Biological vaccine cleanroom design and air pressure control skills

Regarding the future development of the biological products industry, the industry predicts that it will continue to grow, and the industry structure will be further adjusted. As a part of biological products, biological vaccines have developed rapidly in recent years, and their market share has continued to increase. In this context, ensuring the high-quality output of biological vaccines and safely delivering them to patients has become a goal that many biological companies continue to pursue.

There are many factors that affect the quality and safety of biological vaccines, among which the layout design of the clean room is a major key. Under normal circumstances, the basic layout design of a clean room is mainly composed of a working area, two changing rooms and a logistics airlock room. Among them, the outer dressing room is used to change personal clothing, the inner dressing room is used to change work clothes, and the logistics airlock room is used to enter and exit items, equipment or waste. The construction of a clean room is inseparable from cleanroom panels and cleanroom doors.

The design of the biological vaccine clean room should make full use of the existing space, and plan the layout according to the relevant national regulations and the special requirements of the experimental site. The requirements of primary barrier and secondary barrier should be implemented at the same time. The primary barrier is mainly reflected in the layout and maintenance structure of the microbial experimental area, and the secondary barrier is mainly reflected in the air conditioning purification system.

In addition, in terms of layout, the flow of people and logistics should be separated to prevent cross-infection of people and objects. The experiment operator enters the P2 main laboratory through a buffer room and a buffer room two. The experimental objects enter and exit the P2 main laboratory through two interlocking pass boxes. One interlocking pass box is located between the main laboratory and the preparation room, and the other is located between the main laboratory and the washing and disinfection room to ensure cleanliness. The objects are not infected, and at the same time, it ensures that the pollutants are transmitted into the scrubbing and disinfection room as soon as possible for disinfection and sterilization.

On the whole, when the biological vaccine clean room is laid out, the entire layout must meet the requirements of national standards and test sites, and make full use of the building space divided by the test site, and be equipped with various requirements in accordance with the laboratory operating procedures. The size of the functional rooms should also be allocated according to the experimental functions.

The biological vaccine clean room should pay attention to the control of air pressure, because the production of biological vaccine mainly includes antigen production, vaccine emulsification and packaging, raw material allocation, quality inspection, equipment cleaning preparation, and pollutant treatment. The basic feature of a clean area is that there are no contaminants such as viruses. In order to ensure product quality, it is necessary to prevent the harm caused by external pollutants to the produced products, and the air pressure of the clean room must be controlled.

It is worth mentioning that the area where antigen production, quality inspection and pollutant treatment are located is a biological pollution area, and the air pressure is designed to be negative pressure. The area where vaccine emulsification and packaging, raw material allocation, and cleaning preparation of equipment are located is a pollution-free area, also called a clean area, and the general air pressure is designed to be positive pressure.  

The clean room air pressure design principle of the biological vaccine factory is to reduce airborne particles, and at the same time play a corresponding role in controlling pollution. The specific performance is: first, the working area for the purpose of protecting the product should maintain positive pressure; second, the working area for the purpose of protecting the environment should maintain negative pressure; third, it is necessary to protect the product and the environment The working area must have both positive and negative pressure.

Regarding the air pressure control of the biological vaccine clean room, there are mainly these aspects, including the pollution control area, the pollution control clean area for operating special viruses, the clean cleaning area, and the nested work area. The air pressure control in these aspects is worthy of careful consideration of the new biological vaccine project, in order to better avoid contamination of the product.

In addition to the design and layout of the clean room and the control of air pressure, for new projects, the project cost can also be reduced by changing the cost factor variables, so as to ensure efficient and safe operation. For example, it can be cleaned by the number of air changes; air filtration; air processor; air pressure difference; temperature control; exhaust system; vibration and noise control; magnetic flux and electromagnetic flux; unidirectional, turbulent, vertical or horizontal airflow The room carries out basic design and standard improvement.