Qualification & Validation

Qualification & Validation

To comply with pharmaceutical industry requirements, various tests and inspections must be performed on systems and devices. bbi-biotech provides comprehensive support for system qualification and process validation from the beginning of engineering tasks. The company assists with installation start-up, delivers required documentation, and supports communication with certifying authorities.

Included Services

Installation Qualification (IQ)

The IQ is the documented verification that all key aspects of the installation adhere to appropriate codes and approved design intentions, ensuring that manufacturer recommendations have been properly considered.

Operation Qualification (OQ)

The OQ is the documented verification that the equipment-related system or subsystem performs as specified throughout its operating range, meeting the properties described in the specification document.

FAT – Factory Acceptance Test

The FAT is the acceptance of the system by the customer at the manufacturer’s site. It includes verification of machine/device functionality, completeness of documentation, spare parts list, and certificates at the place of production.

SAT – Site Acceptance Test

The SAT is the acceptance of the system at the customer’s site. It involves checking functionality, documentation completeness, spare parts list, and certificates on-site or after transportation.

Calibration of Sensors and Measuring Instruments

Sensor signal quality directly impacts product quality in automated processes. Even simple sensors such as temperature or pressure sensors may vary due to aging, leading to deviations in performance. bbi-biotech provides calibration technology for common sensor types (e.g., pH, temperature, pO₂, turbidity) and refits sensors and analytical instruments to ensure reliable performance.
Our service technicians have extensive experience and maintain a large archive of test documentation for calibration and validation support.

Specifications