A new investment – whether it involves expansion, automation, or a greenfield project – is always a serious decision. The return on investment and smooth future operation, essentially the competitiveness, are determined during the preparatory phase. That is why we are pleased when we are involved in pharmaceutical, food, chemical, or other projects even before the design phase, supporting optimal decisions through consultations, advisory services, and feasibility studies. Our decades of experience not only aid in design and execution but also provide our Clients with assurance that their project will be realized as agreed, both in terms of timing and budget, and that the equipment will perform exactly as expected.
Before implementing a new facility or modifying an existing one, we support our Clients with consultations to help them find the right solutions to achieve their goals. During this process, we jointly review the technology, determine the main parameters of the equipment, the material and personnel flow of the production process, the layout, as well as preliminary equipment and piping plans, etc. During design, we not only focus on achieving the required functionality and efficiency but also consider maintenance space and all other needs.
To support investment decisions, we often contribute by preparing feasibility studies. In these studies, we refine the basic design parameters, dimensions, performance, related facilities, examine environmental impacts, investment costs, potential suppliers, and their prices, etc. The feasibility study is naturally prepared in close collaboration with the Client.
Cooptech Ltd. uses the most modern CAD/CAM design tools for automation and system design, such as various versions of AutoCAD, Cadmatic 3D plant design software, SolidWorks, EPLAN, and OhmTech software for pressure equipment design. These applications enable significant time and cost savings, as all discipline designers work from the same database, supporting each other in producing various design documents. This working method and background infrastructure are always available for new pharmaceutical and food industry projects, as well as for the automation of older equipment. Our engineers exclusively use these software tools, so even the simplest modifications are created in a digital environment with detailed documentation.
During the preparation of basic plans, we finalize process flow diagrams, develop medium lists, piping classes, perform necessary calculations, and prepare data sheets for the required equipment to finalize layout plans. If needed, we develop or assist the Client in preparing the User Requirement Specification (URS). This document clearly defines the FDA, GMP, GAMP, and ATEX requirements to be followed for the project, thus establishing the quality assurance principles and recording process control, measurement, qualification, and their documentation and visualization. This documentation already allows for determining the exact costs and implementation schedule of the investment.
Based on the basic plans provided by the Client or prepared by Cooptech Ltd., detailed plans can be developed. We finalize process flow diagrams, equipment, fitting, and instrument lists, equipment and piping layout drawings, detailed mechanical and process control functional specifications, electrical wiring diagrams, panel installation drawings, I/O lists, etc., according to the specific requirements of the pharmaceutical or food industry project, and submit them to the Client for approval.
If required, our engineers with many years of experience develop or support the Client in defining Factory Acceptance Test (FAT) criteria, Site Acceptance Test (SAT) criteria, and Installation and Operational Qualification (IQ, OQ) requirements.
Cooptech produces all mechanical drawing documentation using its own database and 3D design capabilities. Starting from component and fitting lists/data sheets generated from process flow diagrams, we create visual plans for individual equipment and plant sections. The applied method allows for the spatial representation and modeling of piping networks, fittings, panels, instruments, equipment, devices, operator platforms, and all other components, thereby aiding the visual presentation of personnel and material flows and operational spaces. It also provides the opportunity to avoid clashes by incorporating data from electrical, pneumatic, and energy networks into the model.
The process control and automation system is defined in the Hardware Design Specification (HDS) in accordance with the URS. We select the instruments required for the tasks. Using EPLAN, we determine the layout and wiring plans of electrical cabinets, I/O lists, and the installation plan of the cable system. According to the Client’s requirements, we develop the Control Functional Specifications (CFS) for the systems.
For our new equipment, a high level of automation is a basic requirement, and we also provide full support for automating older systems.
Our engineers work daily with the most common GMP, FDA, GAMP, and other standards. In our modern workshop in Kecskemét, we build control cabinets that not only meet the pharmaceutical industry’s strict quality requirements but also operate reliably in the long term. Each cabinet comes with detailed documentation, test protocols, and a CE declaration of conformity. Whether it’s sterile piping systems, PW, WFI, or PS systems, IO tests, or electrical safety inspections – everything is managed in-house, under one roof.
Our programmers develop for Siemens, ABB, and Allen-Bradley PLCs, as well as DCS, SCADA, and HMI systems.
The result is control software that does exactly what you need – nothing more, nothing less. Validation and compliance with 21 CFR Part 11, GMP Annex 11, EU GMP Annex 15, and GAMP 5 are built into every stage of development. And to ensure smooth operation, we support our clients with customized training programs.
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At Cooptech’s site, well-equipped workshops are available for manufacturing pressure vessels, storage tanks, standalone equipment units/skids, and CIP/SIP units, as well as for conducting factory tests. With these, only the actual assembly and commissioning need to be performed on-site, as the qualified testing of individual subsystems and equipment usually takes place at our facility.
Our ISO 9001:2008 audited Quality Management System, PED 97/23/EC, and other certifications qualify us to manufacture devices and pressure vessels that meet not only food industry but also the highest pharmaceutical quality requirements. Since we also handle the design, our experienced staff can perform any modifications immediately on-site.
Manufacturing is carried out according to the approved Quality Plan (QP). The excellent quality and successful certification are guaranteed by our professionally selected, independently approved welding procedures (WPS, WPQR), certified welders, our own non-destructive testing system, our video endoscope, regular surface roughness measurements, and up-to-date welding documentation.
For the Factory Acceptance Test (FAT) and inspection (IQ, OQ) of completed tanks and standalone equipment units/skids, we have all necessary technical conditions and tools – mass flow, pressure, pH, conductivity, and temperature meters – ensuring that the Client’s planned parameters and quality requirements are fully met.
Cooptech’s own installation teams have over two decades of experience in implementing piping networks and industrial equipment for food, chemical, and pharmaceutical facilities. Projects are mostly, though not exclusively, implemented based on the designs of our engineers experienced in process system design, but we also have examples of executing Client-provided plans after reviewing them. Among other things, we build:
For our installation tasks, we have:
Certifications for installation (EN ISO 9001:2008, PED 97/23/EC), welding (EN 1418, EN 287-3, EN 287-1, EN 288-3, EN-1418), and weld inspection personnel certified according to EN 473 (endoscopy, penetration, X-ray evaluation).
Equipment such as orbital welding machines, AWI manual welding machines, pipe cutting and machining tools, inspection and calibration devices.
Trained professionals who ensure the documentation of execution according to manufacturing documentation (compliance with data sheets, material quality, dimensional tolerances, surface roughness), compilation of welding documentation (welding logs, isometrics, weld inspections), performance and documentation of on-site inspection tests (SAT) (slope, insulation, pressure testing, riboflavin test), as well as the execution and documentation of IQ, OQ tasks as required.
Upon Client request, Cooptech Ltd. undertakes the full vertical implementation of a project, from design through project coordination to training, maintenance, operation, and service. To fulfill the task, our dedicated project team leverages the expertise of our specialists and engineers to deliver the project on time and within the planned budget, including:
Cooptech’s team of qualification experts has extensive experience in qualifying systems produced in-house or supplied by external specialists. During the process, we prove that the supplied systems, hardware, and software are installed according to user requirements and operate as specified in the technical specifications, considering GMP guidelines.
In the Project Quality Plan (PQP), agreed upon with the Client, the organizational structure of the project, communication methods, schedule, required tests, test procedures, and participant responsibilities are defined.
Qualification is an integral part of the design task, based on the Client-approved URS. The qualification team has extensive experience, developed procedures, and templates to prepare documentation appropriate for the project phase:
Typical qualification tasks include not only developing the above documents but also performing the tests specified in the documentation provided by us or the Client and completing the related documentation.
Cooptech’s goal is to provide Clients with comprehensive, high-quality, long-term, and reliable services. Under separate agreements, we ensure continuous maintenance, repair, and operation of equipment and plant sections supplied by us or others after handover. According to the terms specified in annual contracts, experienced, well-equipped teams familiar with on-site conditions are available to our Clients to ensure uninterrupted production.
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