Latest generation ISO 11607.2 Validatable medical rotary heat sealer, with essential and clean lines. The cutting edge of the most technological design.
• Compliance with World Health Organization guidelines, World Federation for Hospital Sterilization Sciences (WFHSS) EN ISO 11607.2, EN ISO TS 16775, EN 868-2, DIN 58953-7
• Management from 4.3” colour touch screen
• Sealing 15mm
• SmartPrint automatically adjusts font size to pouch width
Rotary Sealer Validable ISO 11607.2 with Securscan Data Upload Software
• Validable according to ISO 11607.2, ISO TS 16775, EN 868-2, DIN 58953-7 standards.
• Sealing mm 15
• Sealing speed 10 m/min.
• Interfaceable with external systems
• Materials: EN 868-5 bags and rolls, TYVEK bags, EN 868-4 paper/paper bags, with gussets, Laminated aluminium, PP
New rotary heat sealer validated to ISO 11607.2 with programming touch screen.
• Compliance with ISO 11607.2 standards and international guidelines EN-ISO TS 16775
• 9mm knurled or flat sealing
• 4.3″ colour touch screen
• Complete with traceability system
• USB and RS 232 interface
• Label printer
Rotary heat sealer designed for hospital and industrial facilities that want to equip themselves with entry-level heat sealers Validable according to ISO standards
• Validable according to ISO 11607.2, ISO TS 16775, EN 868-2, DIN 58953-7 standards
• Sealing 15mm
• Extended keyboard
• Bright 2-line 16-character display
• USB interface
• Interfaceable with label printer
Compact, reliable and easy-to-use rotary heat sealers for high production levels.
Highly customizable with options and accessories to meet the most diverse packaging needs.
• Sealing 12mm
• Sealing speed 6 m/min (further versions on request)
• Touch screen interface
• USB interface
• Traceability
• Press
• Validable versions ISO 11607.2
Impulse heat sealers Validated according to ISO 11607.2, ISO TS 16775, EN 868-2, DIN 58953-7 standards.
• New ROPEX RESISTRON® RES 5450 controller
• Flat seal, mm 460 – mm 610 – mm 710 x mm 8
• RS 232 interface
• Remote Management Traceability Software
• 4-line, 20-character digital display
• Roll holder and cutting system
Pneumatic impulse validatable heat sealers, in AISI 304 stainless steel, designed for LifeScience and for all applications that require high performance and maximum control.
• 7″ color touch screen management
• Venturi air suction system with adjustable nozzle
• Easy Access App for remote interaction
• Maximum operational flexibility
• Mechanical or motorized support • Val Pack service
• Standards: ISO 11607.2 / ISO/TS 16775 / EN 868-5:2019 / DIN 58953-7
Pneumatic heat sealer Validated according to ISO 11607.2, ISO TS 16775, EN 868-2, DIN 58953-7 standards. Specifically designed for the medical, pharmaceutical, laboratory and chemical industries.
• Sealing 520/720/1020mm x 8mm
• Vertical / horizontal sealing
• Vacuum version (Serie SI Vacuum(Med.)
• IP 65 version
• Numerous accessories
Pneumatic vacuum heat sealers. Validated according to ISO 11607.2, ISO TS 16775, EN 868-2, DIN 58953-7 standards.
• Sealing 520/720/1020mm x 8mm
• Venturi pump suction system
• Accurate control and recording of critical sealing parameters, to guarantee constant and repeatable high quality over time.
• Vertical / horizontal sealing
• Applications: medical, pharmaceutical, laboratory, chemical industry sectors
• IP 65 version
Validation, Calibration and Recalibration services dedicated to the ISO 11607.2 Validation process.
• Absolute compliance with current regulations
• Carried out on new Validable sealing machines and on Validable sealing machines already in use
• Issuance of the Calibration Certificate
Gandus Saldatrici, through its highly specialized technicians, offers control services relating to Installation Qualification and Operation Qualification, to certify, as required by current legislation in terms of process validation, that the devices have been supplied, are installed and work in accordance with the requirements of the legislation.
• IQ compliance checks
• OQ compliance checks
• Documentation issuance
Heat-sealed joint leak tests as required by EN 868-5 and Performance Qualification (QP) procedures.
• Calibrated instruments for Peel Strength Test on welding
• EN 868-5 compliant
• Compliance with Performance Qualification (QP) procedures
• Certificate issuance
New generation indicator tests, for daily control of the integrity of the seals made with sterilization pouch sealers. In accordance with EN ISO 11607.1.2 and ASTM F1929 standards
• Simple, safe and fast use and reading of the result
• Reliability of the results
• Materials: pouches and rolls as per EN ISO 11607.1/ EN 868-5 in paper and film as per EN 868-3, pouches and rolls as per EN ISO 11607.1.2 / EN 868-9 for uncoated polyolefin materials (e.g. Tyvek®)
Test system for daily verification of the locking system and for Operational Qualification (OQ) according to EN ISO 11607.2.
• Simplicity, speed of use
• Reliability of results
• Compliance with EN ISO 11607.2 standards.
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