EU GMP Annex 1 Production of Sterile Products 2020 edition has been released on February 20. Compared with the previous asepsis requirements, this asepsis appendix has been revised to be more detailed and rigorous, and for the first time clearly sets out the CCS assessment requirements for sterile products.
Pollution Control Strategy (CCS) : A set of planned controls for microorganisms, pyrogen and particulates derived from an understanding of current products and processes to ensure process performance and product quality. Controls include materials and components of raw materials, excipients and pharmaceutical products, operating conditions of facilities and equipment, process control, finished product standards, and related monitoring methods and frequency related parameters and attributes. Elements to be considered include plant and process design, plant facilities and equipment, personnel, utility systems, control of starting materials (including intermediate controls), product packaging, supplier approval, outsourcing services, process risk assessment, process validation, preventive maintenance, cleaning and disinfection, monitoring systems, preventive measures, etc.

According to ISPE statistical data analysis, the results of media filling tests in major pharmaceutical factories around the world show that each aseptic process generates an average risk ratio as follows:

In the pharmaceutical industry, the regulations and standards are more and more stringent, "human" as the biggest source of aseptic pollution, their own hygiene habits, health problems, behavior and operation standards and other exogenous factors will bring risks to the pharmaceutical industry, "human" is the most uncontrollable risk factor. The basic and effective methods for personnel risk control are as follows:
1. Establish and maintain a good quality assurance system;
2. Equipped with sufficient quantity and qualified personnel to complete all operations, production operators should master the basic knowledge of microorganisms and develop good hygiene habits;
3. All personnel should clearly understand their responsibilities and operational norms;
4. High-quality personal protective equipment should be equipped. All personnel entering the clean area need to undergo dressing training and develop scientific clean clothing management system;
5. The process and production operation should minimize the risk of pollution caused by personnel and production operation, and wear, walk, move and operate correctly;
6. Master relevant knowledge of laws and regulations;
7. Received systematic training and passed the assessment.

To sum up the above points, the pollution control of personnel can be summarized into several key words: personnel training, health and behavior. Today, we will discuss the behavior and habits of personnel. We should pay attention to posture, movement, speech and habits.

1. Posture
Don't lean on any surface;
Don't squeeze the overalls;
Do not lean materials against people;
Body away from the product;
Stand up straight to minimize disruption of airflow;
Keep your arms at or above your waist line;
2. Action
Avoid strenuous physical activity, do not walk quickly, turn around;
Open and close slowly, not open and shut;
Do not let any item pass over the product, do not operate above the product;
Do not contact with each other, keep a distance;
Avoid unnecessary movements and try not to do squats;
Keep standing or sitting when not participating in the process;
3. Talk
Try not to talk, do need to exit the key area before talking;
Don't shout unless you really need to;
Do not communicate through openings, inlets, or airlocks;
Sneeze away from the product, then change the mask;
Do not touch the mask with your hands, and do not take off the mask to speak in the sterile area.
4. Habits
Exit the clean area immediately after the work is completed to reduce the number of personnel in the clean area;
People should stand in the lower outlet: the air supply first to the exposed products, then to the personnel, and finally to the return air or exhaust air;
Do not touch, scratch the skin, rub the nose, if the occurrence should go back to the locker room for a new glove, mask;
Do not touch the floor, when there are items falling, if there is no risk, can be removed at the end of the day cleaning;
The equipment in the critical area shall be sterilized or cleaned again when it re-enters the production state after leaving the area;
Contact sterile materials only with sterile tools, do not leave the A-level area;
Do not pass near the laminar flow zone, leaving at least one meter;

"Human" is the most uncontrollable factor in aseptic pollution, so it is very important to develop good behavior habits for pollution control. The following articles will elaborate on personnel training and health, and welcome your continuous attention.