Dentale

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

rebiTech 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 6m/min, 8 m/min, 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

Vseal.it Pouch Maker

Pouch Production System for Medical Applications Engineered to Ensure Compliance, Traceability, and Full Process Control 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

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

GD 310

Compact manual heat sealer with constant heat for sealing medical bags and rolls according to DIN 58953-7. Maximum simplicity and high performance for medical, veterinary, tattoo, beauty practices. • Fast and accurate heating • Perfect film spreading inside the machine • 310 mm sealing bar • Sealing technology for savings on consumables

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

Seal Integrity 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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