Choosing the Right Filter for Sterile Filtration

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 Streams | Plugging Streams |
|---|---|
Millipore Express® SHF filters
| Millipore Express® SHC filters
|
Millipore Express® PHF filters
| |
| Plugging and Non-Plugging Streams | |
Millipore Express® Ace 0.2 µm filters*
*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.
Products

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule
Fittings 3/4 in. TC/TC, Gamma Compatible

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule
Fittings 3/4 in. TC/TC, Sterile

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule
Fittings 3/4 in. TC- 9/16 in. HB, Gamma Compatible

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule
Fittings 9/16 in. HB/HB, Gamma Compatible

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule
Fittings 3/4 in. TC- 9/16 in. HB, Sterile

Millipore Express® Ace 0.2µm, Opticap® XL 150 Capsule
Fittings 9/16 in. HB/HB, Sterile

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule
Fittings 3/4 in. TC/TC, Gamma Compatible

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule
Fittings 3/4 in. TC/TC, Sterile

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule
Fittings 3/4 in. TC- 9/16 in. HB, Gamma Compatible

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule
Fittings 9/16 in. HB/HB, Gamma Compatible

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule
Fittings 3/4 in. TC- 9/16 in. HB, Sterile

Millipore Express® Ace 0.2µm, Opticap® XL 300 Capsule
Fittings 9/16 in. HB/HB, Sterile

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule
Fittings 3/4 in. TC/TC, Gamma Compatible

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule
Fittings 3/4 in. TC/TC, Sterile

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule
Fittings 3/4 in. TC- 9/16 in. HB, Gamma Compatible

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule
Fittings 9/16 in. HB/HB, Gamma Compatible

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule
Fittings 3/4 in. TC- 9/16 in. HB, Sterile

Millipore Express® Ace 0.2µm, Opticap® XL 600 Capsule
Fittings 9/16 in. HB/HB, Sterile

Millipore Express® SHC 0.5/0.2µm, Opticap® XL 10 Capsule
Fittings 9/16 in. HB/HB, Sterile

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.
Related Resources
- Data sheet: Millipore Express® Ace 0.2 µm Filters
Advanced Sterilizing-Grade Solution for Exceptional Filtration Capacity and Flux
- Application Note: Millipore Express® Ace 0.2 µm Membrane
An innovative sterilizing-grade membrane for efficient filtration of biologics
- Prefilters and Sterilizing-grade Filter Formats: Selection Guide
Aseptic filters are offered in disposable capsules and cartridge formats. This guide will help you find the right format for your bioburden control.
- Article: Millipore Express® Express Sterilizing-Grade Membrane Filters Selection Guide
Discover various Millipore Express® sterilizing-grade membrane filters for liquid filtration in aseptic drug production.
- Article: Optimizing Upstream Processing: Media Filtration and Cell Culture Performance
This technical article provides guidance on selecting and sizing filters for cell culture media filtration.
- Brochure: Mission Control: Strategies for Effective Bioburden and Aseptic Control
Read this brochure to learn more about bioburden control, filter selection, and optimization of your filtration process
- Technical Note: Performance of High-Area Millipore Express® Cartridge Filters
High area filters can improve filtration productivity for mid- to high- plugging streams. Read how our model can help predict the benefits for different streams.
- Technical Note: Extended Bacterial Retention Testing of Millipore Express® SHF 0.2 μm Filters in a Continuous Flow System
This technical note summarizes retention performance of Millipore Express SHF sterilizing filter over long duration, constant flow processing conditions.
- Millipore Express® Family Guide
Read this guide to review key differentiators and product specifications of Millipore Express® membrane filters.
- Technical Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
Filter integrity testing doesn’t always go smoothly. Learn how to avoid costly mistakes and troubleshoot integrity test challenges.
- Brochure: Vmax™ Constant Pressure Test for sizing Aseptic Filters
This protocol describes how to use results from small scale studies to predict filtration area requirements.
- Article: Prefilters and Sterilizing-grade Filter Formats: Selection Guide
Aseptic filters are offered in disposable capsules and cartridge formats. This guide will help you find the right format for your bioburden control.
- Application Note: Improved Accuracy of Scaling with OptiScale® 25 Devices
This application note explains the benefits of well-designed scaling tools for accurately predicting filtration area requirements for larger scale processes.
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