DrM FUNDALOOP® Single Use Candle Filter

The DrM range of single-use filtration solutions includes the innovative FUNDALOOP® Candle Filter that offers a superior alternative to disposable cartridge filters for cell harvesting and clarification in pharmaceutical, biotech, and other processes.

The FUNDALOOP® system pioneered the concept of an automatic, fully enclosed and single-use filtration solution for high sterility solid-liquid separation applications.

FUNDALOOP® principle and design

The FUNDALOOP® single-use filtration system consists of multiple vertically aligned filter elements packed into a fully contained FUNDALOOP® Bag that is placed inside a transparent pressure vessel. This system can be used for batch or multiple filtration processes (see illustrations).

The system is inherently versatile capable of operating pressures up to 4 bar (g), running temperatures up to 50 ºC, compatible with Gamma or X-Ray sterilization.

A range of options to extend versatility even further includes customizable filtration areas, hose barb, tri-clamp, sterile or luer connectors, and batch volume options ranging from one liter to 1,000 litres. Pre-sterilised and validated filter enclosures for Pharma/Biotech applications make the system compliant with ISO, EMA, USP Class VI, FDA 21 CFR 177, ASME BPE and Animal-free standards.

FUNDALOOP® applications

Application areas for FUNDALOOP® filter systems include cell culturing and harvesting, homogenization, blood plasma fractionation, product clarification, vaccine production, and API manufacturing.

Detailed applications include:

• Active Pharmaceutical Ingredient (API) production: Filtration of catalyst recovery, active carbon treatment, crystal separation, impurities removal or polishing. Cake treatment such as washing, extraction, and drying to increase the yield and reduce contamination of intermediates.
• Antibiotics production: Filtration of fermentation broths, removal of activated carbon from antibiotic solutions, washing and purification of antibiotic crystals.
• Manufacture of Insulin, vaccines and other Injectables: Filtration of cell debris and active ingredients after fermentation.
• Mammalian Cell Harvesting (CHO): Removal of debris from ruptured cells following fermentation.
• Microbial Cell Harvesting (E. Coli): Efficient clarification of E. coli lysates without clogging.
• Vitamin production: Catalyst recovery, activated carbon removal, salt filtration and polishing of product solutions.

FUNDALOOP advantages

DrM single use FUNDALOOP® solution helps Pharma and Biotech manufacturers avoid validation and cleaning costs of their filtration and mixing equipment by eliminating disposable filter cartridges.

FUNDALOOP® is particularly effective in overcoming industry problems with Pharma filtration machinery that is too big and complex and with depth filters are insufficiently efficient. Its compact form ensures ultra-effective filtration on a smaller footprint for smaller rooms while still being more efficient than conventional depth filters.

Other advantages include:

• High throughput
• Increased yield in cell recovery and enzyme recovery operations
• Shorter reactor downtime due to reduced cleaning and validation requirements
• Reduced heel volume and compaction of solid waste thanks to the external pressure
• Fully enclosed containment made completely with plastics ensuring safe handling and disposal of hazardous components
• Multilayered plastic bag construction for superior robustness

Resources

Click on FUNDALOOP® Single-use candle filter for further information.
Click on Single-Use Filter: FUNDALOOP® 30L Filtration for YouTube video of system in action.
Click on FUNDALOOP® Single-Use Filtration Technology to learn more.