Qualification QI/QO
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Qualification QI/QO

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We offer a complete IQ/OQ qualification service and issue a certificate of conformity.

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Description

To ensure that your equipment operates correctly within its production environment and delivers seals that comply with applicable standards (particularly for sterile packaging), Franco Pack offers a comprehensive IQ/OQ qualification service.

Installation Qualification (IQ)

In the first phase, we carry out the Installation Qualification (IQ), which aims to:

  • Verify that the equipment is installed according to technical specifications (location, connections, power supply, safety devices, etc.),

  • Check documentation, interfaces, and record ambient conditions,

  • Confirm that the equipment is ready to be operated in your environment,

  • Provide initial operator training, if requested.

Operational Qualification (OQ)

In the second phase, the Operational Qualification (OQ) aims to:

  • Define a test plan covering critical parameters: nominal ranges, acceptable limits, and tolerances,

  • Perform reproducible tests under “worst-case” scenarios (extreme parameter values),

  • Conduct sealing tests (including seal integrity and strength checks) on representative samples,

  • Measure performance and robustness (ability to remain within tolerance limits).

These two stages validate that the machine functions correctly and can consistently produce compliant seals. Complete documentation is provided for your quality records.

Seal Quality Control Tests

Finally, we perform seal quality controls using the following methods:

  • Methylene blue dye test: this dye penetrates any leaks or channels, revealing otherwise invisible defects,

  • Peel test: checks the mechanical strength of the seal according to applicable standards,

  • Leak test with control sheets according to ISO 11607-2 or equivalent standards,

  • Worst-case analysis: evaluation of the most unfavorable parameter combinations.

These tests ensure that seals or joints are free from defects, leaks, or channels that could compromise sterility or integrity. Carried out with certified instruments, they are accompanied by a detailed report and tailored recommendations.