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MilliporeSigma

Choosing the Right Filter for Sterile Filtration

White and blue Millipore Express® filters of different formats and sizes for sterile filtration. Blue filters are gamma compatible, white capsules are autoclave-compatible. Cartridge filter elements with no filter housing are shown.

Aseptic capsule and cartridge filters for sterile filtration

Sterilizing filters are used throughout drug manufacturing to control bioburden by removing bacterial contaminants. Choosing the right sterilizing filter for each step is critical to developing an efficient, cost-effective process.

Filter selection depends on your process fluid: does it contain high or low levels of particulates, have high viscosity or more ‘water-like’ flow properties? Our Millipore Express® polyethersulfone (PES) sterilizing-grade membrane filters offer options for all application needs and will help you develop an efficient, sustainable sterile filtration step at any process scale.

Each of our Millipore Express®, non-PFAS, sterilizing-grade membrane filters will deliver sterility assurance and is supported by the Emprove® Program which provides the information you need to streamline risk assessments and simplify compliance.

For help choosing the right filter, contact us.

Section Overview

Non-plugging StreamsPlugging Streams
Millipore Express® SHF filters
  • Sterilizing filters (0.2 µm)
  • High flux PES* filters for critical process steps
Millipore Express® SHC filters
  • Sterilizing filters (0.5/0.2 µm)
  • High-capacity PES filters for critical process steps
  • High area formats available for improved process efficiency
Millipore Express® PHF filters
  • Sterilizing filters (0.2 µm)
  • Cost-effective PES filters for non-critical steps
Plugging and Non-Plugging Streams

Millipore Express® Ace 0.2 µm filters*

  • Sterilizing-grade filters (0.2 µm)
  • High-flux and high-capacity PES filters with low protein binding for critical process steps

*Currently available in OptiScale® 25 and Opticap® XL 150, XL 300 and XL 600 formats.

Visit our Final Sterile Filtration and Filling page for more information on Durapore 0.22 µm filters for critical filtration operations.

Sterilizing Filters for Non-Plugging Streams

For sterile filtration of non-plugging process streams we recommend Millipore Express® SHF (Sterile, High Flux) filters or Millipore Express® PHF (Process protection, High Flux) filters. These capsule and cartridge filters contain a 0.2 µm polyethersulfone (PES) sterilizing membrane, that provides high permeability, easy wetting and integrity testing and broad chemical compatibility.

  • Millipore Express® SHF filters should be used for critical process steps that require validated sterility assurance.
  • Millipore Express® PHF filters are a cost-effective filtration option for less critical steps, including buffer filtration.

Sterilizing Filters for Plugging Streams

For sterile filtration of plugging process streams we recommend Millipore Express® SHC (Sterile, High Capacity) filters. These capsule and cartridge filters deliver extremely high filtration capacity as the integrated 0.5 µm PES membrane prefilter protects the 0.2 µm PES sterilizing membrane, maximizing filter capacity and improving filtration robustness.

  • Millipore Express® SHC filters provide high permeability, are easy to wet and integrity test and offer broad chemical compatibility.
  • High area capsule and cartridge formats maximize filtration efficiency without increasing footprint.

Millipore Express® SHC filters, are 100% integrity tested during manufacturing and can be used for critical process steps that require validated sterility assurance.

Sterilizing Filters for Non-Plugging & Plugging Streams

Millipore Express® Ace 0.2 µm filters are recommended for efficient sterile filtration of both plugging and non-plugging streams. These filters contain a single layer membrane with optimized pore asymmetry that enables more membrane area within a standard filter format, leading to exceptional filter capacity and flux. With enhanced surface chemistry designed to minimize protein binding, Millipore Express® Ace 0.2 µm filters offer a more sustainable alternative to Durapore® 0.22 µm polyvinylidene fluoride (PVDF) for final filtration applications:

  • Exceptional filter capacity and flux with novel low protein binding surface chemistry for a wide range of sterile filtration applications.
  • Available in OptiScale® 25, Opticap® XL 150, XL 300 and XL 600 formats.

Millipore Express® Ace 0.2 µm filters are 100% integrity tested during manufacturing.

Explore details of Millipore Express® Membrane Filters in this Technical Article.


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Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 150 Capsule
KAFTG015FF3

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule

Fittings 3/4 in. TC/TC, Gamma Compatible

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 150 Capsule
KAFTS015FF3

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule

Fittings 3/4 in. TC/TC, Sterile

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 150 Capsule
KAFTG015FH3

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule

Fittings 3/4 in. TC- 9/16 in. HB, Gamma Compatible

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 150 Capsule
KAFTG015HH3

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule

Fittings 9/16 in. HB/HB, Gamma Compatible

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 150 Capsule
KAFTS015FH3

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule

Fittings 3/4 in. TC- 9/16 in. HB, Sterile

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 150 Capsule
KAFTS015HH3

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule

Fittings 9/16 in. HB/HB, Sterile

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 300 Capsule
KAFTG003FF3

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule

Fittings 3/4 in. TC/TC, Gamma Compatible

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 300 Capsule
KAFTS003FF3

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule

Fittings 3/4 in. TC/TC, Sterile

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 300 Capsule
KAFTG003FH3

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule

Fittings 3/4 in. TC- 9/16 in. HB, Gamma Compatible

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 300 Capsule
KAFTG003HH3

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule

Fittings 9/16 in. HB/HB, Gamma Compatible

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 300 Capsule
KAFTS003FH3

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule

Fittings 3/4 in. TC- 9/16 in. HB, Sterile

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 300 Capsule
KAFTS003HH3

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule

Fittings 9/16 in. HB/HB, Sterile

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 600 Capsule
KAFTG006FF3

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule

Fittings 3/4 in. TC/TC, Gamma Compatible

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 600 Capsule
KAFTS006FF3

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule

Fittings 3/4 in. TC/TC, Sterile

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 600 Capsule
KAFTG006FH3

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule

Fittings 3/4 in. TC- 9/16 in. HB, Gamma Compatible

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 600 Capsule
KAFTG006HH3

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule

Fittings 9/16 in. HB/HB, Gamma Compatible

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 600 Capsule
KAFTS006FH3

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule

Fittings 3/4 in. TC- 9/16 in. HB, Sterile

Millipore Express<SUP>®</SUP> Ace 0.2µm, Opticap<SUP>®</SUP> XL 600 Capsule
KAFTS006HH3

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule

Fittings 9/16 in. HB/HB, Sterile

Millipore Express<SUP>®</SUP> SHC, Opticap<SUP>®</SUP> XL Capsule
KHGES10HH1

Millipore Express® SHC 0.5/0.2µm, Opticap® XL 10 Capsule

Fittings 9/16 in. HB/HB, Sterile

Millipore Express<SUP>®</SUP> SHC, Opticap<SUP>®</SUP> XL Capsule
KHGES05HH1

Millipore Express® SHC 0.5/0.2µm, Opticap® XL 5 Capsule

Fittings 9/16 in. HB/HB, Sterile



Formats From Bench to Production Scales

All our sterilizing filters offer:

  • OptiScale® formats for efficient screening and scaling, and cartridge and capsule formats that can be easily scaled for manufacturing.
  • Autoclavable, presterilized or gamma-compatible formats, that can be integrated into Mobius® single-use assemblies.

Approximate filtration areas of capsule and cartridge filters. Refer to product specifications for complete information and accurate filtration areas for each product line. Read our technical article for additional information on different filter formats.

Format

Size

Filtration area (m2)

OptiScale® Capsules

25 mm

3.5 cm2

47 mm

17.7 cm2

Opticap® Small Scale Capsules*

XL 150

0.014-0.025

XL 300

0.028-0.050

XL 600

0.059-0.101

Opticap® Capsules

XL 3

~0.13-0.17

XL 5

~0.23-0.31

XL 10

~0.49-60

XLT 10

~0.49-60

XLT 20

~0.98-1.21

XLT 30

~1.47–1.81

Per 10” High Area Opticap® XLT Capsule*†

~1.0

Per Cartridge

5”

~0.23-0.29

10”

~0.48-0.54

Per 10” High Area cartridge†

~1.0

Opticap® capsules are autoclavable, gamma compatible or sterile except where noted.

*Sterile and gamma compatible filters only

†Millipore Express® SHC filters only

Quality Standards and Documentation

All Millipore Express® filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO 9001 Quality Systems Standard, and are supported by a certificate of quality.

Millipore Express® Ace 0.22 µm, Millipore Express® SHC, and Millipore Express® SHF filters are supported by the Emprove® Program which provides three types of dossiers to support different stages of development and manufacturing operations such as qualification, risk assessment, and process optimization. The dossiers consolidate comprehensive product-specific testing data, quality statements, and regulatory information in a readily available format so you can move forward with confidence.


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