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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 and high-grade chemicals, 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 litres of reagents leave the plant by lorry – enough to analyse blood samples from some three 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
What’s more, we’ve had FDA approval since 2011 and accreditation from the Japanese Ministry of Health since 2012.
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 13485.
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 test 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 50 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.