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
Vseal.it VP
The only automatic Seal-Cut sealing machine validated to ISO 11607.2 for the production of medical pouches with V-weld (Chevron weld), starting from a standard roll.
• Customized production flexibility
• Peelability, safety and correct opening of the bags
• High productivity
• Touch screen programming
• Interface with Traceability systems
• Savings in material, time, space
• STANDARDS: UNI EN ISO 11607-2; UNI EN 868-5: 2019; EN ISO TS 16775; DIN-58953 7; Directives 2006/42/EC-2014/30/UE-2014/35/UE; UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company
minirò H-data Evo
Rotary heat sealer for sealing medical pouches and rolls compliant with EN 868-5 and DIN 58953-7 standards.
• Sealing mm 15
• Sealing speed 10 m/min
• 20 character 4 line digital display and new alphanumeric keyboard
• Integrated 9-pin printer
• USB and RS 232 interface
• AISI 304 stainless steel cover
• STANDARDS: UNI EN 868-5; DIN 58953.7; 2006/42/CE; 2014/30/CE; 2014/35/CE; Sterilization Guidelines – MEMO 5
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company
Medical H 460/610/710
Impulse heat sealer for sealing medical pouches and rolls according to DIN 58953-7
• Flat sealing mm 460/610/710 x 8mm
• Electronic control of sealing and cooling times
• AISI 304 stainless steel cover
• Can be equipped with integrated roll holder and cutting system; cutting length 370mm, 500mm, 610mm
• Roll holder and cutting system
• STANDARDS: UNI EN 868-5; DIN-58953 7; 2006/42/EC-2014/30/UE-2014/35/UE
• Produced in an UNI EN ISO 9001:2015 Quality System Certified Company
minirò H-seal Evo
Rotary heat sealer for sealing medical pouches and rolls according to UNI EN 868-5:2009 and DIN 58953-7 standards
• Ideal for high production
• 15mm seal
• Speed 10 m/min
• AISI 304 stainless steel cover
• Adjustable input guide
• Two-line liquid crystal display
• Quick and simple temperature and counter programming menu
• STANDARDS: UNI EN 868-5; DIN 58953.7; Directives 2006/42/EC; 2014/30/EU; 2014/35 EU
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company
DN 350
Impulse heat sealer for sealing medical pouches and rolls according to DIN 58953-7. Simple and safe to use, ideal for medical and dental practices.
• Sealing mm 350 x mm8
• Quick operation
• Complete with roll holder and cutting system.
• Electronic control of sealing times
• Materials: all heat-sealable sterile barrier systems for steam sterilization
• STANDARDS: UNI EN 868-5:2009 DIN 58953-7; Directives 2006/42/EC—2014/30/EU-2014/35/EU
• Manufactured in a UNI EN ISO 9001:2015 Certified Company
One4All
Complete Pouch Packaging Station, designed to combine in a single element all the devices needed for a perfect sealing process to guarantee simple and efficient storage of both packaging materials and packaged products.
• Design and ergonomics for maximum safety and efficiency
• Ethernet interface to communicate with software dedicated to total traceability
• Maximum operational flexibility
• Small size and large work space
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
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.
