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Crystal™ L1

Crystal™ L1

Crystal™ L1

Product catalog summary
Overview: The Crystal™ L1 Filling Line is an automated system designed for biopharmaceutical companies to scale up production. It is suitable for filling stability batches, clinical batches, and mid-size production, ensuring compliance with cGMP requirements and CFR 21 part 11.
Compliance and Capacity: The system can process AT-Closed Vial® ranging from 1ml to 50ml and fill up to 500 vials per hour without manual intervention.
Automation and Adaptability: The line uses a six-axis robot to minimize format parts and reduce changeover time. It can be integrated with either a Restricted-Access Barrier System (RABS) or a SKAN Cellana isolator.
RABS Features: When combined with RABS, the system provides a controlled environment for aseptic filling with a minimal footprint, suitable for installation in a Grade B environment. It includes features like Active Laminar Air Flow and AT-Port™ for fluid transfer.
Cellana L1 Features: The Cellana L1 system combines Aseptic Technologies and SKAN isolator for high sterility assurance, suitable for Grade C or D environments. It includes an automated skanfog H2O2 decontamination system and SARA for material transfer.
Operational Process: The filling process involves a clean 6-axis robotic arm that fills, laser re-seals, and caps each vial. The system is controlled via a Human Machine Interface (HMI) for high dosing accuracy.
Validation and Certifications: A full Validation Master Plan is provided, and the system is certified under ISO 9001:2015 and ISO 15378:2017 standards.
Contact Information: The document provides contact details for Aseptic Technologies and SKAN offices worldwide.
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Catalog excerpts

Crystal™ L1-1

Automated Filling Line

 Open the catalog to page 1
Crystal™ L1-2

Automated Filling Line for commercial production The Crystal™ L1 Filling Line enables the scaling-up strategies of biopharmaceutical companies globally. This automated equipment is designed to perform filling of stability batches, clinical batches and mid-size production. Fully compliant with cGMP requirements and CFR 21 part 11, the Crystal™ L1 Filling Line is able to process the complete range of the ready-to-fill AT-Closed Vial® from 1ml to 50ml. This automated Filling Line can fill up to 500 AT-Closed Vial® per hour, filling an entire AT-Nest™ without any manual intervention. The Crystal™...

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Crystal™ L1-3

The Crystal™ L1, when combined with an active Restricted-Access Barrier System (RABS), provides the enclosed controlled environment for aseptic filling process with a minimal footprint. —> To be installed in a Grade B environment —> Reduced footprint —» CFR 21 Part l1 compliant —> AT-Port™ for fluid transfer —> Active Laminar Air Flow (LAF) or mousehole for material transfer —> Installed and qualified in one week Relying on the Aseptic Technologies single-use materials and the AT-Closed Vial® of various formats, the Crystal™ L1 in RABS provides flexibility in cGMP fill & finish operations, while...

 Open the catalog to page 3
Crystal™ L1-4

Highest sterility assurance Combining Aseptic Technologies Filling Line and SKAN isolator, the Cellana L1 allows aseptic processes to take place quickly and safely within the highest sterility conditions. To be installed in a Grade C or D environment Integrated automated skanfog H2O2 decontamination system CFR 21 Part 11 compliant AT-Port™ for fluid transfer SARA (SAfe and RApid decontamination airlock) for material transfer The Aseptic Technologies L1 Filling Line is an automated filling line for ATClosed Vial® with high filling accuracy, which reduces contamination risks with its unique AT-Closed...

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Crystal™ L1-5

Quick, safe and easy fill & finish The bulk product container, remaining outside of the RABS or isolator, is connected to the operating area with the AT-Port™ System, the aseptic liquid connector. Through the selected material transfer system of the equipment, the nested ready-to-fill AT-Closed Vial®, and other single-use material, are introduced to the critical area, where prepared for operation. The operator positions the AT-Nest™ and prepares the fluid path, rendered possible with the AT-Filling Kit™. Activated from the HMI, the clean 6 axis robot then initiates the closed vial filling process....

 Open the catalog to page 5
Crystal™ L1-6

SKAN AG Kreuzstrasse 5 4123 Allschwil, Switzerland +41 61 485 44 44, [email protected] 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] © 2024 – Aseptic Technologies S.A. – Brochure Crystal™ L1 – V1.4 Aseptic Technologies S.A. reserves...

 Open the catalog to page 6

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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.