Pharmaceutical production lines with aseptic and aseptic-toxic processes aim at highest efficiency under compliance with the highest hygiene standards. In order to achieve these goals and reach the regulatory approval, SKANs isolators provide state-of-the-art automation and digitalization of processes and procedures. In doing so, SKAN relies on patented and unique isolator technology.
The sophisticated skanfog® decontamination technology and the integrated catalyst SKAN nanox® guarantee a fast and safe cycle time and help to accelerate every isolator process and therefore the overall efficiency of production and filling lines. With predefined solutions, the isolator system can be easily customized and precisely adapted to production-specific requirements.
The added value of SKANs isolator technology
- The application requires at minimum an EU-GMP Class D (ISO 8) environment.
- SKANs isolators provide the highest level of safety for filling processes, freeze-drying, and other large-scale production processes.
- Integrated EU-GMP Class A (ISO 5) production chamber provides the highest level of product and operator protection.
- Integrated skanfog® technology enables fast decontamination cycles.
- Various combination and predefined transfer solutions increase flexibility and modularity for individual application.
- How our Custom Production Isolators work
Aseptic production isolators are often used in combination with filling or freeze-drying processes. To make these processes the most efficient and safe, our isolators are equipped with a powerful decontamination and ventilation system. The sophisticated system with double HEPA filtration and integrated nanox® catalyst, to neutralize hydrogen peroxide (H2O2), extracts air from the surrounding space and recirculates it. This process guarantees a safe environment for the product and the operators.
A large control panel provides the necessary information about the running process and securely records the actual values. - Creating individual solutions together
Our customers needs are the focus of every process design. That is why it is important to us to understand and analyze these needs. Together with selected partners, we transfer these requirements to our concepts, resulting in practicable and efficient systems for every challenge.
We design the best processes for every application, for all types of containers, for all types of filling, with and without freeze-drying. Our unique technology for isolators and filling equipment designs a reliable system for your individual product and environment. - SKANs isolator technology is more than just technology
In the development and manufacturing of complex equipment and isolators, it is indispensable to cooperate with experienced partners in order to bundle knowledge and innovation, to realize them fast and make them accessible for our customers. Therefore, we have been working together with our experienced partners in a trustful manner for many years, thus ensuring quality, costs, deadlines, and performance for our production. In this way, we are always able to provide the best solution with regard to the individual needs of our customers. We are confident in our products that we have no hesitation in taking responsibility for the decontamination of the entire system.
- Robotic systems are the future of today
SKAN offers a variety of solutions for all types of manufacturing processes and applications. The customized isolators are not only used for product protection, but mainly for operator protection of aseptic processes. To ensure the highest possible level of safety, manual operator intervention is reduced to a minimum by robotic equipment. The process machines and robot systems used in the isolator are almost unlimited and can support any individual process in an optimal and operator-friendly way. Because robots are indispensable, SKAN has realized the best robot systems for integrated processes together with reliable partners.
- Automation
SKAN automated solutions are developed according to current GMP and fulfil regulatory requirements.
- GMP guidelines, CFR 21 Part 11, EndraLex Volume 4
- Supervisory Control And Data Acquisition (SCADA)
- PLC Siemens or Allen Bradley
- HMI Beckhoff Industrial PC
- Beckhoff touchscreen monitor
- Active Directory
- Decontamination report
- Batch report
- Campagne report
- Audit trail functionalities
- Electronic records
- Electronic signature
- OPC interface
- Options and Accessories
- Rapid transfer material airlock SARA
- Rapid transfer port for solids (RTP)
- Rapid transfer port for liquids (AT-Port™)
- H2O2 TLV sensor for room monitoring (operator safety)
- H2O2 LC sensor (low concentration) for isolator chamber
- H2O2 HC sensor (high concentration) for isolator chamber
- Viable monitoring according to your choice
- Particle counter (non-viable) according to your choice
- Glove testing devices with position control function
- Negative pressure operation mode for special application
- Robot and conveyor system for heavy powder cans
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SKAN offers professional support to ensure that your equipment is operating at maximum productivity and reliability. The development of comprehensive maintenance programs and services covering all aspects of SKAN equipment was inspired by the decades of hands-on experience of SKANs experts.
Our certified technicians perform precise recalibrations and repairs as well as modification requests on site, to maintain the qualified status of your equipment. Also microbiological recalibrations to check the effectiveness of the decontamination process and to guarantee the safety of the workplace, can be realized professionally and reliably.
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Optimal operation of an isolator can only be guaranteed if every part functions reliably. Even minimal malfunctions as well as the unavoidable wear of parts in an isolator can lead to long downtimes. Therefore, it is important to be able to rely on the right partner, with worldwide spare parts warehouses and well-planned stock levels.
SKAN offers a comprehensive spare parts service as well as reliable obsolescence analysis, through which you benefit from active risk minimization and a flawless production.
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Engineering
Innovative and creative engineering for optimal solutions
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Thanks to state-of-the-art equipment and in-depth expertise, SKAN Stein AG is the right partner to perform tests and simulations of your machines and processes. In addition to strength calculations (FEM) of containers and pedestals and calculations of air flows (CFD), the experienced engineering team also takes care of the design and implementation of individually designed tests. Our experienced technicians are able to carry out various tests and simulations remotely at SKANs facilities. With SKAN Stein AG, you can count on the best possible all-round support for your project.
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Realistic Mockup Studies
Pre-design of individual isolators and plants with SKANs mockups
Realistic Mockup Studies
Pre-design of individual isolators and plants with SKAN Mockups
Isolator systems and integrated technology are becoming increasingly complex. Individual plants and isolators often combine a variety of process systems from different manufacturers. Due to the integration of different systems, even the smallest detail can be crucial to the successful operation and validation of the entire system.
SKAN offers its customers the possibility of realistic mockup studies. These studies have a significant impact on the design phase of an isolator process by pre-designing the entire system according to reality conditions in a model. The mockups are always developed in close cooperation between SKAN, the customer and the supplier to meet the individual requirements.
Design individual previews with SKAN Mockups:
- The special CAM cardboard system enables dimensionally accurate production
- The cardboard system enables simple and quick design adjustments
- The three-dimensional structure conveys a realistic feeling and supports a more precise idea of the implementation
- The glove openings are easily adjustable on all sides
- Thanks to 3D printing, complete components can also be displayed
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Computational Fluid Dynamics Simulation
CFD – The latest method for flow simulation of liquids and gases
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CFD – The latest method for flow simulation of liquids and gases
Understanding and controlling airflow in aseptic isolators is crucial for ensuring a sterile environment, but it’s often complex due to various factors affecting the flow dynamics.
Computational Fluid Dynamics (CFD), a specialized area within fluid mechanics, uses numerical algorithms to model and simulate fluid flows. Employing CFD allows for a detailed analysis of airflow patterns inside isolators, eliminating the need for costly and time-consuming experiments like smoke studies.
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- High-fidelity simulations employing state-of-the-art techniques for predicting airflow patterns in isolators
- Rigorous risk assessment analysis for contamination using detailed particle tracking
- Comprehensive reports with visualizations to facilitate decision-making and reduce design risks
- Performing sensitivity analysis on desired parameters across critical sections
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Our CFD services include:
Employ the expertise of SKAN’s CFD services to optimize your processes and minimize risks through advanced CFD analysis.
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SKANalytix
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SKANalytix
Analytical services provided by SKAN analytics experts
In addition to the successful operation of isolators and plants, SKAN also supports its customers with SKANalytix in the area of data analysis, data evaluation and documentation. To meet the different requirements SKAN offers the analytical service packages active, clean and persist.
The services include the analysis of the cleanability of isolators, the evaluation and development of individual cleaning processes, the determination of suitable packaging materials and the H2O2 influence on sterility tests.
It goes without saying that we follow the standards of “Good Manufacturing Practice” (GMP) as well as common standards and guidelines both in the execution and documentation of services.