Qualification tests ensuring high-quality bioprocess equipments
All Installation and Operational Qualification tests are performed following precise instructions and specifying both method and acceptance criteria. These instructions, validated and routinely updated in the framework of the Kbiotech Quality Assurance System, are accessible to users who have full knowledge of the conditions under which his system has been tested.
Performance Qualification tests are documented in special procedures prepared by Kbiotech in agreement with the user. This condition allows to work out a precise definition of the methodology in accordance with the process for which the installation has been designed.
The Installation Qualification tests (IQ):
They consist in a verification of systems and subsystems, collection of documents to show that characteristics of installation comply with predefined specifications and regulatory requirements. Construction and Inspection File is set up as of initial manufacturing operations and follows the product up until the end of its process. It will be subject to final inspection before the product is released for initial Qualification tests. These tests, conducted by Kbiotech qualified technicians, allow the verification of hydraulic, pneumatic and electrical characteristics of the various components in the system and the automated process control.
The Operational Qualification tests (OQ):
They verify the systems and subsystems are in proper operating condition and work within the ranges and tolerances stipulated in the job instructions and predefined specifications. These qualification tests are conducted by Kbiotech specialized technicians and enable, once the equipment has been installed, the verification of the proper operation of all the system’s items and its automated process control.
The Performance Qualification tests (PQ):
They are a verification by means of dynamic tests on the system’s overall aptitude to accomplish the process in a reproducible way, with all critical parameters maintained within their tolerance range. Kbiotech can provide the necessary technical support to carry out on-site dummy runs (product replaced by a Placebo), until the achievement of the predefined performance-levels and verification of reproducibility of results.
The protocol, adapted to the requirements of each product, is documented in a specific procedure prepared and accepted by Kbiotech along with the client.