Clamason’s precision namufacturing solution helps diabetics to dial and dispense correct insulin dosage. The Kingswinford, UK, based precision pressings manufacturer Clamason Industries Ltd is the subcontractor supplying the highly complex indexing washers (with associated tooling) which allow the user to accurately dial and dispense the correct dosage of insulin on the new SoloStar® insulin pen.
SoloStar® is the first product to come out of the Sanofi-Aventis Device development and production site at Frankfurt-am-Main, Germany. It is an own-brand insulin pen for diabetics worldwide from the French group who are the World’s third largest pharmaceutical company.
Sanofi-Aventis is acknowledged as a global leader in the development and manufacture of insulin. Before it embarked upon device supply, Sanofi-Aventis supplied its liquid insulin through existing pharmaceutical delivery systems. SoloStar® represents the company’s first totally owned device. Launched initially in Australia and now worldwide, the product dispenses the famous Lantus® long-lasting insulin, as well as the shorter acting Apidra® brand.
Clamason’s 15mm diameter, complex indexing washer is vital to the pen; once fitted it is designed to sit tightly into the grooves of the mating plastic during the dial phase, yet flatten out during dispense before returning to its original shape ready for the next dose. This procedure can occur many times depending upon the user’s requirements, hence the need for a hard and thin stainless steel.
With the exception of the injection needle itself, the Clamason washer is the only metal part, replacing a plastic concept early in the development work. It benefited from a number of process innovations, including single-operation tooling, before the design was finalised.
The totally custom built cell at Clamason in Kingswinford producing this component consists of a precision decoiler for the strip, two state-of-the-art Bruderer presses, a 3D, CNC video measuring system, plus off-line GMP compliant cleaning, and laser measuring for batch control.
The 3D realtime vision system views several hundred parts per minute, measuring the key or control dimensions, and recording the results. In addition, samples are taken out of every batch and 100% inspected using a laser measuring machine, the only device capable of accurately accumulating data on such an intricate part in the given time.
The components are then cut, washed and finally packed into sealed plastic bags through custom-designed air showers using strict GMP compliant procedures. All personnel involved in the project have completed GMP training and are the only people able to access the electronically controlled cell.
The Clamason process is comprehensively validated to Design, Installation, Operational and Production Qualification protocols (DQ / IQ / OQ / PQ), working within the requirements of the US Food & Drug Administration’s (FDA) Code of Federal Regulations, Title 21, “Part 820: Medical Devices – Quality System Regulation”, in addition to being approved to the more common BS EN 13485 standard.
Clamason is capable of fully process validating all its medical components by means of these protocols. In addition, the Clamason team is trained in the use of CAPA (Corrective and Preventative Actions) – essential for medical industry processes.
The shared objective of all companies co-operating in the project internationally is to make life easier in the future for the increasing numbers of diabetics requiring subcutaneous insulin.
