Crystal™ M1

Crystal™ M1

Crystal™ M1

Product catalog summary
Overview
The Crystal™ M1 Filling Station is a tabletop aseptic filling system optimized for small batch production, particularly suitable for R&D and early phase clinical development. It ensures contamination management through the AT-Closed Vial® technology, maintaining a closed system throughout the filling process.

Key Features
  • Fills up to 150 AT-Closed Vials® per hour with volumes ranging from 0.1 ml to 50 ml.
  • High filling accuracy and easy validation.
  • Installation and qualification completed in one day, available within six weeks.
  • Compatible with standard biosafety cabinets or isolators.
  • Single-use materials for product contact parts and toolless format change.

Filling Process
  1. Filling: The AT-Closed Vial® is manually placed and filled using a peristaltic pump.
  2. Laser Re-sealing: The vial is transferred to a laser safety cabinet where the puncture is re-sealed with a laser shot.
  3. Capping: A plastic cap is snap-fitted using the AT-EasyCap™.

Adaptability and Future Scalability
The system is designed for easy scaling out of production, with options for robotic filling lines to scale up manufacturing. Aseptic Technologies offers customized solutions to meet specific needs.

Environmental Adaptation
  • Can be installed in biosafety cabinets or isolators.
  • Optional features include a peristaltic dispensing pump, foot switch, and high precision balance.

Cleaning and Validation
Components are made of 316L stainless steel and POM, compatible with standard sanitizing agents and H2O2 decontamination. The system comes with a full Validation Master Plan.

Certifications
  • ISO 9001:2015 for quality management systems.
  • ISO 15378:2017 for primary packaging materials for medicinal products.

Contact Information
For further inquiries, contact Aseptic Technologies or SKAN at their respective locations in Belgium, Switzerland, Germany, USA, and Japan.
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Catalog excerpts

Crystal™ M1-1

Manual Filling Station

 Open the catalog to page 1
Crystal™ M1-2

Small batch Filling Station for R&D and niche commercialized products Optimized for small batches, the Crystal™ M1 Filling Station is a tabletop aseptic filling system, derisking your manual fill & finish operation. Manage your production in house The Crystal™ M1 Filling Station is a manual laboratory equipment. Available in 6 weeks, installed and qualified in one day, you can quickly and safely engage in fill & finish processes without relying on external entities. Choose adaptivity The Crystal™ M1 Filling Station can easily adapt to your needs. From R&D to early phase clinical development,...

 Open the catalog to page 2
Crystal™ M1-3

the needs of small batch processing The Crystal™ M1 is used for aseptic filling of liquid parenterals. Perfect for small production, it presents the following characteristics: Up to 150 AT-Closed Vial® per hour 0,1 ml to 50 ml filling High filling accuracy At your site in 6 weeks Installed and qualified in 1 day Easy validation For installation in a standard biosafety cabinet or an isolator Single-use materials for product contact parts Toolless format change

 Open the catalog to page 3
Crystal™ M1-4

The Crystal™ M1 Filling Station is an easy-to-use manual filling equipment. In just three steps, you can fill the AT-Closed Vial®. 1. Filling —> The ready-to-fill AT-Closed Vial® is manually placed on its supporting base. —> Piercing of the stopper is accurately achieved by simple action on the lever. Filling is performed using a peristaltic pump. —> The vial is manually transferred into the laser safety cabinet. The laser control unit, installed outside the ISO5 containment, is activated via the embedded remote. —» The puncture trace is re-sealed by a 1 second laser shot on the stopper surface....

 Open the catalog to page 4
Crystal™ M1-5

The Crystal™ M1 Filling Station can be installed in the following types of containment: —> The integrated equipment M1 for Pure is available for manual filling under SKAN Pure isolator. —> The integrated equipment M1 for Spectra is available for manual filling under SKAN Spectra isolator. Several optional features are available to ease your manual filling process: —> Peristaltic dispensing pump —> Foot switch for the pump —> High precision balance The exposed surfaces of the filling tool, the laser housing and the capping tool are made of 316L stainless steel and polymer materials (Polyoxymethylene,...

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Crystal™ M1-6

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] © 2023 – Aseptic Technologies S.A. – Brochure Crystal™ M1 – V2.0 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.