AseptiFill is an integrated modular solution specifically designed for small batch aseptic filling in pharma and biotech applications. Developed in compliance with cGMP standards, Aseptifill can be easily integrated with specific process equipment, such as lyophilizers.
More than a filling platform, AseptiFill is a complete, all-in-one isolated solution that supports your Contamination Control Strategy (CCS), and meets the most stringent regulatory expectations.
Starting from one Transfer Chamber and Grade A ISO 5 Process Chamber, the aseptic isolator can be configured and expanded according to specific process requirements, enabling flexible layouts and scalable configurations.
Applications
Typical applications are: R&D, Batch Scale Aseptic Filling, Pre-clinical and Clinical production.
Compliances
Annex 1, EU Guidelines, cGMP, Gamp5, FDA CFR 21 part 11.
Decontamination Process (VPHP)
The bio-decontamination process is performed by HYPER, Tema Sinergie’s Integrated Vapour Phase Hydrogen Peroxide Generator for fast decon cycles.
