Validatable Perfection through Pureness.
ISO 11607.2 Validatable Medical rotary heat sealer.
Management from 4.3” color touch screen.
Essential and clean lines.
AISI 304 stainless steel.
Heat Sealable Materials: Heat Sealable Sterile Barrier Systems, Tyvek®, Next Generation Packaging Materials.
Rotary sealing, mm 15 height .
Sealing speed 10 m/min.
Maximum sealing temperature 200°C, tolerance +/- 1%.
Compliance with World Health Organization guidelines, World Federation for Hospital Sterilization Sciences (WFHSS).
Benefits and Advantages
Packaging Process Validation
Next-generation hardware and software for accurate temperature control. Compliant with ISO 11607.2 standards and International Guidelines EN-ISO TS 16775.
Safety
mm 15 Gandus multi-line sealing to guarantee ideal sealing and easy, safe peeling.
Maximum ergonomics
Built-in entry guide and double access, top and front, for quick and easy maintenance.
Efficiency and effectiveness in communication
USB and RS 232 interfaces for effective and efficient communication with external systems.
Complete and automatic traceability
Complete traceability of all process data with automatic recording to standard USB media.
Operator Interface
The large 4,3” colour touch screen and the specifically developed software represent the perfect interface to guarantee the operator a simple and safe working method.
SecurScan Data Upload Software
Operating via scanner, SecurScan Data Upload Software allows the download of all data on the sealing machine.
SmartPrint Smart printing
Latest generation needle printer for printing text and barcodes on packaging.
Simple and efficient front cartridge change.
Automatic print font sizing in relation to the pouch dimensions, with alarm in case of too small pouch.
Space optimization
Pura requires just 0,15 square meters space to be used to its full potential.
Sanitization at the highest levels
Stainless steel, anodized aluminum and ergonomic design with essential lines for maximum cleaning and disinfection.
Energy saving
Designed and built for process optimization in full compliance with energy saving efficiencies.
New firmware for:
- copy operator, batch and catalog libraries stored on a USB stick
- perform a quick search for a catalog string by typing the initial letters of the string.
- the new firmware can be implemented on all machines produced so far via USB stick.
Materials
Pura is ideal for sealing of all heat-sealable sterile barrier systems, Tyvek®, as well as all new generation packaging materials.
Versions
Stainless steel and anodized aluminum version
Stainless steel version
No Print version (Pura NP)
Accessories on request
Work plan
Roller tray
Roll holder
Label printer
Barcode scanner
Ethernet module
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
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
Product design and engineering developed with the scientific consultancy of the Design Department of the Politecnico University of Milan.
