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ISO 11607.2 Validatable Packaging

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minirò Qube – UDI Ready Sealing

Reliable. Connected. Validatable rotary sealer.
UDI-Ready Sealing for the Future of Medical and Pharmaceutical Packaging.
• ISO 11607.2 Validatable
• mm 9 seal
• Variable speed
• Integrated print system for UDI print
• Double colour Touch screen
• IP connectivity and Networking
• Two versions for excellent sealing results on all materials
• Traceability
• STANDARDS: Directives 2006/42/CE; 2014/30/UE; UNI EN ISO 11607-2:2020; World Health Organisation Guidelines; World Federation for Hospital Sterilization 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

Pura

Latest generation ISO 11607.2 Validatable medical rotary heat sealer, with essential and clean lines. The cutting edge of the most technological design.
• Management from 4.3” colour touch screen
• Sealing 15mm
• SmartPrint automatically adjusts font size to pouch width
• STANDARDS: 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 Organization guidelines; World Federation for Hospital Sterilization Sciences (WFHSS)
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

minirò H-net Evo

Rotary Sealer Validable ISO 11607.2 with Securscan Data Upload Software
• Reliable performance for intensive medical devices packaging
• 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
• STANDARDS: 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
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

minirò poly VP Touch

New rotary heat sealer validated to ISO 11607.2 with programming touch screen.
• 9mm knurled or flat sealing
• 4.3″ colour touch screen
• Complete with traceability system
• USB and RS 232 interface
• Label printer
• STANDARDS: 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
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

minirò H-seal Evo VP

Rotary heat sealer designed for hospital and industrial facilities that want to equip themselves with entry-level heat sealers Validable according to ISO standards
• Sealing 15mm
• Extended keyboard
• Bright 2-line 16-character display
• USB interface
• Interfaceable with label printer
• STANDARDS: 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
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

rebiTech 230 series

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 8 m/min or 10 m/min (on request)
• Touch screen interface
• USB interface
• Traceability
• Integrated printing
• ISO 11607.2 Validable versions
• STANDARDS: 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
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

Medical H ATDP RS25

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
• STANDARDS: UNI EN ISO 11607-2; UNI EN 868-5; DIN-58953 7; 2006/42/EC-2014/30/UE-2014/35/UE; UNI/TR 11408; EU GMP Annex 1: Manufacture of Sterile Medicinal Products
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

UNICA Series

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
• Sealing lengths mm 610, mm 810, mm 1010, mm 1210
• Sealing height mm 8
• Venturi air suction system with adjustable nozzle
• Easy Access App for remote interaction
• Maximum operational flexibility
• Mechanical or motorized support
• Val Pack service
• Audit Trail
• STANDARDS: ISO 11607.2; ISO TS 16775; EN 868-5:2019; DIN 58953-7; UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; EU GMP Annex 1: Manufacture of Sterile Medicinal Products; Directives 2006/42/EC-2014/30/UE-2014/35/UE
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

UNICA Vacuum Series

Pneumatic Vacuum 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
• Sealing lengths mm 610, mm 810, mm 1010, mm 1210
• Sealing height mm 8
• Venturi air suction system with adjustable nozzle
• Easy Access App for remote interaction
• Maximum operational flexibility
• Mechanical or motorized support
• Val Pack service
• Audit Trail
• STANDARDS: ISO 11607.2; ISO TS 16775; EN 868-5:2019; DIN 58953-7; UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; EU GMP Annex 1: Manufacture of Sterile Medicinal Products; Directives 2006/42/EC-2014/30/UE-2014/35/UE
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

SI Med

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 mm 720 x mm 8
• Vertical / horizontal sealing
• Vacuum version (SI Vacuum Med)
• IP 65 version
• Numerous accessories

SI Vacuum Med

Pneumatic vacuum heat sealers. Validated according to ISO 11607.2, ISO TS 16775, EN 868-2, DIN 58953-7 standards.
• Sealing mm 720 x mm 8
• 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 and Calibration Services

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
• Calibration Certificate issuance

IQ – OQ Certifications

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

Peel Strength Test

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

Routine Tests

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®)

Seal CheckIT

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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