The Swiss life science company Hamilton is experiencing eventful times. The coronavirus pandemic has led to an enormous surge in demand for its products. Not only does one in five ventilators in use worldwide come from the Swiss company’s production facilities. Two thirds of all automated PCR tests worldwide run with Hamilton technologies. The enormous demand for liquid handling solutions pushed the company, based in Domat/Ems in the mountainous canton of Graubünden, to its capacity limits. Hamilton was able to respond to the surge in demand. This is shown by the example of pipette tip production. Hamilton almost doubled the Cleanroom and its production capacity in record time.
When Hamilton Bonaduz AG opened a 560 m² production facility for pipette tips in 2018 Cleanroom for the production of pipette tips, no one could have imagined that demand for laboratory diagnostics would suddenly skyrocket during the coronavirus pandemic. The plastic tips are used in areas such as biotechnology, forensics, cell research and diagnostics, where the smallest amounts of liquid need to be pipetted precisely. To ensure the safety of diagnoses, the pipettes must not be contaminated in any way. Hamilton therefore produces and packs under controlled clean room conditions.
In order to meet the increased demand from the laboratories, not only the injection molding capacity but also the entire handling of contamination-free production had to be expanded to meet the requirements of the GMP specifications. This also included an expansion of the cleanroom, to which two additional machines have since been docked.
When installing the first cleanroom in Domat/Ems a few years earlier, the Swiss company had already taken care to install a modular cleanroom system that could be converted and expanded. Georg Schischkin, Quality Leader at Hamilton, would not have thought it possible that an expansion on this scale would be necessary in 2021. But thanks to forward-looking planning, Hamilton was able to expand its capacities quickly, as Shishkin explains:
“When we planned the Cleanroom 2018 in our new building, we had already decided to provide for the possibility of expansion in the event of growth. That’s why we opted for a modular system that can be easily converted. However, nobody could have imagined that this would come to fruition so quickly.”
Rapid expansion thanks to modular extension
The existing Cleanroom and the extension were carried out by the cleanroom company Schilling Engineering. Thanks to the modular CleanMediCell system, the 560 m² Cleanroom was extended by a further 320 m² in just six weeks. Production was maintained during the entire conversion.
Wall and ceiling modules of the cleanroom system are connected with a silicone-free GMP sealing clip system, which ensures that the room is extremely airtight. Thanks to the patented connection, the lateral cleanroom wall of the original cleanroom could be dismantled non-destructively and the existing wall and ceiling elements connected to the new Cleanroom. Thanks to a temporary dust protection wall, production continued in full during the conversion. Only four hours of downtime were scheduled in order to adjust and test the pressure and ventilation of the two combined room modules. The entire clean room system meets GMP D requirements.
Georg Schischkin, who had to coordinate the production expansion under time pressure, already knew the cleanroom company Schilling Engineering from several projects and was very pleased to be able to rely on the external expertise for the planning and implementation of the cleanroom expansion. The Swiss high-tech company’s deadline was very tight and the speed of the conversion was of great importance:
“The fact that we were able to continue production during the extension was an essential requirement and it really worked very well. Schilling Engineering responded very flexibly to our needs and gave us good advice. The project management and service technicians were always available and very competent. That took a lot of pressure off us. The timing of the conversion could not have gone better”
Fully automated handling
With the expansion of the clean room, Hamilton was able to commission three additional injection molding machines to produce pipette tips contamination-free in a controlled GMP process. Each injection molding machine is equipped with a laminar flow enclosure, which protects the open areas of production from contamination with a controlled supply of ultra-pure air. The finished parts are then grouped fully automatically into trays of 96 pieces each via cleanroom conveyor belts and a connected robot handling system and fed into the Cleanroom. The pipette tips are checked and packaged in the Cleanroom. The sealed end product is safely conveyed to the outside via an automatic lift system and automatic material locks and thus finds its way safely to the end customer.
To ensure that the quality of the product is not compromised, the Cleanroom has a connected air conditioning system and is operated at a constant temperature and humidity. The cooled and filtered air is fed back into the air circulation system in an energy-efficient and filter-friendly manner. The low-cost deep well water is used for cooling.
GMP monitoring and GMP qualification
In order to meet all the requirements of the end customer, Cleanroom was qualified in accordance with GMP and GMP monitoring was integrated. The evaluation of the particle measurement is also carried out in accordance with the ISO 8 standard, which is important for medical technology.
Georg Schischkin explains these special features of the system: “We produce in accordance with GMP, but also meet the requirements of cleanroom class ISO 8 for our end customers in the medical technology sector. The CleanMediCell cleanroom system is particularly suitable for this. GMP qualification is very complex and requires a great deal of precise documentation. We were happy to receive advice and support from experienced cleanroom engineers.”
A special feature of the cleanroom system is the integrated GMP monitoring. The particle concentration within the cleanroom is monitored, as are the parameters of pressure, humidity and temperature. All values are constantly recorded and documented in a tamper-proof manner at defined intervals. The controlled process can thus be verified over the entire production period, as required by GMP specifications. Continuous testing allows trends to be evaluated and enables timely countermeasures to be taken in the event of deviations. In addition, the Cleanroom is monitored via the CR-Control software. The operators at Cleanroom receive immediate feedback if warning limits are exceeded or undercut and can follow the instructions on the touch panel for troubleshooting.
Thanks to the rapid increase in production, several billion pipette tips from Switzerland find their way safely into laboratory diagnostics every year and play their part in implementing the coronavirus measures. And despite all our admiration for the Swiss company’s flexible and courageous approach, we hope that the majority of these special plastic parts will soon be used again for diagnoses that are far removed from a pandemic.
This article was published: reinraum online 6/2022
