Certification

EP Scientific Purified Water Used for Final Rinses

USP Purified Water: Container Sizes >250 mL

      USP Specifications       Typical EP Values
TOC <500 ppb 10-20 ppb
Conductivity  <1.3 µS/cm 0.06 µS/cm
Bacteria 100 cfu / mL 0 cfu / 100 mL

USP Water for Injection (WFI): Containers ≤ 250 mL

      USP Specifications       Typical EP Values
TOC <500 ppb 10-20 ppb
Conductivity  <1.3 µS/cm 0.06 µS/cm
Bacteria 10 cfu / 100 mL 0 cfu / 100 mL
Endotoxin <0.25 EU/ mL <0.06 EU/ mL

Critical Environment Technical Data

PARTICULATES GLASS OR PLASTIC
GROUP L		   LOW-PARTICLE / METALS COMBINATION
  (µg/L) PLASTICS ONLY GROUP E
COMPOUND   SPEC  CONTAINER SIZE  COMPOUND    SPEC  COMPOUND   SPEC  
Particulates General 1  <5 pcs/mL @ 0.5 µm >100 mL Aluminum <10 Potassium <10
Particulates General 2  <10 pcs/mL @ 0.5 µm 20-100 mL Calcium <10 Magnesium <10
Particulates General 3  <20 pcs/mL @ 0.5 µm >20 mL Copper <10 Manganese <10
Particulates General 4  <50 pcs/mL @ 0.5 µm >125 mL Iron Particulates
<50pcs/mL
@ 0.2 µm		 <10 Sodium <10

LOW LEVEL METALS (µg/L) TEFLON
GROUP F		   TOC PARTICLE COMBINATION GLASS
  GROUP J
COMPOUND   SPEC   COMPOUND   SPEC  COMPOUND    SPEC  COMPOUND   SPEC  
Aluminum  <0.5 Potassium <1.0 TOC <1 ppm Particles:
pcs/mL
@ 0.5 µm		 <10
Calcium  <1.0 Lead <0.5
Copper  <0.5 Sodium <1.0
Iron <1.0 Zinc <0.5




TOC GLASS
GROUP M		   TOC GLASS
  GROUP J
COMPOUND   SPEC  COMPOUND    SPEC  COMPOUND   SPEC  
TOC General 1     <10 ppb   TOC <1 ppm Particles:
pcs/mL
@ 0.5 µm		 <10
TOC General 2   <20 ppb  




ENDOTOXIN GLASS
GROUP N		   ENDOTOXIN / PARTICLE
  COMBINATION GLASS GROUP K
COMPOUND   SPEC  COMPOUND    SPEC  COMPOUND   SPEC  
Endotoxin
General  		   <.06  
  EU/mL  		 Endotoxin <.06
EU/mL		 Particles:
pcs/mL
@ 0.5 µm		 <100

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