We design and implement systems for the preparation and distribution of Clean Utilities in the pharmaceutical, biotechnological and medical industries.
• pure water PW, WFI, CS
• clean gases
• CIP units
• prefabricated assemblies: pumping, storage and tempering units
• implementation of Clean Utilities installations: storage, distribution, installation
• qualifications according to cGMP: DQ, IQ, FAT, OQ
• cleaning and passivation of stainless-steel systems
• technological and process engineering installations
Experts monitor the implementation and ensure compliance with plans, specifications, cGMP and regulations.
We advise and help in creating concept drafts, URS or basic designs. Offering our clients maximum reliability, we strive to execute ordered services and projects at the highest level of service possible.
The use of modern design tools such as BIM, plant, MEP and 3D modelling enables our experts to anticipate and find solutions for particularly demanding details and to plan the system and its implementation accordingly.
• Conceptual design,
• Basic design,
• Detailed design,
• 3D modelling,
We have our own project department with experience in the design of complex technological equipment in the pharmaceutical and biotechnological industry, medicine and energy.
In cooperation with our long-standing partners, we offer a complete solution for the design and functional installation of clean rooms or laboratories, guaranteeing a high-quality, cGMP compliant standard.
We strive for a long-term and successful cooperation with our customers, helping them to develop ideas, plan their progress and execute the set goals through professional implementation. The outcome is a multitude of successfully conducted projects for many satisfied customers. We offer a complete service from first concept to the realization thereof, as well as the qualification of projects, their first-run and final handover to the customers.
Our work is based on top knowledge, experience, quality assurance and reliability. We offer our customers full support and consultation from the first concept to the implementation thereof.
We go above and beyond for our customers in helping them to prepare, plan or conduct a project by optimizing its costs and implementation period.
Teamwork – A wide range of experts highly trained in the fields of planning, conducting, qualifying and running projects ensures our capabilities to continuously monitor and adjust projects from the very beginning. First-hand feedback complements our knowledge and enables us to anticipate, adapt and implement the best solutions and experiences in the shortest possible time.
Committed to excellence
Our customers hold high standards regarding the quality and reliability of Clean Utilities systems. The fact that they place their trust in us for ever new and more demanding projects confirms that we meet these requirements.
We offer technically advanced solutions in the field of Clean Utilities installations in the pharmaceutical, bioprocess and medical industries. We particularly welcome demanding projects, where we can demonstrate our expertise and level of skill in offering optimal solutions.
Adapting to each and every specific project, we strive to find optimal solutions, taking into account the special features of individual projects/facilities and the customers’ requirements/wishes.
A large part of our services in constructing flawless installations of Clean Utilities is welding.
Holding a certificate compliant to the ISO 3834 standard for demanding welding processes, we are proud of our certified and experienced orbital welding teams.
With our welding engineers (IWE) we cover the entire welding process from WPS preparation to the NDT weld inspection. Achieving the highest quality requirements for orbital welding according to AWS 18.2 or ASME BPE MJ-3 is our work standard; our welding engineers and welding controllers continuously monitor and control the welding process on site. All projects are complete with our standard welding documentation, welding logs, isometrics, endoscopy.
Welding procedures and documentation are always cGMP compliant
Assuring the quality of the services provided and the installed materials is the foundation of our work ethics and reliability. In the qualification process we continuously monitor the parameters that are of key importance for the quality of the installed materials and equipment, as well as the parameters decisive for the reliability of the process.
We monitor the compliance of the selected solutions, materials, equipment and services with specifications, plans, URS, cGMP and technical standards, ensuring that they meet predefined acceptance criteria. In our work we follow the requirements and recommendations of cGMP, ASME, ISPE and the internal regulations/standards of our customers.
• DQ (Design Qualification)
• IQ (Installation Qualification)
• OQ (Operational Qualification)
• FAT (Factory acceptance test)
• preparation of qualification plans
• control of changes
• control of the chemical composition of the materials used (XRF/PMI);
• traceability of the installed components and equipment (certificates EN 10204 3.1 for metals and FDA 21 CFR for polymers);
• control of surfaces/roughness degree;
• traceability of services provided (welding certificates, isometrics, blind spots, possibility of optimum draining, 3D/6D rule).
• Leakage/drainage, pressure tests, tightness tests, helium test
We offer a well-planned, documented and managed engineering approach to the start-up and handover of premises, systems and equipment to end users. The aim is to provide a functional and safe environment that meets the planned requirements and expectations of the users.