PRODUCT UPDATE
Filtertek B.V.
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A manufacturer designs and fabricates filters, check valves, and technical mouldings for medical applications such as infusion therapy, drug transfer, drug delivery, respiratory care, blood processing, in vitro diagnostics, and laboratory work. The standard product range from Filtertek B.V. (Newcastle West, Co. Limerick, Ireland; www.filtertek.com) includes filters for IV sets and enteral feeding, as well as filters for pain control products and anaesthesia. Custom devices also can be developed to meet specific application needs.
The firm’s one-way check valves feature a sealing mechanism that is designed to prevent backflow without sacrificing forward flow performance. The check valves are available in a variety of materials, including lipid-resistant polycarbonate and ABS. They also are latex- and DEHP-free. Designed with critical infusion processes in mind, the valves are offered with tube port and luer lock configurations as well.
The firm is certified to ISO 13485:2003 and it operates Class 10,000 to Class 100,000 cleanrooms. The company has more than 40 years of experience making filters for the medical and pharmaceutical markets.
Stork Veco
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Metallic microfilters offered by a specialist in electroforming and photoetching are made of rigid sieve materials with relatively large open areas and small holes. Stork Veco (Eerbeek, Netherlands; www.storkveco.com) produces the filters from a variety of conductive alloys under cleanroom conditions in order to ensure that holes are perfect and consistently formed and that part surfaces are smooth. The filters are strong and designed for total material throughput and no particle entrapment. Easy to clean, the filters resist organic solvents. Electroforming allows for holes as small as 0.2 µm in diameter. Applications include sieves and nozzles as well as filters. Standard and custom sizes can be supplied.
Two new microfilter ranges have been introduced for medical and biotechnology applications. One, for sterile filtration, absolute filtration, critical call-cell separation, cell deformability testing, and cell harvesting, is designed for filtration in the range of 0.2–1.0 µm and features hole tolerances of ±10% of diameter. These have a double-layer design with slotted holes between the layers, and hole positioning on the filter is entirely up to the designer. Also available are microfilters for 2- through 10-µm filtration that have tapered or conical holes with 0.5-µm tolerances. They are suited for nebulizers and spray nozzles.
Reliance Precision Ltd.
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Quadrupole mass filters for mass spectrometers are supplied by a company that over the years has developed state-of-the-art manufacturing facilities for cleanroom assembly, inspection, and precision cleaning. The designers at Reliance Precision Ltd. (Huddersfield, W Yorks, UK; www.reliance.co.uk) use a quadrupole mass filter computer model to evaluate their designs against performance criteria. Tolerances for size, straightness, orthogonality, symmetry, positional accuracy, curvature, taper, and parallelism can be studied. Then tolerances relevant to the customer’s application can be stipulated to ensure the requisite mechanical accuracy in the finished filter. The model can produce details regarding ion entrance conditions, trajectories, and exit conditions and also representative mass peak shapes. In addition, it enables rapid assessment of transmission versus resolution to allow specification of the optimum in injection conditions.
Filter manufacture is based around 12-mm-diam electrode rods, the dimensions and features of which can exhibit submicron precision. Test equipment designed and built by the manufacturer is used to check mechanical dimensions of parts and assemblies with micron-scale accuracy. Because quadrupole mass filters are highly sensitive to contamination, the manufacturer uses a specially designed cleaning process on an automated line to perform consistent, high-precision cleaning of parts. The company carries out manual assembly in a laminar-flow cleanroom certified to ISO Class 6 (Class 1000).
GVS S.p.A.
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Based on a special design, an intravenous (IV) filter for neonatal applications comes with a wide variety of inlet and outlet microbore-tubing connectors and a double luer lock that facilitates assembly of the filter. The full range of low-flow-volume applications for the Speedflow Baby from GVS S.p.A. (Zola Predosa, BO, Italy; www.gvs.com) includes chemotherapy, antibiotic therapy, total-parenteral-nutrition and lipid solutions, high-accuracy drug delivery, portable pumps, and syringe filtration, as well as IV therapy for neonates. The 0.25-cm2 hydrophobic PTFE membrane in two vents allows for fast air elimination in any orientation, while a 1.45-cm2 hydrophilic membrane provides the highest possible flow rate for this device.
This IV filter’s membranes and acrylic housing material comply with ISO 10993-1 and USP Class VI 121°C testing requirements and can be sterilized by EtO and by gamma and electron-beam radiation methods. Hi-Flo hydrophilic membranes made of PES come in pore sizes of 0.2 and 1.2 µm, along with options of 0.2 positive and 5.0 µm. Pores in the hydrophobic PTFE vents measure 0.02 µm. Also available is a nonventing version of the filter that features a priming volume below 0.35 ml and a high burst pressure of 8.0 bar.
B. Braun Medical Inc.
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An ISO 13485:2003–certified, US FDA–registered manufacturer of disposable medical devices offers a complete line of transfer and filter devices for a variety of fluid-transfer applications. The products available from B. Braun Medical Inc. (Bethlehem, PA, USA; www.bbraunusa.com) include the patented Mini-Spike dispensing pin and the Micro Chemo pin. The former is intended for preparing and dispensing diluent or additive from multidose rubber-stoppered vials. The latter includes a 0.2-µm hydrophobic air-venting filter that prevents user exposure to toxic fumes during drug reconstitution. Other devices offered are filter needles, vented needles, double-ended transfer devices, and air-venting filters and filter hubs in a variety of configurations.
