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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 Filter	Filter 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 Filter	Filter 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 Filter	Filter 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

Product News & Releases

• Millipore Introduces Solvex™ Solvent Filters - New cartridge filters ideal for sterile manufacture of APIs
• Millipore Introduces the Mobius® MIX500 Disposable Mixing System - Increased process speed and reduced risk now in a 500L size
• Millipore Expands Its NovAseptic® Mixer Family - The new GMP30000 mixer is ideal for effective mixing in large volumes
• Millipore Introduces New Service Offer for Evaluating Mixing Solutions

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