26
REQUIREMENTS AND SPECIFICATIONS
Water specications
Product Water
The system has been designed to produce water according to specications when operating
within feed water requirements.
Parameter Value or range
Resistivity 18.2 Mohm.cm @ 25°C
Conductivity 0.055 μS/cm @ 25°C
Total Organic Carbon (TOC) ≤ 2 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 < 1 pg/mL (with Biopak
®
lter)
DNases < 5 pg/mL (with Biopak
®
lter)
Proteases < 0.15 µg/mL
Flow rate 0.05 - 2 L/min
* in the appropriate operating conditions, otherwise typically < 5ppb.
The Milli-Q IQ 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 Highly puried water
U.S. Pharmacopeia Puried Water in bulk
Japanese Pharmacopeia Puried Water
Chinese Pharmacopeia Puried Water
ASTM
®
D1193 Type I water
ASTM
®
D5196 Bio-Application Grade Water (with appropriate nal lter)
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)