Control System for Ethylene Oxide Sterilization Processing

AccuSOLO™ Control System

The AccuSOLO process control system software is tailored for gaseous sterilants, such as individual ethylene oxide (EO) chambers, including options for controlling and monitoring preconditioning and aeration areas and common plant utilities. The patented modular design ensures a standardized system is achieved regardless of chamber manufacturer or its components. Its purpose is to eliminate uncertainty in the sterilization process by ensuring rigorous adherence to the ISO 11135 standard and parametric release requirements. 

What are AccuSOLO’s key features?

Universally consistent 

The modular design provides additional organizational efficiencies, such as providing f lexibility when supporting and/or upgrading existing processing chambers, and can execute cycles with varying chamber types and chamber equipment.

Rapid commissioning 

Rapid commissioning of the AccuSOLO control system is offered to minimize chamber downtime. With retrofit kits and a lower GAMP category to reduce qualification requirements, chambers can be commissioned in days instead of weeks or months. 

Cycle simulator

A sophisticated online simulator creates a replica of any chamber with the full suite of AccuSOLO functions, allowing for the development and conversion of existing cycles as if it were a real chamber. 

Multi-chamber support

The AccuSOLO system works across multiple chamber types and features a single, centralized cycle design and management system that allows for easier process management, standardized reports, remote monitoring, and collaborative cycle development. 

Additional features

Safety

AccuSOLO is compliant with NFPA 55 standards and includes safety interlocks, f lammability analysis, and email alerts to mitigate safety risks. Additionally, the Real-Time Intelligence Equipment Monitor (RTiQ) service provides fugitive emissions monitoring. 

User-friendly

AccuSOLO features a user-friendly and intuitive interface that has been designed to accommodate both new and experienced users. Localization features are available, allowing users to experience the client/web applications in multiple languages. 

Legacy compatible

AccuSOLO is completely compatible with legacy Antares controls systems and represents a viable alternative to other legacy control systems. 

Parametric release

AccuSOLO complies with regulatory requirements and industry standards, such as ISO 11135 guidelines can comply monitoring systems, to support parametric release. The system includes redundant sensor monitoring that measures key process indicators, including humidity, temperature, pressure, and EO concentration.

Quality assurance

AccuSOLO complies with industry standards, such as 21 CFR Part 11 and Annex 11 of the EU GMP guidelines, and has trained quality personnel available to assist with operational qualification (OQ) and installation qualification (IQ) validation and documentation. Fully traceable loads provide assurance during audits where information is easily accessible, including historical reports. The user audit log service keeps records of any changes including old vs. new values, time, date, terminal, and user. 

Standardization across an organization

STERIS AST Equipment and Technologies supports radiation and gas processing through our Mevex equipment and Konnexis technologies. The Mevex equipment offering includes linear accelerators (linacs) that provide exceptional flexibility in energy, power, and treatment modalities. The AccuSOLO process control system software from Konnexis technologies allow for tailored EO parameters, helping ensure each Customer’s unique processing requirements are met. The combination of Mevex equipment and Konnexis technologies provides a comprehensive offering that includes product handling and process control software designed to enhance operational efficiency and effectiveness. 

AccuSOLO is a universally consistent product, operating seamlessly across all chamber designs. Specific chamber hardware requirements and system operations are handled via a patented template approach whereas the core module’s cycle execution engine remains the same regardless of chamber design. This allows for reduced operational costs and ease of user training while maintaining a standard product and reports across multiple facilities and chambers. The result is a highly developed system that is easily upgradeable as new features become available. 

Customer support

Global technical support is available to Customers in need of assistance with software corrections or updates 24 hours a day, seven days a week, helping to reduce downtime.