Fluorodyne® II DJL - Novasip™ Capsules product photo Primary L

Fluorodyne® II DJL - Novasip™ Capsules

These 0.1 micron-rated filters with serial layer (0.2/0.1 micron) membrane construction assure high flow rates compared with other 0.1 micron (and even some 0.2 micron)-rated filters. Fluorodyne II grade DJL filters are validated for removal of Acholeplasma laidlawii mycoplasma (ATCC 28206) with a typical TR >1011 and retention of Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm² effective filter area (EFA). This allows enhanced sterilization assurance as well as efficient mycoplasma control.

Novasip™ capsules are the first and only single-use filter capsules that can be sterilized by in-line steaming (SIP). These robust filter capsules are an ideal low-maintenance alternative to a stainless steel housing and cartridge assembly, often still considered the only option when a filter must be integrated into an SIP system. Novasip capsules are certified for use in pharmaceutical manufacturing environments and sized for liquid volumes of 30 L to 500 L or in low-to-moderate flow air/gas/vent applications.

Features and Benefits

  • Low installation cost - up to 80% less than a comparable stainless steel system
  • Steam-in-place capability with no housing cleaning or maintenance
  • Clear housing for easy venting 
  • Laser-etched serial number for easy identification 
  • New design sanitary valves
    • Non-removable for safety 
    • Non-threaded for cleanliness
  • Integral Stäubli*-compatible vent valve enables direct on-line connection to integrity test equipment
  • Non-rotating hose barb drain for safe and hygienic operation
  • Available in a range of media and removal ratings
    * Stäubli is a trademark of Stäubli AG


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Description

These 0.1 micron-rated filters with serial layer (0.2/0.1 micron) membrane construction assure high flow rates compared with other 0.1 micron (and even some 0.2 micron)-rated filters. Fluorodyne II grade DJL filters are validated for removal of Acholeplasma laidlawii mycoplasma (ATCC 28206) with a typical TR >1011 and retention of Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm² effective filter area (EFA). This allows enhanced sterilization assurance as well as efficient mycoplasma control.

Novasip™ capsules are the first and only single-use filter capsules that can be sterilized by in-line steaming (SIP). These robust filter capsules are an ideal low-maintenance alternative to a stainless steel housing and cartridge assembly, often still considered the only option when a filter must be integrated into an SIP system. Novasip capsules are certified for use in pharmaceutical manufacturing environments and sized for liquid volumes of 30 L to 500 L or in low-to-moderate flow air/gas/vent applications.

Features and Benefits

  • Low installation cost - up to 80% less than a comparable stainless steel system
  • Steam-in-place capability with no housing cleaning or maintenance
  • Clear housing for easy venting 
  • Laser-etched serial number for easy identification 
  • New design sanitary valves
    • Non-removable for safety 
    • Non-threaded for cleanliness
  • Integral Stäubli*-compatible vent valve enables direct on-line connection to integrity test equipment
  • Non-rotating hose barb drain for safe and hygienic operation
  • Available in a range of media and removal ratings
    * Stäubli is a trademark of Stäubli AG

Specifications

Materials Of Construction

 
Filter Membrane  Hydrophilic modified PVDF
Support/Drainage Polypropylene
End Cap, Core and Cage Polypropylene
Capsule Bowl Polyetherimide
Sealing Technology Thermal bonding without adhesives
Housing Head Polyetherimide with TiO2 whitener¹
 
¹ TiO2 is an insoluble inorganic mineral filler that does not contribute to organic extractables

Operating Parameters²

 
Maximum Operating Temperature  60 °C 
Maximum Operating Pressure 6.5 bar (94 psi) at 40 °C
2.0 bar (29 psi) at 60 °C
Maximum Differential Pressure (Forward Direction) 5.3 bar (77 psi) at 40 °C
4.1 bar (60 psi) at 60 °C
 
² In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction


Sterilization³

 
Autoclave or In-Situ steam 30 x 60 minutes at 125 °C
5 x 60 minutes at 140 °C
 

Typical Extractables in Water at 20 °C³

 
< 5 mg per capsule
 
³ Tested on capsules without pre-flushing

Nominal Dimensions

 
  CLM05 C05/C3
Diameter Incl. Valves  123 mm (4.8 in.) 123 mm (4.8 in.)
Overall Length 84 mm (3.3 in.) 157 mm (6.2 in.)
 


Nominal Effective Filter Area (EFA)

 
C(LM)05 400 cm² (0.4 ft²)
C(L)3 1500 cm² (1.6 ft²)
 

Type

Filter Capsules

Use

Mycoplasma Removal

Product Summary

This system needs low installation costs and features steam in place technology for no operator maintenance. Fluorodyne® II DJL Membrane in Novasip™ Capsules are designed to be self-maintaining with vents and sanitary valves. Its efficient mycoplasma control retains B. diminuta and other bioburden. Parts are integral with SIP system and Staubli components.

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