Studies have shown that most microbial contamination in an aseptic process comes from humans. But still, researchers are coming up with studies to make the aseptic process airtight. Remember, the main aim of this process is to reduce the need for refrigeration of pharmaceutical products by sterilizing the environment and providing the cleanest conditions possible for the packaging and storage of pharmaceutical substances.
Over the last few decades, aseptic processing has gained lots of traction from researchers and the FDA. In the period between 2004 and 2011, the majority of FDA recalls came from sterile products. Low quality sterilization was the leading cause of these recalls. The majority of them failed in packaging, as well as contaminations. Steps have been taken to ensure that the aseptic processing is safe. Some of the measures include the following:
It is always crucial for pharmacists to ensure that the physical environment of handling and packaging substances is clean enough. By monitoring the environment, personnel, and appliances, pharmaceuticals can maintain a sterile environment that is ideal for maintaining the quality of the products.
Clean water has high demand during aseptic processing. Water primarily used as a cleaning agent for the vials as well as the instruments and equipment. Water needs to be scanned for chemical and microbial contaminants.
Operator interventions can also cause contaminants in the process. Human operators in the factories and laboratories may end up introducing contaminants. The microbial loads are a threat to a seamless aseptic process. Researchers advise that there should be expanded use of automation and isolators to solve the risk of contamination of the product.
Protecting people who operate in the laboratories
As already noted, the highest percentage of microbial contamination comes from the humans who work inside the facilities. The aseptic filling needs to be safe all the time, and being able to protect the people who work in there might increase the accuracy.
The operators should be reliable, especially when they are handling highly potent and cytotoxic drugs. They need to have the right protection gear and safety measures in place. All the operators must be well conversant with isolator technology.
Tight sealing technology
Contamination by operators gets reduced in case the automated Blow Fill Seal (BFS) technology is used. The container needs to be sealed within the shortest time to prevent any microbial infections from finding their way in.
The BFS process converts plastic pellets into wire using heat. Then the feeling process takes place in a flash of time. Therefore, BFS technology can reduce contaminants from interacting with the contents of the sealed plastic.
Disinfection and thorough cleaning of aseptic areas
It is wise to clean the aseptic processing areas regularly. At all times, the operators need to use modern disinfection protocols. The majority of people typically rely on hydrogen peroxide vaporization (VHP). Experts are torn between considering its pasteurization process or a disinfectant.
The hydrogen peroxide ends up producing the performance of the isolator line. So, pharmaceutical specialists are beginning to look for newer methods of disinfecting aseptic areas. Catalytic converters, for example, have been highlighted to speed up the process and improved turnaround time.
Another way to ensure that they are septic areas are clean at all time is to use single-use containers. Filters, connectors, tubings, and bags are usually used in aseptic filling, and they can lower the potentiality of contaminating the pharmaceutical products.
Many of these items are sterilized and, therefore, safe enough for use in the aseptic process. The other components, such as needles and pumps, are generally made for the specific process. But even in that case, the single-use parts and systems are still cleaner and more efficient than the rest.
Testing new containers
Technologists and manufacturers continue to research how they can introduce new containers that are not only compatible but also have firm closure. The new designs come with a wide array of dimensions and attributes that make the filling process simple and more effective. New container designs offer innovative ways to deliver drugs and pharmaceutical products more cleanly.
The market keeps on changing, and the delivery should follow that route. Recently, there have been challenges in the manufacturing of glass vials, which means that manufacturers must come up with new technologies to package their products. Research is still ongoing to make sure that the material used to make these containers does not contain toxic leachables.
Aseptic processing with Steriline
For several decades, Steriline has continued to provide the world with advanced mechanic and robotic accessories for aseptic processes. Whether you need systems for the manufacture or packaging of toxic or non-toxic products, the company will always be there for you. The single-source provider of pharmaceutical solutions also boasts of airtight packaging of injectables. They supply vials, ampules, and cartilages as well as needles.