Packaging Services Offered in Cleanroom Conditions
Packaging and related services are provided by a company that recently completed the construction of Class 100,000, Class 10,000, and Class 1000 cleanrooms. In addition to packaging and labeling, the firm provides washing and final rinsing, cleanroom assembly, final sterilization, and logistics services. Orthopaedic and dental implants, surgical instruments, and traumatology products are among the medical devices that are routinely processed. The packaging of pharmaceutical products and clinical trial samples is also part of the company’s core capabilities. It is certified to ISO 13485:2003. IL-MedTec AG, Burgdorf, Switzerland.
Orthopaedic Instrument Provides Torque-Limiting Performance
Designed for medical device OEMs as well as orthopaedic and spinal surgeons, a ratcheting torque limiter (RTL) driver reportedly provides smooth torque-limiting performance with less recoil than competing products. The device’s two-in-one design eliminates the need for physicians to switch instruments during use, and only 20° of rotation are required to actuate the device. The design allows physicians to tighten and torque constructs with minimal hand and arm motion while maintaining an optimal grip. Under test conditions, the RTL driver held ±8% at 106 lb-in. after more than 150 autoclave cycles and more than 6000 actuations. Bidirectional and precise unidirectional models are available. Gauthier Biomedical Inc., Grafton, WI, USA.
Machine Vision Systems Support a Variety of Cameras
Turnkey vision systems based on a company’s image processing software platform are now available with 4-, 5-, and 8-million-pixel cameras. This product line comprises 20 models with resolutions ranging from VGA to 8 million pixels. All of the cameras can be arbitrarily combined, separately configured, and operated in parallel using a device manager. They can be triggered by means of an interface mounted on the camera, and feature integrated 8-Mbyte image memory. NeuroCheck GmbH, Remseck, Germany.
Thin-Film Coating Produces Spectrally Selective Optics Material
Dichroic hybrid coatings have been developed that are highly reflective over selected wavelength bands and minimally reflective over the rest of the spectrum. The HeatBuster Spectral Metal coatings reportedly combine the advantages of glass mirrors with the cost savings and durability of sheet-metal fabrication.
The base material is highly polished stainless steel. A “dark mirror” coating is initially deposited onto the substrate, which optically couples the unwanted wavelengths into the metal. A highly reflective dichroic coating is then deposited onto the dark mirror.
For curved optics, parts can be formed using standard sheet-metal fabrication methods prior to coating. They can be produced in the form of long trough reflectors and laser cut into desired lengths. Alternatively, the sheets can be coated prior to being laser cut into simple or complex shapes.
The uniform coating is stable over temperature and humidity changes, and meets the severe abrasion, adhesion, humidity, and salt fog tests of the MIL-C-675 standard. Medical systems, digital imaging, and portable optical systems are among the applications. Deposition Sciences Inc., Santa Rosa, CA, USA.
Makeover Announced for Microsphere Standards
A maker of glass microspheres used for calibration has announced that it will introduce a new packaging design throughout its product range. New, more-durable plastic bottles individually held in foam and supplied in a clear plastic display case will be shown for the first time at Powtech, an exhibition devoted to mechanical processing technologies and instrumentation in Nuremberg on 27–29 March.
The firm has been manufacturing glass microspheres for 24 years and is the highest-ranking European certification laboratory for primary methods of particle-size analysis. The reference standards, almost all of which are NIST traceable, range in size from 0.1 µm to 5 mm. They are available as single-size microspheres or in broad size distributions.
Calibration procedures for NIST-traceable measurement of filter apertures are also available. Whitehouse Scientific, Waverton, Cheshire, UK.
New Composites Combine Best of Metallic and Thermoplastic Materials
Composite materials designed for minimally invasive surgical devices among other medical products reportedly blend the advantages of traditional metals and thermoplastics. PolyMed composites are rigid and exhibit a tensile and compressive strength similar to stainless steel, according to the firm. At the same time, they have structural versatility.
The materials’ overall strength eliminates the need to design a sheath to fit over a device and protect it from electrical connective capacitance. Tests conducted in accordance with ISO 10993 reportedly demonstrate the composites’ suitability for most surgical applications.
Traditional metallic and thermoplastic applications are tubular in nature. PolyMed composites, however, are sufficiently versatile for use in applications that require structural dimensions such as linear profiles and shapes. They can also incorporate embedded insulated electrical paths, fluid passages, sensors, or other electronic identifiers as part of the structure itself. Polygon Co., Walkerton, IN, USA.
Equipment Eases Handling of Thermoplastic Tubing in Sterile Manufacturing Processes
Welding and sealing instruments have been introduced for connecting or disconnecting thermoplastic tubing in biopharmaceutical manufacturing processes. The BioWelder and BioSealer accommodate various types of thermoplastic tubing with outer diameters ranging from 1/4 to 3/4 in. They are designed for use in the manufacture of disposable products.
The instruments feature automated operation and short cycle times. They allow users of disposable bag assemblies, for example, to intervene between the process steps without compromising process sterility. The thermal welds and seals ensure stability and sterility.
The underlying technology, developed by Wave Biotech Switzerland with whom the manufacturer has a strategic alliance, will be integrated into the Gammasart BioSystems line of disposable sterile fluid–handling products. Sartorius AG, Göttingen, Germany.
Modular Implantable Batteries Developed
Described as an industry first, a company has announced the availability of modular rechargeable lithium-ion implantable batteries. The product line has the potential to speed time to market for implantable products.
The modular design of the Contego series of batteries leverages the company’s many years of experience with proven chemistry and fabrication methods for medical implantable–grade batteries. The products will be available in capacities from 50 to 500 mAh; other chemistries will be added as dictated by customer demand.
Instead of developing a custom battery for each new device, OEMs can make use of the modular batteries and shave as much as 12 months from the product design cycle, according to the firm.
A supplier of batteries to manufacturers of implantable medical devices, the firm is certified to ISO 13485. EaglePicher Medical Power, Surrey, BC, Canada.
New Medical Valves Facilitate Assembly
Catering to customer demand for functional variety and ease of assembly, a supplier of medical-grade valves has introduced two new product lines. The Belleville and sleeved duckbill valves were presented to device OEMs for the first time at MEDTEC in Stuttgart, Germany, at the end of February.
Inspired by the Belleville spring design, the company’s new rubber valve has a steeper opening profile than traditional umbrella valves and is easy to assemble. The valve is available in silicone, EPDM, and FFKM materials and in a range of diameters.
Ease of assembly is also a key characteristic of the company’s new sleeved duckbill valve. Unlike standard flanged valves that are clamped between two housing parts, the new valve barrel slips over a spigot or slips inside a bore and maintains its hold by means of friction. This technique requires fewer components compared with clamp-type systems and results in accelerated assembly. The valve comes in four standard sizes in a range of elastomers. Minivalve International B.V., Oldenzaal, Netherlands.
Modem Packs Phone Jack and Data, Voice, and Fax Features into Tiny Box
A full-feature modem with an RJ-11 connector measures just 0.66 × 1.25 × 0.75 in., making it easy to integrate into small-footprint devices. According to the manufacturer, it is the smallest modem module with an RJ-11 connector on the market.
The TinyModem has full data, voice, and fax capability, and includes EMI shielding, a built-in data pump, and modem controller. It can tolerate isolation voltages up to 3750 V, and the materials used in its manufacture are RoHS compliant. Its small scale combined with the advantages of a standard RJ-11 connection and shielding simplify embedding data communications functionality into devices, according to the firm. Radicom Research Inc., San Jose, CA, USA.
