Services

Tailor-made development, qualification and maintenance of machines and equipment for clean rooms and classified areas.

Custom development

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

Adaptation to Machinery

We integrate and customize the modules of our auxiliary systems to those machinery that performs functions such as injection, filling, transfer, packaging, or any treatment that requires classified air.

Adaptation to Clean Rooms

We adapt the modules of our auxiliary systems to the dimensions and characteristics of the classified areas, modulating them for specific spaces or integrating them into the ceiling of the operating room or clean room.

Development from 0 Special Teams

We develop and customize equipment from 0 depending on the need.
Due to the increasingly stringent regulatory restrictions for classified areas, our customers are faced with the need to create unique and special process equipment adapted to the characteristics of their activity.

Qualification

Verification tests are used to demonstrate that the system is operating in accordance with regulations and pre-established specifications.

DQ/IQ/OQ/OQ/PQ qualification

We will certify the quality of the equipment by performing and delivering the documentation of the following tests:

Design Qualification (DQ)

It will serve to verify that the equipment complies with the design requirements previously established.

Installation Qualification (IQ)

It will serve to verify that the equipment has been made in accordance with user requirements.

Operational Qualification (OQ)

It will serve to verify that the installation is working according to the required environmental parameters. Measurement of data such as particle count, class recovery, filter integrity, air renewal will be performed.

Process Qualification (PQ)

It will serve to verify that, under activity and process conditions, the required environmental parameters are maintained. The same tests as in the OQ qualification will be carried out.

Factory Acceptance Tests – FAT

The FAT tests are carried out in our facilities, it is usually done together with the client in order to train him in the basic notions of the equipment. The purpose of this procedure is to inspect and approve the system and its operation in accordance with the specifications in the user requirements.

Field Acceptance Tests – SAT

SAT tests are carried out at the customer’s premises. The purpose of this procedure is to ensure that the equipment performs the intended activity.

Maintenance

In order to extend the life of the equipment we have maintenance technicians in charge of providing a preventive and corrective service. With this, we enable the machinery to continue complying with GMP, ISO and FDA regulations.

Preventive Maintenance

  • We agree with the property the frequency of the revision, as well as the consumables to be replaced.
  • We reflect in a Maintenance Dossier the items to be checked.
  • At the end of each intervention, we deliver the status report and recommendations to those anomalies detected.
  • The thoroughness of the documentation provided allows its presentation in an audit.

Corrective Maintenance

The breakdown of a piece of equipment means stopping the production process, so we are committed to respond to the request for intervention within 24 hours.