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Astm D 1193 06
Astm D 1193 06
Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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II C DistillationB 1.0 1.0 50 5 5 3 100/10
III Distillation, DI, EDI, and/or RO, 0.25 4.0 200 10 10 500
followed by 0.45 m filtration.C
III A Distillation, DI, EDI, and/or RO, 0.25 4.0 200 10 10 500 10/1000 0.03
followed by 0.45 m filtration.C
III B Distillation, DI, EDI, and/or RO, 0.25 4.0 200 10 10 500 10/100 0.25
followed by 0.45 m filtration.C
III C Distillation, DI, EDI, and/or RO, 0.25 4.0 200 10 10 500 1000/100
followed by 0.45 m filtration.C
IV Distillation, DI, EDI, and/or RO.D 5.0 0.2 5.0 to 8.0 50 50
IV A Distillation, DI, EDI, and/or RO.D 5.0 0.2 5.0 to 8.0 50 50 10/1000 0.03
IV B Distillation, DI, EDI, and/or RO.D 5.0 0.2 5.0 to 8.0 50 50 10/100 0.25
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-m
membrane filter. Feed water to the final polishing step must have a maximum conductivity of 20 S/cm at 298K (25C). 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 use
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 1.0 S/cm at 298 K (25C).
Ion exchange, distillation, or reverse 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 use of such water is specified.
C
Type III grade of reagent water shall be prepared by distillation, ion exchange, continuous electrodeionization, reverse osmosis, or a combination thereof, followed by
polishing with a 0.45-m 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 appropriate for the application where the use of such water is specified.
D
Type IV grade of reagent water may be prepared by distillation, ion exchange, continuous electrodeionization, reverse 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 use of such water is specified.
E
Electrical conductivity at 25C.
F
Electrical resistivity at 25C.
G
pH at 25C, 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.
APPENDIX
(Nonmandatory Information)
INTRODUCTION
This Appendix is provided as a guide to various issues in the production, application, storage, and
monitoring of Reagent Water. These issues are very complex and extensive. This guidance is not
intended to be comprehensive or complete. Producers and users of Reagent Water are encouraged to
seek out additional sources of guidance in this area.
itself result in contamination. idly impacted as soon as Type I water is be stored). Water
X1.2.2.3 Type II water is typically pyrogen-free as pro- types, other than Type I, can be stored if particular attention is
duced, but should be tested in conformance with the require- taken regarding the materials, design of the storage system and
ments of the referenced edition of United States Pharma- time of storage. The material of the storage reservoir in contact
copeia, if proof is needed. with water should be selected to minimize the release of
X1.2.3 All Types of Water: extractables.
X1.2.3.1 Biological contaminants may be important in the X1.4.1.1 The design of the storage reservoir should be fully
test procedure using any of the reagent waters specified. A drainable, either opaque or placed in an environment which
classification of bacterial levels is included and should be limit bacterial growth by the effects of light.
specified if it is of significance to the test being performed. X1.4.1.2 The storage container should be adequately pro-
X1.2.3.2 It should also be noted that the method used to tected from air contaminants (particles and CO2, especially
prepare the different types of reagent water may or may not when water is drawn) and from bacteriological contamination.
remove non-ionized dissolved gases. If non-ionized dissolved This should be achieved by air filtration, inert gas blanketing,
gases are of concern for the application considered, the UV irradiation, chemical sanitization, heating above 80 de-
selection of a method to produce water appropriate for the grees C, or a combination thereof. It should be recognized that
purpose and compliant with the Table 1 specifications for the the mere fact that the water is stored will likely reduce its
type and grade of water should be considered. purity despite attempts to prevent contamination. Storage
X1.2.3.3 To obtain sterile water, any of the types of reagent should be sized to ensure a good turnover of water.
water listed in this section may be produced, bottled, and X1.4.1.3 Manual or automatic draw-off and periodic saniti-
heated to 121C for 20 min. This procedure is most easily zation should be performed in particular after long periods of
carried out by autoclaving at 103 kPa (15 psi) for 20 min. non-use. The periodicity of such draw-offs and sanitization
Alternatively, sterilizing filtration of any types of the reagent should be defined by the user depending on the water purifi-
water listed with a validated filter may also produce sterile cation system usage and water use. This periodicity can be
water when performed in aseptic conditions. The user should defined during a qualification phase. After each sanitization,
choose the appropriate sterilization technique for the intended verification of the absence of the sanitization agent should be
use. performed.
X1.3 Monitoring X1.4.2 If a distribution system is used to transfer the water
to a laboratory, it should be of special design to minimize
X1.3.1 The limits of Table 1 apply to the water sampled at
contamination. Gravity feed is the preferred method (if pos-
the point of use or, when for practical reasons and/or to avoid
sible), since pumps are a potential source of contamination.
contamination (for example connection of an equipment after a
0.2 m filter), as close as possible to the point of use and with X1.4.2.1 If circulating systems are employed, the pumps
a regular verification of a low impact of the purification steps should be designed to limit any contamination.
and/or equipment placed downstream of the monitoring sam- X1.4.2.2 The piping materials, fittings, faucets, and joints
pling point. should be designed to limit any contamination.
X1.3.2 Because atmospheric gases and impurities rapidly X1.4.2.3 Outlets should be protected by UV or by micro-
recontaminate exposed water, an on-line sensor should be filtration (absolute 0.22 m filter) or other means to prevent
employed for determining the electrical conductivity of reagent back contamination by airborne biological impurities.
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installation and to be able to anticipate any failures. verification of the appropriateness of the specifications, defined
X1.6.3 The frequency of system calibration and mainte- according to the applications, and verification of the water
nance of the system should be defined by the user depending on quality produced should be conducted.
the importance of the water in applications, but should not be
X1.7.2 Re-qualification should be conducted on a regular
performed less than once a year.
time-basis and also each time components are replaced which
X1.7 Validation can affect the quality or the quantity of water.
X1.7.1 Because quality assurance is the key to ensure X1.7.2.1 The frequency of re-qualification depends on the
safety, efficiency and reliability, validation is becoming in- importance of purified water in applications but cannot exceed
creasingly important. The validation process can be divided one year. This ensures complete annual verification of the
into 4 major qualification steps: system alerts and calibration of the measuring instrument.
X1.7.1.1 Design Qualification (DQ)The Design Qualifi- X1.7.2.2 A preventive maintenance (see Maintenance and
cation is carried out before the selection of water purification Calibration section) should be conducted regularly and all
system is made and consists of defining the water types actions should be documented in a dedicated system logbook.
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