Medical manufacturing case study

The commissioning of a new MecWash MWX400 has led to "big wins” for the quality team at Croom Precision Medical, the Co. Limerick based manufacturer of medical implants and instruments.
The company is an FDA-registered contract manufacturer of orthopaedic implants, specialising in designing and manufacturing components for the medical device industry, and machining and handling precious metals for use in a sterile environment. Croom Precision Medical supplies precision components and high value consultancy services for medical applications, like orthopaedics, trauma and extremities, cardiovascular and vascular.
The firm has invested €8.6 million into its new production facilities, manufacturing Class I, II and III medical implants and instruments. Part of the investment went into a MecWash MWX400 to support the exacting cleanliness standards required of medical equipment, increasing decontamination levels, according to Patrick Byrnes, chief executive officer of Croom Precision Medical.
“In the manufacture of Class II and III medical implants, we must raise the bar on qualification criteria to ensure that every implant is prepared for sterility. After all, everything we produce here ends up in a human body somewhere around the world,” Byrnes says. “The MecWash system is utilised in our validated production process. The system has undergone full qualifications in installation, operation and process. These conditions test the process under ‘worst case cleaning conditions’ according to a set of parameters defined by our quality team.
“It’s imperative that our products for the medical industry are cleaned with the sophistication required. Everything in the machining process, all oils, contaminants, swarf, tissue papers; all of these elements must be removed in the cleaning process as the standards for medical equipment are so stringent,” he adds.
Byrnes explains: “Previously we used a series of single modular ultrasonic baths. We were limited by volume, pressure and power. The MecWash machine meets all of our requirements and more by giving a controlled, validated outcome on each processing cycle. This was a big win for our quality team where operator interference was completely removed. In addition, the system’s cycle time is a great deal faster, enabling our operations team to get more production through on a shift basis. It’s a big win.”
John Pattison, managing director of MecWash, says: “This application of the MWX400 is further proof of our credentials within the healthcare industry. We have a proud history of providing the immaculate cleaning standards required by the medical and precision engineering industries.”


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