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 allowing multiple configuration options for seamless process integration. The novel design provides integrated fluid distribution using 80% less tubing and only two process connections. This decreases the risk of faulty connections by up to 90% and shortens installation, test, and dismantling time by up to 87%.
Maxicaps® MR represents a new way to perform large-scale single-use filtration for clinical and commercial scales. It enables fast and easy installation, minimizes the number of components required, and mitigates risk in a novel, compact design.
Simplified Single-Use Filtration
Using complex and difficult-to-handle single-use assemblies is time-consuming and limits production output. See how Maxicaps® MR is a compact, single-use large-volume filtration device designed for simplicity and efficiency.
The system is preassembled with between two and nine 30" filters for up to 27 m² of filter area in one device that arrives ready to use. Installation, filter integrity test, and dismantling times are shortened 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 by reducing storage space, packaging waste, and overall costs.
Platform Components
Maxicaps® MR at a Glance
The Maxicaps® MR consits of a reusable holder and the single-use filter device. The filter device can be configured according to specific process needs.
A Broad Range of Filters to Meet a Variety of Applications and Volumes
- Configurable standardized design, filters, connectors, and tubings
- 2 – 9 30" filter capsules, effective filter area (EFA) range from 2.7 m² to 27 m²
Filter | Application | Filtration Area (Min.) | Filtration Area (Max.) | |
Sartoguard PES | Pre-Filtration Bioburden Reduction | 4.8 m² | 51.6 ft² | 21.6 m² | 232.2 ft² | |
Sartoguard GF | Pre-Filtration Bioburden Reduction | 2.7 m² | 29 ft² | 12.15 m² | 130.5 ft² | |
| Sartopure® GF Plus | Clarification Particle Reduction | 2.4 m² | 25.8 ft² | 10.8 m² | 116.1 ft² | |
| Sartopure® PP3 | Clarification Particle Reduction | 2.4 m² | 25.8 ft² | 17.55 m² | 189 ft² | |
| Sartoclean® CA | Pre-Filtration Bioburden Reduction | 3.6 m² | 38.8 ft² | 16.2 m² | 174.6 ft² | |
| Sartoclean® GF | Pre-Filtration Bioburden Reduction | 2.82 m² | 30.6 ft² | 12.69 m² | 137.7 ft² | |
| Sartopore® Platinum | Sterilizing Grade Filtration | 6 m² | 64.6 ft² | 27 m² | 290.7 ft² | |
| Sartopore® 2 | Sterilizing Grade Filtration | 3.6 m² | 38.8 ft² | 16.2 m² | 174.6 ft² | |
| Sartopore® 2 XLG | Sterilizing Grade Filtration | 4.8 m² | 51.6 ft² | 21.6 m² | 232.2 ft² | |
| Sartopore® 2 XLI | Sterilizing Grade Filtration | 4.8 m² | 51.6 ft² | 21.6 m² | 232.2 ft² | |
| Sartopore® 2 XLM | Mycoplasma Filtration | 4.8 m² | 51.6 ft² | 21.6 m² | 232.2 ft² | |
| Sartobran® P | Sterilizing Grade Filtration | 3.6 m² | 38.8 ft² | 16.2 m² | 174.6 ft² | |
| Virosart® Max | Virus Pre-Filtration | 4.2 m² | 45.2 ft² | 18.9 m² | 203.4 ft² | |
| Virosart® Media | Virus Filtration | 3 m² | 32.3 ft² | 6 m² | 64.6 ft² | |
| Virosart® HF | Virus Filtration | 4.8 m² | 51.7 ft² | 14.4 m² | 155 ft² |
Reusable Stainless-Steel Holder Simplifies Operations
- Tilting holder for optimal venting and draining
- Storage spaces for lifting handles and valve actuators when not in use
- One holder for all possible system configurations
Integrated Valves and Reusable Valve Actuators For Easy Operation
- Integrated diaphragm valve for inlet, outlet, and venting
- Bayonet lock for easy installation and lever-action for simple and fast operation
- Stainless steel and reusable, meaning fewer disposable components
One Vent | Integrity Testing Line Means Fast and Simple Venting and Integrity Testing
- Pressure resistant up to 3 barg | 44 psig
- With sterilizing-grade Sartopore® Air filter
- Includes a semi-transparent expansion vessel to prevent wetting of the air filter during the filling process
Simplified Capsule-to-Capsule Connections
- Integrated fluid distribution and valves and sterile connectors between capsules
- "Cable tie" connections reduced to an absolute minimum
- Only 2 process connections to be performed by the operator
Seamless Scale-Up from Screening to Production
Filter Material Available in Various Formats Up to Commercial Scale
Filtration is a critical and one of the most commonly used steps in biopharmaceutical processing. Therefore, the small-scale device filter material used for process development must also be available in a device format designed for commercial production.
Application
Streamlining Large Scale Filtration
The Maxicaps® MR is a large-scale filter device that utilizes a unique filter capsule connection concept and integrated valves. The standardized design is compact and easy to use, while the wide range of options for filter types and configurations allows the Maxicaps® MR to be easily integrated into different process steps requiring large filter areas.
Clarification of Vaccines and Viral Vectors
Clarification of vaccines and viral vectors is a critical step that has a significant impact on product recovery and subsequent downstream purification. The main challenge is to recover a high yield while efficiently removing cell debris, large aggregates, and insoluble contaminants. The Maxicaps® MR is a perfect fit for these applications due to the closed system design and the large effective filter area starting from 50 L bioreactor batch volume.
For Bioburden Reduction and Particulate Reduction
Prefilters are critical in the overall filtration strategy. They protect downstream filters and processes, remove particulates, and reduce microbial levels. Prefilters can also be used as guard filters to protect high-value chromatography steps.
Selecting the best design for the large-scale filtration device is a crucial step in ensuring the quality and safety of biopharmaceutical products. With the flexibility to configure the Maxicaps® MR with a range of Sartorius filter types and the amount of filter area needed, Maxicaps® MR provides an easy-to-use solution specifically designed for your large-scale filtration needs.
- Sartoguard Membrane Prefilters
- Sartoclean® Membrane Prefilters
- Sartopure® Synthetic Depth Filters
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 and are suitable for any large-volume media and downstream intermediates sterilizing-grade filtration.
Filter integrity testing of complex filter assemblies poses a challenge as each filter element must be tested individually. With its novel integrated valve and connection technology, the Maxicaps® MR can be integrity tested as one unit, significantly reducing the complexity and testing time.
Efficient Removal of Mycoplasma
Mycoplasma contamination – carried into the process by the culture media due to a contaminated raw material - can negatively impact the quality of the final product if not treated appropriately. Mycoplasma filtration of media mitigates contamination risks, preventing costly batch losses.
Maxicaps® MR with Sartopore® XLM filters is a single-use solution designed for large-scale media filtration that can effectively remove mycoplasma from biopharmaceutical fluids. This plug-and-play system can help ensure the quality and safety of biopharmaceutical products by reducing the risk of mycoplasma contamination.
Next Level Virus Filter Protection
Our virus prefilter - the Virosart® Max – uses patented technology to protect the valuable virus filter. It combines a size exclusion mechanism with efficient adsorptive capacities to increase the robustness of the subsequent virus filtration step. The most challenging molecules for the final virus retentive membrane are aggregates and | or small hydrophobic molecules. Virosart® Max binds aggregates very efficiently through hydrophobic interactions, independently of process conditions such as conductivity.
Large Scale Filtration Solutions
Risk Reduction and Time Savings with Integrated Connection and Valve Technologies
Stainless steel multi-round housings are commonly used in conventional large-scale filtration processes. While filter assemblies with multiple components and connections provide a single-use alternative, these systems are complex and tedious to operate. Systems with many connections and components can produce supply chain challenges, increase operator time and effort, contribute to leakage risk, and add to transportation and storage costs.
Maxicaps® MR represents a paradigm shift in large-scale single-use filtration, offering a standardized solution that saves time and mitigates risk due to its simple design and operation.
The table below compares available large scale filtration solutions.
Maxicaps® MR | Filter Assemblies | Multi-Round Housing | |
|---|---|---|---|
Filter area per device | Up to 27 m² | Smaller < 8 m² | Various |
System design | Standardized, single-use | Predominantly customized, | Engineered |
| Sterilization | Sterile delivery* | Sterile delivery | Steam-in-place |
Throughput | Medium | Low - Medium | High |
Central venting | Yes | No, individual capsule vent | Yes |
Closed system | Yes | Feasible | Yes |
Required filter integrity testing | 1 | Multiple | 1 |
Holder design | Re-usable stainless steel holder | Various, customer specific | 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 |
Project duration to implementation | Short | Medium - long | Long |
* for gamma stable filter material
Featured Assets
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FAQs
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 catridges in stainless steel housings or single-use filter assemblies.
Large scale filter validation follows the same prinicples as smaller filters. However, large filtration areas typically involve more complex and sophisticated equipment, which may require additional validation steps to ensure that the equipment is operating correctly.
Sterilzing grade filters are validated using a bacterial challenge test with the product solution. In addition, extractable and leachables studies, adsorption studies, chemical compatibility testing, and product specific integrity tests are carried out.
Large scale filters are tested as a unit in one test with a filter integrity test system such as Sartocheck®. Due to the use of multilpe filter elements in a single housing, there is a risk of potential masking of defective filter elements by intact filter elements. In single-use systems the risk of a defect Large scale filters are tested as a unit in one test with a filter integrity test system such as Sartocheck®. Due to the use of multilpe filter elements in a single housing, there is a risk of potential masking of defective filter elements by intact filter elements. In single-use systems the risk of a defect filter cartidge is unlikely due to gentle sterilization conditions and manufacturer tests. cartidge is unlikely due to gentle sterilization conditions and manufacturer tests.
Stainless steel systems suffer from a lack of flexibility due to their fixed piping and fixed 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, as well as 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 safe 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, as well as 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 pre-filtration.
