Breakthrough in Medical Moulding Technology Delivers No-Fail Reliability with Micro Systems UK

In a recent medical device project, Micro Systems delivered groundbreaking performance on an 8-cavity mould designed to meet a strict 'no-fail' requirement.

Tasked with achieving CpK and PpK values greater than 2.0 on every dimension-over 30 in total-the project demanded exceptional precision and consistency. Through close collaboration across mould design, manufacture, metrology, and process development, the Micro Systems team successfully met all customer specifications, ensuring the life-saving device complies with the stringent standards set by industry regulators.

For components used in critical devices like epinephrine auto-injectors, any failure could have severe-and potentially fatal-consequences, such as anaphylactic shock. Achieving exceptionally high Process Capability (CpK) and Process Performance (PpK) values across all cavities significantly increases confidence in the fail-safe performance required for these life-saving medical devices.

Reliability is critical in the production of life-saving medical devices, where even minor deviations can compromise performance and patient safety. High-precision, dependable mould tools are essential for consistently manufacturing components to exacting standards. Micro Systems' latest 8-cavity medical mould sets a benchmark for precision, delivering ultra-accurate parts with minimal variation across cavities.

This consistency not only ensures regulatory compliance but also reduces downstream inspection and rejection rates. In medical applications where precision is non-negotiable, reliable mould performance directly supports safer, more effective devices. Micro Systems excels in these demanding projects, providing end-to-end support-from pre-production tooling design, manufacture, metrology, and validation to full-scale production tooling-enabling faster, more efficient medical device development and significantly reducing time-to-market.

Founded in 2003 with a small team, Micro Systems has grown into a global leader in high-precision mould manufacturing, now employing over 100 skilled professionals. The company operates more than 800 square metres of advanced manufacturing space in Warrington, UK-including clean manufacturing areas, Class 7 and 8 cleanrooms, and white rooms-alongside a modern production facility in Singapore.

Serving hundreds of customers worldwide, Micro Systems delivers consistent excellence through ongoing investment in cutting-edge technologies, from advanced design software and high-precision injection moulding machines to state-of-the-art metrology equipment. Accredited to ISO 13485 and ISO 9001, the company brings deep expertise and specialised capabilities in mould manufacture for drug-delivery medical devices.

Visit us at https://www.medicalmoulds.com

Micro Systems (UK) Ltd - 101 Golborne Enterprise Park, Warrington, WA3 3GR
44 (0)1942 290 960
https://www.medicalmoulds.com

Micro Systems is a leading manufacturer in precision-engineered injection moulds and micro moulds for the medical, pharmaceutical and ophthalmic markets. Micro Systems offers innovative solutions for designing and manufacturing multi-cavity, high-volume moulds, and turnkey solutions for medical device manufacturing needs, with Class-7 cleanroom production capabilities. In addition to mould making and component supply, Micro Systems also provides factory acceptance testing (FAT), mould validations and technical moulding support as part of our comprehensive service. The company is ISO 9001 and ISO 13485 certified, and has facilities in Warrington, UK and in Singapore.

This release was published on openPR.