Sterility Assurance with Confidence!
Efficient Processing for Every Step
Sterilizing Filters: Optimized Performance Delivers Confidence at Every Processing Step
Every filtration step has its own complexity and challenges. Our time-tested portfolio can meet your filtration goals by reducing risk and delivering:
- Effective prefiltration solutions to maximize processing efficiency.
- Excellent capacity, flux and retention performance for liquid sterile filtration applications.
- Robust process protection with our gas and vent filters.
We deliver what you need, when you need it, so you can be confident in your long-term supply. To accelerate and simplify your path to market our Validation Services can help you select, test, and validate your filters and single-use systems for drug manufacturing while the Emprove® Program provides the documentation you need for product qualification and preparation of your regulatory filing. Backed by decades of experience and technical, scientific, and regulatory support, our filtration solutions will help you stay ahead of the curve.
Explore our sterilizing filters offering:
Prefilters are a cost-effective, proven technology used throughout drug manufacturing to remove particulates, reduce bioburden and improve processing efficiency.
Milligard® PES membrane filters are gamma-compatible, bioburden reduction filters, offered in three pore sizes, and are the best choice for most pharma and biopharma applications. These prefilters increase the capacity of sterilizing filters and protect unit operations from particulate impurities. They can also be used to reduce bioburden, where sterile filtration may not be needed.
Key Benefits:
- Validated bioburden reduction claims (1.2/0.2 µm nominal, 1.2/0.45 µm only).
- Fast flow and high throughput.
- Available in cartridge and gamma-compatible formats, that can be integrated into Mobius® single-use assemblies.
- Supported by the Emprove® Program to help you make agile risk-based decisions and maintain compliance.
Filters used for large- and small- volume parenteral (LVP and SVP) manufacturing should be cost effective and deliver reliable bioburden reduction or sterile filtration performance. Recommended filters include:
- Filters are available in cartridge and capsule formats.
- All filters are supported by the documentation that provides the product and testing information you need to move forward with confidence. Milligard® PES, Millipore Express® SHF, Millipore Express® SHC and Durapore® 0.22 µm filters are supported by the Emprove® Program to help you make agile risk-based decisions and maintain compliance.
Filtration of Buffers & Non-Plugging Liquids
Non-plugging liquids include buffers and clean in place (CIP) solutions. For process efficiency, filters for these fluid streams should deliver fast flow and high throughput. Recommended filters include:
- All filters are available in cartridge and gamma-compatible capsule formats that can be integrated into Mobius® single-use assemblies.
- Millipore Express® SHF and Milligard® PES filters are supported by the Emprove® Program to help you make agile risk-based decisions and maintain compliance.
Read the Millipore Express® Family Guide
Filtration of Complex Streams
Complex streams such as cell culture media and bioprocessing intermediates, can be a challenge to liquid filtration as the high levels of plugging components can lead to premature fouling and limit filter capacity. Recommended filters include:
- High area formats of both Millipore Express® SHC and Millipore Express® SHRP filters maximize filtration capacity without increasing footprint, while reducing costs and supporting sustainability goals.
- Filters are available in cartridge, presterilized and gamma-compatible capsule formats that can be integrated into Mobius® single-use assemblies.
- Supported by the Emprove® Program to help you make agile risk-based decisions and maintain compliance.
Read the Technical Brief: Cell Culture Media Filtration
Final Sterile Filtration
Final sterile filtration and filling are the last steps in the production process and are critical operations to assure product sterility and drug safety for patients. Either capsule or cartridge filters can be implemented, and redundant filtration is common to mitigate the risk of a non-integral filter. Recommended filters include:
- Filters are available in cartridge, presterilized and gamma-compatible capsule formats that can be integrated into Mobius® single-use assemblies.
- Supported by the Emprove® Program to help you make agile risk-based decisions and maintain compliance.
Read the Technical Brief: Millipak® Final Fill Filters Reduce Contamination Risks and Simplify Filtration System Design and Operation
Gas or vent filters containing hydrophobic membrane are used throughout drug biomanufacturing to maintain near-ambient pressure in processing tanks and closed systems. They prevent contamination of the product flow path and release of aerosols to the environment. Recommended filters include:
- Cartridge and capsule formats are available for different applications.
- All filters are supported by a comprehensive documentation package to support compliance needs.
Related Resources
- How Membrane Prefilters Enhance Bioprocessing Efficiency
Milligard® PES filters improve sterilizing-grade filter capacity and process economics
- Sterile Filtration of Ophthalmic Solutions
The preferred method to achieve sterility of ophthalmic preparations is sterile filtration. By this method, the finished preparation is passed through a sterilizing-grade membrane during fill of the final (presterilized) product container.
- Cell Culture Media Filtration
Membrane filtration is a robust, easy to implement, time-tested solution for processing cell culture media that significantly reduces the risk of bioreactor contamination.
- Millipak® Final Fill Filters Reduce Contamination Risks and Simplify Filtration System Design and Operation
Final sterile filtration of parenteral drugs is a key step in assuring microbial integrity of the drug product and is often performed in single-use assemblies.
- Emprove® Filters and Single-Use Components
Emprove® Filter and Single-use Components ensure transparency, aiding biopharmaceutical product development with confidence by meeting industry demand.
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