In medical packaging, we hear the word aseptic a lot. By definition, the word aseptic means free from pathogenic microorganisms. But how does it relate to the manufacturing process? Aseptic manufacturing is the process of producing products free from contamination. It takes place in various industries but is a common requirement for the pharmaceutical and medical device industries because of the need to prioritize patient safety. Following stringent aseptic guidelines ensures that a product’s integrity is not compromised before use.
While aseptic manufacturing isn’t always necessary or available, it is an alternative for sterilizing medical devices, pharmaceuticals, or biotechnologies that are sensitive to heat or radiation. It also ensures the sterility of products that cannot be sterilized after packaging. To be considered aseptic manufacturing, the entire manufacturing process is conducted under sterile conditions, which includes maintaining the sterility of equipment, facilities, and persons involved.
Sterile Materials and Equipment: As a baseline, all materials and equipment used in the manufacturing process must be sterilized to prevent microbial contamination. This is often done using sterilization methods such as gamma irradiation or chemical sterilization.
Sterile Environment: Aseptic manufacturing occurs in a certified cleanroom that eliminates airborne particles. This environment is controlled by monitoring air filtration systems, temperature, and cleaning protocols. These standards also require those working within the environment to comply by wearing hairnets, gowns, and facial coverings.
A cleanroom is an environment that minimizes airborne particles by regulating air quality, temperature, and humidity. This room “controls” the levels of cleanliness required for aseptic manufacturing.
Aseptic Filling: After developing a product, the insertion of the device or pharmaceutical into the final package must be done under, you guessed it, sterile conditions. This step is critical because it involves handling the product in a way that prevents microbial contamination. Often, aseptic filling techniques include isolator technology, blow-fill-seal technology, and other specialized methods to maintain sterility.
Monitoring: Aseptic manufacturing processes are closely monitored through various quality control measures, including regular environment and machine monitoring, sterility testing, and validation studies.
All these components contribute to successful aseptic manufacturing and ensure that industry-required standards of sterility and quality are met. Whether your product requires aseptic manufacturing or post-manufacturing sterilization, reducing contamination is crucial to ensure patient safety – the ultimate priority.