How a Sterile Filling Machine Works
In an industry where product safety is paramount, a sterile filling machine can help manufacturers ensure that their products are sterile and safe for consumption. TECH-LONG provides an overview of how these machines work to meet today’s demanding pharmaceutical industry standards.
Sterility is maintained during the entire process by using isolator-barrier systems. This also eliminates the need for cleaning.
1. Sterilization
Sterilization using a sterile filling machine ensures that products are contaminant free. The goal of a linear aseptic laboratory filler, like MicroThermic’s Aseptic Laboratory Filler, is to sterilize bottles (and their caps) and then fill and seal the sterile product, all within a sterile environment. The process begins when the container is inserted into the machine via a vial loading tray, which can reduce wear and tear on the machine while also boosting efficiency by eliminating the need to load individual bottles manually.
Then, the container goes through a series of heating and cooling components to kill any pathogens that remain in the packaging. The heating and cooling system is a critical component to a sterile filling machine that complies with the requirements for aseptic processing.
As the product is processed, a high-pressure washing solution can remove any excess residues or contaminants from the containers’ exterior surfaces before the nozzles start to fill them. This helps maintain the sterility of the contents inside the containers and extends the shelf life of the liquid products after they’re filled and sealed.
The sterile filling machine operates in a cleanroom with extensive sterile gowning and sanitization procedures for operational personnel to limit contamination risks. The cleanroom also requires a comprehensive environmental monitoring program with qualified sterile filling machine methodologies for routine and frequent sampling and analysis of the cleanroom to identify potential viable or non-viable contamination.
2. Filling
The aseptic fill/finish production process is an important step in pharmaceutical manufacturing. It allows for the production of sterile drug products using an efficient, effective and economical method that is compliant with FDA guidelines. Using a dedicated aseptic filling machine is an excellent way to ensure that you’re using the best manufacturing techniques possible.
A specialized aseptic filling machine is designed to maintain the sterility of liquid products throughout the filling process. This is achieved by separating the operator and product in a clean room and providing a safe environment that minimizes contamination. Specialized machines also incorporate RABS and isolators to further protect the product from contaminants.
To ensure that your aseptic filling machines are performing to the highest standards, they must be inspected and cleaned on a regular basis. It’s also essential to make sure that your facility follows all standardized procedures and is in compliance with FDA guidelines. This includes ensuring that all employees who use the aseptic filling machine have been properly trained and qualified to operate it, and that they have a complete understanding of how the system works.
The aseptic filling machine should be used in a sterile filling machine manufacturers cleanroom with laminar airflow to prevent the spread of microorganisms during the filling process. Employees should also be sanitized and trained on proper hygiene practices, especially when touching the product or the equipment.
3. Sealing
Using a sterile filling machine, liquid products can be sealed in an aseptic environment, protecting them from contamination that could reduce their effectiveness and safety. This process helps extend shelf life, enabling manufacturers to store and ship their products over long distances without the risk of spoilage.
Aseptic fill/finish production requires extensive cleaning and sanitization procedures to eliminate bacteria, viruses and other microbes. TECH-LONG’s machines are designed to be easily dismantled, allowing for thorough cleaning and sanitation of all components. This prevents contaminants from building up inside the machine, further mitigating the risk of contamination.
Our flexible aseptic machines enable small batch filling and closing of ready-to-use vials, syringes and cartridges. They provide a wide range of production capabilities, including cGMP aseptic processing, filling and sealing of niche products and clinical and commercial production of sterile injectables. They use the latest technology, including isolator-barrier systems and automation with real-time adjustments to help maintain sterility during the production cycle. Additional features, such as tool-less settings and enhanced filtration systems, further help to ensure stringent aseptic conditions meet updated regulatory norms.
4. Capping
During the capping process, the drug product is sealed inside its final packaging. It’s a critical step because it helps ensure that the drug stays sterile until it’s administered to patients. The lack of a chance for contamination during this stage of production is what makes it such an important component of the entire pharmaceutical manufacturing process.
Specialized filling machines are designed to precisely dose and seal containers with liquid products, maintaining a sterile environment throughout. They use a variety of vital systems, including dosing units, high-speed capping mechanisms, and stoppers. They also feature a number of other features that are tailored to meet the manufacturer’s specific needs.
In addition to reducing the need for operator engagement, aseptic processing machines are capable of meeting stringent quality standards and complying with updated regulatory norms. Advanced features like RABS and tool-less adjustments further enhance the sterility of the entire production process.
The TECH-LONG range of aseptic filling machines from Alfa Laval is engineered to meet the demanding needs of pharmaceutical companies, medical device manufacturers and other high-value industries. This range includes a series of highly advanced models that can handle all aspects of the aseptic filling process. These include dispensing, sealing and capping liquid and viscous food products into pre-sterilized packaging with utmost accuracy. The machines use a closed system for comprehensive end-to-end sterilization, providing superior performance to traditional antiseptic methods.