Customer Centre
ITL Asia Pacific
ITL Asia Pacific is ITL Limited's Malaysia based manufacturing facility. The factory, located in Ipoh near Kuala Lumpar, is fully equipped for tooling, manufacture, cleanroom assembly and testing of medical devices and procedure packs.
ITL AP is responsible for the manufacture and inspection of products to international standards; regulatory and customer requirements. Product testing is conducted at ITL AP internally and/or at external accredited laboratories to meet international regulatory requirements and standards.
ITL AP undertake manufacturing and toolmaking for ITL and Original Equipment Manufacture (OEM) for external customers.
ITL Design & Manufacturing works closely with the R&D team at ITL AP to test and validate the processes and product being produced. The picture shows a team inspecting all dimensions on the part to ensure that they fall within specification.
Testing includes drop and impact tests, cyclic load testing, stress analysis and testing of whether the product actually performs how it should. The picture shows an engineer using a tensile strength testing machine.
Manufacturing
ITL has full in-house manufacturing capabilities based at the ITL AP Malaysian plant. Equipped with German made Arburg injection moulding machines, the facility is a fully certified class 8 cleanroom environment. Certified to ISO 9001, ISO 13485 and TUV accredited for CE marking along with the in-house QA department, your parts are assured to be mass produced to the highest quality standards.
The class 7 in-house assembly cleanroom can package and assemble your parts ready for distribution directly to your market.
The molding room is a 4200 sqft Class 8 cleanroom (less than 100,000 particles per cubic foot). Our injection molding machines range from 50T to 200T.
All processes are validated and products are inspected before being released to the customer. Pictured is a leak testing station for the Samplok® Sample Port.
Donorcare® Needleguards being inspected for quality. 100% visual inspection is used to assist in detecting cracks or imperfections in the molded parts.
Our packaging room is a 2000 sqft Class 7 cleanroom (less than 10,000 particles per cubic foot). Procedure pack packaging and other assembly work is conducted in this area. The picture shows workers assembling Clinical Choice medical procedure packs.
Our Form-Fill-Seal packing machine packs medical devices into sterile, lightweight products for transport and distribution.
Toolmaking
ITL has full in house tool making capabilities. Run from the ITLAP Malaysian manufacturing facility the 12 full time staff of tool designers, pattern makers and mould specialists can design and produce production tooling to suit mass manufactured parts.
All the staff, software, and equipment are in place to produce almost any tooling solution you may require. The tool room has succesfully produced countless high tolerance, high volume, quality medical tools. Through working closely with the ‘in house’ moulding and QA departments they know what is required to ensure consistent production of quality components.
The toolmakers have over 17 yrs experience in specialised precision toolmaking. The toolroom has the capacity to produce a range of tools for low volume and prototype tooling in addition to durable, hardened tools for high volume production. The range of toolmaking expertise covers:
- Customisable 2 and 3 plate tools with various gating, ejecting and stripping systems.
- Special releasing systems such as thread unscrewing, cam ejector slides, internal sliding cores and curved slides.
- Runnerless systems with customised direct gating, semi-hot and full-hot pin point gating.
- Modification, rework and maintenance for tools, jigs and fixtures.
The toolmaking team are equipped with the latest in tool design and engineering software.
Precision CNC machinery and the latest equipment enable complex, high tolerance steel tooling.
We can manufacture parts in low volume (1,000 - 15,000 units) or high volume using a variety of tooling solutions.
Highly skilled technicians and engineers ensure that our tools are maintained to the highest standard, ensuring the continual production of high quality parts within QA specification.