Control System for Gaseous Sterilization Processing 

AccuSOLO^SM Control System 

The AccuSOLO Process Control System software is tailored for gaseous sterilants, such as individual ethylene oxide (EO) or vaporized hydrogen peroxide (VHP) chambers, including options for controlling and monitoring preconditioning and aeration areas and common plant utilities. The patented modular design ensures that a standardized system is achieved regardless of chamber manufacturer or its components. Its purpose is to eliminate uncertainty in the sterilization process by enabling adherence to the ISO 11135, ISO 14937, ISO 22441 standards, and parametric release requirements.  

What are the AccuSOLO Control Systems’s key features?

Universally consistent  

The modular design offers additional organizational efficiencies, such as providing flexibility 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.  

Online simulator

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

Multi-chamber support

The AccuSOLO Control 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

The AccuSOLO Control System performs a flammability analysis of programmed cycles using the NFPA 560 flammability chart and includes additional safety mitigation features such as safety interlocks and email alerts. Additionally, the Real-Time Intelligence Equipment Monitor (RTiQ) service provides fugitive emissions monitoring.  

User-friendly

The AccuSOLO Control System 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.  

Compatible with legacy control systems

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

Parametric release

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

Regulatory compliance

The AccuSOLO Control System complies with industry standards and regulations, 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

The STERIS Applied Sterilization Technologies Equipment and Technologies offering 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 and VHP 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.  

The AccuSOLO Control System 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.