Fluorodyne® II DFL Membrane in Novasip™ Capsules product photo Primary L

Fluorodyne® II DFL Membrane in Novasip™ Capsules

These validated 0.2 micron-rated sterilizing-grade filters retain Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm² effective filter area (EFA) and ensure very low extractables and adsorption. They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions.

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


* Required
Need Help?
Description
These validated 0.2 micron-rated sterilizing-grade filters retain Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm² effective filter area (EFA) and ensure very low extractables and adsorption. They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions.

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


Sterilization

 
Autoclave or In-Situ steam 30 x 60 minutes at 125 °C
10 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/C1/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)

 
CL(M)05 400 cm² (0.4 ft²)
C(L)1 700 cm² (0.7 ft²)
C(L)3 1500 cm² (1.6 ft²)
 

Application
Filters - Liquid - Sterile (0.2 micron)