Gandus Saldatrici VALPACKAGE.
Qualify. Verify. Document your heat-sealing process.
Reliability and control, from the heat sealer to the final package.
Heat-sealing process validation requires accurate, documented checks to demonstrate that the equipment is correctly installed and performs consistently within defined parameters.
With VALPACKAGE, Gandus Saldatrici combines technical expertise, validated protocols and calibrated measuring instruments to perform Installation Qualification (IQ) and Operational Qualification (OQ) activities in support of process validation in accordance with ISO 11607-2.
A complete qualification service for your heat-sealing process
Gandus VALPACKAGE brings together all the essential checks required to verify the correct installation and operation of your heat sealer and provide documented evidence of its performance.
Installation Qualification – IQ
We verify that the heat sealer is correctly installed and meets the required conditions for its intended use, including:
✓ correct equipment operation;
✓ compliance with performance and safety requirements;
✓ correct positioning;
✓ electrical and pneumatic connections, where applicable;
✓ environmental and technical installation conditions;
✓ availability of the required documentation.
Operational Qualification – OQ
Using calibrated measuring instruments, we verify that the heat sealer operates correctly under defined operating conditions and that the sealing parameters remain within the specified tolerance limits.
The service also includes personnel training on the correct operation and maintenance of the equipment.
Seal and Package Testing
VALPACKAGE goes beyond equipment qualification by including specific tests on sealed packages.
For medical pouches, seal peel and strength testing is performed in accordance with EN 868-5.
For other types of pouches, dye penetration testing can be performed in accordance with ASTM F1929 to assess seal integrity.
VALPACKAGE activities are carried out by highly specialized Gandus Saldatrici technicians, using validated protocols and calibrated measuring instruments.
Upon completion of the qualification activities, you receive the relevant IQ/OQ documentation and calibration certificate, providing documented evidence of the checks, measurements and activities performed.
VALPACKAGE
Greater process control. Greater confidence in heat sealing.
