|
IQ/OQ Validation
IQ/OQ: Ensuring Packaging Machine Performance
Maintaining consistent and reliable packaging is crucial, especially when it comes to validatable (medical) devices. Genpack offers a comprehensive solution to ensure your packaging machines operate at peak performance and comply with ISO 11607-2 standards. This includes essential Installation Qualification (IQ) and Operational Qualification (OQ) checks, conducted by our experienced service engineers at your location.
Contact me about this product
Installation Qualification (IQ): Verifying Proper Setup
This process guarantees your packaging machine is installed and configured according to Audion's specifications and installation checklist. Our engineer inspects for correct installation and functionality. All critical parameters and documents are reviewed for completeness. Comprehensive training is provided to your staff on operation and maintenance.
Operational Qualification (OQ): Optimizing Performance
The OQ phase focuses on determining the optimal parameter settings and tolerances for your specific packaging needs. This includes establishing acceptable criteria for consistent closure quality. "Worst-case testing" pushes parameters to their upper and lower limits, followed by integrity tests on these samples. These integrity tests include seal checks (EN ISO 11607-2), dye penetration tests (ASTM F 1929), and peel tests (EN 868-5:2018 Annex D).
IQ/OQ Documentation: Maintaining Compliance
Genpack provides all necessary documentation for IQ and OQ, facilitating validation of your packaging machines. Developed in accordance with ISO/TS 16775:2014 checklists, these documents become crucial components of your overall validation record. The documentation will be delivered to you digitally for easy access and record-keeping.
Investing in Peace of Mind
By choosing Genpack for IQ and OQ checks, you gain peace of mind knowing your packaging machines are operating optimally and are compliant with ISO 11607-2 standards. This translates to consistent, high-quality packaging, ultimately contributing to the safety and integrity of your validatable (medical) devices.
This process guarantees your packaging machine is installed and configured according to Audion's specifications and installation checklist. Our engineer inspects for correct installation and functionality. All critical parameters and documents are reviewed for completeness. Comprehensive training is provided to your staff on operation and maintenance.
Operational Qualification (OQ): Optimizing Performance
The OQ phase focuses on determining the optimal parameter settings and tolerances for your specific packaging needs. This includes establishing acceptable criteria for consistent closure quality. "Worst-case testing" pushes parameters to their upper and lower limits, followed by integrity tests on these samples. These integrity tests include seal checks (EN ISO 11607-2), dye penetration tests (ASTM F 1929), and peel tests (EN 868-5:2018 Annex D).
IQ/OQ Documentation: Maintaining Compliance
Genpack provides all necessary documentation for IQ and OQ, facilitating validation of your packaging machines. Developed in accordance with ISO/TS 16775:2014 checklists, these documents become crucial components of your overall validation record. The documentation will be delivered to you digitally for easy access and record-keeping.
Investing in Peace of Mind
By choosing Genpack for IQ and OQ checks, you gain peace of mind knowing your packaging machines are operating optimally and are compliant with ISO 11607-2 standards. This translates to consistent, high-quality packaging, ultimately contributing to the safety and integrity of your validatable (medical) devices.