ABSTRACT
Airborne non-viable particles are usually filtered through HEPA filters. If the contamination happens by the transport of particulates into the clean room by moving equipment into the room, people with improper gowning, or materials carried into the clean room without proper sanitization or handling such as contact parts that required sterilization before entry into the room, all these factors might jeopardize room cleanliness and create alarms on the continuous particle monitoring systems (CPMS), which create a deviation that requires justification for compliance reasons and continuity of sterile manufacturing in that suite. Vegetative, endospores, and molds are viable microorganisms that constitute a threat to room sterility and aseptic conditions. Extensive aseptic operator training and certification are very important steps to reduce the impact of people’s unconventional movements in aseptic environments. In addition, the introduction of barriers between the surfaces of equipment used in filling and capping in the aseptic core from the operators surrounding the equipment is helpful in minimizing contamination. The introduction of more automation behind these barriers will improve the quality of consistent products and eliminate unnecessary operator interventions. Ensuring that unidirectional laminar flow confirmed by smoke studies is important in the qualification of aseptic core filling operations by confirming flow regimes through visual smoke. Operators enter through separate gowning and leave through de-gowning areas. The liquid is pumped through channels and filtered using a 0.22-micron sterile filter. All components entering the sterile core must be either depyrogenated or sterilized through irradiation or steam sterilization depending on component chemical characteristics to maintain its functionality and quality.
