Qualification

 

 

Why is the qualification
of your BINDER unit important?

The consistent quality of the products we manufacture – not to mention the reproducibility of our test processes – is fundamental to the laboratories and production facilities which operate subject to GMP or GLP requirements. The resulting obligation to provide supporting evidence requires a large number of unit tests to be carried out and recorded precisely. BINDER can help you significantly reduce the workload associated with qualifying and validating units.

What do IQ, OQ and PQ mean?

IQ – Installation qualification

IQ, which stands for Installation Qualification, confirms that the unit has been properly installed according to customer requirements including documentation. The technician checks that the unit has been installed correctly, as specified in the qualification folder. The qualification folders can be ordered on a unit-specific basis. 

 

OQ – Functional qualification

OQ, or Operational Qualification, checks and confirms that the unit is operating properly in an unloaded state. The required tests are available in the qualification folder.

 

PQ – Performance qualification

PQ, which stands for Performance Qualification, checks and documents the unit function in the loaded state under customer-specific requirements. The required tests are defined by mutual agreement according to customer specifications.

Benefits

BINDER can help you significantly reduce the workload associated with qualifying and validating units.

Reproducible data

Reproducible data for your BINDER unit – matched to your processes and standards

BINDER expertise

Use of BINDER expertise during validation and qualification

qualified and experienced specialists

Implementation by qualified and experienced specialists

Validation and qualification

Validation and qualification carried out on site

Range of services

Qualification folder as supporting documents for validation performed by customer Includes: IQ / OQ checklists, unit schematics, QM

Certificate according to ISO 9001

IQ / OQ of the BINDER software carried out with the connected unit

IQ / OQ carried out with or without light photometry

Our Services

Customized service - the big plus for your success

To Overview

Maintenance

Secure individual maintenance contracts tailored to you now

Read more

Calibration

Maximum process reliability through calibration and adjustment

Read more

Spare part request

Only BINDER original spare parts ensure the full performance of your simulation chamber over the long term and the unlimited warranty from us as the manufacturer

To request form

Error notification

Does your BINDER simulation chamber require maintenance or repair? Our technical experts can advise you competently on all technical questions

To request form

Product registration

Congratulations! Your new BINDER product will bring you much joy. Simply register it and enjoy many benefits

To request form

Complaint message

Would you like to report a complaint?
Our technical experts can advise you competently on all technical questions

To request form

Question to the product

You have a question about your BINDER product, a performance question about your device or would like advice on buying a new product?

To request form

You would like to request qualification?

Write us

Contact us. We are looking forward to your request.

To the request form

Do you have a question or would you like advice?

 

Feel free to contact us!