OVERCOMING BOTTLENECKS IN LARGE VOLUME SINGLE USE FILTRATION
The biopharmaceutical industry is rapidly moving towards single-use solutions for production. Major drive for single-use is multi product facilities (esp. CMOs), time to market, quick clinical phase production, higher titers in upstream which brings overall scale of production down. An unexpected bottleneck in existing stainless steel facility also necessitates single use implementation for a quick resolution.
High volume single-use bioreactors, mixing systems and storage solutions are already established in the industry. High volumes are encountered during media filtration, post clarification sterile filtration and viral vector harvest filtration. The current size of single use filter capsule is a maximum of 30 inch which may not be sufficient for large volume processing. Traditional facilities utilize multi-round housings for this, a single-use version of such set-up was not available until now. Multiple capsules were connected in parallel using Y connection tubing to make a large single-use filtration unit. An 8 capsule arrangement would require making more than 10 manual connections. Sterilization of such arrangement or assembly under laminar flow area is another hurdle.
MaxiCaps® MR from Sartorius Stedim Biotech is a fully contained singleuse assembly with up to 27 m² filtration area, designed for large scale filtration in biopharmaceutical applications typically more than 2000 L of processing volume.
It is a ready to use pre-assembled, pre-sterilized, double packaged system which has a small footprint. It mitigates the risk of in house assembly and sterilization of capsules. Hence, it helps a unit operation to save up to 4 hours. Sterilization is done using gamma irradiation method and all the components used in the system are compatible with validated dose of radiation. The user is required to make only the inlet and outlet connection to integrate Maxicap® MR in their process, making it a solution that can be used ‘out of the box’. The connection options include triclamp, sterile Opta® connector or weldable TPE tubing. Single-use pressure and flow-rate sensors can be connected easily to the MaxiCaps® MR system for measurement and control of process operating parameters.
The system has the option of being configured to have 3, 6 or 9 filter capsules of 30 inch each. It is possible to fit sterile or bioburden reduction filters. In case of nonirradiated clarification filters, the system can be supplied pre-assembled but non sterile. If an integrity testing system is connected to the Maxicap® MR for integrity testing of the filters both pre and post use, the filter capsules are not individually tested but the total system is tested for integrity using methods such as diffusion flow or forward flow. This feature of integrity testing of the complete system as a unit saves 90% time. The venting of the system takes place through a specially designed channel with glass window and gamma radiation compatible air filter.
The system has undergone comprehensive validation testing, and its packaging for transportation meets ASTM D4169-09 requirements.
Maxicap® MR is the answer to the long standing problem of multi-round single use filtration with added benefits of risk mitigation, time saving, space saving, less validation requirements and easy integrity testing.
Amit handles the filtration & purification portfolio of Sartorius Stedim Biotech in India & SAARC. An expert in areas like scaleup trials, integrity testing for filters & xflow cassettes, process optimization and troubleshooting, Amit leads a team of application specialists and regularly delivers talks and trainings across the country.
ConventionalMulti Round Housing