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Validation and Calibration Services

Validation and Recalibration Services dedicated to the Validation process
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 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.

On this page the Validation and Calibration Services

 

Validation of the Packaging Process in accordance with ISO 11607-2 requires that the sealing machine used is properly calibrated and maintained under controlled conditions.

Leveraging extensive industry experience and a continuous commitment to full regulatory compliance, Gandus Saldatrici provides specialized services dedicated to the Calibration and Re-Calibration of our Validable sealing machines.

The service is available for both newly installed equipment and machines already in operation.

Calibration activities are performed through precise measurement and verification of the critical process parameters, including sealing temperature, pressure, and dwell time, ensuring full traceability and alignment with applicable standards.

Upon completion of the process, an official Calibration Certificate is issued, documenting conformity and measurement results.

The Re-Calibration process includes:

  • Comprehensive technical inspection of the sealing machine

  • Verification of operational performance

  • Replacement of wear components where necessary

  • Fine adjustment and optimization of critical sealing parameters

  • Final validation and issuance of the updated Calibration Certificate

This structured approach guarantees process reliability, repeatability, and documented compliance with current regulatory requirements.

Contact service@gandus.it for more information and/or to arrange an appointment.