Developing a hospital sterile processing water specification for a new water treatment system should start with the department, its water uses and the site conditions that will shape the design. Across the healthcare sector, facilities are already taking practical steps to implement ST108, with successful projects demonstrating that the required water quality can be achieved through appropriate assessment, design, implementation and validation.
Envirogen combines U.S. healthcare project-delivery capability with many years of healthcare water-treatment experience across international markets, giving U.S. project teams access to practical experience of water quality, decontamination and system-delivery challenges beyond the U.S. The project will often be led by the hospital, with input from a water-treatment specialist, equipment OEM, MEP/consulting engineer or wider project team. Whoever leads it, the site needs to be understood before the water-treatment system is selected.
Before selecting a new ST108 water system, the site review should establish five things:
- Start with actual use and demand: Review the department’s water uses, workflow and demand, including the applicable equipment manufacturers’ instructions for use (IFUs), so the design reflects how the SPD actually operates.
- Establish the feedwater and system baseline: Confirm what is known, what is assumed and what still needs to be verified before fixing the treatment specification.
- Assess the complete water pathway: Consider storage, distribution, recirculation, building constraints and changeover so the selected solution can be installed, operated and maintained effectively within the facility.
- Plan for resilience, future capacity and lifecycle cost: Look beyond initial equipment CAPEX to the operational, maintenance, testing, sanitization and support requirements that shape long-term value over a potential 10-15+ year system life.
- Use multidisciplinary review and independent due diligence: Challenge assumptions before procurement, compare solutions on a consistent basis and give the hospital greater confidence in the final specification.
START WITH THE DEPARTMENT, ITS WATER USES AND ACTUAL DEMAND
Start with what the Sterile Processing Department (SPD) and its equipment need the water system to support. Identify the processing stages and points of use in scope, the water quality required at each, and the applicable manufacturers’ IFUs for washers, ultrasonic cleaners, endoscope reprocessors, sterilizers and other equipment. The design should be based on the department’s actual workflow, rather than a generic equipment package.
Demand should reflect how the department operates, not simply the rated output of a water-treatment unit or an individual washer. Peak simultaneous use, shift patterns, production rate, storage volume and recovery time can all affect duty, along with expected growth, new equipment and changes in surgical or reprocessing throughput. Where reverse osmosis (RO) forms part of the treatment train, feedwater temperature and inlet pressure can also affect actual output, so rated capacity should be checked against site conditions. The sterile processing water requirements should be translated into a realistic operating duty before a treatment configuration is selected.
ESTABLISH THE BASELINE: A PRE-SPECIFICATION WATER AND SYSTEM AUDIT
Before an ST108 specification is fixed, establish what is known, what is assumed and what still needs to be verified. A robust hospital sterile processing water specification should be built on that evidence before the treatment design is fixed. Think of this as a practical pre-specification audit: a structured assessment of the incoming water, the existing or proposed water pathway, the department’s operating requirements and the site conditions that will shape the design.
The baseline should bring together representative feedwater analysis where needed, current sterile processing water testing results where available, system drawings and equipment records, maintenance and sanitization history, known changes to the building supply, existing storage and distribution arrangements, and relevant operational observations. If the available feedwater evidence is incomplete or no longer representative, targeted analysis should establish the starting conditions before pretreatment and purification are selected.
Water testing is one part of that evidence base, not the whole assessment. Results can establish starting conditions and help inform both treatment and distribution requirements. A treatment-outlet result alone does not establish what is happening at every downstream point of use. A separate article on sterile processing water testing covers sampling, interpretation and response in more detail. Here, the purpose of testing is to provide enough evidence to support the specification without duplicating the hospital’s ongoing monitoring program.
FEEDWATER, REQUIRED WATER QUALITY AND SITE CONDITIONS SHOULD DRIVE THE TREATMENT DESIGN
ST108 does not define a single treatment technology or system package for every facility. It establishes water-quality requirements and provides informative guidance on treatment technologies and system design. Depending on the feedwater, required water quality and application, the treatment train may include pretreatment such as water softening before RO, followed where appropriate by deionization (DI) or other treatment stages and combinations. Storage, microbial-control measures and distribution need to be designed as part of the same water system, not added as disconnected afterthoughts.
EndoTherm Duo healthcare water-treatment arrangement. On the left, upstream pretreatment includes duplex water softening, a break tank and pump set, with the EndoTherm Duo RO water purification system shown on the right. The treatment configuration is engineered around the site’s feedwater conditions and required water quality.
Start with the site requirements rather than a preferred RO model or pre-selected technology. Feedwater quality, required water quality, actual demand, available space, operating conditions, distribution, maintenance strategy and lifecycle considerations should establish the design basis first. An experienced water-treatment specialist can then determine the appropriate treatment train and configuration for the facility.
An existing department does not need every component replaced simply because a new treatment system is being considered. But existing storage, distribution and recirculation should not be assumed suitable simply because they are already there. Assess what can be retained, what needs verification, and what may need to be upgraded, modified or replaced to support the required water quality and operating duty.
DESIGN AROUND THE BUILDING, DISTRIBUTION AND CHANGEOVER
An engineered water-treatment system still has to fit the building and the project delivery plan. Plant-room footprint, access routes, doorway widths, lifting and handling, power, drainage, service clearances and the position of tanks, pumps and connections can all affect what is feasible. Identifying those constraints before equipment is specified gives the project more options than discovering them after the specification is fixed. Late discovery can drive redesign, rework, wasted project resource, program delay and avoidable cost, so buildability should be tested while the project still has room to change.
Distribution and recirculation matter just as much as the treatment system. Their condition and design affect what reaches the points of use. Sampling access, stagnant sections, the route back to the treatment area and the chosen sanitization or disinfection approach all need to be considered if the complete pathway is to be operated, tested and maintained effectively.
We explore the complete ST108 water pathway in more detail in a separate article. The key point here is to bring these interfaces into scope early enough to influence the design.
Sanitization timing should also match department operations. EndoTherm systems can carry out automatic hot thermal sanitization during off hours, allowing routine sanitization to be scheduled outside periods of normal water demand. This can help hospitals maintain microbiological control while reducing disruption to normal sterile-processing activity.
U.S. HOSPITAL PERSPECTIVE: THE AMBULATORY SURGERY CENTER AT ST. MARY
Melissa Bogaski, Director of Nursing at The Ambulatory Surgery Center at St. Mary, Langhorne, PA, says:
““As we worked toward full alignment with ST108, it became clear that replacing our aging water system was necessary due to ongoing conductivity inconsistencies and reliability concerns. Envirogen’s EndoTherm Mini 300 provided us with a compact and dependable solution that now supports our sterilizers, washers, and sinks through one RO system, while allowing installation in an adjacent utility space so we could preserve valuable department space within the ASC.
The addition of the new 300-foot NUPI Niron recirculation loop and hygienic manifold design has significantly improved our water distribution system and overall day-to-day reliability. The automatic after-hours thermal sanitization allows us to consistently maintain microbiological quality without interrupting operating room workflow or impacting surgical throughput during busy hours.
With the ongoing service agreement in place, we now have the support, consistency, and confidence needed to maintain compliance and reliability well into the future.”
If the work is being carried out in a live SPD, changeover becomes part of the specification. The hospital and project team need to understand how existing processing will be supported while the new arrangement is installed, connected, qualified, validated and brought into service. Temporary supply, phased installation or planned shutdowns may be appropriate depending on the site, and continuity should be planned as part of business continuity management rather than assumed.
A water-treatment specialist should be able to demonstrate experience working in live healthcare environments, because that experience can help reduce implementation risk and avoid unnecessary disruption to patient care, operating-room schedules and procedure throughput. Unplanned interruption can also create avoidable operational and financial costs.
BUILD RESILIENCE, FUTURE CAPACITY AND LIFECYCLE COST ANALYSIS INTO THE DECISION
The right level of resilience is a site decision, not a standard configuration for every hospital. It should reflect current operating risk, contingency arrangements and the hospital’s wider business strategy, including planned expansion, additional equipment or changes in procedure volumes. A department with little tolerance for water-system downtime may justify additional storage, redundancy, duty/standby equipment, critical spares, or a more proactive service and monitoring model incorporating measures such as remote monitoring, alarm notification and defined support response times.
Look beyond purchase price as well. Preventive maintenance, energy, consumables, sanitization, testing, replacement parts, service access, remote monitoring and the resources needed to operate the system all affect whole-life cost over the full lifespan of the system, potentially 10 to 15 years or more when properly maintained and serviced.
Where a system relies on chemical sanitizing agents, lifecycle cost analysis should account for recurring chemical purchases, price volatility, supply availability, and the on-site storage and handling requirements associated with those chemicals.
EndoTherm takes a different approach. Its automated thermal sanitization requires no chemical sanitizing agents, removing the recurring chemical costs and supply dependencies associated with the sanitization process. That can make long-term operating expenditure more predictable while also avoiding the storage and handling requirements associated with those sanitizing chemicals.
Future capacity matters too. If the SPD is likely to add equipment or increase throughput, it is usually easier to make provision while the system, plant space and surrounding infrastructure are still being designed. One Brooklyn Health provides a practical example of how capacity, resilience, thermal sanitization, distribution and lifecycle support can come together.
U.S. HOSPITAL PERSPECTIVE: ONE BROOKLYN HEALTH
Joseph Ruiz, Director of Sterile Processing at One Brooklyn Health and HSPA New York Chapter President, says:
““As we evaluated the shift toward ST108-aligned water quality requirements, it was clear we needed a solution that would integrate reliably with our infrastructure while supporting long-term operational performance. Envirogen’s EndoTherm Duo XL 600, with its automated hot-water thermal sanitization, gave us the capacity, resilience, and confidence we were looking for to proactively manage biofilm risk, while feeding into our existing plastic distribution loop. Combined with a service agreement, this investment gives us dependable support, predictable lifecycle costs, and the assurance that our department is positioned for long-term, sustainable compliance. Throughout the project, the Envirogen team was responsive and easy to work with.”
AGREE THE CROSS-FUNCTIONAL TEAM AND WHO OWNS EACH INTERFACE
ST108 implementation is a multidisciplinary decision, and the right team should be assembled before the specification is fixed. Each stakeholder sees a different part of the requirement. Depending on the project and organization, this may include:
- SPD, Clinical Operations and Infection Prevention/Quality: workflow, demand, points of use, risk and the operational consequences of any change.
- Facilities/Engineering: building services, utilities, access, maintenance and site constraints.
- MEP/consulting engineers: buildability, distribution, utilities and interfaces with the wider facility design.
- Equipment OEMs and Clinical Engineering: equipment instructions for use, utility requirements and equipment interfaces.
- Finance, Procurement and Project Management: CAPEX, OPEX and whole-life cost, supplier comparison, commercial terms, program, changeover and delivery responsibilities.
- Water-treatment specialist: feedwater, treatment, distribution, sanitization, system sizing and lifecycle support, backed where appropriate by its own project-management, engineering, manufacturing and commissioning capability.
Other stakeholders may also need to be involved depending on the facility, project scope and organizational structure. The key point is to identify the relevant disciplines early and make responsibility for each technical, operational, and project interface clear.
Before procurement, every unresolved technical or project interface should have a named owner and a clear route to resolution. That includes the water-system risk assessment, equipment utilities, building-service changes, baseline water data, qualification and validation, handover, and ongoing testing, monitoring, maintenance and corrective action.
The water-treatment specialist should be comfortable coordinating these interfaces with the hospital team, OEMs and MEP/consulting engineers, rather than leaving gaps to be resolved during installation.
The most effective specialist relationship is collaborative. The water-treatment provider should work as a member of the wider project team, coordinating with the hospital, OEMs, consultants and contractors while respecting the responsibilities and decision-making structure already in place.
TURN THE REVIEW INTO A DECISION-READY SPECIFICATION
A good site review should leave the project team with a clear design basis that different suppliers can respond to consistently. Define the required water quality and operating duty, the feedwater and baseline evidence, the infrastructure to be retained or changed, the physical and operational constraints, the required resilience and future capacity, and the responsibilities for installation, qualification, validation, handover and lifecycle support.
Before procurement, bring an additional water-treatment specialist into the review to provide an independent technical perspective, even where the hospital already has an established provider. The purpose is not necessarily to change supplier, but to challenge inherited assumptions, benchmark the proposed approach against site evidence and current requirements, and compare alternative solutions before the scope is fixed.
If the existing provider remains the right choice after that review, the process has still provided valuable due diligence and greater confidence in the decision.
Even where a detailed specification has already been developed, the competitive procurement process should allow suitably qualified water-treatment specialists to challenge assumptions and propose alternative approaches where appropriate. A specialist should be able to explain how its solution meets the defined requirements and, where a different approach could improve performance, resilience, lifecycle cost or implementation, set out the rationale and implications clearly.
A common design basis makes that comparison more meaningful. Giving suppliers the same treatment boundary, duty, feedwater basis, site conditions, validation expectations and support assumptions creates a consistent baseline against which proposals can be assessed on a like-for-like basis.
That baseline should support comparison without closing down innovation. Any departure from the specification should be clearly identified, with the technical reasoning, benefits and implications explained so the hospital can make an informed decision.
FROM EARLY PROJECT DISCUSSION TO A COMPLETE ENGINEERED WATER-TREATMENT SOLUTION
Once the site assessment has established the required water quality, operating duty, infrastructure and constraints, the treatment specialist can assess how different technologies and configurations fit the project. This is where EndoTherm can be considered as part of a complete engineered water-treatment solution, rather than as a preselected package.
For a visual introduction to the EndoTherm range and how the treatment process is configured, watch this short technology overview.
The EndoTherm reverse osmosis (RO) water purification range includes:
• EndoTherm Mini: small-footprint simplex system, with various output options available.
• EndoTherm Duo: compact duplex system with built-in redundancy, including Duo XL options for higher-capacity demand.
• EndoTherm Modular: Modular and upgradeable duplex system for large centralized Endoscopy and Sterile Processing Departments.
The complete engineered solution can extend beyond the core RO system. Depending on feedwater conditions and site requirements, this may include pretreatment such as water softening, together with storage, pumps, distribution and recirculation pipework, controls, monitoring and other site-specific infrastructure.
Envirogen can work with hospital teams, MEP/consulting engineers and equipment OEMs to translate the agreed requirements into a site-specific treatment-system design, with capacity, footprint, resilience, distribution interfaces, thermal sanitization and monitoring considered as part of the complete solution.
Early engagement can be flexible to the hospital’s preferred approach. Envirogen can offer complementary site surveys, visit hospitals to discuss specific requirements, and engage with HSPA chapters and regional healthcare networks where appropriate. The aim is to work alongside existing teams in the way that is most useful to them, whether the discussion begins before a specification is developed or later in the procurement process.
Envirogen also brings many years of healthcare water-treatment experience across international markets, including the UK, Australia and New Zealand. These markets operate within established regulatory and healthcare quality frameworks, supported by detailed standards and technical guidance similar in intent to ST108.
That experience comes from delivering healthcare water-treatment projects in environments where water quality, decontamination and infection-control requirements are already subject to established regulatory and quality frameworks. It is transferable across system design, distribution, thermal sanitization, monitoring and lifecycle support. Every U.S. design remains grounded in the specific requirements of ST108 and the individual facility.
That depth of healthcare water-treatment experience, combined with a site-specific engineered approach, gives Envirogen the confidence to guarantee project outcomes on a warrantied basis. The principle is straightforward: define the requirement properly, engineer the complete solution around the site, and stand behind the performance expected from the delivered system.
The U.S. team is supported by Envirogen’s Memphis healthcare center of excellence, where hospital teams, OEMs, MEP/consulting engineers and other project stakeholders can meet the team, experience the EndoTherm demonstration facility first-hand and discuss project requirements. Early involvement can also draw on Envirogen’s project-management, engineering and service expertise as the project moves from specification into delivery.
For a quick introduction to the EndoTherm proposition and how the range can form part of a wider engineered ST108 water-treatment solution, watch Episode 1 of the Envirogen Problem Solver series:
USE SITE EVIDENCE TO DEFINE THE RIGHT ST108 WATER SYSTEM
A decision-ready hospital sterile processing water specification should be traceable back to site evidence. The hospital and project team should be able to explain how the selected treatment and infrastructure address the required water quality, actual department demand, feedwater conditions, applicable equipment IFUs, building and changeover constraints, storage and distribution, resilience, future capacity and long-term lifecycle support. Lifecycle cost should form part of that decision from the outset, not be considered only after equipment has been selected.
That does not mean every supplier must propose the same technology. A clear design basis creates a common starting point for procurement, while still allowing experienced specialists to challenge assumptions and explain where an alternative approach could improve performance, resilience, lifecycle cost or implementation. The important point is that any departure from the baseline is explicit, technically justified and assessed against the same site evidence.
Existing infrastructure may be retained, verified, upgraded or replaced where appropriate, or the project may justify a wider redesign and a complete engineered water-treatment solution. The sequence should remain consistent: understand the department, establish the baseline, assess the complete water pathway and site constraints, agree resilience and lifecycle requirements, challenge the proposed approach, and then select the system.
For ST108 implementation, the strongest specification is one that follows the evidence and engineering assessment, rather than forcing the site to fit a predetermined solution.
ADDITIONAL READING
- ANSI/AAMI ST108 Explained: What Water Quality Requirements Mean for Sterile Processing
- From AAMI TIR34 to ST108: What Changed for Sterile Processing Water?
- Sterile Processing Water Requirements: Designing the Complete ST108 Water Pathway
- Sterile Processing Water Testing: What Hospitals Need to Verify
- Water Quality Issues in Sterile Processing: The Hidden Cost to Instruments, Equipment and Uptime
- Thermal Sanitization vs Chemical Sanitization for Sterile Processing Water Systems
- Maintaining Performance After Commissioning: ST108 Water Monitoring, Testing and Lifecycle Support
GET YOUR FREE ST108 CONSULTATION
Planning a new SPD or developing a hospital sterile processing water specification for a new system? Talk with Envirogen about feedwater, process demand, infrastructure, distribution, site constraints and treatment options before the specification is fixed.
Request a free ST108 consultation to discuss the next steps for your site.