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Understanding the Options:

Large Volume Parenterals (LVP)



Prefiltration

Essential Process Requirements
  • Remove colloidal and particulate contaminants
  • Preserve product purity
  • Operate consistently at high differential pressures and flow rates
  • Prevent plugging and extend the life of downstream filters
  • Able to withstand demanding sanitization cycles
  • Run efficiently to ensure process economics
  • Solute concentration impacts filter selection

Recommended FilterFilter Characteristics

Double-layer Milligard Filters
(Grade SS, 0.5 µm + 0.2 µm, or Grade SC, 1.2 µm + 0.5 µm)
Cartridge Filters
Opticap Capsule Filters
Optiscale Capsule Filters
  • Double-layer pleated configuration of mixed esters of cellulose membranes remove particles and colloids
  • High porosity membranes operate at high flow rates and low pressure drops
  • Better suited for low-solute concentrations
  • Non-fiber releasing structure preserves product purity
  • 100% integrity tested to ensure quality
  • Robust construction validated to withstand multiple SIP or hot water sanitization cycles
  • Available in a variety of pore sizes to accommodate the needs of each user. Grade SS is commonly used to protect downstream 0.22 µm sterilizing-grade filters. Grade SC is better suited to protect 0.45 µm membrane filters. Choice should be made based on small-scale testing.

Double-layer Polysep II Filters
(Grade W6, 1 µm + 0.5 µm, or Grade W3, 1 µm + 0.2 µm)
Cartridge Filters
Opticap Capsules
Optiscale Capsules
  • Borosilicate glass top layer enhances particle and loading capacity in high solute applications
  • Mixed esters of cellulose membrane bottom layer ensures high retention and filtrate quality
  • Ideal for high solute concentration such as 5% Dextrose
  • Robust construction validated to withstand multiple SIP or hot water sanitization cycles
  • Non-fiber releasing structure preserves product purity
  • 100% integrity tested to ensure quality
  • Available in a variety of pore sizes to accommodate the needs of each user. Grade W3 is commonly used to protect downstream 0.22 µm membrane filters. Grade W6 is better suited to protect 0.45 µm membrane filters. Choice should be made based on small-scale testing.


Bioburden Reduction

Essential Process Requirements
  • Reduce bioburden prior to terminal sterilization
  • Preserve product purity
  • Operate consistently at high flow rates
  • Able to withstand demanding sanitization requirements

Recommended FilterFilter Characteristics

Double-layer Durapore 0.45 µm Filters
(with 0.5 µm prefilter layer)
Cartridge Filter
Optiseal Cartridge Filters
Opticap Capsule Filter
  • Low protein-binding PVDF membrane with prefilter
  • Retentive membrane reduces bioburden
  • Low extractables and non-fiber releasing PVDF chemistry preserve product purity and yield
  • High flow rate at low pressure drop for reliable economic processing100% integrity tested to ensure quality
  • validated for multiple SIP and hot water sanitization cycles
Durapore CBR 0.2 µm Filters
  • Low protein-binding 0.2 µm PVDF membrane
  • Bacterial retentive membrane reduces bioburden
  • Low extractables and non-fiber releasing PVDF chemistry preserve product purity and yield
  • High flow rate at low pressure drop for reliable economic processing
  • 100% integrity tested to ensure quality
  • Validated for multiple SIP and hot water sanitization cycles

Final Sterile Filtration

Essential Process Requirements
  • Sterile filtration prior to terminal sterilization
  • Operate consistently at high differential pressures and flow rates
  • Able to withstand rigorous sanitization and process requirements
  • Ensure product safety

Recommended FilterFilter Characteristics

Double-layer Durapore 0.45 µm Filters
(with 0.5 µm prefilter layer)
Cartridge Filter
Optiseal Cartridge Filters
Opticap Capsule Filter
  • Low protein-binding PVDF membrane with prefilter
  • Retentive membrane reduces bioburden
  • Low extractables and non-fiber releasing PVDF chemistry preserve product purity and yield
  • High flow rate at low pressure drop for reliable economic processing
  • 100% integrity tested to ensure quality
  • Validated for multiple SIP and hot water sanitization cycles

ALTERNATIVE: If a PES membrane is required, Millipore suggests including Millipore’s Express SHF Filters in your screening trials.