Aseptic Filling Line
Aseptic filling line uses advanced technology and machinery to handle the delicate process of transferring liquid products into containers without exposing them to contamination. TECH-LONG’s aseptic filling machine allows you to meet strict production requirements and achieve the highest standards of sterility.
The aseptic fill/finish process is highly dependent on technique, detailed procedures and equipment. There are different methods to aseptically produce sterile drug vials, including traditional solution filling, sterile powder filling and lyophilization.
Sterilization
Whether you are manufacturing aseptic or sterile drug products, you need to ensure your products are safe. Both methods require careful decontamination of operational personnel, terminal sterilization of the drug product and sterilized fill/finish equipment system as well as cleaning and sanitizing of the cleanroom and in-place equipment. Although aseptic processing does not include a final sterilization step, thoughtful facility design and robust quality processes make it a safer and more cost-effective method than sterile manufacturing.
The first aseptic processing applications were aseptic filling line food processing and packaging, where pumpable foods were continuously heated to sterilizing temperature in heat exchangers, then cooled before meeting the sterile package. Sterile solutions and glass vials can be sterilized the same way, or in separate units. The sterile solution is then aseptically filled and the vial sealed with a crimp seal or elastomeric plug.
Your bulk drug should be sterilized by a process that is compatible with the aseptic fill/finish method you choose, which could involve a depth filter or another process, such as irradiation. The sterile container systems, which may be either molded glass or tubular glass (more common in Europe than in the United States), must also be sterilized to meet the aseptic fill/finish requirements of your drug and process.
Aseptic fill/finish requires a high level of technique, detailed procedures and tightly coupled equipment. It is more complex than conventional pharmaceutical production, which is why it relies on careful control of the entire process.
Filling
Aseptic filling takes place within a cleanroom, which is designed to operate with stringent protocols that protect drug products from contamination and guarantee their efficacy and shelf life. This meticulous practice is necessary since unlike terminal sterilization, it is not possible to sterilize aseptically assembled drugs after the packaging process.
To avoid recontamination, the equipment used for aseptic filling must be thoroughly cleaned and sterilised between production runs with proper chemicals and high mechanical action. Once clean, the equipment must remain sterile with HEPA-filtered air at overpressure to maintain its integrity throughout the production run.
An aseptic fill-finish machine consists of an insulated isolator and an automated system that delivers lyophilised product to the vials and removes them after the product has been filled with it. It then automatically lowers a series of shelves, which causes the stoppers to attach to the vials and ensures that the lyophilised product is completely enclosed. This highly precise setup calls for meticulous attention to detail and a thorough validation of every component in the manufacturing sequence.
Additional components in an aseptic filling line include a surge tank, a conveyor system and a series of heating and cooling components to sterilize the containers and their contents. The machine also uses a vial loading tray that accommodates batch sizes of different drugs and can be selected based on the composition’s reactivity, pH level and photosensitivity.
Sealing
Aseptic filling lines ensure the safety and quality of sterile pharmaceuticals, food products, and beverages. They are crucial components of a sterile manufacturing process and must be designed to meet industry standards and requirements. TECH-LONG provides innovative solutions for aseptic line designs, including advanced filling machines, sterilization systems, and monitoring and control systems.
In order to maintain a sterile environment during aseptic processing, manufacturers use uninterrupted, unidirectional HEPA-filtered air to create a local Grade A/ISO 5 space. They also rely on a Restricted Access Barrier System (RABS) to minimize contamination from outside sources. These barriers are particularly important when working with sensitive ingredients such as cell and gene therapies, which cannot withstand gamma or heat sterilization.
Another critical component of aseptic processing is the hold tube, which holds the product for a specified time to ensure that all spores of microorganisms are killed. This time varies according to the temperature of the product and the specific pathogens being targeted. For example, milk must be held for a minimum of 10 hours to ensure that all spores are killed.
Developing an efficient aseptic filling line requires careful consideration of the specific needs of each aseptic filling line factory product. In addition to selecting the right equipment and implementing effective sterilization procedures, manufacturers must also focus on ensuring that their production processes are consistent and accurate.
Packaging
An aseptic filling line ensures that liquid foods are produced within hermetically sealed packaging that prevents contamination by harmful bacteria. This process also minimizes nutrient loss and other chemical reactions that affect flavor and color.
Depending on the product, aseptic processing equipment may sterilize containers, product or both by heat treatment (saturated steam, superheated steam, hot air, mixture of water/steam and hot air) or mechanical processes (washing/rinsing/flushing, vacuum cleaning, brushing, sonicating), irradiation (ultraviolet, infrared) or other chemical treatments such as hydrogen peroxide, ozone, chlorine and peracetic acid. Some products require post-sterilization pasteurization to minimize harmful bacteria’s and ensure shelf stability.
A key consideration is the capacity of an aseptic filling line to handle your specific volume and production speed requirements. In addition, the ability to accommodate different bottle types and closures is important — especially when you’re producing multiple products.
A fully connected aseptic line enables you to optimize performance throughout the life cycle of your production and meet your product safety, productivity and environmental goals. Sidel offers a complete package of aseptic solution services, from process solution to PET packaging assessment to equipment definition, delivery and fast ramp-up. Our expertise and industry-leading machinery help you strike the right balance between efficiency and compliance. Contact us today to learn more about our aseptic solutions.