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Filling line

Product catalog summary
Customized Solutions
The document emphasizes the importance of understanding customer needs to create tailored solutions for aseptic filling processes, including freeze drying. It highlights collaboration with partners to design efficient systems that meet individual product and environmental requirements.
Air Treatment and Isolator Technology
Air treatment is crucial for product safety, with HEPA filtered and conditioned air ensuring aseptic conditions. The document details the air handling units' placement and the use of nanox® catalysts for environmentally friendly decontamination, eliminating complex piping needs.
Decontamination Technology
The skanfog® H2O2 system with nanox® catalyst is presented as a market standard, offering short cycle times and reliable decontamination. The system ensures a 6 to 10 log reduction, with efficient aeration and strategic H2O2 distribution.
Double Door System
This system enhances air distribution and accessibility, with features like gas pressure springs and toughened safety glass for durability and ease of use.
Automation and Monitoring
SKAN's automated solutions comply with GMP guidelines, featuring SCADA systems for data integrity and reporting. Environmental monitoring ensures cleanliness, with predefined solutions for particulate sampling.
Material Transfer and Robotic Solutions
The document describes the SARA airlock for efficient aseptic transfer and RTP for secure material transfer. Robotic systems are highlighted for reducing operator intervention and enhancing process safety.
Support and Innovation
SKAN offers local and global support, with digital technologies like AR and VR for maintenance and training. The document underscores the importance of superior documentation and collaboration with filling machine manufacturers.
Quality Assurance and Validation
SKAN emphasizes the importance of documentation quality in inspections. All products and projects include GMP design and validation documents as per the Quality Project Plan (QPP), including the Factory Acceptance Test (FAT). The qualification and validation service encompasses IQ and OQ protocols and reports, along with microbiological qualification and validation packages.
Worldwide Isolator Support
SKAN provides professional support to ensure equipment operates at maximum productivity and reliability. Maintenance programs and services are developed based on extensive experience. Certified technicians perform recalibrations, repairs, and modifications on-site to maintain equipment qualification. Microbiological re-qualification ensures decontamination effectiveness and workplace safety. SKAN offers corrective maintenance both on-site and remotely, with experts familiar with specific plant details to quickly resolve issues.
Contact Information
SKAN provides contact details for its offices in Switzerland, Germany, the USA, Japan, and Belgium, ensuring global support and accessibility.
Disclaimer
SKAN reserves the right to make changes to product design, technology, and features, and accepts no liability for printing errors.
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Catalog excerpts

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Customized Solutions Filling line

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The first step towards success – Creating individual solutions together Our customers' needs are the focus of every process design. That is why it is important for us to understand and analyze these needs. Together with selected partners, we transfer these requirements to our concepts, resulting in practical and efficient systems for every challenge. We design the best processes for every application, container type and process for aseptic filling, including freeze drying. Our unique technology for isolators and filling equipment allows robust designs for a reliable system that meets your individual...

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SKAN Group – The best partner and technology For more than 30 years, SKAN has been promoting isolator technology with innovative techniques and solutions for validatable decontamination processes. As a Swiss company, we are proud to be the global market and technology leader for isolators, clean room devices and decontamination processes for aseptic production in the global biopharmaceutical market. Aseptic isolators have become the standard worldwide for all types of aseptic and aseptic-toxic applications, from small-scale filling to fully automated production processes on a large scale. Thousands...

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The double door system – Perfect distribution Increased distance between the two doors of the double door system enables the best air distribution while still providing maximum accessibility and visibility. The defined air flow of 0.45 m/s generates thousands of cubic metres of air that must be circulated. Thanks to the double door system, this large volume of air can be efficiently removed, filtered and reused without cross-currents or turbulence occurring in the isolator. Thanks to the double doors, no external air ducts are required, which enables good and direct access to the isolator chamber....

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Automation system – Convenient and reliable SKAN automated solutions are developed and validated in-house according to current GAMP5 category guidelines and are CFR 21 Part 11 compliant. Established PLC Siemens or Allen Bradley PLC control systems are used on Beckhoff touchscreen monitors. Supervisory Control and Data Acquisition (SCADA) provides full data integrity, reporting functions, Active Directory and audit trail functionalities. Electronic records and signature, OPC interface and thin client technology with customer server can be provided as options. Customized automation solutions are...

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Environmental monitoring – Proof of quality Environmental monitoring (EM) is a measure to verify the airborne cleanliness in terms of viable and non-viable particles as per cleanroom classification. To ensure a robust process, regulators encourage oversight over the entire manufacturing process. For Grade A zones, particle monitoring should be performed throughout the critical processing period. Risk assessments of aseptic filling lines indicate the frequency and locations of environmental sampling. We have predefined monitoring solutions for viable and non-viable particulate sampling with integrated...

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Material transfer RTP – Rapid Transfer Ports SARA – SAfe and RApid Transfer Airlock Something is always being processed, produced or bottled within an isolator. It is very important that sterile materials such as filling needles, pumps, stoppers, petri dishes and any other materials can be aseptically transferred into the isolator. This is the only way of protecting the aseptic area throughout the entire process. The Rapid Transfer Port (RTP) is a type of transfer lock to which a pre-sterilized container can be docked from the outside. An interlock security mechanism guarantees correct manipulation....

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MTI – Material Transfer Isolator Robotic solutions 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 also for operator protection in aseptic processes. To ensure the highest possible level of safety for product and 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...

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WirelessGT 2® – Reliable glove integrity testing The WirelessGT 2 is the most advanced and fully automated glove testing system on the market. The test system complies with cGMP specifications regarding pressure decay measurement for glove testing systems in isolators and RABS in the pharmaceutical industry. All functions necessary for reliable and fast glove testing are integrated in the battery-powered test cover and do not require any hoses or wires. The system automatically monitors the pressure loss of the glove or sleeve assembly over an individually definable time in accordance with a...

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Worldwide isolator support SKAN's digital support services SKAN offers professional support to ensure that your equipment is operating at maximum productivity and reliability. The development of comprehensive maintenance programmes and services covering all aspects of SKAN equipment was inspired by the decades of hands-on experience acquired by SKAN's experts. SKAN offers two cutting-edge digital technologies to enhance its comprehensive services: Our certified technicians perform precise recalibrations and repairs as well as modification requests on site, to maintain the qualified status of...

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SKAN Stein AG Industriestrasse 3 4332 Stein, Switzerland +41 62 885 03 00, [email protected] SKAN Deutschland GmbH Nickrischer Straße 2 02827 Görlitz/Hagenwerder, Germany +49 358 223 789 0, [email protected] SKAN US, Inc. 7409 ACC Blvd., Suite 200 Raleigh, NC 27617, USA +1 919 354 6380, [email protected] SKAN Japan 5194-61 Katsuren-Haebaru Uruma-shi Okinawa 沖縄県 904-2311, Japan 日本 +81 98 934 9922, [email protected] Aseptic Technologies Rue Camille Hubert 7-9 5032 Gembloux /Les Isnes, Belgium +32 81 409 410, [email protected] V.1 / 2022 As our products are being continually improved, we reserve...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.