Validable Packaging ISO 11607.2

Pura VS

The new Standard in Medical and Pharmaceutical Sterile Packaging.
Engineered for CSSDs, hospitals, cleanrooms, pharmaceutical manufacturing, and LifeScience applications
• Full AISI 304 stainless steel rotary sealing machine
• ISO 11607-2/3 Validatable
• Integrated communication interfaces and advanced connectivity capabilities
• Glove compatible 4.3” colour touch screen
• Sealing 15mm
• Variable Speed 3–14 m/min
• SmartPrint to automatically adjust font size to pouch width
• Compliances: ISO 11607-2:2019; UNI EN ISO 11607-3:2026; EN 868-5:2018; CEN ISO/TS 16775:2021; DIN-58953 7:202-11; Directives 2006/42/EC-2014/30/UE-2014/35/UE; UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; EU GMP Annex 1; World Health Organization (WHO) guidelines; World Federation for Hospital Sterilization Sciences (WFHSS)
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

minirò Qube – UDI Ready Sealing

Reliable. Connected. Validatable rotary sealer.
UDI-Ready Sealing for the Future of Medical and Pharmaceutical Packaging.
• ISO 11607-2/3 Validatable Sealing Process
• 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
• Compliances: ISO 11607-2:2019; ISO 11607-3:2026; EN 868-5:2018; CEN ISO/TS 16775:2021; DIN 58953-7:2020-11; UNI/TR 11408:2011; Directives 2006/42/EC; 2014/30/EU; 2014/35/EU; World Health Organisation (WHO) and World Federation for Hospital Sterilisation Sciences Guidelines; EU GMP Annex 1
• Manufactured in a UNI EN ISO 9001:2015 Quality System Certified Company

Pura

High performance sealing and process Validation system. The cutting edge of most technological design.
• ISO 11607-2/3 Validatable medical rotary heat sealer
• AISI 304 stainless steel housing
• Compact and modern, with clean, essential lines to maximize productivity and space efficiency.
• Management from 4.3” colour touch screen
• Sealing 15mm
• SmartPrint automatically adjusts font size to pouch width
• Complaainces: ISO 11607-2:2019; ISO 11607-3:2026; EN 868-5:2018; CEN ISO/TS 16775:2021; DIN-58953-7:2020-11; Directives 2006/42/EC-2014/30/UE-2014/35/UE; UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; EU GMP Annex 1; World Health Organization (WHO) and World Federation for Hospital Sterilization Sciences (WFHSS) Guidelines
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

minirò H-net Evo

Rotary Sealer Validable ISO 11607-2/3 with Securscan Data Upload Software
• Reliable performance for intensive medical devices packaging
• 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
• Compliances: ISO 11607-2:2019; ISO 11607-3:2026; EN 868-5:2018; CEN ISO/TS 16775:2021; DIN-58953 7:202-11; Directives 2006/42/EC-2014/30/UE-2014/35/UE, UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; WHO and WFHSS Guidelines
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

minirò poly VP Touch

New rotary heat sealer validated to ISO 11607-2/3 with programming touch screen.
• 9 mm knurled or flat sealing
• 4.3″ colour touch screen
• Complete with traceability system
• USB and RS 232 interface
• Label printer
• Compliances: ISO 11607-2:2019; ISO 11607-3:2026; EN 868-5:2018; CEN ISO/TS 16775:2021; DIN-58953-7:202-11; 2006/42/EC-2014/30/UE-2014/35/UE Directives; UNI/TR 11408:2011; WHO and WFHSS Guidelines; 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 11607-2/3 standards
• Sealing 15mm
• Extended keyboard
• Bright 2-line 16-character display
• USB interface
• Interfaceable with label printer
• Compliances: ISO 11607-2:2019; ISO 11607-3:2026; EN 868-5:2018; CEN ISO/TS 16775:2021; DIN-58953 7; 2006/42/EC-2014/30/UE-2014/35/UE Directives; UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; WHO and WFHSS Guidelines
• 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 11607-3:2026 Validable versions
• Compliances*: ISO 11607-3:2026; EN 868-5:2018; CEN ISO/TS 16775:2021; DIN 58953-7:2020-11; Directives 2006/42/EC-2014/30/UE-2014/35/UE; UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; WHO and WFHSS Guidelines
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

Medical H ATDP R25

Impulse heat sealers Validated according to ISO 11607-2/3, CEN ISO/TS 16775, EN 868-5, DIN 58953-7 standards.
• New ROPEX RESISTRON® RES 5450 controller
• Flat seal, mm 460; mm 610; mm 710; mm 810 x mm 8
• RS 232 interface
• Remote Management Traceability Software
• 4-line, 20-character digital display
• Roll holder and cutting system
• Compliance: ISO 11607-2:2019; ISO 11607-3:2026; EN 868-5:2018; DIN-58953 7:2020-11; Directives 2006/42/EC-2014/30/UE-2014/35/UE; UNI/TR 11408:2011; WHO and WFHSS Guidelines; GMP Annex: Sterilization Guidelines-MEMO 5; Manufacture of Sterile Medicinal Products
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

UNICA Series

Excellence in Life Science
Pneumatic impulse ISO 11607-3:2026 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
• ValPackage service
• Audit Trail
• Compliances: ISO 11607-3:2026; CEN ISO/TS 16775:2021; EN 868-5:2018; DIN 58953-7:2020-11; UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; EU GMP Annex 1; Directives 2006/42/EC-2014/30/UE-2014/35/UE; WHO and WFHSS Guidelines
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

UNICA Vacuum Series

Excellence in Life Science
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
• ValPackage service
• Audit Trail
• Compliances: ISO 11607-3:2026; CEN ISO/TS 16775:2021; EN 868-5:2018; DIN 58953-7:2020-11; UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; EU GMP Annex 1; Directives 2006/42/EC-2014/30/UE-2014/35/UE; WHO and WFHSS Guidelines
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

SI Med R25

Pneumatic heat sealer Validated according to ISO 11607-3:2026, CEN ISO/TS 16775:2021, EN 868-5:2018, 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 R25

Pneumatic vacuum heat sealers. Validated according to ISO 11607-3:2026, CEN ISO/TS 16775:2021, EN 868-5:2018, DIN 58953-7:2020-11 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
• Ropex Resistron®RES 5450 controller
• Applications: medical, pharmaceutical, laboratory, chemical industry sectors
• IP 65 version
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

ValPackage

Validation Testing and Services to ensure safe and reliable daily controls and periodic verification of medical sealers for sterilization pouches, in accordance with ISO 11607-1/-2 and ASTM F1929 standards.

• Validation and Calibration Services
• IQ – OQ Qualification and Certification
• Peel Strength Testing
• Routine Seal Integrity Testing

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

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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Validable Packaging ISO 11607.2

Pura VS

minirò Qube – UDI Ready Sealing

Pura

minirò H-net Evo

minirò poly VP Touch

minirò H-seal Evo VP

rebiTech Series

Medical H ATDP R25

UNICA Series

UNICA Vacuum Series

SI Med R25

SI Vacuum Med R25

ValPackage

Validation and Calibration Services

IQ – OQ Certifications

Peel Strength Test

Seal Integrity Routine Tests

Seal CheckIT

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Validable Packaging ISO 11607.2

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