How data and new chemistry are reshaping sterile processing

in a typical Central Sterile Services Department (CSSD), the daily Bowie-Dick test once meant a card pack, a colour change and a manual log entry. This simple pre-vacuum steam steriliser check is key to process quality, verifying air removal and steam penetration: critical prerequisites for downstream sterility assurance.

Yet conventional Bowie-Dick testing presents clear technical and operational limits. Designed for empty chambers loaded with standardised porous material, “it does not reflect real clinical loads and cannot confirm a 10⁻⁶ sterility assurance level”, states the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. Studies have shown that in some edge cases, tests can produce false-negative results, giving a misleading sense of security.

The digital transformation of sterile processing is addressing these challenges. Electronic eBowie-Dick cards now run automatically, transmit time-stamped pass/fail results to monitoring systems and integrate with instrument tracking. By converting a simple penetration check into a data-rich, auditable event, CSSDs can track trends over time, correlate anomalies with cycle parameters and investigate operational issues swiftly, all while supporting compliance and predictive maintenance.

These operational changes coincide with a market moving sharply toward digital infrastructure. Grand View Research estimates that the global sterilisation equipment market will nearly double this decade, from about $8 billion in 2024 to $15 billion by 2030, implying annual growth of roughly 11 per cent. Similar forecasts from Intel Market Research for medical device sterilisation put the market at $5.6 billion in 2023, rising towards $8.9 billion by 2030, with mid to high single-digit growth depending on segment and region. 

Within this expansion, AI and analytics are emerging as differentiators. Solventum’s Attest ecosystem exemplifies the shift: its eBowie-Dick system digitises the steam penetration test and channels results into a broader platform which also ingests biological indicator data and links to instrument tracking.  

By situating these innovations within market growth, regulatory demand and emerging digital infrastructure, CSSDs are no longer just recording a colour change, they are forming part of a networked quality ecosystem, where data, AI and new chemistry converge to improve sterility assurance. 

Pressure on ethylene oxide (EtO) sterilisation is mounting as regulators tighten controls on emissions and exposure at work in view of recognised health risks. In the US, the Environmental Protection Agency has imposed stricter limits on EtO emissions after linking them to increased risk of cancer in adjacent communities, requiring significant reductions in fugitive emissions and extensive monitoring. 

This regulatory backdrop is encouraging investment in alternative chemistry and gas sterilants which can match EtO’s material compatibility but without environmental and health liabilities. One area of active research is nitric oxide-releasing polymers. Polymers engineered to release controlled amounts of nitric oxide (NO) have been studied extensively for antimicrobial and antibiofilm applications, showing potent activity against bacterial pathogens and enabling integration into device coatings or sterilisation processes. Controlled NO release reduces bacterial adhesion and biofilm formation on surfaces such as in urinary and vascular catheters.

Another emerging gas sterilant is nitrogen dioxide (NO₂). Recent peer-reviewed studies describe NO₂ as a gas with inherent microbicidal properties capable of effective sterilisation at ambient temperature in low concentrations, leaving minimal residues. Its physical and chemical properties enable rapid antimicrobial action without condensation, making it attractive for surface sterilisation and devices with sensitive materials or biologics, including combination drug-device products such as pre-filled syringes. 

Heat-sensitive products, including polymer-based pre-filled syringes, complex infusion sets and some implantable combination products, cannot withstand high-temperature or ionising radiation methods without risking degradation or loss of biological activity. While these products often rely on EtO, their intricate shapes and packaging make alternatives complicated. Although NO₂ does not yet provide the same deep penetration into dense multilayer packaging as EtO, its ultra-low-temperature operation and short cycle times position it as a viable alternative where surface sterilisation, material compatibility and limited thermal exposure are critical. 

“Obtaining FDA clearance marks a pivotal milestone for Noxilizer”, said Lawrence Bruder, CEO. “This clearance confirms that nitrogen dioxide sterilisation is another option for companies, especially with products such as pre-filled syringes, drug-delivery systems and medical devices which present challenges with EtO, gamma radiation or other conventional methods”. Noxilizer’s NO₂ platform focuses on low-temperature processing for heat-sensitive devices, emphasising material compatibility and regulatory validation.

Hybrid gas systems, combining sterilant gases with controlled humidity and advanced gas-generation techniques, are also attracting interest. Nitrogen dioxide cycles often incorporate controlled humidity and moderate vacuum to optimise surface contact and antimicrobial action. As described in peer-reviewed studies, these hybrid approaches enhance antimicrobial efficacy by improving inactivation kinetics and process control while supporting shorter cycles and more efficient operation than conventional EtO processes.

Innovative initiatives in early 2026 are focusing on pairing gases with advanced sensors, data analytics and feedback loops, enabling closed-loop control similar to industrial process systems. This enables real-time observation of gas distribution, temperature and humidity. The convergence of novel chemistry and smart control is transforming sterilisation from an “invisible shield” into a smart grid. 

UK-based Ansana, supported by European venture builder NLC, is developing AI-driven gas-phase sterilisation technology which controls gas dosing dynamically. This concept enables adaptive management of concentration, load density and exposure time, with integrated sensors and analytics to optimise cycles and reduce energy and consumables. Self-contained rapid indicators now detect surviving spores in hours instead of days for steam, vapour-phase hydrogen peroxide and increasingly low-temperature gas processes. “When combined with barcodes or RFID tags and integrated into software, each indicator becomes a discrete, traceable event in the data trail, not just a vial in an incubator”, said a spokesperson for Solventum. 

Much of the performance narrative around smart sterilisation still relies on case studies rather than randomised or multi-centre trials. By 2030, the likely scenario is a patchwork: high-income countries and tertiary centres operating fully digital, AI-enhanced sterilisation grids; mid-tier facilities using a mix of analogue and digital tools; and resource-constrained providers relying on basic cycles and manual documentation. Progress toward an “inclusive, smart ecosystem” will depend on open APIs, interoperable data standards, targeted subsidies and setting global standards which recognise both advanced digital systems and validated analogue processes. 

Start-ups are moving alternative sterilants from the laboratory to commercial manufacturing, positioning them as credible industrial platforms. Nitric oxide (NO) and nitrogen dioxide (NO₂), long studied for their antimicrobial properties, are now being developed with clear regulatory and market objectives in the global medical device sterilisation sector.

SterileState (US) is making progress with polymer systems that release NO and which integrate the sterilant directly into device packaging. The approach enables chamberless, in-pack sterilizsation, reduces logistics complexity, shortens processing cycles by around 25 % and lowers environmental impact compared to ethylene oxide (EtO), the dominant low-temperature method for heat- and moisture-sensitive devices. Company data show a six-log reduction in microbial load, meeting conventional sterility assurance levels across gram-positive, gram-negative and spore-forming organisms.

Noxilizer (US) is expanding NO₂ sterilisation as ethylene oxide (EtO) contract providers face remediation mandates and capacity constraints. The company is positioning its NO₂ platform as a viable alternative to EtO1, emphasising regulatory validation, noncarcinogenic emissions and suitability for sensitive biological and combination products. “NO₂ is a proven, commercial-grade sterilisation alternative used for biopharmaceutical products already on the market”, said CEO Christopher A. Thatcher. In September 2025, Noxilizer announced a $30 million investment to expand commercial-scale terminal sterilisation.

Ansana (Netherlands) is developing a proprietary gas-phase sterilisation platform using reusable containers fitted with sensors, targeting instrument reprocessing, hospital workflows and environmental performance. The system integrates sterilant delivery, reusable packaging and real-time monitoring. According to company and investor materials, the Maastricht-based company is aiming to reduce surgical site infections by ~10 %, eliminate single-use wraps and cut the sterilisation carbon footprint by up to 85 %. In Europe, Ansana is positioning its platform as a unified offering combining novel chemistry, embedded sensors and digital data streams. No large-scale, peer-reviewed validation has yet been published.

Recent regulatory developments show growing recognition for  modern sterilisation approaches. In January 2024, the U.S. Food and Drug Administration finalised revisions to its guidance on sterility information in premarket notifications (510(k)), formally recognising vaporised hydrogen peroxide (VHP) alongside traditional methods such as ethylene oxide and radiation, and encouraging alternative adoption where appropriate. The FDA also used its series of Medical Device Sterilization Town Halls in 2024 to discuss method selection, innovation, and supply chain resilience, reaffirming commitment to reduce reliance on EtO while ensuring patient access to sterile devices.

In the European Union, evolving frameworks are interacting with the EU Medical Device Regulation. The EU Artificial Intelligence Act (Regulation (EU) 2024/1689), in force from August 2024, introduces risk-based requirements for AI in high-risk medical devices, emphasising transparency, explainability and auditability. Notified bodies are expected to align MDR conformity assessments with these AI obligations.

Adoption of novel sterilants remains limited by standards and regulatory practice. EN ISO 14937 and ISO 22441 provide validation frameworks, but dedicated standards for newer agents such as nitrogen dioxide (NO₂) are under development, with full integration expected as standards evolve.

Digitisation introduces new risks. Cybersecurity threats increase as CSSDs connect to hospital IT infrastructures, and data fragmentation can hinder analytics. Pilot projects using blockchain and secure data management, led by industry innovators, aim to mitigate these risks while enhancing traceability. Infrastructure constraints in low- and middle-income regions further limit adoption; a 2022 study in Nature Communications highlights connectivity and IT gaps as barriers to scaling digital health technology.

Experts are recommending hybrid strategies, maintaining analogue controls such as Bowie-Dick documentation alongside networked dashboards, and targeted investment in interoperable systems and robust audit trails to ensure equitable adoption.

Australia could be one of the main beneficiaries of this dramatic increase in demand, where private companies and local governments alike are eager to expand the country’s nascent rare earths production. In 2021, Australia produced the fourth-most rare earths in the world. It’s total annual production of 19,958 tonnes remains significantly less than the mammoth 152,407 tonnes produced by China, but a dramatic improvement over the 1,995 tonnes produced domestically in 2011.

The dominance of China in the rare earths space has also encouraged other countries, notably the US, to look further afield for rare earth deposits to diversify their supply of the increasingly vital minerals. With the US eager to ringfence rare earth production within its allies as part of the Inflation Reduction Act, including potentially allowing the Department of Defense to invest in Australian rare earths, there could be an unexpected windfall for Australian rare earths producers.