The use of automation and robotics in medical device manufacture supports the industry in many ways including reducing labour costs while providing both flexibility and repeatability. Here at Innomech we have many repeat customers within the medical device industry because our systems lend themselves perfectly for the processes required.
As with each individual project, our assembly machines are designed uniquely around the production specifications of each customer, including glue dispensing, UV curing and vision inspection. We are able to support with both component compliance and final assembly.
Here are 3 examples of what we achieved here at Innomech in the medical device manufacturing field.
Manufacturing of lenses for Rayner
Prior to Rayner’s new production plant opening in 2015, Innomech was awarded the contract to develop several units that would be used in the lens manufacturing process. They had to compliant with both EU and global regulations and the process was completely unique.
Mike Collins, project director from Raynor had this to say about his experience with Innotech…
‘Innomech is the ideal partner for Rayner because of their experience in precision cutting, working with rotating parts and in developing equipment for regulated manufacturing environments.’
End of Line Medical Device Tester
Pen Tester is a leading biotechnology solutions provider based in California U.S. and operating globally. They wanted our help to manufacture a unique patient administered drug delivery device allows each user to “dial up” a dose and deliver it subcutaneously. There were obvious risk factors as the accuracy of the device had to be 100% accurate.
A simple to use inspection workstation incorporates five independent servo driven axes that together exercise all the mechanical components of the device to perform a mixture of static and dynamic force and torque profile measurements. In a test cycle of a few seconds, the machine measures 15 parameters and compares each with pre-set limits. If any one of these is out of range the item is signalled as faulty and is rejected.
The workstation meets the strict regulatory requirements applying to pharmaceutical products of this type, both in its design, its materials of construction, and in the level of documentation supplied covering functional and design specifications, test protocols, and operational manuals.
Precision Powder Dispensing
Capsugel is a global leader of innovative dosage forms and capsule filling equipment for the pharmaceutical and dietary supplement industries.
They wanted the support of Innotech to manufacture the Xcelodose® Precision Powder Micro-dosing System which enables pharmaceutical companies to dose active pharmaceutical ingredient alone into capsules and other compact containers.
We worked closely with the client to understand the various market opportunities for such a system. It was clear that one solution would not meet all needs and that there needed to be a semi-automatic solution, capable of accepting a wide variety of containers, as well as a system accepting a more limited range of capsules but capable of running at high speeds. Design studies enabled clear specifications to be developed ensuring, where possible, common features, parts and controls.
We produced the semi-automatic Xcelodose® 120 system capable of accepting a wide variety of containers including vials, syringes and blisters; and the fully automatic Xcelodose® 600 system for use with capsule sizes 00 – 4, and capable of automatically filling capsules with prescribed weights as low as 100mcg and with precision levels of ~ 2% RSD at speeds of up to 600 capsules per hour with the amount of powder in every container being recorded to comply with 21 CFR part 11 requirements.
As a result our client had an industry standard offering in automated capsule filling for preparation of early stage clinical trial supplies. Our long term relationship has led to the development of series two systems (Xcelodose® 120S and Xcelodose® 600S systems) which both offer increased functionality.
In addition further developments to the range include the Xcelolab™ powder dispenser which has been specifically designed for laboratory use; the Relative Humidity Control Unit and Xcelohood™ containment system. For further information on these products visit www.xcelodose.com.
GB Innomech can supply a fully validated machine, with full validation documentation based on the Gamp 5 model with full component traceability and CFR21 part 11 compliance. We can also provide full test documentation, including Installation and Operational Qualification (IQ/OQ) , Gauge R&R and other relevant studies.
So with this high level of capabilities and service, what can we help you with? For more information contact us here.