Why is maintenance necessary in sterile processing areas?

Why is maintenance of sterile areas important? What procedures need to be applied in the maintenance of sterile areas? Let's find out detailed information with Anh Khang through the following article.

How to maintain sterile processing areas?

It is important to regularly and planned maintain sterile production areas. Because many things can cause contamination in this area, including the staff working here. A small contamination in the sterile area can contaminate the entire batch.

Procedures to be applied in the maintenance of sterile areas

Applying regulations and good manufacturing practices are important standards to ensure the pharmaceutical manufacturing industry.

Extreme caution is needed, especially when manufacturing sterile drugs and other biological products, by using sterile processing areas.

The critical area is where exposed sterilized drugs, packaging, and utensils can come into contact with external conditions. Therefore, it must be designed and manufactured to keep the product sterile.

Maintenance of sterile processing areas is very important

How important is the maintenance of sterile management areas?

>> See more: What are the costs when building a GMP factory

An exposed product is very susceptible to contamination. It is also likely that it will not be sterilized in the container immediately. Therefore, the quality of the environment in which sterile operations are being conducted needs to be controlled and well maintained. Air quality needs to be properly controlled, especially airborne particles.

Supporting clean areas are needed, as these are areas where non-sterile components, in-process materials, equipment, and containers are stored and transferred. Therefore, the need is to have a clean working environment to minimize the level of particulate contamination in the final product before they are sterilized.

Need to ensure separation of clean areas

Ensuring the separation of clean areas is very important. Because it is an essential part of preventing contamination in pharmaceutical processing. Airflow ensures the quality of higher cleanliness areas compared to other less clean areas.

A positive pressure differential of at least 10 - 15 Pa must be maintained between adjacent rooms with closed doors. Monitoring of these air pressure differences should be regularly monitored from shift to shift.

In addition, air filtration should be performed using HEPA filters to ensure that the air inside the rooms is equal to or better than the air in the environment into which the air is introduced.

Initial design needs to consider the maintenance of sterile areas

The plant design process is a very important factor in the pharmaceutical industry. The sterile process must minimize the exposure of sterile products to potential contamination hazards during manufacturing.

Issues that you need to consider include:

• Processes are optimally designed to limit exposure time to sterile products,
• Good environmental controls, process optimization, and good equipment design to prevent the ingress of lower quality air are very important factors.
• In addition, working personnel and material flow when entering need to be optimized to minimize and prevent activities that could introduce contaminants into the exposed product.

The sterile process needs to be maintained, well designed, and operated to minimize staff intervention. Always use good sterile techniques to ensure the sterility of the product is maintained.

For personnel, appropriate training should be conducted before that individual is allowed access to certain critical areas in the process. Training topics should include hygiene, safety hazards, specific written procedures, regular ongoing programs, aseptic filling techniques, cleanroom behavior, microbiology, etc.

It should be noted that some key techniques for maintaining the sterility of all items and surfaces are critical areas that may include:

• Only touch sterile materials with sterile instruments.
• Slow movements to avoid any disruption to control parameters.
• Keep your entire body out of the path of unidirectional airflow to protect sterile equipment, products, and containers from contamination.
• Maintain proper power supply to control all forms of human-generated pollution.

Hopefully, the information on the maintenance of sterile processing areas will be useful to you. If you are interested in consulting cleanroom design and construction for pharmaceutical, cosmetic, etc. factories, please contact the hotline for the fastest support.

For detailed information on CLEANROOM CONSULTATION - DESIGN - CONSTRUCTION, please contact here:

Anh Khang Cleanroom Mechanical Electrical Joint Stock Company Hotline: 1900 636 814 Email: info@akme.com.vn Website: akme.com.vn Add: Lot B7 Xuan Phuong Garden, Trinh Van Bo Street, Phuong Canh Ward, Nam Tu Liem District, Hanoi.