Services

ASC

Qualifications :
IQ/OQ/PQ

We offer Qualification services as part of every instrument implementation project, including when adding a new format to an existing instrument.

Well before delivery, we prepare all necessary documentation and send it to you for approval. These documents then serve as the foundation for Factory Acceptance Testing (FAT) and for the Qualification procedures during on-site installation.

Need to qualify your CCIT system? Let us guide you through the process!

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ASC

Reference Parts

Positive / negative controls

Every inspection process must be verified—not only at its implementation but also afterwards. Whether to comply with internal procedures, regulatory requirements, or audits, Reference Parts play a crucial role in this approach.

ASC Instrument has extensive expertise in integrating Calibrated Leaks into Customer parts, transforming them into Reference Parts. These are delivered with a Certificate, allowing verification to be conducted objectively and in a standardized manner.

Do you wish to have Calibrated Leaks fitted to your parts ?

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ASC

Validation studies

A test instrument must be capable of fulfilling its intended task: reliably detecting all potential integrity defects that may occur during production. The performance of the inspection process depends on several factors:

  • The instrument quality
  • The design and manufacturing quality of the test chamber
  • The alignment of test parameters with the application

The validation study demonstrates the instrument's ability to detect all defects according to the Client's requirements for their product. A detailed report is provided upon completion of the study, including all obtained results, the parameter settings used to achieve them, our conclusions, and any recommendations.

Validate the capability of our instruments on your application before placing an order?

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ASC

Impact studies

Sometimes, it is necessary to slightly modify a parameter of your validated process—e.g. a change in packaging material, supplier, or fill level. 

Evaluating the impact of such modifications on testing is crucial: Should instrument settings be adjusted? Does the test chamber need adaptation? Are new Reference Parts required?


Our experts are available to guide you through this evaluation. If needed, they can conduct a study to determine the impact and recommend appropriate adjustments based on quantified data.

Are you hesitating on the impact of a modification?

Request our advice
ASC

Calibration/Maintenance

We provide calibration and maintenance services to keep your instrument and its Reference Parts in optimal condition for many years.
Our customized Maintenance Contracts are tailored to the equipment installed on-site, ensuring reliability and performance over time.

More info on our Maintenance Contracts?

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