Page 208 - Facility Piping Systems Handbook for Industrial, Commercial, and Healthcare Facilities

WATER TREATMENT AND PURIFICATION

4.44 CHAPTER FOUR

TABLE 4.14 Standards for Purified Water and Water for Injection

Parameter Standard
TOC 550 ppb Carbon
Conductivity 1.3 μS/cm @ 25 °C
0.1 μS/cm @ 20 °C
Bacteria PW: 100 cfu/mL
WFI: 10 cfu/100 mL
Bacterial endotoxins WFI: 0.25 USP EU/mL
Notes: μS/cm = micro-Siemens per centimeter
cfu/mL = colony forming units per milliliter
EU/mL = endotoxin units per milliliter

TABLE 4.15 Standards for Packaged PW, WFI, and Sterile PW

Parameter Standard
pH 5.0 to 7.0
Chloride (mg/L) 0.5
Sulfate (mg/L) 1.0
Ammonia (mg/L) 0.03
Calcium (mg/L) 1.0
Carbon dioxide (mg/L) 5.0
Oxidizable substances Pass USP Permanganate test
Bacteria
*
Purified water (cfu/mL) 100
* WFI (cfu/100 mL) 10
Sterial PW Pass the USP Sterility test
Endotoxin WFI (EU/mL) 0.25
*
Note: Limits are guidelines in general in this Chapter
Source: U.S. Pharmacopeial Convention Inc., Reference 8.

2. Purified water (PW). The quality of the feedwater shall meet drinking water standards.
The final product shall contain no added substances. The USP requirement with added
substances has always been concerned with additions to the final product and not to
the feedwater. It is commonly interpreted by USP that substances may be added to the
feedwater provided that they are removed to an acceptable level during the final treat-
ment process. PW is used as the feedwater for preparation of compendial water.
3. Sterile purified water. This type, including some Sterile Water for Inhalation, is made
using purified water as a raw water source, sterilized, and suitably packaged. It contains
no antimicrobial agent.
4. Bacteriostatic purified water. PW sterilized and suitably packaged. It contains no anti-
microbial agent.
5. Water for injection (WFI). This type is made using PW as a raw-water source that must
be further purified by distillation or RO. Bacteria and endotoxins must be reduced to the
required level.
6. Sterile bacteriostatic water for injection. WFI sterilized and suitably packaged. It con-
tains no antimicrobial agent.

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