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Solutions for Reliable Analysis

Sysmex is known as a symbol of quality in laboratories and hospitals around the world. Our Neumünster factory produces the reagents and supplies our global network with the solutions required to make our diagnostic devices work. Reagents are hydrous solutions for diluting and/or treating blood samples and are used exclusively in Sysmex analysers.

Manufactured from purified city water, common salt and other additives, Sysmex reagents are tailored according to highly specific recipes. Filling, packing and despatch also happen at Neumünster. Our plant employs around 25 people.

More About Reagent Production

Production

The correct reagent mixture and a CIP (cleaning in place) programme means equipment is kept in superb condition.

Packing station

A fully automated system is used to pack and label the goods so that we can guarantee accurate delivery schedules.

Tank room

The various reagent components are kept in ten stainless steel tanks. The raw materials are weighed, fed directly into the system and mixed automatically.

Quality control and philosophy

Total Quality Management and an Environmental Management system are at the heart of Sysmex Neumünster‘s philosophy. The plant is certified according to ISO 13485 and ISO 14001.

Reagent Production and the Environment

Our company philosophy – The Sysmex Way – is an important part of how we work, and it is reflected in all we do. Being consistent means we take our surroundings into account too when producing our products and interacting with the environment. Using natural resources sustainably. Reducing pollution and waste. And that includes our reagents.

There is no getting round the fact that producing reagents consumes water and other chemicals. It is the nature of the business. We have also made it our business, however, to make sure we produce them responsibly.

Our production plant is located in an area in northern Germany where there is no question of a water shortage. And since 1999, we have been producing our in-vitro diagnostic reagents according to a certified environmental management system: ISO14001. This means we continuously monitor the impact we have on the environment caused by our reagent production. We have also been certified to ISO 9001 since 1996, ISO 13485 since 2010, and have had FDA approval since 2011.

The positive environmental performance of our plant over the years encourages us to keep setting ourselves tough environmental objectives. Using Sysmex reagents with Sysmex equipment demonstrates you support our environmental efforts. And could give you peace of mind knowing your reagents were produced responsibly.

Saving water

Our IVD analysers are of the highest quality, but they only function properly if they have equally good reagents. To produce haematology reagents, you need highly purified water. This purification guarantees the reagents have a long shelf life and that the analysers perform well because of the low background counts and high lot-to-lot stability.

The purification process produces ‘reject’, consisting of concentrated water. Conventional systems have a yield of 65% - i.e. 35 litres is wasted for every 100 litres produced. In 2008, we invested in the latest technology that has helped us to increase our yield to 82%. This special reverse osmosis system produces pure water from the reject and has helped us to reduce the annual water usage of the factory by over 6% compared to 2004.

Reducing waste

Since our reagent plant was founded, we have continued to grow and be successful in the IVD diagnostics market. This also meant we have needed to produce more reagent. To meet the demand, we therefore expanded our production plant in northern Germany in 2006.

More production also means more waste. That’s unavoidable. Initially the amount of general waste increased due to the construction activities at the factory. However, from 2007 onwards, we have managed to reduce waste by 3.5%, which works out at around 2000 kg per year. We managed this by increasing the lot sizes, which reduces initial scrap, by reducing the weight of our cardboard boxes, and by reducing the number of cardboard box rejects by using higher quality materials.

Saving energy

When the plant was expanded in 2006, the consumption of natural gas and electricity increased. Since then, we have made significant changes and improvements at the plant to reduce our energy consumption. In 2008, we invested in modern heating technology, as a result of which we cut our natural gas use to less than 60% of the 2004 level.

From 2007 onwards, we have reduced average electricity consumption thanks to the more efficient use of our production equipment. For example, we replaced autoclave sterilisation by steam-in-lace sterilisation, which has reduced our steam requirements when disinfecting materials.

The greatest change, however, has occurred since we introduced our photovoltaic system.

The Sysmex System

Instruments, reagents, controls and calibration

Our main aims in business are to make sure we provide excellent products and service, that we contribute positively to healthcare around the world and that our customers are fully satisfied. Of course, these aims apply especially to our in-vitro diagnostic testing. It’s fair to say, this focus on excellence is one of the contributing factors for our success.

A prerequisite for reliable and correct results – for which we take full responsibility – is that our users use the ‘Sysmex System’. This means using not only Sysmex instruments, but also our reagents, controls and calibrators. Each of these is aligned to the other and interacts and complements perfectly, forming a system. We and our partners can only take full responsibility for the reliability of the results and provide you with our excellent service when you make use of the complete Sysmex System.

There are several non-Sysmex reagents on the market. Manufacturers claim that they are compatible with our analysers, and they use names similar to ours. Clearly these are not approved by us. We have to point out that by using such third-party products, you are actively changing the stated ‘intended use’ of our system – Sysmex analyser, Sysmex reagents, Sysmex controls, and Sysmex calibrators. As a result, you legally become the ‘responsible manufacturer’ with all IVD-CE mark duties in Europe for this ‘new combination’ of Sysmex products with non-Sysmex products. Please understand that we cannot assume any liability for our systems’ performance in such cases.

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