Optimize processes, enhance accountability and streamline operations — these are common goals shared by many organizations, particularly those conducting business within medical, pharmaceutical and other regulated industries. To this end, OnSite Sterilization LLC had an idea to radically improve the most common sterilization process employed by most medical waste processing facilities. The new solution, dubbed the VariClave, also helps modernize the associated reporting methods required in the medical industries. It leverages new technologies to deliver improved performance while maintaining compliance with FDA and other regulations.

OnSite selected Ai Control Systems Inc., a Control System Integrators Association (CSIA) Certified Member based in Reading, PA, to ensure timely project scheduling, business integrity and overall success.

As with any systems integration project of similar size and scope, requirements and goals were many. Ai was tasked with delivering:

• State-of-the-art solution that would “wow” OnSite’s potential market;
• System capable of working with multiple power sources, both within North America and worldwide;
• Compact footprint for the controls package due to limited space at potential market sites;
• Data collection process that would move away from “paper only” chart recording to an electronic format with the ability for hardcopy medium and digital storage, including adherence to FDA regulation 21 CFR Part 11B.

All successful projects require and begin with a properly defined scope or roadmap. This scope protects the customer from over-runs and keeps the integrator focused on, and accountable for, the end product. As a standard practice, engineers at Ai drafted a functional specification to address the known requirements and goals as presented. After customer review, revision and approval of the specification, the engineering team’s task was to define the necessary software and hardware architecture to fulfill OnSite’s requirements.

Due to the turnover rate and education level of the typical operator, the controls interface needed to be intuitive, while the solution as a whole needed to be cost-effective to compete with existing waste process systems and technology. Additional product definition included the need to deliver multiple storage methods and timeframes for associated process data, including a one-month period for hard copy and a one-month period for local electronic storage and retrieval. The system also needed to deliver the ability to remotely monitor installed sites from a central location, as well as accommodate automatic variable parametric settings, a feature that adjusts time intervals based on physical properties of the process medium.

Ai recommended a Rockwell Automation solution using an Allen-Bradley CompactLogix processor for control and Allen-Bradley VersaView PC as the operator interface for its small footprint and robust computing power and data storage capacity.

To address the complexities associated with deploying to areas with varying types of available power sources, Ai proposed a multi-voltage input power acceptance scheme for the new systems. Using this approach, the input voltage was easily selected at the site via simple jumper settings on the back panel. The hardware and wiring efforts required were further minimized by the virtual controls available via the VersaView operator interface.

The combination of these technologies allowed Ai to meet OnSite’s defined compact footprint constraints and deliver a single enclosure that provided housing for the operator interface, power distribution and controls, and the cycle-report printer.

Ai exceeded expectations from a software perspective as well. The proposed database package exceeded the customer’s requirement of 30 days of data storage by delivering a solution with a storage capacity of seven years. This selection also provided the ability to customize interim storage intervals and back-ups. A multi-program, format architecture was selected to optimize the interface application. The data storage and Microsoft .Net technology that was employed delivered the ability to both expand interface requirements and provide a long lifecycle for the chosen development software.

The remote reporting requirement was met by implementing Internet Information Services (IIS) from a central location via a Web browser. Rockwell Automation’s RS Logix5000 development software provided multiple, tag-based, programming formats, including ladder logic, function block diagram, and sequential function chart. The variety of programming formats helped to decrease development time between the controls and operator interface programming, as well as accelerated the transition of control and display schemas from concepts and flow charts to the actual program body.

The final control package localized power, controls, data recording and an operator interface in a compact footprint, employing widely-available, off-the-shelf components to simplify and enhance OnSite’s optional service plan.

The selection of the interface programming package (MS Visual Studio.net) minimized licensing costs for the controls package in the final product deployment and the .Net programming selection simplified the development of a multiple language operator interface — a requirement that was defined after the initial implementation and scope agreement was accepted. However, the flexibility afforded by .Net technologies made the resulting engineering change order easier and more economical for the customer.

MS SQL Express DB was also implemented, delivering significant benefits, including:

• Remote reporting via an internet/Web browser interface;
• Transport data in multiple formats that satisfy regulatory requirements;
• Storage of routine maintenance logs locally at each unit; and
• Provision of a maintenance interface allowing calibration of the equipment at the site without the use of third-party software or tools.

As a result, the users now have the ability to connect through their intranet, via wired or wireless media, for remote data retrieval and storage for access and maintenance of records for regulatory requirements.

The true testament of any solution, however, is the ability to meet the demands — and exceed the expectations — of the customer. In a comment addressed to Ai Controls, OnSite’s VP of Engineering Services, Timothy Barrett, stated, “Your development and execution of the system and controls has exceeded our expectations, and has raised the bar for all equipment of this type.”