SERVICES

QUALIFICATION

Verification tests serve to demonstrate that the system operates in accordance with the regulations and pre-established specifications.

DQ/IQ/OQ/PQ Qualification

We certify the quality of the equipment, by drafting and delivering the documentation for the following tests:

Design Qualification (DQ)

: will serve to verify that the equipment meets the previously established design requirements.

Installation Qualification (IQ)

: will serve to verify that the equipment has been implemented according to the user’s requirements.

Operational Qualification (OQ)

: will serve to verify that the installation operates in line with the required environmental parameters. Data measurements, such as particle counting, class recovery, filter integrity, air renewal.

Process Qualification (PQ)

: will serve to verify that the required environmental parameters are maintained in the working and processing conditions. The same tests will be carried out as in the OQ qualification.

Factory acceptance test – FAT

The Factory Acceptance Tests (FAT) are carried out in our facilities, and usually together with the customer to train them in the basic concepts of the equipment. The purpose of this procedure is to inspect and approve the system and its operation in accordance with the specifications indicated in the user requirements.

Site acceptance test – SAT

The Site Acceptance Tests (SAT) are carried out in the customer’s facilities. The purpose of this procedure is to ensure that the equipment performs the intended activity.

Maintenance

To extend the useful life of the equipment, we have maintenance technicians in charge of providing a prevention and correction service. In this way, we can ensure that the machinery continues to comply with GMP, ISO and FDA standards.

Customized

Kirhtech dedicates part of its R&D activity to reactive innovation, developing 3D engineering and modulating equipment to meet the specific features and regulations of our customers.