Aseptic processing produces contaminants, foreign bodies, and bacteria-free pharma products without using the terminal sterilizing method. In contrast to traditional pharma product that utilizes terminal sterilization to ensure sterility, aseptic processing products cannot use terminal sterilization because the final finished product cannot tolerate high temperatures for sterilization, which results in the deterioration of internal chemical compounds and API.
Aseptic processing ensures product purity by various alternative methods, such as filtration, specialized equipment design, and other methods, during the manufacturing stage.
Common methods of achieving sterility during aseptic processing include but are not limited to
Before manufacturing aseptic products, items (such as raw materials, equipment, tools, instruments, and containers) are individually sterilized to increase sterility. It eliminates any contamination or traces at the initial level before starting the manufacturing process.
Strict environmental control procedures are deployed to provide sterile working conditions, such as area control, restricted operator movement, and controlled airflow to prevent the effect of contamination from the surrounding.
Aseptic processing is useful for products that cannot withstand high temperatures during terminal sterilization.
Examples of these products include biologics and vaccines that lose efficacy and become ineffective when subjected to terminal sterilization.
Advanced aseptic processing
Advanced aseptic processing is a term used to describe manufacturing processes executed with minimal human involvement, unlike traditional processes that require direct human involvement. Since humans are the major source of contamination, restricting humans in the manufacturing process greatly helps to control contamination.
In advanced aseptic processing, humans execute manufacturing operations through mechanical parts, accessories, and tools purposely built to provide interaction between operators and the manufacturing process. Humans still control and execute manufacturing operations but have zero physical interaction with manufacturing processes and equipment.
In traditional systems, humans fully do not have isolation between manufacturing equipment and process, and they have to interact with the manufacturing process physically. The human operator’s hand, wearables, and gown are some examples that directly connect with the product and equipment during manufacturing. It increases the probability of affecting the sterile product and process with foreign particles, contaminants, and microorganisms.
Applications of advanced aseptic processing
Aseptic processing is commonly used for filling and sterility tests in the pharmaceutical industry. Let’s briefly discuss these applications.
Aseptic Filling
Aseptic filling is the process of filling sterile drug products into containers without human intervention. Sterilized containers are fed to the machine from the input section of this equipment. The machine automatically transfers them to the filling station and performs filling, sealing, and capping in a controlled and sterile environment without direct interaction with humans.
The vials are supplied to the filling machine in a Nest, in which vials are organized according to the filling orientation and are locked for smooth filling.
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