Milli-Q EQ 7000 - Requirements and Specifications; Product Water Specifications

26
REQUIREMENTS AND SPECIFICATIONS
Water specications
Product Water
When operating within feed water requirements listed in table page 26 Requirements &
Specications > Water Specications > Feed Water , the system has been designed to produce
water according to following specications:
Parameter Value or range
Resistivity 18.2 Mohm.cm @ 25°C
Conductivity 0.055 μS/cm @ 25°C
Total Organic Carbon (TOC) ≤ 5 ppb
Particles (size > 0.22µm) No particles with size > 0.22µm
(with Millipak
®
lters)
Bacteria
< 0.01 CFU/mL (with Millipak
®
and Biopak
®
lters)
< 0.005 CFU/mL (with Millipak
®
Gold installed and used in a
laminar ow hood)
Pyrogens (endotoxins) < 0.001 EU/mL (with Biopak
®
lter)
RNases < 2 pg/mL (with Biopak
®
lter)
DNases < 5 pg/mL (with Biopak
®
lter)
Proteases < 0.15 µg/mL (with Biopak
®
lter)
Flow rate up to 2 L/min
The Milli-Q EQ 7000 system is intended to produce ultrapure water that meets or exceeds
requirements as described by the organizations below:
Organization Water quality / grade
European Pharmacopeia Puried Water in bulk
U.S. Pharmacopeia Puried Water in bulk
Japanese Pharmacopeia Puried Water
Chinese Pharmacopeia Puried Water
ASTM
®
D1193 Type I water
ISO
®
3696 Grade 1 water
Chinese National Standard GB 6682 Grade 1 water
JIS K 0557 A4 water
Clinical and Laboratory Standards
Institute (CLSI
®
)
Clinical Laboratory Reagent Water (CLRW)