Qualification & Validation

In order to meet pharmaceutical requirements, a number of tests and inspections need to be carried out on your system and devices. bbi-biotech assists you in all aspects of qualification of your system and validation of your processes from the beginning of all engineering tasks. We support the start-up of your installation with the delivery of required documentation and we give our support during the communication with the certifying authorities.

These include e.g.:

Installation Qualification

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

Operation Qualification

The OQ is the documented verification that the equipment related system or subsystem performs as specified throughout representative or anticipated operating range or meets the properties described in the specification document.

FAT – Factory Acceptance Test

The FAT is the acceptance of the sytem by the customer at the manufacturer site. Among other things, the funcionality of the machine/device, the completeness of the documentation, the spare part list and certificates are checked at the place of production.

SAT – Site Acceptance Test

The SAT is the acceptance of the sytem at customer’s site: Among other things, the funcionality of the machine/device, the completeness of the documentation, the spare part list and certificates are checked on site or after transportation.

Calibration of sensors and measuring instruments

Quality of sensor signals have direct influence on product quality within automated processes. Even sensors which are meant to be simple systems like temperature or pressure sensors may vary due to aging processes. Those small variances may have big influences, even if in most cases the sensor itself still works fine, just with slight range variations. bbi-biotech provides the technology for calibration of the most common sensor types (e.g. pH, t, pO2, turbidity, etc.) and refits your sensors and analytical instruments to the desired reliablity. bbi-biotech and especially our service technicians have many years of experience in this area and have a big archive of necessary test documents on their disposal.