Pipettes from the cleanroom

The 560 sqm large CleanRoom CleanMediCell® provides plenty of brightness with large windows and LED lighting.

In the ISO Class 8 cleanroom, 2.5 billion individual parts are handled annually.

An enclosure with a laminar flow attachment supplies the product with pure air during the injection molding process.

The pipette tips manufactured in the cleanroom are used, among other things, for DNA analyses.

Hamilton is investing in a modern manufacturing facility in Domat/Ems. The centerpiece of the four-story new building is a 560 sqm cleanroom, where 2.5 billion pipette tips are produced annually under controlled conditions.

The Hamilton Group is a leader in the development and production of liquid handling and process analytics in the core areas of BioPharma and ChemPharma. The high-tech company with 2,500 employees worldwide has been setting revenue records for several years and has become one of the most important employers in Eastern Switzerland with its plants in Bonaduz and Domat/Ems. Through a high automation rate and nearly error-free production, the Swiss plants maintain a competitive advantage on the international market. A new building has now been put into operation in Domat/Ems, precisely tailored to the needs of safe and efficient production. The modern glass building, whose roof and facade are clad with photovoltaic panels, impresses with highly automated storage and production.

The core of the new building is a 560 sqm ISO Class 8 cleanroom, built for the production of pipette tips. Here, 2.5 billion individual parts are produced, inspected, and prepared for secure shipping annually. The applications of the tips include molecular biological research and laboratory diagnostics, such as DNA analyses. Very small amounts of liquids must be pipetted precisely. The pipettes must be free of any traces of DNA, RNase, or endotoxins/pyrogens for the safety of the diagnoses. To guarantee this to customers, Hamilton relies on controlled production under cleanroom conditions.

Innovative technology also characterizes the CleanMediCell® cleanroom system from SCHILLING ENGINEERING, which was specifically designed to meet the requirements arising from handling the large number of sensitive plastic components.

In addition to the actual cleanroom, which guarantees an ISO Class 8 air quality, the cleanroom specialist also supplied the laminar flow enclosures for the injection molding machines for contamination-free production. The pipette tips are manufactured in a controlled injection molding process. Each machine is equipped with a laminar flow enclosure that, with a regulated supply of ISO Class 5 pure air, protects the open areas of production from contamination. The finished parts are now automatically transferred via cleanroom transport rails and an attached robotic handling system into trays of 96 pieces each and introduced into the cleanroom. This process excludes contamination.

The principle of cleanroom technology is based on high-performance filters that remove particles from the surrounding air. The low-particle air is fed into the cleanroom and permanently displaces airborne particles still present in the cleanroom through continuous air exchanges. The cleanroom is equipped with an attached climate control system and operated with constant temperature and humidity. The cooled and filtered air is efficiently and gently recirculated in the air circulation system. For cooling, cost-effective deep well water is used. The cleanroom system is equipped with a 900 Lux LED lighting. The GMP cleanroom light strips are integrated into the aluminum profiles surface-mounted and produce a very bright yet pleasant light. In addition to artificial lighting, the cleanroom features large windows that provide natural light and blend well into the modern environment of the redesigned building.

The required media are integrated surface-mounted and run within the walls, ensuring excellent cleanability.

Wall and ceiling modules of the cleanroom are connected with a silicone-free sealing clip system, ensuring a high level of airtightness. Thanks to the modular design and patented connection, the cleanrooms from SCHILLING ENGINEERING can be easily reconfigured or expanded.

A special feature of the cleanroom system is the integrated GMP monitoring. The particle concentration within the cleanroom is monitored as well as parameters such as pressure, humidity, and temperature. All values are continuously recorded and documented. The controlled process, which meets high GMP standards, can thus be verified throughout the entire production period. The measurements and settings are consolidated in the control system CR_Control®, operated via an easy-to-use touchscreen. Maintenance and error messages are displayed here, and all parameters, including climate control, can be easily selected and controlled.

The safe entry and exit of personnel and materials is another important aspect of every cleanroom concept. It is carried out via separate sluice systems.

Employees enter the cleanroom through a specially furnished personnel sluice where they change into cleanroom clothing that emits few particles. Inside the cleanroom, the pipette tips are inspected, sterilized in part, and packaged. The double-packaged final product is safely transported outside via the material sluice and can now reach the end customer risk-free.

The cleanroom system from SCHILLING ENGINEERING was commissioned on time for the opening of the new building in Domat/Ems, to which American Managing Director Steve Hamilton from Nevada also traveled.