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Calibration & Validation Services

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Calibration, Validation and Verfication for Audion Sealing Systems

Ensure your packaging is fully compliant with ISO 11607-2:2019 through our expert calibration and validation services.

We offer comprehensive calibration services for our extensive range of Audion validatable sealers, widely used in the Medical, Pharma, and high-tech industries. Our calibration and validation services ensure that your packaging always complies with the strict requirements of ISO 11607-2:2019. Our services are essential because traceability, reproducibility, and the availability of documentation are central to the standard and depend on regular verification, calibration, and validation.

We offer three distinct services for the calibration and validation of Audion packaging machines:

Factory Calibration
IQ/OQ Check (Installation/Operational Qualification)
Seal Integrity Tests

Contact us today to discuss your requirements.

sales@npp.ie +353 1 880 9299

Factory Calibration

NPP offers comprehensive calibration services for our range of Audion validatable sealers, widely used in the Medical, Pharma, and high-tech industries. The range includes validatable sealers, validatable continuous bandsealers, validatable Speedpack and validatable vacuum chambers. Regular user verification and annual re-calibration ensure that our sealers consistently deliver the required seal quality.

Calibration certifies the preciseness of the sealing parameters of the packaging machine and is the first step towards a seal that is compliant with ISO 11607-2:201.

The quality and consistency of the seal are determined by three key parameters: temperature, time/speed and pressure/force. For vacuum chambers, vacuum pressure is also a critical factor.

During calibration, our service engineers calibrate and adjust these parameters as needed, providing you a traceable calibration certificate issued in accordance with an ISO 9001 quality management system.

IQ/OQ Check

We also offer Installation and Operational Qualification checks at our customers location.

Installation Qualification (IQ) verifies that the packaging machine has been installed and configured according to Audion’s specifications and the installation checklist.

Operational Qualification (OQ) defines the correct parameter settings and tolerances as well as ensuring that the closure is consistent and meets the acceptance criteria.

NPP will provide you will all the necessary IQ and OQ documents for the validation of Audion packaging machines. The documents are an essential component of your validation documentation and will be provided to you digitally.

Seal Integrity Tests

Regular verification of your seal quality is an important part of quality control. We off Seal Integrity Tests as a seperate service to support your seal quality inspection.

Our service engineer will visit your site with test kits to complete the following tests:

Seal Check
Peel Test
Dye Penetration Test

A detailed certificate, including all relevant documentation, will be provided upon completion. For regular seal inspection, we offer a comprehensive range of tools and accessories tailored to your specific needs.