Ultrapure Water Systems for Medical and Pharmaceutical Applications

Ultrapure Water for Medical and Pharmaceutical Applications

Whether it’s dialysis water, feed water for steam sterilizers, or ultrapure water for active pharmaceutical ingredient production – medical and pharmaceutical applications place some of the strictest demands on water quality that exist. Our reverse osmosis and EDI systems deliver not just the required purity, but also the complete documentation your quality assurance needs.

Relevant Standards in This Application Field

Medical and pharmaceutical water treatment is a regulated field with high quality requirements. The following standards are common reference points in this application field – we design each system individually to match the requirements of your specific project.

• ISO 23500-2 / -3:2024 – water treatment equipment and water quality requirements for hemodialysis
• ANSI/AAMI ST108 – water for the processing (reprocessing) of medical devices
• DIN EN 285 – feed water for large steam sterilizers
• ASTM Type I–III – ultrapure and laboratory water quality for quality control and analytics
• GMP-oriented IQ/OQ documentation with every system

Water Quality in Detail

• Conductivity down to below 0.1 µS/cm, resistivity up to 18.2 MΩ·cm (ASTM Type I)
• Total Organic Carbon (TOC) < 10 µg/l for ultrapure water applications
• System output from 20 l/h for laboratory needs up to several thousand l/h for hospital and production supply

System Configuration

Depending on the purity required, we combine one- to three-stage reverse osmosis with a downstream electrodeionization (EDI) polishing stage. Choose the housing to match your installation site: enclosed stainless steel housing for cleanrooms and hygiene-sensitive areas, a mobile version on castors, an open frame for integration into existing infrastructure, or a fully enclosed cabinet system.

Typical Applications

Dialysis centers and clinics, central sterile supply departments, pharmaceutical API and drug manufacturing, hospital and laboratory water supply, and dental facilities – for each of these areas, we design the right system individually based on a feed water analysis and the required purity class. Use the tiles below to reach the detail pages for each specific area.

Customer Feedback

„Black Forest Medical nutzt die Osmoseanlage von IEM GmbH in zwei spezialisierten Funktionsbereichen unserer Betriebsstruktur. In der Serviceabteilung betreiben wir Reinigungs- und Desinfektionsgeräte (RDGs) zur Dekontamination von Medizinprodukten sowie zur standardisierten Aufbereitung klinisch eingesetzter Leihware nach Patientenkontakt. In unserer Testabteilung führen wir mit einem RDG sowie einem Autoklav Simulationen der thermisch-chemischen Beanspruchung durch, ein essenzieller Prozess für die Verifizierung von Neuentwicklungen und die Materialverträglichkeitsprüfung. Die Versorgung mit hochreinem Produktwasser (5 µS/cm) erfolgt über eine zentrale Osmoseanlage, ergänzt durch ein Puffersystem mit Tanks. Ein hervorzuhebendes Merkmal von IEM in der Kundenbetreuung nach Beschaffung ist die Serviceeffizienz bei der jährlichen Wartung am Standort Mainz: Wir liefern unsere Anlage morgens an und diese steht bereits zum Geschäftsschluss als einsatzbereit im Rückversand zur Verfügung – ein Serviceniveau, das unsere Prozessintegrität und Produktkontinuität nachhaltig unterstützt.“

Black Forest Medical develops and manufactures precision cranial stabilization and positioning systems for neurosurgery (the DORO® brand) in Freiburg, Germany, under certified manufacturing procedures and a strict quality management system (WZ 32.50.2 / NACE 32.50, manufacture of medical devices). IEM's 2-stage OSL ultrapure water system supplies both the reprocessing of reusable loan equipment and the material and verification testing of new products with water at 5 µS/cm quality.

„We have been working with IEM for 4 years to our complete satisfaction. Installation was completed within the promised time frame; service is always reachable and on hand. Maintenance works reliably. Unfortunately, that is no longer a given these days. All the more reason we value working with IEM.“

ANTITOXIN GmbH has been a partner to the IVD (in-vitro diagnostics) industry since 1966, specializing in the formulation, validation, and production of certified immunological reagents for automated and manual blood typing – from rare sera and erythrocyte stabilization solutions to ABO bedside test cards, manufactured at their site in Bammental, Germany. IEM's ultrapure water system supplies reagent production with water quality comparable to ASTM Type II.

Service & Support

From commissioning to maintenance contracts at fixed intervals to spare parts service, we support your system throughout its entire lifecycle. For regulated environments, we provide supplementary system-related documentation on request to support your own qualification processes. Optional remote monitoring also enables fast support in the event of a fault.