Aseptic Technologies
3 products found

Aseptic Technologies products

Aseptic Filling - Aseptic Filling Lines

Aseptic Crystal - Aseptic Filling Station

The Crystal M1 Filling Station is a tabletop system designed for aseptic filling processes, providing a reliable solution for manual fill and finish operations. It integrates AT-Closed VialĀ® technology, which keeps the vial functionally closed during the entire filling process, thereby reducing contamination risks. This system consists of a filling unit, a dosing system, precision balance, laser re-sealing unit, and a capping tool, all capable of being installed in a biosafety cabinet or isolator. Offering flexibility, the Crystal M1 can fill up to 200 AT-Closed Vials and supports volumes ranging from 0.1 ml to 50 ml. This system is particularly suited for small and personalized batch processes, making it an ideal choice for cGMP manufacturing, process development, and R&D activities. The process ensures high precision using single-use materials and supports easy validation, tool-less format changes, and a reproducible, scalable method.

Crystal - Aseptic Filling System

The pure M1 is an advanced aseptic filling system designed specifically for small cGMP batches in the biopharmaceutical industry. Developed in collaboration with SKAN and end-users, it integrates the AT-Closed Vial technology with an innovative isolator design from SKAN pure Solutions. This system allows for aseptic filling without cumbersome installations, as it requires no connection to HVAC systems. Its ergonomic, space-saving configuration includes a manual filling equipment within an isolator, a rapid material airlock, and an exit laminar airflow. It utilizes H2O2 for fast decontamination cycles, ensuring validated cleaning procedures and enhanced safety. This plug-and-play equipment is equipped with a semi-automated filling process that employs a peristaltic pump for precision and an integrated weighting cell for easy calibration. The pure M1 facilitates streamlined production and can serve as an introduction to isolator technology on manufacturing sites, providing an effective solution for filling requirements in controlled environments.

Aseptic SKAN - Spectra M1 Aseptic Filling Unit

The Spectra M1 is an advanced isolated fill & finish unit specifically designed for small cGMP batches, integrating technologies from Aseptic Technologies and SKAN. It features SKAN's most advanced isolator technology, incorporating elements like the SKAN nanox catalyst and skanfog for optimized processes, ensuring rapid and secure cycle times. This unit employs the AT-Closed Vial technology in conjunction with the M1 Filling Station to enhance small-batch production efficiency. Its design ensures compliance with cGMP standards and offers a closed filling process from 0.1 ml to 50 ml. The bulk product is aseptically connected via the AT-Port System, which allows for external cooling and homogenization. Inside the chamber, vials are automatically filled and sealed with accuracy ensured by an integrated peristaltic pump and weighting cell. Continuous batch status tracking is displayed on a built-in screen. The system supports efficient decontamination cycles and includes a full Validation Master Plan.