AseptiFill

Isolator for aseptic filling

An integrated modular solution specifically designed for the aseptic filling of small batches in pharmaceutical and biotechnology applications.
More than just a filling platform, AseptiFill is a complete, all-in-one isolated solution that supports the Contamination Control Strategy (CCS) and meets the most stringent regulatory requirements.

Designed and Manufactured by Tema Sinergie

Request Information Download the brochure

Class A

EU GMP

Appendix 1

EU GMP

ISO 5

ISO 14644-1

GAMP 5

FDA 21 CFR Part 11

overview

The modular solution for aseptic filling of small batches.

Developed in accordance with cGMP standards, AseptiFill can be easily integrated with specific process equipment, such as freeze dryers, and ensures precise, repeatable, and contamination-free filling and capping operations for R&D, preclinical, and clinical production.

More than just 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 requirements.

Starting with an ISO 5 Grade A Transfer Chamber and Process Chamber, the aseptic isolator can be configured and expanded to meet specific process requirements, enabling flexible layouts and scalable configurations.

GUARANTEED STERILITY

Optimal air quality thanks to the perfect combination of: engineered filtration (HEPA), an integrated VPHP system, inflatable seals, and a laminar flow system.

FILLING SPECIFICATIONS

Specifically designed for aseptic filling of small batches in pharmaceutical and biotech applications, with the ability to handle various types of containers.

INTEGRATED AUTOMATION

Maximum integration of automated filling systems with specific process equipment, such as freeze dryers, for R&D and preclinical and clinical production.

AUTOMATIC LEAK TEST

An automatic leak-test system that performs an independent cycle on each chamber, in accordance with the pressure-varying method described in ISO 10648-2 (E) (5.2).