Automated Filling Line AFL
The efficient and precise filling is of crucial importance for the pharmaceutical industry. Flexibility, accuracy and efficiency are essential, especially in clinical studies, small-batch manufacturing and production.
The modular AFL machine system has been specifically designed to meet these requirements by allowing various machines such as a debagger, delidder, filling and closing machine, freeze dryer loading unit and capping machine to be flexibly combined into a complete solution. The AFL uses the self-developed isolator with a H2O2 decontamination unit with 106 spore reduction. The air is filtered and taken in from the filling chamber and released again in a filtered manner. A catalyst is integrated into the exhaust air for ventilation in the H2O2 cycle.
The filling and closing system in the isolator AFL offer a compact and efficient solution for filling and closing syringes, vials and cartridges.
The AFL is available as a 1‒ head version and for higher performance as a 2‒ head version.
Vials with a capacity of up to 100ml
Syringes with a maximum capacity of 50ml
Cartridges with a capacity of up to 20ml
Advantages
The AFL filling and closing system offers a variety of advantages and features, such as:
Precision
The machine can be equipped with three filling systems.
Peristaltic pump with actively driven rollers for gentle and precise filling, ideal for single-use applications.
Rotary piston pump for high filling accuracy and repeatability, suitable for more viscous products.
ViscoTec Pharma Dispenser for gentle product filling of highly viscous or abrasive products.
All 3 dosing systems can also be installed on the same machine.
Flexibility
The isolator line can be flexibly combined into a complete solution with a debagger, delidder, filling and closing machine, freeze dryer loading system, and capping machine.
The isolator has a total height of <2.7m/<9 feet and takes the supply air and exhaust air from the Class C/ISO 7 filling room.
Through integrating robots, the fully automated processing of lid/liner removal, nest handling/in-process control, and freeze dryer loading is optionally possible.
Efficiency
The machine can be equipped with a scale that enables automatic 1-100% in-process control. This allows the filling quantity to be readjusted. Start-up and empty runs take place without product loss, thus are minimizing the waste of product.
Stability
Through H2O2 decontamination of the isolator, aseptic production is possible.
The AFL also contains automatic monitoring of all critical processes such as airflow, differential pressure sterile filter, H2O2 concentration, temperature, humidity, overpressure, etc. within the isolator.
A seamless integration of viable air sampler and particle counter is also possible.
Features
The AFL is characterized not only by its flexibility, but also by its technical features.
Cleanness
The system is made of high-quality stainless steel and plastics that meet the high hygiene requirements of the pharmaceutical industry.
Quality
The AFL fulfils software requirements in accordance with 21 CFR Part 11 to ensure data security. It complies with the demanding requirements of EMA Annex 1 and the FDA.
Flexibility
The AFL isolator line is operated intuitively via a touchscreen. Recipe management and the creation of production batch reports are also carried out via the touchscreen. The machine has a data interface to the customer's system, which enables seamless integration into existing processes.
The flexible design of the AFL makes it possible to react quickly to changing market conditions and to effectively develop and bring innovative products to the market.
With its outstanding technical features and its wide range of applications, the AFL is a reliable partner for the precise, flexible, and efficient filling of products.
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