Engineered to exceed Medical and Life Science industries most rigorous standards
Experience a new era in precision and safety in medical packaging with UDI ready next-generation Validatable Rotary Heatsealer, designed for medical and pharmaceutical sterile barrier packaging where compliance is critical.
A compact, all-in-one solution that combines precision, safety, and full traceability, designed for environments where compliance is critical.
Key Technical Features
✅ Dual intuitive Touch Screen interfaces for full parameters control
✅ Integrated UDI-ready print system during sealing.
✅ Stainless steel cover and 9 mm wide flat or knurled seal DIN 58953:7 compliant.
✅ Variable Speed for quality and efficiency optimization.
✅Flexible data entry.
✅ Full data Traceability.
✅ Advanced IP and Networking connectivity.
✅ Compliance with World Health Organisation, World Federation for Hospital Sterilisation Sciences (WFHSS), EU GMP Annex 1 Standards: manufacture of Sterile Medicinal Products.
✅ Validatable sealing process according to EN ISO 11607.2 and international guidance ISO/TS 16775.
✅ Multi materials compatibility as from EN ISO 11607-1/EN 868-4; EN 868-5; EN 868-9.
✅ minirò Qube C and minirò Qube P versions.
Gandus Minirò Qube is the all-in-one Validatable sealing and UDI solution that eliminates labeling errors, streamlines Validation, and keeps you compliant worldwide.
Why Minirò Qube is the Smart Choice for Next-Generation Sterile Packaging
Packaging Process Conformity
Fully aligned with World Health Organisation, World Federation for Hospital Sterilisation Sciences (WFHSS); EU GMP Annex 1 Standards: manufacture of Sterile Medicinal Products.
Validatable Sealing Process
Compliant with EN ISO 11607-2 and international guidance ISO/TS 16775, ensuring a fully validatable and audit-ready sealing process.
Excellent Sealing Performance
Innovative Gandus sealing system is engineered to ensure excellent performance, providing secure and uniform hermetic seal to meet process requirements of all most widely used sterile heat-sealable barrier systems, including uncoated Tyvek® materials and Polyolefin materials.
Unmatched Operational Flexibility
Parameters setting via Touchscreen, VNC connection, MODBUS TCP/IP protocol.
Available as benchtop heat sealer or mounted on a height- and tilt-adjustable wheeled stand.
Configurable with conveyor belts of various sizes.
Variable Speed
Optimize sealing quality, improve workflow efficiency, manage peak production loads effectively by adjusting sealing speed according to material and production needs.
Safety
Top-notch safety with stainless steel cover and 9 mm flat seal (knurled opt.) for strong sealing with easy, safe peeling.
Automatic operation stop if temperature deviates from set range.
Full Data Traceability
Technology enables complete monitoring and recording of all critical sealing parameters throughout the entire process.
Parameters monitored and saved in local memory or USB pendrive.
To be exported via MODBUS TCP/IP protocol. Useful for Audit Trails and Quality Documentation.
UDI Ready Technology
Technology with integrated inkjet printer aggregates all relevant data and generates a Data Matrix code to be printed directly onto the pouch.
Data enter via touchscreen, USB, or Ethernet.
Versatile Integrated Printing Capabilities
True integrated printing architecture, eliminating complexity of external printing modules.
Printing performed on either transparent or porous side of the sterile barrier film.
Dedicated ventilation system in printing area to ensure perfect ink drying.
Different types of ink available depending on type of printing substrate.
Technical support available for application optimization.
Dual Touch screen interface
Dual-screen smart interface for real-time parameter monitoring and operator-guided process control to minimize errors and training time.
4.3” colour touch screen for sealing data setting and traceability, to make any operation more and more user friendly.
4.3” colour touch screen to set the integrated inkjet printing system.
Full Connectivity
Wide IP and Networking connectivity through USB and RJ45 serial ports also for included Ethernet connectivity.
Data setting via VNC connection.
Remote data exchange IN/OUT via MODBUS TCP/P protocol.
Full digital integration with hospital IT systems and manufacturing databases enable centralized data management and Audit-ready documentation.
Synchronized Conveyor System
Conveyor belt synchronized with the heat sealer to ensure consistent sealing quality, increased throughput, optimized workflow.
Motorized adjustable wheeled stand
Motorized support designed for maximum ergonomics and adaptability.
AISI 304 Stainless Steel frame.
Aluminium Lifting column.
Electric vertical adjustment via control panel and tilt adjustment via handwheel.
Available Accessories
Sealer-synced conveyor belt for smooth, efficient packaging.
Motorized wheeled stand.
Regulatory Compliance
Directives 2006/42/CE; 2014/30/UE
UNI EN ISO 11607-2:2020
World Health Organisation Guidelines
World Federation for Hospital Sterilisation Sciences Guidelines
UNI EN 868-5
EN ISO TS 16775
DIN 58953-7
UNI/TR 11408:2011
EU GMP Annex 1: manufacture of Sterile Medicinal Products
Manufactured in a UNI EN ISO 9001:2015 Quality System Certified Company
minirò Qube UDI-Ready Sealing
Stay ahead in Medical and Pharmaceutical Packaging
