The company operates from ISO Class 8 (100,000) cleanroom environments in its facilities in Ireland and in the Czech Republic, where both facilities are ISO 13485 compliant.
Injection moulding is at the core of what we do at Tool & Plastic’s. We continuously work to maintain high quality standards, which includes, process control programs, SPC monitoring and regular particle monitoring of our cleanroom environment.
With location in Ireland and the Czech Republic, Tool & Plastic’s, offers complete device services that can be adopted to either full program transfers or brand new programs – This service starts at the front end of the project – This includes, initial product design involvement, mould sourcing & management program, process validation (IQ/OQ/PQ),Scientific moulding principles (Pro-Op),component manufacturing, automation, assembly, GMP Clean Room Finished Device Manufacturing and full supply chain management services for medical devices.
We are acutely aware of the importance of change control, quality assurance and reliability in meeting the needs of customers in the healthcare and medical device sector. Our products are delivered to our Customers that have their market focus in Cardiology, Vascular, Endoscopy, Drug Delivery, Blood filtration, Biotech, and, in General Surgical markets.
We have worked with, and, supported many of the Worlds leading Medical device companies over the years, through their various stages of growth, from their product development needs, through to, supporting their scale-up & commercialisation of their products for market release.
With significant investment in 2 new manufacturing facilities in 2007 & 2008, Tool & Plastic Industries Ltd, operates 7/24 and use the most advanced technology available, including all electric Injection moulding machines, robotics, downstream automation, process control programs & measurement technology.
This investment in technology continues in 2014, with the construction of a new Class 8 (100,000) cleanroom at its facility in Longford.