Maxicaps® MR Large-Scale Single-Use Filtration
Mitigating Risks With Integrated Connection and Valve Technologies
Maxicaps® MR is a unique, pre-assembled, single-use, large-scale filtration unit that reduces connections and complexity while offering multiple configuration options for seamless process integration. Its novel design features integrated fluid distribution, using 80% less tubing and only two process connections. This reduces the risk of faulty connections by up to 90% and shortens installation, testing, and dismantling times by up to 87%. Maxicaps® MR introduces a new approach to large-scale single-use filtration at clinical and commercial scales. It enables fast and simple installation, minimizes the number of required components, and mitigates risk through its compact, innovative design.
The system is pre-assembled with two to nine 30" filters, providing up to 27 m² of filtration area in a single, ready-to-use device. Installation, integrity testing, and dismantling times are reduced by up to 87%.
Maxicaps® MR is a closed system with a central vent line and sterilizing-grade air filter. Only one test is needed to verify filter integrity.
The novel configurable design features integrated fluid distribution, requiring fewer connections and components, meaning leaks are minimized.
By using only one standardized device instead of multiple custom assemblies, ordering becomes simpler, and delivery is accelerated.
Maxicaps® MR minimizes components and connections, reducing storage space, packaging waste, and overall costs.
Explore Maxicaps® MR
Maxicaps® MR at a Glance
The Maxicaps® MR consists of a reusable holder and a single-use filter device, which can be configured according to specific process needs.
Seamless Scale-Up From Screening to Production
Simplified Single-Use Filtration
Complex, difficult-to-handle single-use assemblies are time-consuming and limit production output. Explore Maxicaps® MR: a compact, single-use, large-volume filtration device designed for simplicity and efficiency.
Filter Material Available in Various Formats Up to Commercial Scale
Filtration is one of the most critical and widely used steps in biopharmaceutical processing. Therefore, the same filter material used in small-scale devices for process development must also be available in formats designed for commercial production.
Applications
Streamlining Large-Scale Filtration
Maxicaps® MR is a large-scale filtration device featuring a unique capsule connection concept and integrated valves. Its standardized, compact design ensures ease of use, while the wide range of filter types and configuration options enables seamless integration into diverse process steps requiring large filtration areas.
Clarification
Clarification of Vaccines and Viral Vectors
Clarifying vaccines and viral vectors is a critical step that directly affects product recovery and subsequent downstream purification. The main challenge lies in achieving high yield while efficiently removing cell debris, large aggregates, and insoluble contaminants. Maxicaps® MR is well-suited for these applications thanks to its closed-system design and large effective filter area, starting from a 50 L bioreactor batch volume.
Prefiltration
For Bioburden Reduction and Particulate Reduction
Prefilters play a critical role in an overall filtration strategy. They protect downstream filters and processes, remove particulates, and reduce microbial levels. They can also serve as guard filters to protect high-value chromatography steps.
Choosing the right design for large-scale filtration devices is essential to ensuring product quality and efficacy. With the flexibility to configure Maxicaps® MR using a variety of Sartorius filter types and the required filter area, Maxicaps® MR offers a simple, easy-to-use solution tailored for large-scale filtration needs.
Available options include:
- Sartoguard Membrane Prefilters
- Sartoclean® Membrane Prefilters
- Sartopure® Synthetic Depth Filters
Sterilizing-Grade Filtration
Efficient Sterilizing-Grade Filtration and Filter Integrity Testing
Sartorius’ well-known membrane filters, Sartopore® 2 and Sartopore® Platinum, are available in the Maxicaps® MR format, making them ideal for sterilizing-grade filtration of large-volume media and downstream intermediates.
Integrity testing of complex filter assemblies can be challenging, as each filter element typically must be tested individually. With its novel integrated valve and connection technology, Maxicaps® MR can be tested as a single unit—significantly reducing both complexity and testing time.
Mycoplasma Filtration
Efficient Removal of Mycoplasma
Mycoplasma contamination—carried into the process through culture media due to contaminated raw materials—can compromise the quality of the final product if not addressed properly. Filtration of media is a proven strategy to mitigate this risk and prevent costly batch losses.
Maxicaps® MR with Sartopore® XLM filters is a single-use solution for large-scale media filtration, specifically designed to remove mycoplasma from biopharmaceutical fluids. This plug-and-play system helps ensure product quality and efficacy by reducing the risk of contamination.
Virus Filtration
Ensuring Reliable Retention Across All Process Conditions
Virus filtration is a critical process step in biopharmaceutical manufacturing, ensuring robust virus clearance under various processing conditions. Virosart® virus filters utilize an advanced membrane structure that ensures reliable virus retention despite variations in pressure, high load volumes, or process interruptions. Pre-filtration with Virosart® Max protects the final membrane, combining size exclusion and adsorptive capacities for robustness. The adsorptive polyamide membrane effectively binds aggregates and hydrophobic molecules, ensuring consistent performance of the final virus filter.
Large-Scale Filtration Solutions
Risk Reduction and Time Savings With Integrated Connection and Valve Technologies
In conventional large-scale filtration, stainless-steel multi-round housings are commonly used. While single-use filter assemblies offer an alternative, systems with multiple components and connections are often complex and tedious to operate. They can also create supply chain challenges, increase operator time and effort, contribute to the risk of leakage, and add transportation and storage costs.
Maxicaps® MR represents a paradigm shift in large-scale single-use filtration. With its standardized, streamlined design, it reduces complexity, saves time, and mitigates risk, delivering a simpler, more efficient solution for modern bioprocessing.
| Maxicaps® MR | Filter Assemblies | Multi-Round Housing | |
|---|---|---|---|
| Filter area per device | Up to 27 m² | Smaller < 8 m² | Various |
| System design | Standardized, single-use | Customized, single-use | Engineered stainless steel |
| Sterilization | Sterile delivery* | Sterile delivery | Steam-in-place |
| Throughput | Medium | Low - Medium | High |
| Central venting | Yes | Individual capsule vent | Yes |
| Closed system | Yes | Feasible | Yes |
| Required filter integrity tests | 1 | Per capsule | 1 |
| Holder design | Standardized | Customized | Integrated into piping or tripod |
| Process connections | 2 | Up to 20 | Fixed pipe |
| Cable tie connections | 8 | Up to 94 | N/A |
| Fluid distribution | Integrated | Y-connectors and tubing | Integrated |
| Valve type | location | Diaphragm valve | integrated | Pinch clamp valve | on tube | Diaphragm valve | integrated into piping |
| Implementation time frame | Short | Medium - long | Long |
* for gamma-stable filter material
Learn More About Maxicaps® MR
Related Insights
Frequently Asked Questions
Bioprocess filtration refers to the process of filtering a large volume of bioprocess materials to remove impurities. Depending on the process step, the volume can range from 50 L (clarification in viral vector processes) to several thousand liters in media and buffer filtration.
Typical large-scale filtration systems are multiround cartridges in stainless-steel housings or single-use filter assemblies.
Large-scale filter validation follows the same principles as smaller filters. However, large filtration areas typically involve more complex and sophisticated equipment, which may require additional validation steps to ensure the equipment operates correctly.
Sterilizing-grade filters are validated using a bacterial challenge test with the product solution. In addition, extractable and leachable studies, adsorption studies, chemical compatibility testing, and product-specific integrity tests are carried out.
Large-scale filters are tested as a unit in a single integrity test using a system such as Sartocheck®. Due to the use of multiple filter elements in a single housing, there is a risk of potentially masking defective filter elements by intact filter elements. In single-use systems, the risk of a faulty filter cartridge is unlikely due to gentle sterilization conditions and manufacturer tests.
Stainless-steel systems lack flexibility due to their fixed piping and location. Additionally, they require time-consuming and resource-intensive cleaning procedures. Conventional single-use multifilter assemblies require many process and cable tie connections, creating many tubings and an untidy design, increasing the risk of operator error. Single-use setups also require multiple individual material numbers, each with its own packaging and storage space, and long design and lead times.
Large-scale filtration can be applied to various downstream process steps, including clarification in vaccines and viral vector processes; bioburden reduction post-clarification and in intermediate downstream steps; capture-column guard filtration or particle reduction in vaccine, viral vector, and pDNA processes; and pre-filtration to protect the final virus retentive filter.
High-quality filtration techniques can significantly impact the purity and potency of the product, resulting in a cleaner, more effective biologic that meets regulatory standards. Proper filtration ensures the products manufactured are adequate for patients and mitigates commercial risks. However, it is essential to note that the precise impact of large-scale filtration on product quality may vary depending on the specific product and the filtration method used.
Single-use filtration systems avoid high capital investment in equipment and factory infrastructure and costly clean-in-place and steam-in-place procedures. They are also an economical choice for a contract manufacturing organization (CMO) or any facility that requires agile solutions. In addition, single-use filtration systems are readily available and do not require cleaning validation, which can shorten project timelines.
Large-scale filtration is employed in upstream processes for media and buffer preparation (mycoplasma removal and sterilizing-grade filtration) and clarification. In downstream process steps, large-scale filtration is used for bioburden reduction, capture-column guard filtration, particle reduction, and prefiltration.
Maxicaps® MR is a faster, more efficient solution with no long delivery times. Its lightweight, compact design allows quick installation without the need for time-consuming piping and housing qualification. As a single-use system, it eliminates cleaning and cleaning validation, reducing downtime and costs.
