EnБайду номын сангаасotoxins by LAL
Purified Water
No specification
WFI
<
0.2 EU/ml
Bacteria (Guideline Only)
Purified Water <
100 cfu/ml
WFI
<
10 cfu/100 ml
American Society for Testing and Materials (ASTM)
Endotoxins by LAL
Purified Water
No specification
WFI
< 0.25 EU/ml
Bacteria (Guideline Only)
Purified Water < 100 cfu/ml
WFI
< 10 cfu/100 ml
USP 24 Pharmaceutival Grade Water
Governing Authorities
USP - (United States Pharmacopeia) ASTM - (American Society for Testing and Materials) CAP - (College of American Pathologists0 NCLLS - (National Committee for Clinical Laboratory Standards)
Industrial Water Purification (800) CAL-WATER
Water Purity Specifications
For the Laboratory, Cosmetic and Pharmaceutical Industries
USP-ASTM-CAP-NCLLS
The following is a list of water quality specifications from various authorities used by laboratories and the cosmetic and pharmaceutical industries to establish production standards for OQ, IQ, DQ and other quality control limits. The standards are used to specify the various pure water parameters to be measured for quality assurance.
Conductivity @ 25oC
Purified Water
4.7-5.8 ms/cm
WFI
< 1.3 ms/cm
Organics
Purified Water
5.0-7.0 ppb TOC
WFI
5.0-7.0 ppb TOC
Bacteria Endotoxins
Purified Water
No specification
Organics
Purified Water < 0.5 ppm TOC
WFI
< 0.5 ppm TOC
Conductivity
Purified Water < 1.3 ms/cm @ 25oC in-line Measurement
WFI
< 1.3 ms/cm @ 25oC in-line Measurement
Water Purity Specifications In Use As of: August 24, 2007
USP 27 Pharmaceutical Grade Water
Organics
<
0.5 ppm
Conductivity
<
1.3 ms/cm @ 25oC in-line Measurement
Bacterial Growth (cfu/ml)
10*
Particulate Matter
0.22 mm Filter**
Organics
Activated Carbon**
* Type I water is preferably bacteria free.
** Specifications are process specifications,
1
5
pH
-
-
ASTM Subtype:
A
B
Bacteria (cfu/100 ml)
1
10
Endotoxins (EU/ml)
<0.03
0.25
III
0.25
4 500 200 10 10
C 1000 N/A
IV
5.0
0.2 50 50
5.0-8.0
College of American Pathologists
WFI
< 0.25 EU/ml
TVC
Purified Water < 100 cfu/ml
WFI
< 0.1 cfu/ml
National Committee for Clinical Laboratory Standards
CAP/NCCLS Type:
I
Conductivity (ms/cm @ 25oC)
0.1
Resistivity @ 25oC Meg./cm
10
Total Silica (mg/L)
50
pH
-
not measured by end user.
II
1.0
1 100
1,000
NS NS
III
10
0.1 1,000 5.0-8.0
NS NS NS
Water Purity Specifications previously Used
USP 23 Pharmaceutival Grade Water (Similar to 27)
ASTM Type:
I
II
Conductivity (ms/cm @ 25oC)
0.056
1.0
Resistivity @ 25oC Meg./cm
18
1
Total Silica (mg/L)
3
3
Total Organic Carbon (mg/L)
100
50
Chlorides (mg/L)
1
5
Sodium (mg/L)