Iguña Pharma, experts in clean rooms, puts at your disposal through the brand Kirhtech, his knowledge to design and manufacture custom equipment for clean rooms and classified areas: technological auxiliary equipment for protection, containment and process, such as Cabins, Laminar Flows, Isolators, SAS and Filling Machinery.
We have an R&D team dedicated to improving our standard equipment and designing non-standard prototypes, adapting them in each case to the specific needs of the client and the sector.
Internally we have a quality management system certified according to ISO 9001: 2015, in addition, all products Kirhtech both machines and auxiliary equipment are certified in accordance with the quality requirements of the GMP and ISO regulations.
Kirhtech it is characterized by having a team of technicians with more than 20 years dedicated to the design and certification of Auxiliary Equipment and machinery for Clean Rooms.
- AIR FLOWS
- HEAVY CABINS
- AIR SHOWERS
- SPECIAL MACHINES
- PACKAGING MACHINES
- SUCTION CABINS
- LAMINAR FLOW CABINS
- BIOLOGICAL CABINS
- SPECIAL CABINS
- Custom machinery
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 clients.
- Adaptation to Machinery
We integrate and customize the modules of our auxiliary systems to 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 teams from scratch based on need.
Due to the increasingly demanding regulatory restrictions for classified areas, our clients find themselves with the need to create unique and special process equipment adapted to the characteristics of their activity.
In order to extend the useful life of the equipment, we have maintenance technicians in charge of providing a prevention and correction service. With this, we enable the machinery to continue complying with GMP, ISO and FDA regulations.
- We agree with the property the frequency of the revision, as well as the consumables to be replaced.
- We reflect the items to review in a Maintenance Dossier.
- After each intervention, we deliver the status report and recommendations to those anomalies detected.
- The rigor of the documentation provided allows its presentation in an audit.
- The breakdown of an equipment means stopping the production process, therefore, we are committed to offering a response to the request for intervention in the first 24 hours.
Verification tests serve to demonstrate that the system is operating in accordance with pre-established regulations and specifications.
- DQ / IQ / OQ / PQ qualification
We will certify the quality of the equipment by carrying out and delivering the documentation of the following tests:
- Design Qualification (DQ)
It will serve to verify that the equipment meets 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 works according to the required environmental parameters. Data such as particle count, class recovery, filter integrity, air renewal will be measured.
- Process Qualification (PQ)
It will serve to verify that, under conditions of activity and process, the required environmental parameters are maintained. The same tests will be carried out as in the OQ qualification.
- Factory Acceptance Testing- FAT
The FAT tests are carried out in our facilities, it is usually done together with the client to be able to train them 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 included in the user requirements.
- Field Acceptance Testing – SAT
SAT tests are performed at the customer’s premises. The purpose of this procedure is to ensure that the team performs the intended activity.