Originally Published EMDM September 2005
Product Update
Focus on suppliers of moulding and related contract manufacturing services
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Wilden AG
Turning-stack mould technology is touted as yielding fast turnarounds and cost-efficiencies. The technique involves the use of a centre section that turns vertically during the moulding process. The section contains six cavities on all four sides. As all four sides can be used, productivity is high. In addition, the process requires a low clamping force, and because there are two freely accessible sides at every turn of the mould, automated processing of parts is facilitated.
Wilden AG (Regensburg, Germany) uses the turning-stack mould technology to create the HandiHaler, which has eight separate plastic components and four custom parts. The drug-delivery product is marketed by Boehringer Ingelheim Pharma GmbH & Co. KG (Ingelheim, Germany). Production and assembly takes place in a Class 100,000 cleanroom and on assembly lines that comply with US FDA CFR 21 Part 11 guidelines.
Upchurch Medical
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A company provides precision injection and insert moulding of parts for medical implants, disposable products, and instruments used in orthopaedic, cardiovascular, neurology, and radiology applications. On-site mould development and tooling, custom compounding, and Class 10,000 and Class 100,000 cleanrooms allow Upchurch Medical (Oak Harbor, WA, USA) to meet a complete range of contract manufacturing needs for medical device OEMs.
Product design and development, validation, prototype and production tooling, fixturing design and fabrication, assembly, kitting, packaging, and secondary cleanroom operations are offered.
The company is experienced in the building of moulds for use with exotic resins, such high-performance engineering thermoplastics as PEEK, and other medical-grade polymers. Extrusion and precision machining services are also offered.
Donatelle
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A firm processes thermoplastic, elastomeric, and liquid silicone rubber materials at a plant that is equipped with injection, insert, over-, and micromoulding systems. Donatelle (New Brighton, MN, USA) provides an array of services to medical device manufacturers that range from component design and manufacturing through device assembly, packaging, and sterilization management.
Research and engineering, prototyping, and in-house CAD/CAM/CAE-based tooling design and fabrication services are available. The firm also processes engineered resins and metals, and it has cleanroom facilities on-site. Registered with US FDA, Donatelle is certified to ISO 9001 and ISO 13485. Real-time statistical process control ensures part consistency.
Univac Precision Engineering
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A firm uses multi-cavity tooling for the fabrication of medical disposables. Univac Precision Engineering (Singapore) designs and builds compact moulds with hot-runner technology that can have upwards of 96 cavities. They can be used on machines with presses starting at 80 t.
The company has consistently expanded its product design, tooling, cleanroom moulding, and assembly services for medical device OEMs throughout the Asia Pacific region. Offices are also established in the United States and Europe.
The firm places a priority on rigorously monitored quality systems and zero-defect production.
PARItec GmbH
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To develop and manufacture a custom inhaler product for an OEM customer, a firm applied expertise in product design and development, material selection, injection moulding, and assembly.
A key component of the inhaler is a fixed connection between the valve tip and mouthpiece, which PARItec GmbH (Weilheim, Germany) fabricates using multicomponent injection moulding technology. The process helps to minimize production costs, according to the firm. For the exhalation valve, PARItech partnered with Kraiburg (Waldkraiburg, Germany), which supplies a soft material that meets required biocompatibility requirements and that withstands autoclave sterilization.
The production process includes automated re-moval of the delicate components from the moulding press, to protect them from damage, and assembly.
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