Solutions for reliable analysis
Sysmex symbolises quality in laboratories and hospitals around the world. Our Neumünster factory produces the reagents required to make our diagnostic devices work. Reagents are hydrous solutions for diluting and/or treating blood samples and the Sysmex reagents produced in Neumünster have been specifically developed for use in Sysmex analysers.
Manufactured from purified fresh water, common salt and other additives, Sysmex reagents are tailored to highly specific recipes. Our Neumünster plant, which employs around 50 people, also fills, packs and despatches the reagents to laboratories all over the EMEA Region. On each working day, around 180,000 l of reagents leave the plant by lorry – enough to analyse blood samples from some 3 million patients.
Reagent production in Neumünster
Together with a strict quality management system, it is the high-precision weighing, careful filling and correct mixing of the raw materials that ensures we produce reagents of outstanding quality. Moreover, a cleaning-in-place programme ensures our production equipment is kept in first-class condition.
A fully automated system is used to pack and label the reagents so that we can guarantee timely delivery schedules.
The various components for our reagents are stored in 15 stainless steel tanks from where the raw materials are precisely weighed, fed directly into the system and then mixed automatically.
Comprehensive quality, environmental and energy management systems are at the heart of the production philosophy at Sysmex Neumünster. That’s because we’ve made it our business to produce reagents responsibly. Our plant is certified to:
- ISO 13485, the quality management standard for manufacturing medical devices
- ISO 14001, the standard for environmentally responsible production
- ISO 50001, the standard for efficient energy management
What’s more, we’ve had FDA approval since 2011 and accreditation from the Japanese Ministry of Health since 2012.
Our company philosophy – The Sysmex Way – is an integral part of how we work, and reflected in all we do. Consistency for us means taking the environment into account when producing our products and interacting with our surroundings. In practice, this involves using natural resources sustainably as well as reducing pollution and waste. Since the Neumünster plant began producing reagents in 1993, remarkable advances have been achieved in its environmental performance. By using Sysmex reagents with Sysmex equipment you are supporting our environmental efforts to produce reagents responsibly.
To produce haematology reagents you need highly purified water. This purification guarantees the reagents have a long shelf life and the analysers will perform well because of low background counts and high lot-to-lot stability. But every purification process produces ‘reject’ water. Conventional systems have a yield of 65% – for every 100 litres of purified water produced 35 litres are wasted. Our state-of-the-art reverse osmosis system produces pure water from the reject so our yield is 82%. Water consumption has also fallen relative to the volume of reagents manufactured through steam-in-place equipment sterilisation, which reduces the amount of water required to disinfect production equipment.
In 2016, 91.5% of our cardboard, plastic and metal refuse was recycled as a result of on-going improvements in our waste separation system. Moreover, our cardboard reagent packaging is now made up of around 50% recycled material, while some two-thirds of the non-recycled cardboard comes from sustainable FSC-certified sources.
The greatest progress in saving energy has come from our rooftop solar panels. Approx. 15% of our plant’s electricity is now produced by solar power and all the electricity we purchase from external providers is generated by hydroelectric power. Our flagship solar ice system helps to heat the plant in winter and cool it in summer in an extremely energy-efficient manner: the heating or cooling output is around six times higher than the input of electricity. Another energy-efficient feature of our plant, the heat recovery system, enables us to use warm air inside to heat up the cold air coming in from outside before the used air is released into the atmosphere. This reduces our annual heating costs by about 20%. Last but not least, our average power consumption has fallen through more efficient use of production equipment and replacing autoclave by steam-in-lace sterilisation to reduce our steam requirements when disinfecting materials.
The Sysmex System
One prerequisite for reliable and correct results is that our customers use not only Sysmex instruments, but also our reagents, controls and calibrators – what we call the Sysmex System. Although several non-Sysmex reagents claim to be compatible with our analysers, they are not our approved products. If you use such third-party products, you are actively changing the ‘intended use’ of our Sysmex System and we are unable to assume any liability for the performance of our products.
Ten good reasons for using Sysmex reagents
1. Sysmex reagents undergo strict quality control procedures during production:
- Constant supervision of the same high-quality ingredients for producing reagents
- Regular rigid cleaning cycles
- Strict in-bound, in-process and output/quality controls per batch.
2. We invest significantly to minimise the environmental impact of our production process in a reagent factory certified to ISO 14001 and ISO 50001.
3. Sysmex reagents are specifically designed for Sysmex analysers. Our reagents, instruments, controls and calibrators are intended for use as a ‘closed system’. Any change to this closed system by the user is considered to be ‘non-specified use’.
4. The technology of Sysmex IVD analysers is fine-tuned to the corresponding reagents. As a result, Sysmex reagents deliver an optimum performance as well as the best possible system accuracy.
5. At Sysmex we are constantly researching into the best possible reagents, as there is a high interdependency between research and finding optimal reagents for any new parameters. Sysmex reagents thus fulfil best practice requirements for any research parameters that will later become diagnostic parameters in line with the legally required procedures under Annex VIII-IVD-DIRECTIVE 98/79/EC.
6. You can expect maximum sample stability, as our reagents are designed to have as low an impact on cell shape as possible in order to enhance the precision of sample counts.
7. Instrument calibration with the respective Sysmex calibrator materials ensures tests results are and remain reliable, reproducible and traceable, which particularly benefits accredited labs.
8. Our powerful cleaning reagent Cellclean helps maximise your analysers’ service life.
9. Using our reagents means only minimal equipment maintenance is required because technology and reagents are developed together. Other reagents may adversely affect our Sysmex technology, which will then involve extensive retesting.
10. Over 25 years of experience in producing reagents ensures minimal batch-to-batch variation so you don’t need to re-adjust the analyser for new reagent batches.