Critical Components of an Aseptic Filling System

The aseptic filling system uses a fully automated process and isolates the procedure from the background environment. Compared to conventional methods, it reduces human contamination and guarantees protocol compliance.

TECH-LONG’s BFS machines also include cutting-edge closure application systems that efficiently apply caps, lids, and seals. This ensures a high quality of finished products and prevents contamination.

Pre-treatment system

The pre-treatment system of an aseptic filling system is the most critical component in a sterile process. It ensures that the bulk drug is sterile before it enters the fill/finish equipment system. This is a very challenging process that requires strict environmental controls and specialized equipment.

The department’s OWTS system includes a septic tank, recirculation tanks/chambers and final dosing tanks/chambers that are each paired with a single or multiple E-Z Treat pretreatment pod. Unless properly maintained, these systems can be sources of contamination. To prevent this, septic tank maintenance involves removing solids and debris from the bottom of the septic tank and cleaning the pretreatment components periodically.

Aseptic processing is a high-temperature short-time thermal process that commercially sterilizes and fills cooled sterile product into presterilized packages in a sterile environment. It can also be used to hermetically seal food products. This approach has many advantages over traditional canning and extends the shelf life of food by reducing heat-related losses.

Sterilization system

The sterilization system ensures that the entire aseptic filling machine is sterile and free of contamination. It operates by circulating water above a preset sterilising temperature through heat exchangers and interconnecting piping. When it has reached the required temperature, a reversing valve is triggered to bypass the product back to a surge tank and alert the operator that sterile conditions have been achieved.

This is a critical step in aseptic processing, since any contamination can result in the loss of production and a failed inspection. Aseptic processing involves the transfer of liquid drugs between a sterile environment and a single-use container, so it requires precise control and compliance with stringent quality standards.

In addition to the sterilization system, TECH-LONG’s aseptic filling machines have an extensive CIP (cleaning in place) system that uses a combination of chemicals and steam to thoroughly aseptic filling system clean all the components of the machine. This helps to maintain optimal operating conditions and ensures precision and traceability of the product.

Filling system

Aseptic processing involves transferring a commercially sterile, cooled product into a presterilised container and hermetically sealing it. This reduces to a minimum the destruction by heat of food components that give it its typical organoleptic properties and nutritive value and therefore results in better preservation of these characteristics than is achieved with conventional canning.

The equipment used for aseptic fill/finish operations should be designed to be easy to maintain under sanitary conditions. This is especially important for the sterilized set-up parts, which must be changed for every sterile batch. The design should also reflect the ease with which a person can operate or control the equipment.

The key to successful aseptic fill/finish operation is the cleanroom and its supporting utility systems. These include air handling and sanitization systems that provide high efficiency particulate air (HEPA) to create unidirectional air patterns and a controlled environment with constant environmental monitoring.

Capping system

The capping system of an aseptic filling machine is a vital component of the entire process, ensuring that the product is properly sealed and able to maintain its quality and freshness. A capping system is also necessary for reducing the risk of contamination during the manufacturing process. It should be capable of meeting rigorous quality standards and preventing microbial contamination during the shelf life duration of parenteral drug products.

Aseptic filling machines are designed to operate within a sterile environment, and they must meet stringent requirements for microbial cleanliness and precision. They are a key component of any pharmaceutical production process, and are indispensable for preventing microbial contamination during the fluid transfer process.

A specialized single-use aseptic filling, stoppering and capping machine is an ideal solution for pharmaceutical companies. It reduces the need for cleaning and sterilization at the manufacturer’s site, saving water, energy and time. Moreover, it allows for easy changeover to new container sizes.

Cleaning system

The aseptic filling process depends on the use of techniques, detailed procedures, equipment and controls to ensure that sterile drugs are processed in a clean and safe environment. It is a difficult process because the product must be transferred between a pasteurizer, sterile holding tank and the filler in a sterile zone. If any of these areas are compromised, production will stop until the area is cleaned.

The cleaning systems used in aseptic processing are also highly complex and require specialized detergents and cleaners to keep the processes and equipment sterile. Ecolab offers programs and solutions to optimize cleaning aseptic filling system manufacturers and sanitization of aseptic processes, including the 3D TRASAR CIP system that verifies every wash cycle and provides alerts for potential issues.

Another important aspect of aseptic processing is gowning and degowning procedures, which must be carefully designed to prevent microbial contamination. For example, an employee sheds about ten million particles per day, and the type of clothing worn can influence these particles.

Control system

The control system of an aseptic filling machine is essential for ensuring consistent and rigorous cleaning and sanitization procedures. It also helps monitor the sterility of the product, ensuring that all components remain contaminant-free. TECH-LONG’s cutting-edge aseptic filling machines are the pinnacle of precision engineering and advanced technology, keeping your liquid products safe from contamination.

In aseptic canning, the food is pre-sterilised and then filled under a sterile condition. This process is much faster than conventional canning. During the aseptic processing cycle, the food and cans are continuously heated to sterilizing temperature in heat exchangers. The cans are then hermetically sealed with a capping system that is closely coupled to the filling system.

The pre-treatment system uses a combination of hydrogen peroxide vapor and hot water rinsing to ensure that the container is sterile and free from any contaminants. It is also important to keep in mind that a certain amount of time must pass before the scheduled process is complete. This time varies based on the temperature.