PHC Europe B.V. provides on-site validation of equipment supplied by PHCBi via documented installation and operational qualification, IOQ.

Installation qualification (IQ) verifies and documents whether the installation of the equipment meets the requirements and specifications of the manufacturer.

Operational qualification (OQ) verifies and documents the complete functional operation of the installed equipment (as indicated by PHC or other OEM supplied equipment). Performance mapping data will be compared with the specifications provided by the manufacturer. Product specific parameters such as CO2 / O2,% RH etc. are included in the relevant equipment IOQ protocols.

Process qualification (PQ) is usually performed by customer / end user if the equipment is in the environment where specific user conditions apply and the actual product is loaded, stored and accessible. In particular the actual production or product processing environment.

The PQ will probably refer to the client specific standard documents for the method (SOPs). Example: product identification and specific storage requirements; method of storage etc. so making the PQ is a unique and customer-oriented document. However, PHC Europe B.V. can offer assistance to customers where necessary in preparing or assisting in the execution of the process qualification.

PHC Europe B.V. is also able to provide a "temperature registration (mapping)" for customers who want to verify installed equipment on actual performance. This service is also for all non-PHCbi equipment.

We offer four Validation Services with different components. Find out below which one best suits your needs:

If you would like to make a validation and qualification service request for any biomedical equipment, either through PHC or through a local certified distributor. Just complete the form and we contact you as soon as possible.