Solutions / Pharmaceutical and sanitary water
Water for dialysis compliant with ISO 23500
Water quality is a decisive factor in renal patient safety: each hemodialysis session exposes the patient’s blood, through the dialyzer membrane, to 120 to 200 liters of dialysis fluid. We design, install and verify complete treatment, storage, distribution and concentrate preparation systems that meet the ISO 23500 series and ensure continuity of therapy.
< 0.25 EU/mLEndotoxin limit for dialysis water, ISO 23500-3
ISO 23500 regulatory framework
- ISO 23500-1 Preparation and quality management of fluids
- ISO 23500-2 Water treatment equipment
- ISO 23500-3 Water for hemodialysis and related therapies
- ISO 23500-4 Concentrates for hemodialysis
- ISO 23500-5 Quality of dialysis fluid
Water quality chain in a dialysis unit
1
Pretreatment
Protection of the reverse osmosis and removal of chlorine and chloramines.
2
Medical-grade reverse osmosis
Main barrier against chemical contaminants, bacteria and endotoxins.
3
Endotoxin control
Microbiological polishing for conventional hemodialysis and online HDF.
4
Storage and distribution
Continuous recirculation to every hemodialysis machine.
5
Concentrate preparation
Bicarbonate and acid prepared and distributed automatically.
A solution for every stage of therapy
ISO 23500-3 water
Complete dialysis water system
Pretreatment, medical-grade reverse osmosis and online monitoring to produce water compliant with ISO 23500-3, with a redundant architecture for continuous operation.
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Treatment train
- Multimedia filtration for suspended solids and turbidity.
- Softening that protects the membranes from calcium and magnesium.
- Activated carbon in series against chlorine and chloramines, with a backup column.
- Reverse osmosis single or double pass: a barrier against ions, metals and endotoxins.
- Final polishing by ultrafiltration or UV depending on the therapy modality.
Continuous recirculation
Storage and distribution
A continuous recirculation loop with no stagnant zones that preserves water quality up to every machine.
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Loop components
- Tank of minimum volume, with a conical bottom and bacteriological vent.
- Pumps with variable frequency drive for stable pressure and velocity.
- Continuous recirculation 24 hours a day, returning to the tank or to the osmosis.
- Sanitary outlets with short branches to each machine.
- Scheduled disinfection thermal or chemical, with UV on the loop where applicable.
For online HDF
Endotoxin removal and control
Compact polishing stage that reduces endotoxins and bacterial fragments, recommended for online HDF.
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Installation and benefits
- Installed at the osmosis outlet, before the tank, on the loop or at critical points.
- Reduces endotoxins and retains bacterial fragments.
- Stabilizes the circuit and protects online HDF equipment.
- Lower risk of pyrogenic reactions in the patient.
- Modular: for new or existing systems.
ISO 23500-4 concentrates
Bicarbonate and acid dilution and mixing
Centralized, automated preparation of bicarbonate and acid concentrates, with conductivity control and distribution to each station.
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Automated process
- Filling with dialysis water compliant with ISO 23500-3.
- Dosing and mixing homogeneous, with controlled agitation.
- Verification of concentration by online conductivity.
- Distribution in a closed circuit to each station, with batch records.
- Materials resistant to corrosion, with no metal in contact with the acid.
Dialysis water quality
We design our systems to deliver water with the standard hemodialysis quality established by ISO 23500-3. These are its reference limits:
| Parameter | Limit | Action level |
|---|---|---|
| Microbial count | < 100 CFU/mL | 50 CFU/mL |
| Endotoxins | < 0.25 EU/mL | 0.125 EU/mL |
| Chemical contaminants | Limits for total chlorine, aluminum, heavy metals, nitrate, fluoride and others | — |
Microbiological counts and endotoxins (LAL method) are analyzed at an accredited laboratory or at the institution’s clinical laboratory. The system measures conductivity, temperature, pressure, flow and, where applicable, total chlorine online.
We support you throughout the system’s life cycle
Our systems are designed, documented and verified in accordance with the ISO 23500 series. The goal is chemical, microbiological and endotoxin quality that is consistent, demonstrable and sustainable over time, supporting patient safety and the quality system of your dialysis unit.
Sanitron designs and implements hemodialysis water systems for hospitals, clinics and nephrology units, with local engineering, ongoing technical support and over 40 years of experience in water purification.
- Conceptual, basic and detailed engineering based on your unit’s clinical load
- Installation, start-up and performance verification
- Installation and operational qualification protocols, and support during initial validation
- Microbiological and endotoxin monitoring plan in accordance with ISO 23500
- Technical assistance during health audits and licensing processes
- Training of technical and nursing staff
- Preventive maintenance, scheduled disinfection and instrument calibration
Frequently asked questions
Why are two carbon columns in series required?
Chloramines are toxic to the patient and reverse osmosis does not reliably retain them. The second column ensures their removal even if the first one is exhausted.
How often should the water be tested?
Microbial counts and endotoxins are tested periodically, at the frequency set by your monitoring plan. Chemical contaminants are checked on a schedule and whenever the water source changes.
Is the system compatible with online HDF?
Yes, by integrating the endotoxin control stage and a distribution design that preserves water quality up to the machine.
Patient safety you can demonstrate
Share with our team the number of machines, the operating shifts and the therapy modality of your unit. We will present a technical proposal with the treatment train, the distribution architecture and the monitoring plan.
Contact us
Office in EcuadorDe los Eucaliptos E8-70 y calle E9, Quito 170307
Phone+593 99 871 1330
+593 2 280 8126
Emailinfo@sanitronec.com
Office hoursMonday to Friday
9:00 a.m.–12:00 p.m. and 1:00–6:00 p.m.
Office in the United States9995 NW 9th St. Circle, Suite 3, Miami, FL 33172
+1 786 972 2008