Cleanroom expansion in record time thanks to modularity

The 320 sqm large expansion of the modular cleanroom system was separated from the ongoing production during construction by a dust protection wall and was connected to a total space within one day.

In the CleanRoom CleanMediCell®, several billion individual parts are traded annually.

The production has been expanded with three new injection molding machines. The plastic parts are protected from contamination using laminar flow covers.

The pipette tips manufactured in the cleanroom for use in laboratory diagnostics.

The cleanroom at Hamilton was expanded by 320 m² on short notice due to increased production requirements. Thanks to the modular system of the CleanMediCell® cleanroom, the renovation took only six weeks. Production could be maintained throughout the entire process.

When Hamilton AG commissioned a 560 m² cleanroom in 2018 for the production of 2.5 billion pipette tips annually, no one could have foreseen that the demand for laboratory diagnostics would suddenly surge during the Corona pandemic. An expansion of the injection molding capacity had to be carried out as quickly as possible.

Fortunately, Hamilton had already planned the old cleanroom as a modular system in advance and allocated space for an extension. The 320 m² expansion was again carried out with Schilling Engineering and directly connected to the existing CleanMediCell® cleanroom.

Wall and ceiling modules of the cleanroom system are connected with a silicone-free sealing clip system, ensuring high airtightness of the room. Thanks to the patented connection, the side wall of the original cleanroom could be dismantled without damage, and the existing wall and ceiling elements were connected to the new cleanroom. During the renovation, a temporary dust protection wall allowed production to continue fully. Only four hours of downtime were scheduled to adjust and test the pressure and ventilation of the two combined room modules.

With the expansion of the cleanroom, Hamilton was able to bring three additional injection molding machines into operation to produce pipette tips in a controlled, contamination-free process. Each injection molding machine is equipped with a laminar flow enclosure, which, with a regulated supply of ISO Class 5 clean air, protects the open production areas from contamination. The finished parts are then automatically transferred via cleanroom transport rails and an attached robotic handling system into trays of 96 pieces each and introduced into the cleanroom. Inside the cleanroom, the pipette tips are inspected and packaged. The sealed end product is then safely conveyed outside via a new automatic lift system and material shuttles, ensuring it can now reach the end customer risk-free.

A special feature of the cleanroom system is the integrated GMP monitoring. The particle concentration within the cleanroom is monitored along with parameters such as pressure, humidity, and temperature. All values are continuously recorded and documented. This controlled process, which meets the high GMP requirements, can be verified throughout the entire production period.

Georg Schischkin, who is responsible for cleanroom production as Quality Leader at Hamilton, is very satisfied with the implementation of the expansion. The timeline set by the Swiss high-tech company was very tight, and the speed of the renovation was of great importance. He spontaneously praises the flexible and rapid planning by Schilling Engineering with just one short word: "Chapeau!"