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 2500 employees worldwide has been setting sales records for several years and, with its plants in Bonaduz and Domat/Ems, has advanced to become one of the most important employers in eastern Switzerland. Thanks to a high rate of automation and almost faultless production, the Swiss plants can maintain a competitive edge on the international market. In Domat/Ems, a new building has now been put into operation that was tailored precisely to the needs of safe and efficient production. The modern glass building, whose roof and façade surface are clad with photovoltaics, impresses with its highly automated storage and production.

The centrepiece of the new building is a 560-square-metre ISO Class 8 clean room built for the production of pipette tips. Here, 2.5 billion individual parts are produced, tested and prepared for safe shipment every year. The applications of the tips include molecular biology research and laboratory diagnostics, such as DNA analyses. The smallest quantities of liquids must be pipetted precisely. The pipettes must not have any traces of DNA, RNase or endotoxin/pyrogens for the safety of the diagnoses. To guarantee this to customers, Hamilton relies on controlled production under cleanroom conditions.

Innovative technology also defines the CleanMediCell cleanroom system from SCHILLING ENGINEERING, which was designed precisely for the requirements that arise when handling the high number of sensitive plastic components.

In addition to the actual cleanroom, which ensures ISO Class 8 air quality, the cleanroom specialist also supplied the laminar flow enclosures for the injection moulding machines to ensure contamination-free production. The pipette tips are manufactured in a controlled injection moulding process. Each machine is equipped with a laminar flow enclosure that protects the open areas of production from contamination with a controlled supply of ISO class 5 clean air. The manufactured parts are now grouped fully automatically into trays of 96 pieces each via cleanroom conveyor belts and a connected robot handling system and fed into the cleanroom. Contamination is ruled out in this way.

The principle of cleanroom technology is based on high-performance filters that filter particles from the ambient air. The low-particle air is flushed into the cleanroom and displaces the airborne particles still in the cleanroom in permanent air changes. 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 and filter-friendly manner. The cost-effective deep well water is used for cooling.

The cleanroom system is equipped with 900 lux LED lighting. The GMP cleanroom light strips are integrated flush into the aluminium profiles and create a very bright yet pleasant light. In addition to the artificial light, the cleanroom was equipped with large windows that provide natural lighting and also blend in very well with the modern surroundings of the redesigned building.

The required media are integrated flush and run inside the wall, which results in very good cleanability.

Wall and ceiling modules of the clean room are connected with a silicone-free sealing clip system, which ensures that the room is highly leak-proof. Due to the modular design and the patented connection, the cleanrooms from SCHILLING ENGINEERING can be easily converted or extended.

A special feature of the cleanroom system is the integrated GMP monitoring. The particle concentration within the cleanroom is monitored as well as the parameters pressure, humidity and temperature. All values are constantly recorded and documented. The controlled process, which meets the high GMP requirements, can thus be verified over the entire production period. The measurements and settings are brought together in the CR-Control® control system, which is controlled via an easy-to-use touch screen. Maintenance and error messages are displayed here, and all parameters, including the air-conditioning technology, can be easily selected and controlled.

The safe entry and exit of staff and material is another important point of every cleanroom concept. This is done via separate airlock systems. The staff enter the cleanroom via a specially furnished personnel airlock, where they change into cleanroom clothing that emits few particles. In the clean room, the pipette tips are checked, partially sterilised and packaged. The double-packed end product is safely conveyed to the outside via the material lock and can now find its way to the end customer without risk.

The cleanroom system from SCHILLING ENGINEERING was put into operation in time for the opening of the new building in Domat/Ems, which was also attended by the American managing director Steve Hamilton from Nevada.

This article was published: Plastverarbeiter 5/2019