Sterile Filters
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.
- Millipore Express® SHC (Sterile, High Capacity) Filters: 0.5 and 0.2 µm sterilizing PES membrane for plugging streams
- Millipore Express® SHF (Sterile, High Flux) Filters: 0.2 µm sterilizing PES membrane for non-plugging streams
- Durapore® 0.22 µm Filters: Sterilizing PVDF membrane and are robust and low protein binding
- Multilayer Durapore® Sterilizing Filters: 0.45 and 0.22 µm sterilizing PVDF membrane for plugging streams
- Multimedia Durapore® Filters: 0.22 µm sterilizing PVDF membrane with an integrated prefilter
- Charged Durapore® Filters: Positively charged 0.22 µm sterilizing PVDF membrane for endotoxin removal
- Solvex™ Filters: 0.2 µm sterilizing PTFE membrane for non-aqueous solutions
Products
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
- Brochure: Strategies for Effective Bioburden and Aseptic Control
In this brochure, we provide information to highlight the differing objectives for bioburden control by unit operation and discuss the parameters that guide filter selection and optimization.
- Technical Brief: Extended Bacterial Retention Testing of Millipore Express® 0.2 μm Filters in a Continuous Flow System
The goal of this technical brief is to describe microbial retention performance of sterilizing-grade Millipore Express® SHF (Sterile High-Flux) filters under continuous flow operations for up to 16 hours processing duration.
- Application Note: Integrity Test Troubleshooting – Beyond Rewet and Retest
In this application note, we will consider all the potential sources of test error and apply a logical approach to resolution and retesting.
- Application Note: Establishing Product Specific Bubble Point Values for Sterilizing-Grade Filters
Integrity testing sterilizing filters is a fundamental requirement of critical process filtration applications in the pharmaceutical industry.
- Durapore® Family Guide
A trusted name in the industry, Durapore® polyvinylidene fluoride (PVDF) membranes are available in multiple pore sizes and formats to meet the needs of different operations in bioprocessing including liquid sterile filtration, sterile tank and gas venting, pre-use in-line integrity testing and final sterilizing filtration.
- Millipore Express® Family Guide
Our Millipore Express® filters can be used in a wide range of applications including filtration of cell culture media and feeds and for sterile filtration at different steps in monoclonal antibodies (mAbs), vaccine, plasma, viral vector and large and small volume parenteral production.
- Data Sheet: Solvex™ Solvent Filtration Cartridge Filters
Our Solvex™ brand cartridge filters combine high-performance polytetrafluoroethylene (PTFE) membranes with a robust cartridge design to deliver validated, reliable sterile filtration and efficient particulate removal.
Related Webinars
This webinar summarizes filter design, criteria for filter selection, and how new filter choices can maximize your productivity.
In this webinar, you will learn how filters for microfiltration of biological fluids work, the effect of operating conditions on filtration performance, and how to design an optimal series filtration (prefilter and final filter) process.
This webinar compares the current version of Annex 1 with the proposed changes and highlight areas of specific interest to companies who either manufacture in or export to EMA countries, PICS member countries, and WHO compliant countries.
In this webinar you will learn about the importance of sterilizing grade filters for removal of microorganisms from small volume parenterals, why this last unit operation in the process is a critical step, and how to make it effective for successful manufacturing.
To continue reading please sign in or create an account.
Don't Have An Account?