PHARMACEUTICAL AND BIOPHARMACEUTICAL INDUSTRY
As a technology supplier for the biotechnology and pharmaceutical industries, we design, manufacture, and install appropriate solutions for renowned and respected companies worldwide.
We provide our clients with process- and operationally compliant services, as well as key elements for the professional execution of projects – all in one place. Our experts, with many years of experience in all critical areas, ensure the systematic achievement of the set objectives.
PROCESS VESSELS
All vessels are made of stainless steel and are available as standalone components or as fully automated process systems, such as mixers, homogenizers, vessels with complete measurement equipment, control units, valves, and pipe connections. Versions suitable for operation in hazardous environments are also available. Our products comply with the Pressure Equipment Directive and, in certain cases, are certified according to the ATEX standard.
SKID SYSTEMS
In our metalworking division, we specialize in the development and fabrication of SKID systems, which combine robust metal structures and technological equipment into modular units. Our SKID systems ensure easy transport, rapid assembly, and efficient integration into various industrial processes.
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Our SKID systems are designed with flexibility, robustness, and technological efficiency in mind, enabling their use across various industrial sectors. The key advantages of our SKID systems include:
Modular Design:
- Allows easy upgrades or adjustments according to specific customer requirements.
- Reduces renovation costs and shortens the implementation time of new processes.
Robust Construction:
- High-quality materials and precise workmanship ensure a long service life.
- The design complies with all quality and safety standards, ensuring reliable operation even in demanding industrial environments.
Advanced Technology Integration:
- Includes sensors for process monitoring, automated control systems, and connectivity with industrial information systems (SCADA, MES).
- Enables precise control, rapid detection of anomalies, and optimization of production processes.
Easy Transport and Assembly:
- The modular unit allows quick relocation and integration at the customer's site.
- Reduces assembly time and minimizes production downtime.
Easy Maintenance:
- Practical design allows for quick servicing of individual components.
- Extends the system's service life and reduces operating costs.
Comprehensive Customer Support:
- We provide support from conceptual design, prototype fabrication, and testing, to assembly and service.
- Each SKID system is optimized for the specific needs of individual production processes.
WIP-CIP-SIP UNITS
A key part of high-quality production is an integrated WIP/CIP/SIP system. Btinox ensures efficient and timely cleaning and sterilization procedures, compliant with customer requirements. We offer a wide range of solutions – from mobile and standalone cleaning systems to integrated CIP satellite systems.
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CIP and SIP systems are designed for automatic basic cleaning and disinfection, without unnecessary time lost for assembly and disassembly.
Process optimization depends on effective and reliable cleaning. CIP systems can be integrated into the entire pharmaceutical equipment, including solid and liquid dosing systems. Automation of cleaning processes ensures repeatability, allows validation, and reduces downtime.
The most effective way to implement CIP technology is through its planned integration into the process. When incorporating spray systems, tank cleaners, nozzles, and seals for cleaning automation, we consider all parts of your system – from input to emptying.
Automation of the cleaning cycle primarily transforms batch pharmaceutical processes into continuous operation of production and cleaning cycles.
The advantages of a CIP system include:
- shorter cleaning cycles
- optimized use of detergent and water
- elimination of manual cleaning
Our frameworks for CIP/WIP systems are designed, engineered, automated, and tested. This comprehensive approach ensures open communication between experts and rapid response to any deviations during the project. Each project is managed by a project/process engineer who professionally oversees discussions regarding specific requirements, system integration, and final FAT protocols.
BIOREACTORS-FERMENTERS
Based on our extensive experience in designing, manufacturing, commissioning, and performing validation of pharmaceutical equipment tailored to specific user requirements, we have developed an additional product line.
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Bioreactor and fermenter systems represent the pinnacle of our expertise and are entirely manufactured in our facilities. They feature a sterile design compliant with cGMP, engineering, assembly, and implementation by our electrical and automation department, which brings the equipment to life and ensures excellent performance for clients in the biotechnology industry.
HEATING AND COOLING SYSTEMS
Temperature control and product mixing during the process are key to achieving successful and repeatable results.
Btinox ensures that the product temperature in the vessel remains within a narrow range (+/- 0.5 °C), preventing undesired changes in the product during production. We achieve a high level of temperature control and product homogeneity through the use of state-of-the-art heat transfer technology and careful mixing. Precise measuring devices monitor all key parameters, such as pH, O₂, temperature, and mixing speed throughout the entire process.
GMP MEDIA
We design, install, commission, and validate production processes, operating conditions, and the maintenance of storage and distribution systems, ensuring the appropriate quality of the media.
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The pharmaceutical, biotechnology, food, and chemical industries require the highest standards for high-quality piping systems.
Excellent organization, many years of experience, state-of-the-art equipment, and continuous optimization of various welding techniques are key to successful project execution. Our mission is to ensure that all these conditions are met for our clients.
The client is at the center of all our activities. Our services include the design, coordination, assembly, and documentation of process systems, as well as inspections to ensure quality and smooth commissioning.
In addition to stainless steel constructions, frameworks, and special components, we also provide clients with fully pre-assembled units.
To ensure sufficient quantities of water that meet USP and Ph. EUR standards, water preparation must comply with specific requirements. Numerous regulations and standards must be observed, as the water system is subject to strict monitoring and inspections. We ensure that all these requirements are fulfilled.
Based on your needs, we will design, assemble, deliver, and install a system for storing hot (WFI) or cold (PW) water. Each sampling point in the loop can be equipped with a sampling valve and loop sterilization connections. Required measurement technology for flow and TOC is included as standard equipment. All units necessary for the production of purified media are integrated into these systems.
AUTOMATION
Automation means more than just programming and electrical engineering. In addition to our expertise in automation, this technology also requires a deep understanding of process engineering and manufacturing facilities, as well as extensive experience in meeting requirements.
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Btinox provides modern pharmaceutical manufacturing facilities with automation solutions for the entire process chain – from higher to lower levels, and from standalone systems of individual stations (SKID units) to complex central process control systems.
Various processes in the food industry, such as dairy production, are adapted for the manufacture of different dairy products.
Consequently, the automation of these processes is equally diverse and multi-layered.
DESIGN – VALIDATION – DOCUMENTATION
Planning of all the aforementioned processes, preparation of basic and detailed plans, material and work specifications, URS, 3D modeling, fabrication, detailed manufacturing plans, as-built drawings/projects, technical documentation, validation documentation, and execution of validation.
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Preparation and execution of projects and equipment in accordance with ATEX. Automation of all the above, including electrical connections, project and technical documentation, as well as validation documentation and its execution.
We ensure compliance with GxP and other official requirements (FDA, EMA, etc.) and adherence to applicable standards in the construction and modification of entire equipment or its components in the pharmaceutical industry.
Years of experience, continuous training, and expertise in the pharmaceutical industry enable us to perform qualifications comprehensively and with the highest quality.
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