The advent of COVID-19 has made Australian manufacturing vulnerabilities evident and has confirmed the reality that Australia must onshore critically manufacturing processes in order to negate sovereign risk to the supply of critical goods. In line with this, it has been evident that the Australian government has been intent on driving the transformation of Australia towards becoming a world-class, advanced manufacturing, and biotechnology innovation centre.
To this end, Forme Technologies has become known in the industry for providing its services to clients predominantly in these advanced technology sectors and has participated in projects where critical components for instruments, medical devices and machinery require a high level of precision, quality and in some cases these components that are required to be manufactured within a “clean and controlled” environment.
In instances where high levels of environmental control have been required, we have historically developed environmental capsules/chambers around our production machines. The development and introduction of these encapsulation systems effectively afforded us the equivalent of a cleanroom environment around the machine.
Whilst this development resolved the cleanliness problem, it also introduced additional challenges to the daily operation of the factory. As a custom injection moulding shop, typically one of the ongoing challenges has been the changing of tools/moulds which as a custom moulder is performed on a regular basis. With the introduction of the said chambers, tool changes turned into operations that required higher skill levels and generally took a lot longer than normal. Added to this was the requirement to perform tool changes with less room to manoeuvre around the machine.
A further challenge has been that opening the chamber for tool changes exposed the machine to the ambient environmental conditions of the factory which by default is significantly dirtier than within the chamber. Consequently, a thorough clean of the machine would be required prior to setting up a new job which would consume excessive labour whilst keeping the machine idle for considerable lengths of time.
Perhaps the most significant inconvenience has been that since the operator is required to be on the outside of the chamber, removing parts from the encapsulated environment for inspection or indeed later packaging or post-processing in our white room has been very cumbersome. This has led to the necessity for bespoke automation devices to be implemented - in many cases product specific, and in other cases requiring the use of “glove boxes” which make things rather uncomfortable for our personnel.
As part of Forme’s strategy and focus on providing solutions to advance manufacturing and biotech industries, in mid-2018, Forme’s management decided to build a dedicated manufacturing facility that would house an ISO 8 class cleanroom. It was envisioned that the facility would house the best available technology for the manufacture of products within a clean environment not only for our existing clients but also for Australian and international markets at large.
In April 2019 after diligent scoping of the cleanroom was undertaken, supplier selection for builders, machinery and ancillary equipment was completed as well as the submission of permit applications, etc.
Construction began on the 13th of May 2021 with August 2021 seeing the conclusion of a functional cleanroom that was put together in record time. Unfortunately, after having the structure completed, we endured numerous delays with respect to the supply of machinery and ancillary equipment as a result of COVID-19. Finally, the last piece of equipment arrived at the end of December 2021 which saw the connection of services to machinery etc at the end of February and a completed, ready-for-purpose clean room for our customers.
A significant feature of our 220 m2 ISO 8 cleanroom is the capacity to operate a small fleet of injection moulding machines within the cleanroom, therefore, eliminating the risk of manufacturing in an that could potentially introduce unwanted contaminants. Apart from injection moulding per se’, our cleanroom has been built and designed to provide end-to-end solutions with the capacity to offer value-added processes and assembly space for such critical components.
In May of 2023, the facility was certified to the ISO 13485 certification which allows us to manufacture medical devices and associated componentry whilst subscribing to the regulatory paths that clients are required to follow to get to market.
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