Gandus Saldatrici delivers a comprehensive Sealing Process Control and Validation System, integrating qualification protocols, regulatory compliance services, and performance testing to ensure that medical sealing equipment for sterilization pouches consistently meets validated quality criteria, maintains process reliability, and fully complies with ISO 11607-1, ISO 11607-2, ASTM F1929.
This ensures that seal integrity consistently meets validated quality specifications and applicable regulatory standards, guaranteeing a controlled, reproducible sealing process while safeguarding product sterility, compliance, and patient safety.
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, 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
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
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
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®)
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.
