The polymerase chain reaction, or PCR for short, is used for various diagnostic purposes within human medicine. This laboratory procedure is absolutely essential, particularly for the diagnosis and progress monitoring of bacterial, viral and parasitic infectious diseases. It provides fast and highly reliable results, which are significant advantages over other testing methods. The PCR is also used to detect and identify COVID-19 infections. Now, with the outbreak of the novel SARS-CoV-2 coronavirus, PCR testing capacities are currently increasing on an enormous scale across the globe.
High demandDue to the corona crisis, more diposables are needed for PCR tests (symbol image)
Ramp-up of production capacities
With the increasing demand for COVID-19 testing kits, it quickly became evident that existing capacities for the manufacture of required disposables such as plates, racks and pipette tips would soon be completely exhausted. That also includes the Swiss Weidmann Medical Technology AG, which is manufacturing high-quality plastic consumables for in vitro diagnostics, as well as pharmaceutical primary packaging and medical components for world-renowned medtech companies, at its Bad Ragaz location.
The contract manufacturer has been manufacturing deep well plates featuring 48 wells on a NETSTAL ELION 1750-530 in an ISO-7-class cleanroom for years. These are consumable products which are used on fully automatic real-time PCR analysis systems for the preparation of up to 48 samples. In order to cope with the enormous increase in demand, the production output had to be quickly doubled. For this purpose, an existing and rarely used backup tool was first tested and optimised in the technical centre of the nearby LIBS training company in Rapperswil to determine whether it is suitable for continuous operation in the short term. LIBS had a fully electric NETSTAL ELION with an identical clamping unit, injection unit and control system. At the end of the successful test phase, Weidmann wanted to acquire the machine and put it into operation as quickly as possible. However, there was a slight snag, as the LIBS NETSTAL ELION had been acquired in 2007 as a standard model. Consequently, operating the complete injection molding machine within a cleanroom environment would be an absolute no-go.
A well-drilled teamTwo workers of the overhaul team apply finishing touches
Final inspectionBefore delivery, the NETSTAL ELION was checked to ensure its cleanroom certification
Fit for the ISO-7 cleanroom class in record time
The NETSTAL ELION 1750-530 in question ended up changing hands two times in quick succession. First, it was purchased back from LIBS by the KraussMaffei HighPerformance AG, and then transported from Rapperswil to Näfels on 17 April 2020. It underwent a 12-hour continuous test in the Netstal plant and was then modified by an experienced overhaul team within just 10 working days so as to ensure compliance with the required ISO 7 cleanroom class through a reduced particle discharge. It was then delivered to Weidmann in Bad Ragaz in record speed on 29 April. Following its commissioning in the cleanroom, it was ready for production within just a few days.
Conversion measures from standard to clean room configuration:
- Conversion of the safety cover
- Cleanroom-suitable coating
- Conversion of the cooling water circuit
- Encapsulation of the cooling water line drag chains
- Conversion of the electrical cabinet
- Adaptation of the plasticising unit
- Final inspection of the machine for cleanroom certification
CommissioningThe NETSTAL ELION 1750 is now all set to manufacture 48-well deep well plates in Weidmann’s cleanroom environment. Production started on May 8, 2020.
Faster certification process
For the customer, this was a perfect solution. With its updated injection molding machine, Weidmann Medical Technology AG now boasts a 1:1 copy of the existing system. As a result, this not only guarantees a faster certification process, but operating personnel may also be assigned to work on the new system without any additional training. Furthermore, NETSTAL products are of particularly lasting value, which is why the 13-year-old injection molding machine can, in principle, be considered as good as new after this revision.
Thanks to the long-standing and cooperative relationships between all three companies involved, this exciting project came to fruition within a very short space of time. The time taken from the initial request put forward to the KraussMaffei HighPerformance AG up to the delivery was a mere four weeks. In addition, LIBS will not have to do without an injection molding machine from Näfels when training prospective plastics technicians in the future. A NETSTAL ELION 2200 was ordered as a replacement – naturally also second-hand and in perfect condition.