Requirements and specifications
36
REQUIREMENTS AND SPECIFICATIONS
Water specifications
Elix Water
The system has been designed to produce water according to specifications when operating
within feed water requirements.
Parameter
Value or range
Resistivity
> 5 MΩ.cm @ 25°C
Conductivity
< 0.2 μS/cm @ 25°C
Total Organic Carbon (TOC)
≤ 30 ppb
Particles (size > 0.22µm)
No particles with size > 0,22 µm if 0,22µm filter used
Bacteria
< 0,01 CFU/mL (with Millipak® 40 or Biopak® filters when
installed and used in a laminar flow hood)
Pyrogens (endotoxins)
< 0,001 EU/mL (with Biopak® filter when installed and used in
a laminar flow hood)
RNases
< 1 pg/mL
(with Biopak
®
filter)
DNases
< 5 pg/mL
(with Biopak
®
filter)
Proteases
< 0.15 µg/mL
Flow rate
3 L/h for IQ 7003
5 L/h for IQ 7005
10 L/h for IQ 7010
15 L/h for IQ 7015
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
Purified water
U.S. Pharmacopeia
Purified Water
Japanese Pharmacopeia
Purified Water
Chinese Pharmacopeia
Purified Water
ASTM
®
D1193
Type II water Grade B
ISO
®
3696
Grade 2 water
Chinese National Standard
GB 6682 Grade 2 water
JIS K 0557
A2 water