Contract technical moulder Carclo Technical Plastics (CTP) has successfully ventured into ISO Class 8 manufacturing with the installation of two unique and highly flexible activeCell self-contained cleanroom moulding and packing cells designed and manufactured by Sumitomo (SHI) Demag.
CTP provides injection moulding and contract manufacturing services for medical, automotive, PPE, optics and mechatronics applications and operates in 12 locations across the US, UK, Czech Republic, China and India. Following numerous customer requests for medical devices made to Class 8 standards, CTP’s operation in Brno (Czech Republic) looked to integrate an onsite cleanroom at its 4,730m2 facility, yet looked likely to be exorbitantly costly to build.
When the operation discussed the dilemma with injection moulding equipment supplier Sumitomo (SHI) Demag, the proposal of a self-contained activeCell cleanroom moulding and packing system was mooted.
We required a moulding and packing solution that could easily switch between several different modes of production
It was a ‘Eureka’ moment for Carclo Technical Plastics’ Technical Director Lee Dodd. ‘Without specifying any application details, we challenged Sumitomo (SHI) Demag to build two systems to meet our customer’s proposed capacity requirements,’ says Dodd. ‘We required a moulding and packing solution that had no restrictions, navigated numerous obstacles both technically and commercially, and could easily switch between several different modes of production.’
The activeCell builders had a number of bespoke challenges to overcome: the cell’s seal would be broken by cranes and other equipment regularly entering the machine, yet the system had to retain Class 8 standards; the product portfolio was extensive, requiring large and small parts of all geometries to be manufactured and then either bagged or boxed; the facility to track and trace bagged products was needed; and identical machines were required with inter-transferable mould and robot programmes.
The all-electric compact mini cleanroom system installed was fitted with laminar airflow cabinets for particle-free air in the mould-space area, integral packaging equipment and a six-axis Yaskawa Motoman robot, which removed parts from the mould ready for packing.
‘Over and above its primary purpose, the six-axis robot is a value-add for manufacturers looking for future expansion options, including pick and place, assembly or even palletising,’ says Sumitomo (SHI) Demag’s Managing Director, Nigel Flowers.
The activeCell units were built within 20 weeks, met all CTP requirements and currently manufacture a range of complex single-impression and multi-impression parts (including contact lens cases) to Class 8 standards in volumes from 125,000 to 9,000,000.
With order values to date exceeding £500,000 a year, CTP will see a return on its investment in less than 24 months.
The solution hit a sweet spot, in that it was affordable, flexible and transferable
‘The solution hit a sweet spot, in that it was affordable, flexible and transferable. Without Sumitomo (SHI) Demag’s activeCell solution, we would not be able to offer cleanroom moulding. We now have a cost-effective and highly flexible machine blueprint which any CTP facility worldwide can use should they decide to expand into cleanroom manufacturing,’ says Dodd.
‘ActiveCell has been designed to address current market requirements for a low investment alternative with complete flexibility at a fraction of the cost of a full cleanroom,’ adds Flowers.
The all-electric system is installed fully compliant, meeting GAMP and FDA requirements with DQ, IQ and OQ documentation and available in 100, 160, 220 and 280 tonne formats.