New design for sterile processing areas: Innovative solutions for efficiency and safety
15:54 - 04/09/2025 39
This method offers key benefits such as reducing the risk of contamination and reducing the rate of air changes required during aseptic processing.
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Research Background
In sterile pharmaceutical manufacturing and advanced therapy medicinal products (ATMPs), maintaining a clean environment and controlling airflow are core factors to ensure product quality. A group of researchers has introduced a new zoning design for sterile processing areas, aimed at optimizing air distribution, reducing the risk of microbial contamination, and improving operational efficiency.
Principles of Air Pressure Zoning Design
The proposed model divides the sterile processing area into separate zones:
- Critical processing zone: where the most sensitive operations are performed, requiring strict control of particle and microbial concentrations.
- Support zone: divided vertically into two layers (upper and lower), based on airflow characteristics and particle generation sources.
The highlight of the design is the construction of a particle concentration kinetic model, which helps accurately determine the impact of airflow rate on cleanliness levels, thereby optimally adjusting air change frequency.
Main Benefits of the New Design
- Minimize microbial contamination: rational zoning prevents the intrusion of particles and bacteria into critical areas.
- Energy savings: by reducing the number of air changes while still maintaining cleanliness levels according to GMP/ISO standards.
- Simplify operational procedures: reduce pressure on personnel during the gowning process.
- Limit complex connection requirements: eliminate dependence on external piping systems.
Role of Aseptic Connections in Modern Manufacturing
In the context of rapidly developing cell therapies and biopharmaceutical manufacturing, manual aseptic connections play an important role in maintaining the microbial integrity of processes. The new zoning design provides maximum support for this activity, helping ensure product safety and meet international standards.
Application Prospects
The air pressure zoning design model provides a viable solution for sterile manufacturing facilities, with objectives to:
- Enhance microbial safety.
- Optimize energy consumption.
- Simplify personnel and operational procedures.
In the future, this could be a strategic approach for sterile pharmaceutical manufacturing plants and ATMP research centers, contributing to improved product quality and reliability.
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