Medical Device Link.

Product Update

Valcor Scientific

A line of diaphragm isolation solenoid valves from Valcor Scientific (Springfield, NJ, USA; www.valcor.com) is suited for a variety of medical device applications including sterilisers, endoscopic reprocessing units, blood-gas analysers and urine analysis equipment. The line includes two-way normally closed, two-way normally open, three-way and special multivalve manifold constructions. Offered in a variety of materials including Teflon, PEEK, KEL-F and PPS, the compact valves offer low power consumption and low dead volume.

The company also manufactures a line of pumps suited for dispensing precise doses of reagents and other chemicals. Available in plastic or stainless steel, the pumps provide adjustable and repeatable dispense volumes. They are optionally available with Viton or EPDM seals, making them suitable for handling a variety of fluids. The company additionally specialises in engineered systems.

Lee Products Ltd

An injection manifold mount system enables the precise injection of a fluid into a flow stream. This system is the latest addition to the miniature components product range from Lee Products Ltd (Gerrards Cross, UK; www.leeproducts.co.uk). The company’s Very High Speed micro-dispense solenoid valve is suited for flow injection analysers and laboratory, biomedical and chemical applications. It can be mounted so that the outlet port is in close proximity to the flow stream, ensuring the dual benefit of minimal captive capillary volume and increased injection volume repeatability.

Among the key features of the system are captive capillary volumes of 0.5 µl and pressures up to 120 psi. A Teflon ferrule is the only additional wetted material; the mounting nut and pressure plate do not contact the fluid and the valves can be rotated after installation without compromising the seal. The manifolds are available in one-, two-, three- and four-place standard options. Boss plugs are available to effectively seal any unused valve ports in the manifold, providing greater flexibility and allowing for future expansion. Valves and plugs can be installed and removed repeatedly as required.

Bio-Chem Fluidics

Pump and valve manufacturer Bio-Chem Fluidics (Cincinatti, OH, USA; www.biochemfluidics.com) has introduced a newly redesigned solenoid-operated pinch valve series for more effective fluid control and handling systems. The 075P2 two-way valves have low power requirements and are available with a normally open or normally closed valve function. Eliminating sharp edges, the new design features smooth contours that allow easy insertion and removal of tubing without snares. An integrated insert provides both positive tube retention and confirmation of correct tubing size. Manual push-button override is available as an option. The new design also includes a valve body constructed from Luran resin and a plunger made of polyphenylene sulphide. These materials are resistant to most common cleaning solutions and meet the company’s two million cycle standard.

Ceramaret

Manufacturer of precision parts Ceramaret (Bôle, Switzerland; www.ceramaret.ch) controls all aspects of the production process from the ceramic powder to the finished product. Typical applications are pistons, balls and seats and check valves for HPLC pumps, metering pumps, precision dispensers such as pipettes and blood analysers. All parts are inert, and resistant to mechanical wear and corrosion by aggressive solvents. The company also makes ceramic rotors and stators for injection and rotary valves. Certified to ISO 9001:2000, ISO 14001:2004 and ISO 13485:2003, Ceramaret adheres to strict manufacturing processes at all stages of manufacturing.

Bartels Mikrotechnik

A micropump from microsystems technology provider Bartels Mikrotechnik (Dortmund, Germany; www.bartels-mikrotechnik.de) can be used in various medical technology applications. Measuring 30 × 15 × 3.8 mm, the MP6 micropump is reportedly the smallest serial-produced piezoelectric diaphragm pump made from plastic on the market. Made from medical-grade polymers, the double actuator system reaches a maximum flow rate of 6 ml/min and has a maximum back pressure of 550 mbar when pumping water. The pump can be used in a closed-loop mode for intrinsic operation without the need for additional sensing components.

The company supplies a full line of miniature pumps, valves and filters. In addition, the firm can design and develop custom microfluidic products. It is certified to ISO 9001.

Alcatel Vacuum Technology

A sensor from Alcatel Vacuum Technology (Annecy, France; www.adixen.com) is reportedly the first diagnostic tool to offer real-time monitoring of the water vapour concentration inside freeze-drying chambers. Using inductive coupled plasma–optical emission spectroscopy to provide a high level of precision, the Lyotrack sensor offers real-time monitoring of humidity inside the chambers.

The humidity sensor monitors the parameters of the different freeze-drying phases using sublimation of compounds as well as primary and secondary drying-phases down to 5 µbar. Capable of withstanding sterilisation, the sensor can be integrated as an intrinsic component of the freeze-dryer. It can be installed in a few minutes between the chamber and the condenser using a 1.5-in. tri-clamp connection, according to the manufacturer.

The sensor generates an electromagnetic field that ionises gases in the chamber, breaking the molecules down into simple elements at the freeze-dryer exhaust. Gas atoms are thus identified as they oscillate between excited and stable states, emitting characteristic photons several thousand times a second. The light emitted is then analysed using spectroscopy to isolate wavelengths related to water. The sensor instantly detects the quantity of remaining water vapour. It therefore doesn’t need to rely on less accurate measurements of temperature and pressure.

Using an Ethernet connection, the Lyotrack can be connected to a PC on which analysis software has been installed. The sensor also has an analogue output that can export the humidity signal value for recording purposes by devices complying with the US FDA 21 CFR Part 11 standard.

Halkey-Roberts

Designed to attach directly to solution bags during manufacturing, bag access valves convert any needle port on a bag to a needlefree access site providing high flow as well as a closed system. Available from Halkey-Roberts (St. Petersburg, FL, USA; www.halkey-roberts.com), these valves are designed to fit 6.8-mm ID tube ports. The manufacturer also offers a complete line of needlefree swabable products including tube-end, break-off and stopcock valves. The tube-end valves contain tubing pockets designed to fit five sizes of tubing: 2, 2.5, 2.8, 3.7 and 4 mm. Break-off valves are available in 6 and 6.8 mm sizes.

The firm also manufactures a variety of other plastic components and subassemblies used in disposable medical devices. Certified to ISO 9001 and ISO 13485, the company manufactures its products to GMP standards.