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Sterile Filters

Sterile drug product

Sterile filtration is an important step in the drug production process and is routinely implemented for bacterial removal throughout bioprocessing to achieve bioburden control.  


For sterile filtration of aqueous liquids, we offer filters containing Durapore® polyvinylidene fluoride (PVDF) membranes and Millipore Express® filters containing polyethersulfone (PES) membranes. For sterile filtration of non-aqueous liquids, polytetrafluoroethylene (PTFE) membranes are available.

Selecting the right filter

Choosing the right sterilizing filter and device format for the process step or application is key to developing an efficient, cost-effective process. You can be confident our filter portfolio encompasses the standard-setting products your work deserves.
Filter selection is dependent on the feed characteristics and particulate levels, the level of contamination risk, and the specific process step. For critical aseptic processing operations, sterilizing-grade filters are the preferred solution. For non-critical or “low risk” operations such as buffer filtration and column protection, bioburden reduction filters may be used. 

  • All filters are fully scalable from small-scale tools to pilot and production-scale manufacturing
  • Most are offered as single-use capsules or cartridge filters
  • For plugging streams, high-area formats double the membrane area, without increasing filter footprint
  • Filters are offered in autoclavable, gamma-compatible or pre-sterilized formats with different connection options

Regulatory Compliance

Complementing our product portfolio, the Emprove® Program consolidates comprehensive product-specific testing data, quality statements, and regulatory information in a readily available format to simplify your compliance needs.

Related Product Resources

Product Selection

Brochure: Mission Control: Strategies for Effective Bioburden and Aseptic Control
Tech Bulletin: Extended Bacterial Retention Testing of Millipore Express® 0.2 μm Filters in a Continuous Flow System
Webinar: Selection, Sizing, and Operation of Bioprocess Filtration Trains for Optimal Performance
Webinar: Find Your Filter – Which Aseptic Filter is Best for Your Process?
Webinar: Strategies to Address Bioburden Control in Downstream Processing
Webinar: Does Your SVP Process Assure Sterile Drug Product? 
Webinar: Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes for Investigational Medicinal Compounds
Webinar: Scale-up of High-Area Filters for Microfiltration of Biological Fluids

 

Product Operations

Tech Bulletin: Integrity Test Troubleshooting – Beyond Rewet and Retest
Tech Bulletin: Establishing Product Specific Bubble Point Specifications for Sterilizing Grade Filters
Webinar: Filter Integrity Testing Best Practices 
Webinar: Potential Impact of Draft Annex 1 on Sterilizing Filtration

Product Specifications 

Durapore® Family Guide
Millipore Express® Family Guide
Solvex™ Solvent Filtration Cartridge Filters

Products

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Product Number
Product Description
Pricing
MPGL02GH2
Durapore® 0.22 µm, Millipak® Capsule, sterile
KHGES10HH1
Millipore Express® SHC, Opticap® XL Capsule, Opticap® XL 10, sterile, inlet connection diam. 9/16 in., pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm)
MPGL02GF2
Durapore® 0.22 µm, Millipak® Capsule, sterile
KHGES03HH3
Millipore Express® SHC, Opticap® XL Capsule, sterile, Opticap® XL 3, inlet connection diam. 9/16 in., pore size 0.5/0.2 μm, cartridge nominal length 3 in. (7.5 cm)
MPGL1GCF3
Durapore® 0.22 µm, Millipak® Capsule, sterile
MTGR15010
Aervent® Capsule Filter, pore size 0.2 μm
MCGB10S02
Hydrophobic Durapore® 0.22 µm, Millidisk® Cartridge, filtration area 500 cm2, hydrophobic
MPGL1GCA3
Durapore® 0.22 µm, Millipak® Capsule, sterile
KVGLA10HH1
Durapore® 0.22 µm, Opticap® XL Capsule, Opticap® XL 10, inlet connection diam. 9/16 in., cartridge nominal length 10 in. (25 cm)
KHGES006FF3
Millipore Express® SHC, Opticap® XL Capsule, Opticap® XL 600, sterile, inlet connection diam. 3/4 in., pore size 0.5/0.2 μm, cartridge nominal length 6.5 in. (16.5 cm)
MPGL2GCF3
Durapore® 0.22 µm, Millipak® Capsule, sterile
CVDI73TPE
Durapore® CBR 0.2 µm, Cartridge, pore size 0.2 μm, cartridge nominal length 30 in. (75 cm), Code 7 (2-226; O-rings w/locking-tabs)
KHGES003HH3
Millipore Express® SHC, Opticap® XL Capsule, Opticap® XL 3, sterile, outlet connection diam. 9/16 in., pore size 0.5/0.2 μm, cartridge nominal length 4.7 in. (11.9 cm)
KVVLA2TTH1
Durapore® 0.1 µm, Opticap® XLT Capsule, Opticap® XLT 20, cartridge nominal length 20 in. (50 cm), filter diam. 4.2 in. (10.7 cm)
MTGR85010
Aervent® Capsule Filter, pore size 0.2 μm
MPHL02GH2
Durapore® 0.45 µm, Millipak® Capsule, sterile, Millipak® 20
KTGRA04TT3
Aervent® 0.2 µm, Opticap® XL Capsule, Opticap® XL 4, inlet connection diam. 1.5 in., pore size 0.2 μm, cartridge nominal length 7.7 in. (19.6 cm)
KHGES003FF3
Millipore Express® SHC, Opticap® XL Capsule, Opticap® XL 3, sterile, inlet connection diam. 3/4 in., pore size 0.5/0.2 μm, cartridge nominal length 4.7 in. (11.9 cm)
LAGR04TP6
Aervent® 0.2 µm, Optiseal® Cartridge, pore size 0.2 μm, OptiSeal® 4 in., filtration area 0.18 m2, matrix Aervent®
CHGE75TS3
Millipore Express® SHC, Cartridge, pore size 0.5/0.2 μm, cartridge nominal length 5 in. (12.5 cm), Code 7, silicone seal
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Highlights

Find Your Filter – Which Aseptic Filter is Best for Your Process?
Find Your Filter – Which Aseptic Filter is Best for Your Process?

This webinar summarizes filter design, criteria for filter selection, and how new filter choices can maximize your productivity. 

Selection, sizing, and operation of bioprocess filtration trains for optimal performance
Selection, sizing, and operation of bioprocess filtration trains for optimal performance

A model and test methodology are described for rapidly and efficiently determining an optimal prefilter and final filter system design for filtration of bioprocess fluids.

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