Sterile Filtration
From Membrane Filter Pioneers to Today's Innovators
Sterile filtration in biopharmaceutical processes demands rigorous maintenance of sterility and integrity to prevent contamination, while also ensuring scalability and efficiency in system operations.
Optimize performance and sustainability in sterile filtration with Sartorius. Our solutions are designed to support efficient bioprocessing while ensuring compliance and environmental responsibility.
PES and CA membranes offer a high-performance, environmentally friendly alternative to PVDF, making them ideal for sustainable and reliable filtration processes in the future.
Intended to comply with regulatory requirements like cGMP, USP, and EU Annex 1 standards for sterile processes, backed by comprehensive documentation including validation and extractables guides.
Available in a range of formats, our solutions are suitable for all process conditions, from small to large process volumes, and from single-use to stainless steel applications.
Virosart® is offered in multiple device formats, meeting specific processing requirements and scales, to support your scale-down studies to large-scale industrial production. With options including capsules and cartridges, the product delivers.
Sterile Filtration Portfolio
Sartopore®, Sartobran®, and Sartolon
In the production of biopharmaceuticals and pharmaceuticals, sterile filters are indispensable for controlling contamination and bacterial loads. Choosing the right sterile filter is crucial for developing efficient and cost-effective production processes. The selection of a suitable sterile filter depends on the composition of the process fluids and their specific properties.
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Historical Innovation in Filtration Technology
Sartorius has a rich history of innovation in filtration technology, closely linked to the pioneering work of Richard Zsigmondy. As a renowned chemist, Zsigmondy invented the membrane filter, revolutionizing the way liquids are sterilized and purified. Sartorius collaborated with Zsigmondy in its early years, leveraging his groundbreaking research to expand its product offerings and establish itself as a leader in filtration solutions. This partnership laid the scientific foundation for many of the advanced technologies Sartorius provides today, underscoring our commitment to innovation and excellence in the field of filtration.
- Supported over 300 biopharmaceutical development projects: Sartorius has played a crucial role in developing and optimizing filtration processes for biopharmaceuticals to ensure their safety and efficacy.
- Collaborated with over 70 biopharmaceutical developers worldwide: Through close partnerships with leading developers, Sartorius has provided innovative filtration solutions tailored to the specific needs of the industry.
- Extensive Global Reach and Impact: Sartorius has established a robust global presence, with its filtration technologies being utilized in over 100 countries. This widespread adoption highlights the trust and reliance placed on Sartorius' filtration solutions by industries worldwide, further solidifying its position as a leader in the field. Through its international network, Sartorius continues to drive advancements in filtration technology, ensuring that its innovative solutions are accessible to a diverse range of applications and industries.
Frequently Asked Questions
Sterile filtration is a method used to remove bacteria and other microorganisms from liquids, widely employed in the pharmaceutical and biotechnology industries. It is essential for sterilizing heat-sensitive solutions where thermal methods are not feasible. In medical settings, 0.2 µm filters are commonly used during intravenous drug preparation and administration to ensure solutions are free from bacterial contamination and to protect patient safety.
In biopharmaceutical manufacturing, sterile filters play a critical role in maintaining product sterility, particularly during final production steps where contamination could compromise both safety and efficacy.
A 0.2 µm filter refers to a filter with pores that are 0.2 micrometers in size. These filters are commonly used in sterile filtration because most bacteria are larger than 0.2 micrometers, allowing the filter to effectively remove them from liquids.
However, not every pore is exactly 0.2 µm in size. The 0.2 µm rating indicates the nominal pore size—the average size across the membrane—engineered to retain microorganisms above that threshold. While minor variations in pore size can occur due to manufacturing tolerances, the filter is validated to reliably block bacteria and other microorganisms, ensuring sterile filtration.
Selecting the appropriate sterile filter depends on factors such as liquid type, volume, desired flow rate, and particle size to be removed. Our Filter Finder can provide a first point of orientation. Our Field Application Specialists are also happy to support you find the right filter for your unique processes.
To ensure that a sterilization filter is effectively sterilizing, several methods and tests can be employed:
Integrity Testing
- Bubble-Point Test: This test measures the pressure required to force air through a wetted filter. It helps confirm that the filter pores are intact and functioning as expected.
- Diffusion Test: This test measures the rate of gas diffusion through a wetted filter, providing information on the filter's integrity.
Validation Studies
- Conducting validation studies using bacterial challenge tests with specific microorganisms can demonstrate the filter's ability to remove or retain these organisms effectively. For all our sterilizing-grade filters, we provide you with a validation guide to support you in accurately documenting and executing cGMP-relevant processes to ensure compliance with Good Practice standards.
Manufacturer Certification
- Filters are often supplied with certification from the manufacturer, indicating that they have been tested and meet specific standards for sterilization.
Visual Inspection
- Regular visual inspection of the filter for any signs of damage or wear can help ensure its effectiveness.
Routine Monitoring
- Implementing routine monitoring and testing of the filtered product for microbial contamination can provide ongoing assurance of the filter's performance.
Proper Installation and Use
- Ensuring that the filter is correctly installed and used according to the manufacturer's guidelines is crucial for its effective operation.
A sterilization filter is validated to ensure that it reliably and effectively removes microorganisms from a liquid, thereby guaranteeing the sterility of the final product. Validation is a critical step, especially in the pharmaceutical and biotechnology industries, to ensure the safety and quality of products.
Here are the reasons and methods for validating a sterilization filter:
- Safety Assurance: Validation ensures that the filter effectively removes all unwanted microorganisms that could compromise product safety.
- Regulatory Compliance: Many industries are subject to strict regulatory standards that require validation of filtration processes.
- Quality Assurance: Validation helps ensure the consistency and quality of the filtered product.
- Process Confidence: Validation strengthens confidence in the filtration processes, which is crucial for the manufacturing and distribution of products.
Microbiological Challenge Tests:
- The filter is tested with a defined quantity of specific microorganisms to demonstrate its ability to effectively retain them.
Integrity Testing:
- Tests such as the bubble-point test or diffusion test are conducted to verify the physical integrity of the filter.
Simulated Process Conditions:
- The filter is tested under real or simulated process conditions to confirm its performance under actual usage scenarios.
Long-Term Studies:
- Long-term studies may be conducted to assess the durability and reliability of the filter over an extended period.
Documentation and Reporting:
- All tests and results are meticulously documented to ensure compliance with regulatory requirements and serve as a reference for future reviews.
Our Confidence® Service will to support you with the sterile filter validation. This includes physicochemical, microbiological as well as tests for extractable and leachable substances for filters that are used to reduce biological stress or for sterilization.
