Requirements and specications
37
REQUIREMENTS AND SPECIFICATIONS
Waterspecications
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 MΩ.cm @ 25°C
Conductivity 0.055 μS/cm @ 25°C
Total Organic Carbon (TOC) ≤ 5 ppb
Particles (size > 0.22µm)
No particles with size > 0,22 µm if 0,22µm lter used
Bacteria
< 0,01 CFU/mL (with Millipak® 40 or Biopak® lters when in-
stalled and used in a laminar ow hood)
Pyrogens (endotoxins)
< 0,001 EU/mL (with Biopak® lter when installed and used in
a laminar ow hood)
RNases < 1 pg/mL (with Biopak
®
lter)
DNases < 5 pg/mL (with Biopak
®
lter)
Proteases < 0.15 µg/mL
Flow rate up to 2 L/min
Volumetric Dispensing Accuracy +/- 2% for QPOD ; +/- 5% for EPOD
The Milli-Q IQ 7003/7005/7010/7015 system is intended to produce ultrapure water that
meets or exceeds requirements as described by the organizations below:
Organization Water quality / grade
European Pharmacopeia puried water
U.S. Pharmacopeia Puried Water
Japanese Pharmacopeia Puried Water
Chinese Pharmacopeia Puried Water
ASTM
®
D1193 Type I water grade B
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)