SubscribeIsolators - the state of the art technology for aseptic filling.
SKAN AG, the developer of the integrated hydrogen peroxide (H2O2) decontamination system, is the world's leading provider of pharmaceutical isolators for product and personal protection.
In order to meet the demanding requirements of our clients in the pharmaceutical industry, our products are fully compliant with GMP.
Our renowned, FDA-approved isolators are in use by many clients worldwide.
The advantages of this isolator technology for the filling process
- Reproducibility and stability of the process
- The highest product quality with maximum efficiency
- Product and operator protection of the highest level
- The controlled production area is held to a minimum
- Excellent financial efficiency compared to traditional clean room concept
Isolator features
SKAN attaches considerable importance to the 'hygienic design' of the GMP-compliant construction of its equipment.
- Our chambers are constructed free of cracks and with generous radii and rounded corners
- Good reach and simple cleaning of all surfaces
- Construction with high quality stainless steel and FDA-approved gasketing material
- The material choice is a result of our technical research for optimal H2O2 decontamination and durability
- Low maintenance and spare parts use for high utilization of the equipment
- Large door openings for good accessibility of the equipment
Isolator for aseptic filling
In the technical floor
- HEPA filtered inlet air from the room
- Air treatment (temperature, relative humidity, nitrogen atmosphere)
- Pressure zone regulation
- HEPAfiltered exhaust system
In the isolator chamber
- Dynamic sealed HEPA filters
- Monitoring of the filter pressure drop
- Vertical, unidirectional controlled air flow
- Recirculation air flow with double window design
- Monitoring
- air speed
- differential pressure
- temperature
- relative humidity
- particle counting
- microbiological monitoring
Isolator for aseptic-toxic filling
In addition to the aseptic filling concept, the following is required:
In the technical floor
- Double filters in the return channels
- Simple and safe filter change system for personal protection
In the isolator chamber
- Separate return air channels with integrated and fully automated cleaning system
- Isolator chamber washable with spray balls and spray wands
- Quick drying capability
SIS 700 - the integrated H2O2 decontamination system
The key feature of our isolators is the process and control integrated H2O2 decontamination system.
In addition to the decontamination system SIS 700, SKAN has also developed detailed process know-how from a scientific perspective. Today hundreds of these systems are being used with great success, providing users with the benefits of highly reproducible and reliable processes.
The decontamination system ensures the rapid and fully automatic H2O2 decontamination of the equipment.
The stable and reproducible performance of the decontamination system guarantees quantifiable germ reduction on the interior surfaces of the equipment.
In order to qualify the units quickly and successfully, SKAN has developed specific SOPs over the years. These methodologies are now referenced in the FDA guideline "Sterile Drug Products Produced by Aseptic Processing".
Skan can perform a wide range of experiments in connection with H2O2 for clients in its own microbiology laboratory. These experiments include: material compatibility, diffusion characteristics, germ-killing ability on various materials and D-value determination.
Qualification
At SKAN, GMP-compliant qualification accompanies the entire project, from the start of the planning phase to the FAT. This guarantees our clients a targeted and effective qualification process within the project schedule.
SKAN's quality management system has been successfully audited many times by our clients in the pharmaceutical industry.
Process automation
Overlaying the process technology is a modular automation process that offers a high level of process safety and optimal reliability. This can be combined with the SKAN Monitoring System and offers optimal process transparency with convenient evaluation tools.
Controls
- The software complies with GAMP4 guidelines with regard to programming and documentation
- Electronic records are created in accordance with CFR 21 Part 11
- Logic controllers from Siemens, Allan Bradley and Mitsubishi are used
- All process data can be transmitted to customer SCADA systems
Visualization
- Clearly structured user interfaces with touch panels give the user the necessary process overview.
Equipment documentation
The thorough documentation of the equipment complies fully with current GMP requirements for pharmaceutical machines. The package supplied is rounded off by operator and maintenance staff training.
Accessories
A wide range of accessories and services are an integral part of SKAN's isolators on filling lines. In accordance with customer requirements, SKAN uses the products developed both internally and by third parties.
Glove leak tester
In close collaboration with our customers, the SKAN glove leak tester has been enhanced on an ongoing basis by means of a series of documented experiments in the field. The tester can determine the process-critical integrity of up to twelve gloves with sleeves simultaneously.
Transfer systems
The transfer of material is a key element of isolator technology. SKAN offers a broad spectrum of tested and qualified systems, with the range of sizes available enabling all customer requirements to be met.
Services and customer care
Our service package includes elements such as pre-engineering, simulation and modelling, as well as expansions and the qualification of existing or third-party equipment.
SKAN's worldwide service network enables us to reach every installation within a short space of time, and our well-developed service and maintenance program ensures full and long-term availability of the equipment.
Products may be subject to amendments resulting from technological progress.