The Validation of a Sealing Process and the conformity of a sealing machine with ISO 11607-2 requirements necessitate the execution of documented qualification activities.
These activities are intended to demonstrate that the equipment has been supplied, installed, and operates in full compliance with applicable regulatory and technical specifications.
Installation Qualification (IQ)
Installation Qualification provides documented evidence that the supplied equipment:
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Complies with specified performance and safety requirements
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Is installed in an environment that meets defined technical and operational specifications
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Has been properly connected to required utilities
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Is accompanied by complete and controlled technical documentation (manuals, declarations, certificates, drawings)
IQ ensures that the sealing machine is correctly installed and ready to proceed to operational verification under controlled conditions.
Operational Qualification (OQ)
Operational Qualification is the documented process of verifying that the installed equipment operates within predefined and validated operating ranges when used according to approved procedures.
OQ activities typically include:
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Verification of critical process parameters (temperature, pressure, dwell time)
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Functional testing under worst-case and nominal operating conditions
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Repeatability and consistency checks
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Recording and analysis of measured data
The objective is to demonstrate that the sealing machine consistently performs within established limits and is capable of producing compliant seals.
Gandus Saldatrici deploys highly specialized technicians to execute IQ and OQ services using validated protocols and calibrated measuring instruments, ensuring full traceability, regulatory alignment, and documented evidence in accordance with ISO 11607-2 requirements.
