TEMA Sinergie has launched a new technology for filling and closing vials in an aseptic environment that can be completely integrated within any Tema Sinergie isolator. AseptiFill has been specifically designed for the production of small batches of injectable products for clinical and pre-clinical trials and tests.
The main components of the unit are: a peristaltic pump to allow a repeatable and homogeneous dispensing flow, a robotic arm for vial manipulation, a weighing cell that grants a real-time control during the whole process, an environmental monitoring system and a dedicated filling nozzle with a lifting movement, to prevent foam.
The first AseptiFill unit has been installed within a custom project
The first AseptiFill unit has been installed within a custom project involving the making of a class A/ISO 5 cGMP compliant isolator system - Aseptic Filling Isolator - to meet the filling needs of a customer in an aseptic environment.
The entire system allows for a complete filling and closing cycle to be carried out in aseptic conditions and limited space.
A peek inside the process
There are five steps to using the new system.
1. The first step consists of bringing the vials to the pre-chamber, where the sterilisation process takes place prior to the vials being passed into the aseptic chamber. Sterilisation is achieved through a VPHP cycle, thanks to our HYPER technology, fully integrated into the isolator.
2. Once the cycle is complete, the vials can be easily moved into the main chamber by means of a sliding trolley.
3. The insertion of the filling liquid into the work chamber takes place through the aseptic liquid transfer system SART Port, and is settled in a bag, which is connected to the AseptiFill.
4. Once the preparatory operations are done, the first vial is positioned on the AseptiFill starting station and the machine goes off, carrying out the whole filling and capping cycle independently.
5. When all of the vials have been filled, they can be extracted through an outlet chamber (previously decontaminated).
AseptiFill allows operators to work on custom projects aimed at meeting any different filling and sealing need, since it can be integrated on the whole range of aseptic isolators by Tema Sinergie.