Seal Cut Machine for Medical Pouch Sealing

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 11607-3:2026 for the production of medical pouches with V-sel (Chevron seal), 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
• Compliances: ISO 11607-3:2026; EN 868-5: 2018; CEN ISO/TS 16775:2021; DIN 58953-7:2020-11; 2006/42/EC-2014/30/UE-2014/35/UE Directives: UNI/TR 11408:2011; Sterilization Guidelines-MEMO 5; EU GMP Annex 1; WHO and WFHSS Guidelines
Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company
• Manufactured in an UNI EN ISO 9001:2015 Quality System Certified Company

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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Seal-Cut automatic sealing machine for the production of medical pouches

Vseal.it Pouch Maker

Validation and Calibration Services

IQ – OQ Certifications

Peel Strength Test

Seal Integrity Routine Tests

Seal CheckIT

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Heat sealers for sterile products packaging

Weighing and Dosing Systems

Sealing machines for bags and tubes

Seal-Cut automatic sealing machine for medical pouches production

Tubular and bags-on-a-roll packaging machines

Validable Packaging ISO 11607.2

Testing and Validation Services

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Vacuum packaging

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Gandus Saldatrici Srl