White Paper

Integration of Robotics for Automated Instrument Handling in CSSDs: An Australian Healthcare Perspective

October 2026

Disclaimer

This content is provided for information only. The authors make no representation or warranty regarding the accuracy, completeness or currency of the content. No information in this whitepaper should be construed as medical advice. Readers should seek appropriate professional guidance before acting on any information contained in this document. The authors expressly disclaim all liability for any direct or indirect loss or damage arising from the use of or reliance on this information.

Introduction

Central Sterile Supply Departments (CSSDs) clean, disinfect, inspect, package, sterilise and store reusable medical devices (RMDs). This white paper sets out engineering requirements for integrating robotic and automated handling into Australian CSSDs. It covers washer-disinfector loading systems, automated guided vehicles (AGVs), autonomous mobile robots (AMRs), robotic wrapping, automated storage and retrieval systems (ASRS) and the control systems that coordinate them.

Requirements are referenced to AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities. AS 5369:2023 was published in December 2023 and supersedes AS/NZS 4187:2014 and AS/NZS 4815:2006.

Process Constraints and Automation Drivers

Used RMDs are received in the decontamination zone and cleaned and thermally disinfected in washer-disinfectors. They are then inspected, assembled and packaged in the clean zone, steam sterilised, cooled, released against defined acceptance criteria and placed in sterile storage. Each transfer between stages is a manual handling task, a potential cross-contamination path and a traceability record point.

Manual handling loads set the first design limit. SafeWork NSW guidance on surgical instrument transport cases sets a preferred maximum of 5 kg [11 lb] and an absolute maximum of 7 kg [15 lb] for a fully laden inner tray, and a maximum of 80 kg [176 lb] for a stacked transport load. The informative guidance in AS 5369:2023 also states that instrument sets should not exceed 7 kg [15 lb]. Loaded steriliser trolleys are pushed rather than carried, and after a 134 deg C [273 deg F] steam cycle the trolley frame leaves the chamber close to chamber temperature.

Justify each automated function against one or more of three drivers: elimination of a hazardous manual task, removal of a measured throughput constraint, or enforcement of a process interlock that a manual system cannot enforce reliably (e.g. blocking release of a load that has not met every release criterion). Quantify each driver from site data before selecting equipment.

Automation by Process Stage

Transport of Used Instruments

AS 5369:2023 requires documented procedures for transporting used RMDs that protect the devices, personnel and the environment from contamination and harm. Where AGVs or AMRs return used instruments from operating theatres, carry them in closed carts dedicated to used instruments and deliver them to the decontamination zone without passing through clean or sterile zones. Where one vehicle fleet tows both used and sterile carts, segregate by cart and specify cleaning of vehicle contact surfaces between duties.

Cleaning and Disinfection

Washer-disinfector loading systems stage load carriers on an infeed conveyor in the decontamination zone, transfer each carrier into the chamber and discharge it to an outfeed conveyor in the clean zone through pass-through washer-disinfectors. AS 5369:2023 requires effective segregation of clean and dirty activities and states that pass-through reprocessing equipment should be included in new or refurbished facilities. Specify the following:

• Infeed and outfeed queue positions sized to the peak-hour load rate and the longest cycle time, so that a clean-side delay does not hold completed loads in the chambers.
• Carrier identification by barcode or RFID before chamber entry, automatic selection of the validated cycle for the carrier type, and an interlock that prevents cycle start on an unidentified carrier.
• Drives, sensors and enclosures in the decontamination zone with ingress protection suited to wet cleaning of the area (e.g. IP65), and surfaces that are smooth, non-shedding and able to withstand frequent cleaning.
• Requalification of each washer-disinfector. AS 5369:2023 requires operational qualification (OQ) when new loading configurations are introduced, and performance qualification (PQ) for new or modified loading configurations unless equivalence to a previously qualified loading pattern is demonstrated.

Inspection and Assembly

Inspection, functional testing and set assembly remain predominantly manual because they depend on instrument recognition and judgement of cleanliness and function. Machine-vision instrument identification and robotic set assembly are at development or early deployment stage. Specify them only after a site trial on the facility's own instrument range, with acceptance criteria for identification accuracy and a retained manual verification step. Display set lists from the tracking system at each workstation and record counts electronically. AS 5369:2023 requires an ergonomic risk assessment of workstations, and task lighting and magnification. Provide height-adjustable benches with a range of 750 to 1150 mm [30 to 45"] and mechanical lifters reaching at least 1000 mm [39"] for heavy sets.

Packaging

Robotic wrapping cells receive assembled trays from an infeed conveyor, fold sterilisation wrap around each tray, close the pack with indicator tape and apply the traceability label. Cells that cut wrap from roll stock to tray size reduce the number of stocked sheet sizes and the wrap offcut per pack. Specify the following:

• Tray envelope: maximum length, width, height and mass accepted by the cell. Extract the site tray mix from the tracking system and calculate the share of annual volume within the envelope. Trays outside the envelope, and rigid containers, remain manual.
• Rate and buffer: specify the sustained rate as peak-day trays within the envelope divided by available cell hours, and size the infeed buffer for the excess of peak-hour arrivals over that rate for the duration of the peak. Demonstrate the rate at factory acceptance testing with site trays and the site wrap material.
• Validation: AS 5369:2023 requires wrapping processes to be validated, with PQ demonstrating that the process consistently produces acceptable sterile barrier systems under specified operating conditions. Validate to ISO 11607-2 with ISO/TS 16775 as guidance, and include robot-wrapped packs in steriliser PQ loads to confirm sterilant penetration and dryness.
• Safeguarding of the cell to ISO 10218-2:2025, with non-shedding, cleanable surfaces suitable for the clean zone.
• Label printing and read-back verification integrated with the tracking system, with automatic rejection of any pack whose label cannot be verified.

Sterilisation, Cooling and Release

Steriliser loading systems and AMRs transfer loaded trolleys from the packing area into the steriliser and from the steriliser to the cooling area. AS 5369:2023 requires heat-sterilised devices to cool before handling and a dedicated cooling area within the steriliser unloading zone. Its guidance states that sterilised devices should remain on the sterilisation trolley until cool. Automation that moves the whole trolley without handling the packs suits this sequence. Specify the following:

• Docking and towing interfaces, wheels and bumpers rated for contact with trolley frames at up to chamber temperature.
• A cooling dwell time set from cooling trials on the heaviest validated load and enforced by the control system before the load can be moved to storage.
• Release interlocks. AS 5369:2023 prohibits release until all acceptance criteria are met and requires nonconforming devices to be quarantined. Route any load with a failed or missing criterion to a physically separate quarantine location.
• OQ and PQ of each steriliser for the automated loading configuration, on the same triggers that apply to washer-disinfectors.

Sterile Storage and Distribution

An ASRS uses stacker cranes, shuttles or vertical carousels to store sterile sets in indexed locations and retrieve them against theatre case lists. Specify the following:

• Environment: AS 5369:2023 guidance specifies sterile storage at 18 to 25 deg C [64 to 77 deg F] and 35 to 70% relative humidity, and the standard requires ventilation of storage areas to control temperature and humidity and to operate continuously in sterile store rooms. Monitor temperature and humidity inside the ASRS enclosure as well as in the room, because drive heat and enclosure airflow can produce local conditions that differ from the room.
• Handling: retrieve sets in rigid containers or totes. Do not allow grippers or shuttles to grip, compress or slide wrapped packs. AS 5369:2023 requires shelving with smooth surfaces that do not damage product or packaging.
• Inventory logic: issue first in, first out by sterilisation date, block issue of expired, unreleased or quarantined sets, and log every storage and retrieval event to the set record.
• Structure: confirm slab capacity for rack and crane point loads and design tall storage structures for earthquake actions to AS 1170.4.
• Fallback: manual access to stored sets during power failure or system fault, with a documented retrieval procedure and uninterruptible power to the controls where the risk assessment requires it.

Distribute sterile sets to theatres in closed carts on routes that do not pass through decontamination areas, scheduled against the theatre list so that sets arrive when required rather than in bulk at the start of the day.

Mobile Robot Design Requirements

AGVs follow fixed paths defined by floor markers, magnetic tape or reflectors. AMRs navigate from onboard maps using laser scanners and cameras and replan around obstacles. Both are driverless industrial trucks under ISO 3691-4:2023. Specify the following:

• Payload rating greater than the measured mass of the heaviest loaded trolley, including the towing or lifting interface.
• Personnel detection, speed limitation in shared areas and emergency stops to ISO 3691-4:2023, supported by a hazard analysis of every route, docking position and lift interface.
• Route survey of floor gradients, joints, door thresholds and lift sill gaps against the vehicle's traversal limits, wireless coverage along the full route including lift cars, and a controlled stop on loss of communications.
• Charging stations within the zone each vehicle serves, and a fleet size that meets the peak-hour move rate with charging time included.
• Lift and door interfaces through the lift controller and automatic door controllers. Dedicated goods lifts remove contention with people. Fire and smoke doors on vehicle routes may be held open only by hold-open devices that release on activation of the fire detection system, and vehicles must stop clear of doorways on alarm.

Control and Traceability Systems

The instrument tracking system is the system of record. Programmable logic controllers, vehicle fleet managers and warehouse management systems execute the physical moves. Define the following in the interface specification:

• The system of record for each data item: set identity, load identity, cycle selected, cycle result, release status and location.
• The message set, response times and fail-safe behaviour on interface failure. The default on any lost or invalid message is to hold the load, never to release it.
• Capture of accountable persons. AS 5369:2023 requires sterilisation records to identify the steriliser, the cycle number and date, the devices or sets and their number in the load, the competent person accountable for loading and the competent person accountable for release. Where automation loads the steriliser, record the operator who commits the load to the automated system so that each record identifies an accountable competent person.
• Network segmentation of automation systems from clinical and corporate networks, controlled supplier remote access, and security requirements to IEC 62443. Treat instrument records linked to identifiable patients as health information under the Privacy Act 1988 (Cth).

Project Delivery

Baseline data: Extract at least 12 months of tracking data: sets processed by hour of day and day of week, set dimensions and mass, and washer-disinfector and steriliser cycle counts and durations. Conduct time studies of the tasks to be automated and a hazardous manual task risk assessment for each.

Process map and simulation: AS 5369:2023 requires a process map or flow diagram that manages cross-contamination risks, including airflows. Extend it to the automated flow and model peak-hour operation by discrete-event simulation, including equipment cycle times, availability, vehicle charging and lift contention. Size buffers for the peak hour, not the daily average.

Layout and building services: Maintain unidirectional dirty-to-clean flow and plan the layout to the Australasian Health Facility Guidelines, Part B, Sterilizing Services Unit. Wall penetrations for conveyors and vehicle doors alter the pressure regime between zones. AS 5369:2023 guidance recommends that the decontamination area be at negative pressure and the packing area at positive pressure to adjoining areas. Rebalance the air-handling system and verify differential pressures after installation. Installation qualification (IQ) under AS 5369:2023 covers the services and environment as well as the equipment, so define power, data, compressed air and ventilation at design stage.

Phasing and continuity: Sequence works so that each phase is qualified before the next begins. Maintain reprocessing capacity during works with temporary facilities or reprocessing at another site. AS 5369:2023 requires a risk assessment for transport of RMDs between sites, with documented nonconformance conditions.

Acceptance: Specify measurable criteria for peak-hour throughput, availability, mean time to repair and identification read rate. Verify at factory acceptance testing with site trays and at site acceptance testing, then complete IQ, OQ and PQ.

Fallback, maintenance and training: Document and test a manual fallback for each automated function. Include robots, conveyors and storage systems in the planned preventive maintenance program, performed by competent persons as AS 5369:2023 requires for all equipment. Set spares holdings and local service response times in the contract. Train operators in exception handling, safe interaction with vehicles and manual fallback.

Cost-Benefit Analysis

Model Basis

Equipment prices vary with scope and are confirmed only by tender. The model therefore solves for the maximum equipment price (E) that achieves net present value (NPV) break-even and a 5-year simple payback. Compare tendered prices against these limits. All values are in real 2026 Australian dollars, exclusive of GST. The analysis period is 10 years with zero residual value. The real discount rate is 7%, tested at 4% and 10%. Use the state treasury rate where one is prescribed. Labour savings escalate at 1.0% per year above inflation. Year 1 benefits are taken at 50% to cover commissioning, qualification and operator learning. Every value marked as an assumption is to be replaced with site data before use.

Costs comprise installed capital (equipment, integration, building works, validation, project management and contingency), transition (parallel running and training) and recurring costs (service contract, spares, software licences, electricity, requalification and mid-life overhaul). Benefits comprise released labour, consumable reduction, avoided injury cost and deferred capacity expansion. Released labour is a cash saving only where rostered hours are removed or redeployed into funded vacancies. Otherwise the benefit is capacity.

Labour Cost Basis

Health Professionals and Support Services Award 2020 minimum rates for support services employees were A$978.20 to A$1,429.90 per week from 1 July 2025. The 2026 Annual Wage Review increased modern award rates by 4.75% from the first full pay period on or after 1 July 2026, giving approximately A$1,025 to A$1,498 per week (A$53,500 to A$78,200 per year). Substitute the applicable award or enterprise agreement rate. Public hospitals are generally exempt from payroll tax. For-profit private operators pay it at the state rate.

Table 1. Loaded cost per full-time equivalent (FTE).

Table 2. Productive hours per FTE.

Robotic Wrapping Model

The model evaluates one robotic wrapping cell in a public hospital CSSD wrapping 100,000 trays per year over 300 operating days. Manual standard time is built from wrapping elements plus a relaxation and contingency allowance. Replace the element times with a site time study covering each operator and shift.

Table 3. Manual wrapping standard time.

Table 4. Labour displacement and robot attendance.

Table 5. Consumable savings and recurring costs.

Table 6. Installed capital and transition costs.

Base case result: the maximum equipment price is A$756,000 for NPV break-even (installed capital A$1,033,000) and A$567,000 for a 5-year simple payback (installed capital A$782,000). At the NPV break-even price the net annual cash flow is approximately A$160,000 in year 2, rising with wage growth, and A$93,000 in the overhaul year.

Table 7. Sensitivity of maximum equipment price. The private case applies 30% company tax, straight-line depreciation of installed capital over 10 years (confirm against the applicable effective life) and a 7% real after-tax discount rate.

The annual labour saving, the product of realisable FTE reduction and loaded cost, governs the result. Without released labour, consumable savings support a maximum equipment price of only A$21,000, so the investment is not justified where no rostered hours are removed. Rounding to roster increments costs approximately A$23,000 of maximum price in the base case and more at volumes where the net reduction falls just below an increment.

Capacity Check

At 80,000 robot-wrapped trays over 300 operating days the average is 267 trays per day. With an assumed peak-day factor of 1.25 (333 trays) and 14 hours of cell availability per day, the cell must sustain at least 24 trays per hour. If assembly delivers trays over a 12-hour window with an assumed peak-hour factor of 1.6, arrivals peak at 44 trays per hour. Over a 2-hour peak the infeed must hold approximately 41 trays, equal to 25 m [81 ft] of accumulating conveyor at 600 mm [24"] tray pitch, or equivalent trolley storage. Size the sustained rate and buffer from site arrival data and confirm the rate at factory acceptance testing.

Trolley Transport Model

The model evaluates an AMR fleet transferring steriliser trolleys within the same CSSD.

Table 8. In-department trolley transport model.

Safe Work Australia reports for health care and social assistance (2023 to 2024, preliminary) a serious claim frequency of 9.4 per million hours worked, a median time lost of 7.0 weeks and a median compensation payment of A$12,100. Adding backfill for 7.0 weeks at the loaded rate of A$51.19 per paid hour with an assumed 50% overtime or agency premium gives an employer cost of approximately A$32,500 per serious claim. Each 0.25 serious claims avoided per year raises the maximum fleet price by approximately A$31,000, to A$221,000 at 0.25, A$251,000 at 0.5 and A$313,000 at 1.0 claims per year. Applying the industry frequency to the 1,074 exposed hours predicts 0.01 serious claims per year, so monetised injury cost adds little at industry-average risk. Assess in-department transport robots under the WHS duty to eliminate or minimise the risk of pushing heavy, hot trolleys so far as is reasonably practicable, using the site's own hazard and claims data.

Model Use

Insert tendered prices for E, including conveyors and interfaces, and compare with the maximum equipment price for the site case. Re-run the model with site data for every assumption. High-volume and centralised facilities spread fixed costs over more trays. Where the tendered price exceeds the maximum price, select automation on manual handling risk rather than return, or consider outsourcing to a centralised reprocessing facility subject to the inter-site transport risk assessment required by AS 5369:2023. Twelve months after commissioning, measure realised roster reduction, attendance hours, reject rate, wrap consumption, availability and maintenance cost, and update the model for the next investment decision.

Regulatory and Standards Compliance

AS 5369:2023 and the NSQHS Standards: Australian Commission on Safety and Quality in Health Care Advisory AS24/01 required health service organisations to complete a gap analysis against AS 5369:2023 by 30 June 2025 and to implement the standard through a compliance plan with defined timeframes. Compliance is assessed under Action 3.17 of the Preventing and Controlling Infections Standard. Include automation projects that close identified gaps in the compliance plan. The AS 5369:2023 requirements that bear directly on automation projects are:

• Purchasing procedures for reprocessing equipment with risk-based selection criteria that address workplace health and safety, and evaluation of compatibility with the reprocessing systems in use.
• IQ of reprocessing equipment, including packaging equipment, and of the services and environment it depends on.
• OQ after installation or relocation, a change to a service, modification to deliver a new process, introduction of new loading configurations and repair.
• PQ after IQ and OQ of new or relocated equipment, after modification to deliver a new process and for new or modified loading configurations unless equivalence to a qualified reference load is demonstrated.
• A competent person directly accountable for reprocessing, with relevant qualifications and experience and direct involvement in day-to-day supervision, regardless of the level of automation.

Therapeutic Goods Administration: Washer-disinfectors and sterilisers supplied for reprocessing medical devices are medical devices included in the Australian Register of Therapeutic Goods (ARTG). Robots, conveyors and storage systems are generally supplied as industrial machinery. Where an automated loading system is supplied as part of an ARTG-included washer-disinfector or steriliser, obtain written confirmation from the supplier before modifying it.

Work health and safety: The model WHS Regulations require risks from hazardous manual tasks to be eliminated or minimised so far as is reasonably practicable (Part 4.2) and set duties for the design, manufacture, supply, installation, commissioning and use of plant (Chapter 5). Victoria applies the Occupational Health and Safety Regulations 2017. Conduct machinery risk assessment to the AS/NZS 4024.1 series. Apply ISO 10218-1:2025 and ISO 10218-2:2025 to industrial robots and robot applications, including collaborative applications formerly covered by ISO/TS 15066, and ISO 3691-4:2023 to AGVs and AMRs. Provide emergency stops, isolation and lockout for maintenance, and signage on vehicle routes.

Electrical and building services: Install to AS/NZS 3000:2018 and specify the electrical equipment of machines to IEC 60204-1. Ventilate cleaning, inspection, assembly and packaging areas to AS 1668.2 as AS 5369:2023 requires. Carry out lift interface works through the lift maintenance contractor to the AS 1735 series.

Case Studies

Royal Hobart Hospital, Tasmania: Mobile Robot Transfer to Sterilisers

The Royal Hobart Hospital Central Sterilising Department relocated to K-Block Level 5 as part of the hospital redevelopment and began operating on 17 June 2020. The department is arranged in three precincts: dirty (decontamination, washers and dryers), clean (assembly, storage and sterilisers), and cooling and sterile stock. Two robotic AGVs deliver packed instrument trays to the sterilisers. The department supplies approximately 100,000 packed instrument trays per year. The Tasmanian Government reported the installation as the first use of CSSD robots in an Australian hospital. The fit-out also included height-adjustable sinks and workstations, automated chemical dosing and electronic instrument tracking. The automation is confined to one task, trolley transfer into the sterilisers, integrated into a new departmental layout.

Royal Adelaide Hospital, South Australia: Hospital-Wide AGV Logistics

The 800-bed Royal Adelaide Hospital opened on 5 September 2017 with a fleet of 25 AGVs transporting food, linen, waste, stores, pharmaceuticals and surgical instruments. At opening the fleet was reported to move approximately 1,600 trolleys per day using dedicated lifts, corridors and lift lobbies. The fleet later underwent a hardware and control system life-cycle upgrade after the original control system reached limited supplier support. Dedicated vertical transport and corridors separate vehicle traffic from people, and fleet control systems require a planned obsolescence and replacement strategy over the building life.

Sengkang General Hospital, Singapore: Automated Sterile Storage

The Central Sterile Supplies Unit at Sengkang General Hospital installed an ASRS comprising a three-arm storage and retrieval system, four vertical carousels, an automatic robotic loader and a warehouse management system linked to the instrument tracking system. The hospital reported it as the first ASRS for sterile storage in Singapore's healthcare sector, with set retrieval time reduced by 50% and storage slots increased by 75%. The project addressed surgical delays from manual instrument order entry and wrong deliveries from picking errors. Reported lessons were early stakeholder engagement, structured training and a small-scale pilot before full deployment.

Capital Region of Denmark: Centralised Automated Reprocessing

Den Fælles Sterilcentral (the Joint Sterile Central) of the Capital Region of Denmark operates two reprocessing facilities, at Herlev Hospital and Rigshospitalet, supplying sterile instruments and procedure sets to the region's hospitals. The region describes them as among the most automated sterile centrals in the world, combining manual and fully automated processes. Robots perform the repetitive heavy lifts previously done by hand. A manufacturing execution system tracks the location of equipment in the process flow, logs process events for quality assurance of washing and is integrated with the instrument tracking system. Procurement for the two facilities included multi-chamber washer-disinfectors with loading and unloading conveyors. At regional scale, a dedicated execution layer between the tracking system and the equipment coordinates material flow and generates the process records.

Conclusion

Robotic and automated handling in a CSSD is justified where it removes a hazardous manual task, relieves a measured throughput constraint or enforces a release interlock. Labour savings are material for packaging automation at high volume and small for in-department transport. Each automated function becomes part of the validated reprocessing process under AS 5369:2023. For each project:

• Size equipment and buffers from site tracking data at peak hour.
• Requalify washer-disinfectors and sterilisers when automated loading changes the loading configuration, and validate robotic wrapping as a packaging process.
• Specify the control interface, the system of record and fail-safe behaviour, and capture the accountable competent person in every automated record.
• Maintain zone segregation and the pressure regime across every conveyor and vehicle penetration.
• Provide and test a manual fallback for each automated function.
• Contract for local service, spares and control system life-cycle replacement.