact of the purification steps
been defined specifically for use with ASTM Standards, they
and/or equipment placed downstream of the monitoring sam-
may be appropriate for other applications. It is the responsi-
pling point. If in-line measurements are not possible then
bility of the users of this standard to ensure that the selected
analyses of the water produced should be conducted to
water types or grades are suitable for their intended use.
determine that the total ionic concentration of all the analytes
described in Table 2 does not exceed the compositions given in
6. Reagents
Table 1 (≤1 µg/L total). Table 2 lists common cations and
6.1 Purity of Water—Unless otherwise indicated, references
anions that have an impact on the resistivity value and may
to water shall be understood to mean water types as defined in
haveanimpactonsomeBio-Applications.Theusershouldadd
this guide.
any other ionic contaminants (not already indicated) to this list
if the application being performed may be sensitive to those
7. Summary of Preparation Methods
ions.
7.1 The method of preparation used for the water must be
designed to remove organic, inorganic, volatile, biological
impurities and particulates to provide water that meets the
TABLE 2 Ionic Suggested Contaminant List
concentration limits in Table 1. These are suggested limits,
Cations Anions
since the actual maximum levels for the individual impurities
Aluminium Chloride
will depend on the end use for which the water is required.
Ammonium Nitrate
More restrictive limits than those suggested in Table 1 may be
Arsenic Phosphate
required by mutual consent of the parties concerned, provided Cadmium Sulfate
Calcium Fluoride
a suitable test method is agreed upon.
Chromium
Cobalt
7.2 The Bio-Applications grade water needs to be prepared
Copper
from tap water complying with U.S. EPA National Primary
Iron
Drinking Water regulations or comparable regulations of the
Lead
Magnesium
European Union or Japan.
Nickel
7.3 The purification of tap water shall be accomplished by a Potassium
Sodium
single technology or a combination of suitable purification
Titanium
technologies such as distillation, deionization,
Zinc
electrodeionization, carbon adsorption, reverse osmosis,
D5196 − 06 (2013)
8.4 Heterotrophic Bacterial Count—The maximum concen- 10.2 The precision of detection will depend on the purity of
trations proposed in Table 1 is given for
...
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