EN ISO 11607.2 Validatable rotary heat sealer for sealing medical pouches and rolls.
The ideal basic solution for all hospital and industrial facilities that want to equip themselves with heat sealers validatable according to ISO standards.
mm 15 sealing, rotary, multi-line or flat.
Heat sealable materials EN 868-5 pouches/rolls, Tyvek® pouches, EN 868 -4 paper/paper pouches, pouches with gussets, laminated aluminium pouches, PP pouches.
Sealing speed 10 m/min.
All operating data can be encoded on board the machine, immediately recalled from memory and easily exported via USB.
Compliance with World Health Organization guidelines, World Federation for Hospital Sterilization Sciences (WFHSS).
Benefits and Advantages
Packaging Process Validation
New generation hardware and software ensure accurate control of sealing parameters to guarantee maximum compliance with ISO 11607.2 standards and international EN-ISO TS 16775 guidelines.
Safety
mm 15 Gandus multi-line sealing to guarantee ideal sealing, with easy and safe peeling.
Maximum ergonomics
Built-in and adjustable entry guide.
Interfaces
USB and RS 232 interfaces for effective and efficient communication with external systems.
Operator interface
Clear and intuitive interface thanks to the extensive keyboard and the bright 2-line, 16-character display.
Traceability
All operating data can be encoded on board the machine, immediately recalled from memory and easily exported via USB.
Print
Interfaceable with new generation label printers.
Sanitization at the highest levels
Stainless steel cover for maximum cleaning and disinfection.
Energy saving
Designed and built for process optimization in full compliance with energy saving efficiencies.
Materials
Bags/Rolls EN 868-5, Tyvek®, Paper/Paper EN 868-4, with gussets, in laminated aluminium, in PP
Accessories
PS 654 worktop
RL 80 roller conveyor
PR H50 roll holder complete with cutting device
PRN 2000 label printer
Compliances
UNI EN ISO 11607-2
UNI EN 868-5
EN ISO TS 16775
DIN-58953 7
Direttive 2006/42/EC-2014/30/UE-2014/35/UE
UNI/TR 11408
Sterilization Guidelines-MEMO 5
Produced in a Company certified with the UNI EN ISO 9001:2015 Quality System
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
