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 is highly dependent on your process fluid: does it contain high or low levels of particulates, have high viscosity or more ‘water-like’ flow properties? This type of information, along with chemical composition of the process fluid, needs for the process step, and the type of process, either single- or multi-use, will guide filter selection.
Each of our Millipore Express®, non-PFAS, sterilizing-grade membrane filters will produce a sterile effluent and provide sterility assurance, giving you confidence in your filtration process. In addition, they’re supported by the Emprove® Program which provides the documentation you need to streamline risk assessments and simplify compliance.
For help determining the right filter for your process, contact us.
Section Overview
- Sterilizing filters for non-plugging streams
- Sterilizing filters for plugging streams
- Formats from bench to production scales
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 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.
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.
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.
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® 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 Product Resources
- 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.
- Aseptic 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.
Related Videos
Related Webinars
To continue reading please sign in or create an account.
Don't Have An Account?