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Cleanroom expansion in record time - Hamilton Bonaduz AG

The enormous demand for liquid handling solutions pushed the Swiss life science company Hamilton to its capacity limits. Hamilton was able to respond to the surge in demand caused by the pandemic. This is illustrated by the example of pipette tip production. The clean room and the production capacities located in it were almost doubled in record time.

The Swiss life science company Hamilton is experiencing eventful times. The Corona 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 on Hamilton technologies. The enormous demand for liquid handling solutions pushed the company, based in Domat/Ems in the mountainous canton of Graubünden, to the limits of its capacity. Hamilton was able to respond to the surge in demand. This is illustrated by the example of pipette tip production. Hamilton almost doubled the cleanroom and the production capacities located in it in record time.

When Hamilton Bonaduz AG commissioned a 560 m² cleanroom for the production of pipette tips in 2018, no one could have guessed that the demand for laboratory diagnostics would suddenly skyrocket in times of the Corona pandemic. The plastic tips are used in biotechnology, forensics, cell research and diagnostics, among others, where the smallest quantities of liquids have to be pipetted precisely. For the safety of the diagnoses, the pipettes must not contain any impurities. Hamilton therefore produces and packages under controlled cleanroom conditions.


In order to meet the increased demand from the laboratories, it was necessary to expand not only the injection molding capacity but also the entire handling of contamination-free production, which meets the requirements of GMP specifications. This also included an enlargement of the clean room, to which two additional machines have since been docked.
When the first cleanroom was installed in Domat/Ems a few years earlier, the Swiss company had already made sure to install a modular cleanroom system that could be converted and expanded. Georg Schischkin, Quality Leader at Hamilton, would not have thought that an expansion on this scale would be necessary as early as 2021. But thanks to foresighted planning, Hamilton was able to quickly expand its capacities, as Shishkin explains:
"When we planned the cleanroom in our new building in 2018, we already decided to provide for an expansion option for possible growth. That's why we opted for a modular system that can be easily converted. On the other hand, no one could have guessed that this would come into play so soon."

Quick expansion thanks to modular extension
The existing cleanroom and the expansion were carried out by the cleanroom company Schilling Engineering. Thanks to the CleanMediCell modular system, the 560 m² cleanroom was enlarged 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 a high degree of tightness of the room. Due 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 to adjust and test the pressure and ventilation of the two merged room modules. The entire cleanroom facility meets the requirements according to GMP D.

Georg Schischkin, who had to coordinate the production expansion under time pressure, already knows the cleanroom company Schilling Engineering from several projects and was very satisfied to be able to rely on the external know-how for the planning and implementation of the cleanroom expansion. The time constraint of the Swiss high-tech company was very tight and the speed of the conversion was of great importance:
"The fact that we could continue production during the extension was an indispensable prerequisite and it really worked very well. Schilling Engineering responded very flexibly to our needs and advised us well. The project management and the service technicians were always approachable and very competent. That took a lot of pressure off us. The timing of the conversion could not have been better."


Fully automated handling
With the expansion of the clean room, Hamilton was able to commission three additional injection molding machines to produce the pipette tips in a controlled GMP process free of contamination. Each injection molding machine is equipped with a laminar flow enclosure that uses a controlled supply of ultra-clean air to protect the open areas of production from contamination. The manufactured parts are then grouped fully automatically into trays of 96 pieces each via cleanroom conveyor belts and a connected robotic handling system and fed into the cleanroom. In the clean room, the pipette tips are inspected and packaged. The sealed end product is safely guided to the outside via an automatic lift system and automatic material locks and thus finds its safe way to the end customer. In order not to endanger the quality of the product, 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 recirculating air circuit in an energy-efficient manner that is gentle on the filter. The low-cost deep well water available is used for cooling.


GMP monitoring and GMP qualification
In order to meet all the requirements of the end customers, the cleanroom was qualified according to GMP and GMP monitoring was integrated. The evaluation of the particle measurement is also carried out according to the ISO 8 standard, which is important for medical technology.
Georg Schischkin explains these special features of the system: "We produce according to GMP, but also fulfill the proof of cleanroom class ISO 8 for our end customers from the medical technology sector. The CleanMediCell cleanroom system is especially suitable for this. A GMP qualification is very time-consuming and requires the most precise and a great deal of documentation. Here we were glad 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 pressure, humidity and temperature. All values are constantly recorded and documented at defined time intervals in a tamper-proof manner. 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 deviation trends. In addition, the cleanroom is monitored via the CR-Control software. The operators in the cleanroom receive immediate feedback when warning limits are exceeded or not reached and can follow the instructions of the messages on the touch panel for troubleshooting.
Thanks to the rapid replenishment, several billion pipette tips from Switzerland find their way safely into laboratory diagnostics every year and play their part in the implementation of the Corona measures. And despite all admiration for the flexible and courageous approach of the Swiss company, we hope that soon the majority of these special plastic parts will be used again for diagnoses that are far from pandemic.

This article was published: reinraum online 6/2022

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