In the classical sense, vial filling describes the aseptic filling of pharmaceutical products into prefabricated glass vials. The Blow-Fill-Seal (BFS) technology offers a technologically advanced alternative: Here, the containers – often referred to as plastic vials – are formed, filled, and hermetically sealed directly in the process. Thermoplastics such as polyethylene (LDPE/HDPE) or polypropylene (PP) serve as the material. The corresponding systems are characterized by a small footprint in the cleanroom and meet the highest requirements for product safety. Since the containers extruded from granulate are processed in a closed system without manual intervention, the risk of contamination is reduced to a minimum. The aseptic chain is maintained in every process step by eliminating the cleaning and transport of open empty containers.
Where is vial filling used?
The production and filling of rigid as well as flexible plastic vials – for example with a Luer-Lock connection – takes place in compliance with the guidelines for Good Manufacturing Practice (GMP). This technology is widely used in the pharmaceutical industry for:
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Ophthalmics: Eye drops or sterile gels.
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Parenterals: Injection and infusion solutions.
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Inhalation solutions: For respiratory therapy.
Product protection is guaranteed by the hermetic sealing in the BFS process. Due to their thermal resistance, PP containers are also suitable for subsequent terminal sterilization in the autoclave, provided the product allows this. For heat-sensitive substances such as biologics or vaccines, the special cool-BFS process is used, which minimizes the thermal stress during the forming of the container and thus preserves the integrity of the active ingredient. Specific closure designs and precise wall thickness distribution also enable exact dosing by the user.
What distinguishes the process?
The efficiency of vial filling in integrated systems is primarily demonstrated by the combination of production, filling, and sealing at high output rates of over 30,000 units per hour. By using BFS technology directly at the manufacturing site, complex logistics and warehousing for empty containers are eliminated, which sustainably reduces operating costs. A decisive economic advantage over conventional glass lines is also the elimination of complex cleaning steps such as depyrogenation. While glass vials must be closed with separate stoppers and caps, in the case of plastic vials, the material of the container itself forms the hermetic seal by fusion. This not only minimizes the risk of glass breakage but also reduces the number of primary packaging components required and the energy footprint of the entire plant.
Qualification and regulatory security
The commissioning of systems for vial filling is subject to strict regulatory requirements in accordance with the requirements of EU-GMP Annex 1 for sterile products as well as Annex 15 and the requirements of the FDA. A structured qualification process begins as early as the design qualification to ensure planning in accordance with specifications and continues through the installation and operational qualification.
The process concludes with the performance qualification, which provides evidence of consistently high product quality under real production conditions. Professional support from the plant manufacturer, for example in the form of validated test protocols, risk analyses according to the FMEA standard, and the performance of factory acceptance tests (FAT) and site acceptance tests (SAT), ensures legally compliant validation. This holistic approach ensures that all international standards for avoiding particulate or microbial contamination are permanently maintained.