Vial Filling Machine: Machine Types and Process Steps
Last updated: 04 February 2026
A Vial Filling Machine (German: Fläschchenabfüllmaschine) is a technically highly complex system that precisely doses and fills liquid or powder substances. It fills – as the name describes – so-called vials. These are prefabricated small bottles, usually consisting of borosilicate glass or special plastics. In pharmaceutical manufacturing, they are used in the fill-and-finish process. A critical point here is the open handling of the containers between cleaning and sealing, which is why the highest requirements for environmental hygiene apply.
The various machine types of the Vial Filling Machine
Which machine is used mostly depends on the production volume and the required safety level.
- Manual systems, which are predominantly found in research laboratories. Since process safety depends heavily on the skills of the operating personnel and the environmental conditions, the contamination risk here is comparatively high.
- Semi-automatic systems, which take over the precise dosing of the filling volume. Individual steps, such as the handling of the vials or the placement of the closures, continue to be carried out manually. Thus, a residual risk for sterility remains.
- Fully automatic filling lines form a closed process chain. They connect washing machines, sterilization tunnels, filling units, and closing and crimping stations into one unit. This minimizes errors and ensures maximum reproducibility (fewer dosing deviations) and safety from contamination.
- Blow-Fill-Seal systems (BFS), such as the bottelpack systems developed by Rommelag, represent an integrated process in which forming, filling, and sealing take place in a closed system. In contrast to the Vial Filling Machine, the BFS system forms the container directly in the machine from sterile plastic granules, fills it immediately, and seals it hermetically. This is the benchmark particularly for biotechnological products or ophthalmic applications, as the elaborate preparation (washing, depyrogenation) and logistics of empty containers are completely eliminated.
Distinction between Vial Filling Machines and aseptic filling systems
Not every Vial Filling Machine is automatically an aseptic filling system. While simple machines merely ensure exact dosing, aseptic filling systems go a decisive step further: they integrate advanced protection concepts (such as RABS or isolators) to protect the product from microbial contamination during the entire process.
The technological process of the (aseptic) filling machine
In a fully automatic filling process, production follows a sequential order and strict logic. Thus, in pharmaceutical production, sterile products are filled with high dosing accuracy to ensure patient safety. In compliance with GMP, it looks like this, for example:
- Preparation and feeding of the vials: The system cleans the vials and removes pyrogens in a sterilization tunnel (depyrogenation). Via precisely defined transfer systems, they then reach the aseptic area of the filling machine, where they are precisely positioned.
- Filling with absolute precision dosing: The heart of the process, in which the volume-accurate dosing of the product takes place. Depending on the medium (liquid or powder), peristaltic pumps, piston pumps, or auger fillers are used, which ensure the highest possible dosing accuracy with minimal tolerances.
- Stoppering and closing: The machine inserts elastomer stoppers into the vial necks. For mechanical securing and to ensure container closure integrity (CCI), flanged aluminum caps are also crimped. This seals the container securely.
- Downstream quality control: 100% inspection using Automated Optical Inspection (AOI) for particle-free status and CCI: Sensors and AOI systems (Automated Optical Inspection) check every finished container for particle-free status immediately after sealing. Defective units are automatically rejected.
Key components and technologies
To correspond to modern industrial standards, modern systems rely on specialized modules. In this way, any cross-contamination is avoided. Peristaltic pumps are particularly popular, as the medium only comes into contact with the (single-use) tubing system. State-of-the-art transport and handling systems also ensure that the vials pass through the system without vibration. The already mentioned In-Process Control units (IPC) secure quality control by continuously weighing the vials and checking them for their integrity.
Cleanroom and compliance requirements
The operation of a Vial Filling Machine in the pharmaceutical industry is subject to the strictest guidelines such as EU-GMP Annex 1. While vial lines often require Grade A in B, BFS enables reduced cleanroom requirements in the background due to the closed system. This is necessary for the seamless validatability of all process steps, which on one hand enables patient safety, but on the other hand is essential for approval for the pharmaceutical market.
Areas of application of Vial Filling Machines
They are indispensable everywhere where precision is relevant, especially regarding the dose. This includes, for example: Biologics and cytostatics: Highly sensitive active ingredients that require an extremely low bioburden. Injection solutions: including vaccines, in glass or plastic vials. Cosmetics & Chemistry: High-quality serums or chemical reagents that must be precisely dosed.