The new Standard in Medical and Pharmaceutical Sterile Packaging
Advanced AISI 304 stainless steel rotary sealing machine specifically designed for the packaging of terminally sterilized medical and pharmaceutical devices in compliance with ISO 11607-2 and GMP-oriented environments.
Engineered for CSSDs, hospitals, cleanrooms, pharmaceutical manufacturing, and LifeScience applications, PURA VS ensures fully validated, repeatable, and traceable sealing processes for sterile barrier systems.
PURA VS combines industrial robustness with a modern digital architecture, offering enhanced usability, connectivity, and process control for both medical and pharmaceutical applications.
Large intuitive touchscreen, Variable Speed from 3–14 m/min, preset sealing parameters for the most commonly used materials in sterile reprocessing (Paper/PP, Tyvek®, Ultra®) make Pura VS the ideal solution for those seeking maximum versatility, operational efficiency and long-term reliability.
Whatever your application may be, wherever the sealer is used, Pura VS adds a touch of technologic Italian style to your sealing process.
Compliant to World Health Organisation guideline requirements and World Federation for Hospital Sterilisation Sciences (WFHSS) new guideline.
Validatable sealing process according to EN ISO 11607-2 and international guidance ISO/TS 16775.
Key Technical Features
✔ Regulatory compliance, Monitoring and recording of critical sealing parameters, Complete cycle traceability
✔ Fully stainless steel AISI 304 structure
✔ 4.3” color touchscreen display, operable even with gloves
✔ Variable speed for maximum flexibility
✔ Designed for heat-sealable sterile barrier systems compliant with EN 868-5 and EN 868-4 standards, Tyvek®, and next-generation packaging materials
✔ 15 mm sealing width
✔ SmartPrint technology with automatic character size adjustment according to pouch width
✔ Top and front access for easy maintenance and quick printer cartridge replacement
✔ Freely programmable packaging lists
✔ Full process control with complete traceability of sealing parameters
✔ Integrated communication interfaces for connection with external systems
✔ Advanced connectivity capabilities for process management and monitoring
✔ Ethernet included
✔ Compact and ergonomic design
✔ Sustainable and efficient engineering, thanks also to Temperature Energy Saving function
Why Pura VS stands out
The choice of a premium heat sealer is based on its ability to ensure a compliant, controlled, and fully traceable process, delivering reliable seals over time and enabling straightforward validation in accordance with the highest medical and pharmaceutical standards.
Gandus Pura VS ensures:
Premium Construction for Critical Environments
Superior hygiene, long-term durability, and corrosion resistance thanks to the full AISI 304 stainless steel housing.
Lower environmental impact and improved energy efficiency thanks to a sustainable and efficient design and manufacturing approach.
Smart Ergonomics and Maximum Usability
Improved operator efficiency and ease of use thanks to the 4.3” touchscreen display operable with gloves.
Optimized workspace organization and greater operator comfort thanks to the compact and ergonomic design.
Reduced downtime and simplified maintenance operations thanks to the front and top opening design.
Quicker routine maintenance thanks to the front door allowing easy print cartridge replacement.
Conveyor Belt synchronized with the rotary sealer and Mobile Stand, to ensure production continuity, ease of use and operational flexiblity.
Operational Flexibility & Material Compatibility
Maximum operational flexibility thanks to variable speed control, adaptable to different packaging materials and production requirements.
Faster workflows and customized operations thanks to freely programmable packaging lists.
High versatility through compatibility with all EN 868-5 packaging materials, including uncoated Tyvek® and nonwoven PP.
Sealing Performance & Packaging Quality
Enhanced packaging safety and easier sterile opening thanks to the 15 mm wide multiline seal, ensuring strong and reliable sealing performance.
Higher printing efficiency, accuracy, and process optimization thanks to Smart Print functionality, which automatically adjusts font size to pouch dimensions and efficiently manages text and barcode printing.
Traceability, Connectivity & Digital Integration
Complete process control, regulatory compliance, and improved patient safety thanks to full data traceability.
Advanced digital integration and centralized management capabilities enabled by extensive connectivity features.
Seamless integration with external systems and enhanced workflow automation through communication interfaces with external devices.
Data Exchange Versatility
Flexible data configuration through touch screen control panel, VNC connection, MODBUS TCP/IP protocol (IN/OUT mode).
Compliance, Safety & Reliability
Maximum safety, process integrity, and long-term reliability, ensured by full compliance with the most stringent international standards for sterile packaging and validation.
Materials
Ideal for all heat-sealable sterile barrier systems, Tyvek®, and next-generation packaging materials, ensuring versatile and reliable sealing.
Versions available
Stainless steel version
No Print version (Pura VS NP)
Accessories and Options
Work plan
Roller tray
Roll holder
Label printer
Barcode scanner
Conveyor belt with speed synchronized to the rotary sealer
Mobile Stand
Regulatory Compliances
UNI EN ISO 11607-2
UNI EN 868-5
EN ISO TS 16775
DIN-58953 7
Directives 2006/42/EC-2014/30/UE-2014/35/UE
UNI/TR 11408
Sterilization Guidelines-MEMO 5
EU GMP Annex 1: manufacture of Sterile Medicinal Products
World Health Organisation guideline requirements
World Federation for Hospital Sterilisation Sciences (WFHSS) new guideline
Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company
Testing and Validation Services
Gandus Saldatrici offers a range of Testing and Validation Services to ensure safe and reliable daily monitoring of medical sealing machines for sterilization pouches in accordance with ISO 11607.1.2 and ASTM F1929 Standards. learn more
