Control System for Radiation Sterilization Processing

KonnTRACK™ Control System

KonnTRACK Control System software integrates the radiation source with the product handling system, helping ensure products meet qualified specifications while maximizing machine efficiency through an end-to-end sterilization process and an internal scheduling application.

KonnTRACK Control System software provides users with: 

• Simplified processing - Integrated sensors, such as barcode readers and photo eyes, help eliminate human error by recognizing previously qualified products, then retrieving and setting system processing parameters to those established during Customer product qualifications, including modality, energy, speed, and geometry.
• Improved operational efficiency – Early detection of potential scheduling deviations.
• Automated reporting – Ability to generate and store detailed processing reports for each processing run, capturing all critical processing parameters outlined in ISO 11137.
• A single central KonnTRACK application that allows for the control of multiple irradiators and modalities, including X-ray, gamma, and E-beam.

What are the KonnTRACK Control System’s main features?

Electronic records and reporting

The KonnTRACK Control System features electronic records and reports to verify process compliance while adhering to Customer documentation requirements. 

Electronic signatures support the validation and retention of product processing specifications and routine process run reports.

Dosimetry integration

Dosimeter load specifications combined with product and dosimeter barcode tracking capabilities help support dosimeter placement and frequency, while providing full traceability of all dosimeters used in routine processing, reducing the potential for human error. 

KonnTRACK Control System mobile access

KonnTRACK features the use of mobile, handheld devices to help streamline operations and allow for flexibility to perform various functions from any location within the sterilization facility.

Gamma SmartLOG reporting

SmartLOG reporting assists facilities in creating a lean environment by tracking gamma irradiator activity and generating reports that provide insight into the overall operational performance of the treatment system. 

E-beam and X-ray SmartLOG reporting is available upon request. 

Optional Feature(s):

Enterprise Resource Planning (ERP) integration: Custom development of the KonnTRACK Control System may be possible to allow for its integration into existing IT infrastructure regardless of ERP configuration, accepting non-sterile inventory and updating the status of sterile inventory in real time without manual intervention.

Customer ERP system integration is available upon request

Simulation tools: Simulation tools can be made available to assist users and developers to test process control behaviors without the presence of physical hardware, allowing users to simulate and verify all software operations, and provide operator level training capabilities prior to applying upgrades or changes to the production environment. 

This helps to reduce facility downtime and improve project planning insights.

Additional Support Services:

Customer service and support

With locations in Americas, EMEA, and APAC, our technical support teams provide Customers true 24/7 technical support regardless of their location, globally. 

Our dedicated support teams assists Customers with troubleshooting and system recovery, enhancements, new features, and regular software updates designed to transfer product continuous improvements to our Customers. 

Safety

The KonnTRACK Control System has been carefully designed to meet the most stringent safety standards. 

Whether it is machine or radiation safety, the necessary compliance is maintained to provide the safest environment for a processing facility.

KonnTRACK Control Systems use the following standards when designing safety systems:

• Standard, ISO 13849-1, Safety of Machinery - Safety-related parts of control systems - Part 1: General principles for design
• IAEA Safety Standards, Radiation Safety of Gamma, Electron and X Ray Irradiation Facilities, SSG-8

Quality assurance

The KonnTRACK Control System supports compliance with industry standards, such as ISO/ASTM 51261, 21 CFR Part 11, EudraLex volume 4 GMP, and Annex 11 of the EU GMP guidelines.