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From initial engineering through installation and maintenance, our team works closely with customers to ensure that equipment meets the requirements of the cleanroom or classified space.
In addition, we qualify all equipment to ensure performance and regulatory compliance, and we offer preventive and corrective maintenance service to ensure their We offer preventive and corrective maintenance services to ensure their optimal and continuous operation.
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 of Special Equipment from scratch
We develop and customize equipment from scratch according to the functional or regulatory needs of our customers and their activity.
With more than 3,000m2 of productive space and a highly technological industrial system certified with the most demanding standards, in our own facilities, and thanks to a team of highly qualified professionals, we carry out the following activities from the engineering of design, going through the manufacturing of all the necessary components for to build all types of clean rooms and classified spaces, up to the assembly process executed by our own staff.
Kirhtech manufactures auxiliary and containment machinery for clean rooms: SAS, weighing cabinets, laminar flow cabinets, air showers, biosafety cabinets… both standard and customized.
Also, and under our brand name Modular Clean Panelwe manufacture sandwich panels, connectors, doors, viewers and profiles that complement each other to create totally homogeneous classified spaces in which our equipment is perfectly integrated.
Our specialized fitters offer a professional and agile service for the installation and commissioning of containment and process equipment.
Efficiently and in compliance with all safety measures, our technicians perfectly adapt our equipment to the sanitary architecture or to the customer’s packaging or processing machines.
Verification tests are used to demonstrate that the system is operating in accordance with regulations and pre-established specifications.
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.
In order to extend the useful 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
Our Preventive Maintenance Service focuses on offering rigorous and detailed maintenance to our customers’ equipment. In collaboration with the owners, we agree on the frequency of servicing and the consumables that need to be replaced. All items to be checked are reflected in a complete Maintenance Dossier.
After each intervention, we provide a detailed report on the condition of the equipment, as well as recommendations for correcting any anomalies detected.
Thanks to the thoroughness of the documentation provided, our customers can rest assured that their equipment meets the necessary requirements for 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.
Venus 55-B
Pol. Ind. Can Parellada
08228 Terrassa (Barcelona)
Tel. +34 93 784 28 25
Mail. info@kirhtech.net
© Iguña Pharmaceutical Technologies, S.L. | All rights reserved.
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