Advantages of LSR

Miniaturisation The LSR moulding process is well-suited for miniature parts. It can produce micro- and nano-sized components below 10 mg through specialised micro and needle-point injection technology. An example of a small piece manufactured is a septum — the membrane in the cap of a medicine bottle through which a syringe is inserted and withdrawn. This typically weighs just 0.003 g. At that size, you can hardly pick the part up … and standard moulding burrs are larger than the part itself. Manufacturing a microcomponent such as this requires extreme accuracy in tool construction, control of shot weight and the moulding process. After moulding, automatic handling of the product is performed by a specially developed robot gripper arm. The process ensures reliability and accuracy for millions of shots. Automation and quality The example of the septum highlights the importance of automation for medical device component manufacturing; it makes the high-volume production of extremely complex multicomponent LSR geometries possible. Automation can also help ensure cleanliness requirements are met by reducing the risk of contamination during the production process Quality is paramount for medical devices. The ‘holy grail’ here is to ensure quality in process rather than to conduct post-production quality checks; thus, certified quality systems and process controls are built into the production process. The ability to segregate suspect products effectively with minimal disruption is crucial to minimising downtime in a high-volume, rapid production process. Ideally, in-line quality checks should be electronically recorded to allow full traceability. Any issue can therefore be isolated to just a small number of components and separated by a cavity. Cleanliness Though standards vary, cleanliness in medical device manufacturing is always vital. For some medical devices, production in an ‘uncontrolled environment’ is clean enough. Due to the nature and positioning of LSR mouldings within a medical device, however, they may need to be manufactured and packed in a fully ‘controlled’ cleanroom of class 100,000, ISO 8 or class 10,000, ISO 7, or even higher. Although they’re not generally a sterile environment, cleanrooms control a specified number of particles per cubic meter, at a maximum specified particle size. This includes environmental pollutants, such as dust, airborne microbes, aerosol particles and chemical vapors. Current applications for LSR technologies range from drug delivery, such as primary drug packaging or wearable smart drug pump systems, to fluid management, diagnostics, short- and long-term implantable medical devices, and biotechnology. With so many advantages, it’s no surprise that LSR technology is seeing exponential growth.