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Advanced Aseptic Processing starts with the facility:
To assure safety and efficacy of the medicines many rely on, the manufacturers must embrace advanced aseptic processing. To the regular person, this might sound like a fancy buzz phrase but to those in the industry and those creating the powerful therapeutics that patients rely on, this is a powerful concept that is embraced. You might ask, “What is Advanced Aseptic Processing?” or “How does that work?”
Advanced Aseptic Manufacturing starts at the beginning, during the design of the facilities where sterile products are manufactured. The facility design helps to build the foundation for clean and efficient aseptic manufacturing of biological and pharmaceutical products. This starts with the architects’ and engineers’ choices in materials of construction. The spaces where sterility is required, need to be built out of materials that are conducive to cleaning and that are not food for microbiological organisms. This includes impervious, hard surface wall, floor, and ceiling materials, which biocidal agents like peroxyacetic acid, sodium hypochlorite, and various alcohols do not impact. Materials that stand up to those agents help to ensure contamination can be controlled.
Once the construction materials are identified, the facility layout and process flow can be designed into the facility. A robust aseptic design can be defined by the layered control of material, people, and product flows from the non-controlled, aka dirty space to the clean areas where processing takes place. To maintain aseptic conditions, the facility’s layers of control come into place. This stepwise, progressive decontamination or contamination control process allows for incremental control of contamination when transitioning into and out of the clean space where aseptic processing occurs.
The final aspect of the facility that is critical to the assurance of aseptic process control includes the design and implementation of robust heating, ventilation, and air conditioning (HVAC) systems. The design of the HVAC is critical to the maintenance of clean spaces. The design elements for the HVAC that matter most for advances aseptic processing include the temperature control, humidity control, airflow characteristics, and the filtration designed into the system. The temperature and humidity control in the aseptic processing spaces is not just for comfort of the personnel but also can help with the control of microbial contamination. Maintenance of a controlled temperature and humidity environment reduces the likelihood that microbial growth can flourish. A cool and dry environment is not conducive to the growth of bacteria, molds and fungi.
Airflow is critical in aseptic processing to ensure that the airflow is laminar, that it flows smoothly from ceiling to floor, without agitating the surfaces that it passes over. Laminar airflow must be designed into the HVAC using engineering calculations and then must be confirmed with critical airflow visualization, also known as smoke studies. When laminar airflow is established, the filtration can do its job to remove particulate matter from the air stream before it is introduced into the clean space. Not only is the design critical, but the testing of the high efficiency particulate air (HEPA) filtration is required to ensure that integral filters have been installed. Continuous monitoring of the air is the final HVAC control. Continuous particulate monitoring ensures the space remains clean and alerts the staff to the introduction of particulate contamination.
Once the facility is established, the equipment can be selected, further enhancing advanced aseptic processing capability. Coming up, equipment choice and implementation matters for advanced aseptic processing.
