HYPER (USP/EP) Water for Injection

HYPER

PACKAGED PRODUCT ANALYSIS

METHOD OF REFERENCE

SPECIFICATION

Appearance

Visual

Clear & Colorless Liquid

Total Organic Carbon

USP <643>

< 8000 ppb

Conductivity

USP <645>

≤ 5 µS/cm

Endotoxin

USP <85>

≤ 0.25 EU/mL

Sterility

USP <71>

No Growth

Particulate Matter

USP <788>

≥ 25 µm in size

≤ 3 particles/mL

≥ 10 µm in size

≤ 25 particles/mL

Oxidizable Substances

EP Sterilized WFI

Solution remains faintly pink

Residue on Evaporation

EP Sterilized WFI

≤ 3 mg (0.003%)

Nitrates

EP Sterilized WFI

≤ 0.2 ppm

WFI Generation Online Analysis		WFI-USP
Conductivity (µS/cm)	≤ 0.06 µS/cm	≤ 1.3 µS/cm
TOC	≤ 20 ppb	< 500 ppb

ULTRA (USP) Water for Injection

ULTRA

PACKAGED PRODUCT ANALYSIS

METHOD OF REFERENCE

SPECIFICATION

Appearance

Visual

Clear & Colorless Liquid

Total Organic Carbon

USP <643>

< 8000 ppb

Conductivity

USP <645>

≤ 5 µS/cm

Particulate Matter

USP <788>

≥ 25 µm in size

≤ 3 particles/mL

≥ 10 µm in size

≤ 25 particles/mL

Endotoxin

USP <85>

≤ 0.25 EU/mL

Sterility

USP <71>

No Growth

WFI Generation Online Analysis		WFI-USP
Conductivity (µS/cm)	≤ 0.06 µS/cm	≤ 1.3 µS/cm
TOC	≤ 20 ppb	< 500 ppb

WIR Water for Irrigation

WIR

PACKAGED PRODUCT ANALYSIS	METHOD OF REFERENCE	SPECIFICATION
Appearance	Visual	Clear & Colorless Liquid
Total Organic Carbon	USP <643>	< 8000 ppb
Conductivity	USP <645>	≤ 5 µS/cm
Endotoxin	USP <85>	≤ 0.25 EU/mL
Sterility	USP <71>	No Growth

SPW Sterile Purified Water

SPW

PACKAGED PRODUCT ANALYSIS	METHOD OF REFERENCE	SPECIFICATION
Appearance	Visual	Clear & Colorless Liquid
Total Organic Carbon	USP <643>	< 8000 ppb
Conductivity	USP <645>	≤ 5 µS/cm
Sterility	USP <71>	No Growth

Sterile Fluid & Path Flush Syringes

Pre-filled Flush Syringes with 0.9% Sodium Chloride (Saline)
  

  
      Code Number
      510(k) Number
      Device Number
      Volume (fill)
      Packaging
    


  
      2T0805
      K113555
      D218483
      5mL
      Sterile Fluid & Path
    

      2T0806
      K113555
      D218483
      10mL
      Sterile Fluid & Path
    

      2T0807
      K113555
      D218483
      3mL
      Sterile Fluid & Path
    

Syringe Information
  

  
      Code Number
      Capacity
      Length (inches)
      Width (inches)
      Weight (lbs)
    


  
      2T0805 (5mL fill)
      12mL
      6.25"
      1.25"
      0.035
    

      2T0806 (10mL fill)
      12mL
      6.25"
      1.25"
      0.045
    

      2T0807 (3mL fill)
      12mL
      6.25"
      1.25"
      0.027
    

Case (shipper) Information

Code Number	Quantity (case)	Cartons* per case	Carton* quantity
2T0805	400	4	100
2T0806	400	4	100
2T0807	400	4	100

*carton aka box

Carton Dimensions
  

  
      Code Number
      Length (inches)
      Height (inches)
      Width (inches)
      Weight (lbs)
    


  
      2T0805
      11"
      7.125"
      7.5"
      4.06
    

      2T0806
      11"
      7.125"
      7.5"
      5.06
    

      2T0807
      11"
      7.125"
      7.5"
      3.38
    

Case Dimensions
  

  
      Code Number
      Length (inches)
      Height (inches)
      Width (inches)
      Weight (lbs)
    


  
      2T0805
      22.5"
      7.25"
      15.25"
      18
    

      2T0805
      22.5"
      7.25"
      15.25"
      22
    

      2T0805
      22.5"
      7.25"
      15.25"
      15.25
    

Sterile Field Ready Flush Syringes

Pre-filled Flush Syringes with 0.9% Sodium Chloride (Saline)
  

  
      Code Number
      510(k) Number
      Device Number
      Volume (fill)
      Packaging
    


  
      2S0706
      K120836
      D218482
      10mL
      100% Sterile (Sterile Field Ready)
    

      2S0708
      K133685
      D412001
      20mL
      100% Sterile (Sterile Field Ready)
    

Syringe Information
  

  
      Code Number
      Capacity
      Length (inches)
      Width (inches)
      Weight (lbs)
    


  
      2S0706 (10mL fill)
      12mL
      6.25"
      1.25"
      0.056
    

      2S0708 (20mL fill)
      20mL
      7.00"
      1.95"
      0.086
    

Case (Shipper) Information

Code Number	Quantity (case)	Cartons* per case	Carton* quantity
2S0706	240	4	60
2S0708	80	4	20

*carton aka box

Carton Dimensions
  

  
      Code Number
      Length (inches)
      Height (inches)
      Width (inches)
      Weight (lbs)
    


  
      2S0706
      11"
      7.125"
      7.5"
      3.52
    

      2S0708
      8.75"
      5.00"
      5.00"
      2.86
    

Documentation

Product Information Instructions For Use (IFU)

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