The concept of a pollution control strategy (CCS) was first introduced in Annex 1 of EU GMP, Production of Sterile Products, with personnel listed as one of the control elements.
Personnel pollution control includes personnel training, hygiene and behavior. On the training of personnel, behavior habits, we have described in the previous article, this time on the health of personnel to do with you to discuss the content of health.
The importance of human health
People are the biggest source of pollution in clean rooms. According to the source analysis diagram of clean room particles, it can be seen that personnel pollution is the first factor, followed by equipment and production process.
Pollution is the most important factor affecting the quality and safety of drugs, so it is very important to control and manage the health of personnel.

Establishment of personnel health records
1. Health check for new staff
When new employees enter the company, they must have a comprehensive health check to ensure that they do not suffer from acute or chronic infectious diseases. In addition, we need to arrange other specific inspection items according to the specific post.
2. Establish employees' personal health records
Pharmaceutical manufacturers shall establish personal health records of their employees to facilitate the inspection, understanding and tracking of their health status. Human health conditions are dynamic. In order to prevent employees with infectious diseases or health carriers, skin diseases and injuries from directly participating in drug production, which may cause pollution and affect drug quality, drug manufacturers should formulate strict procedures.
3. Requirements of personnel health condition
(1) The health condition of personnel is closely related to the quality of drugs. Procedures should be formulated to carry out annual health examination for employees and keep them in good health. Patients with infectious diseases or personnel with wounds on the body surface should not engage in drug production.
(2) When the staff who enter the sterile operation area fall ill (such as cold, cough or other types of infection), they should report to the management in time; If the disease condition may affect the quality of the product, the manager should arrange other appropriate temporary work.
(3) Other areas shall develop corresponding SOP according to the requirements of different levels of clean areas.

Procedures and training for staff health work
The establishment, training and implementation of scientific personnel health procedures are beneficial to the development of personnel health work. The development of hygiene procedures is conducive to the development of good hygiene habits for employees and the cultivation of employees' consciousness and initiative to strictly follow all cleaning plans and written hygiene procedures.
Practice shows that a large number of pollution problems are caused by the lack of hygiene training for employees and the employees do not follow the relevant hygiene rules. All personnel should receive training on hygiene requirements. The health training plan of drug manufacturing enterprises should emphasize its effectiveness and comprehensiveness, so that employees are familiar with the hygiene procedures of the enterprise and can comply with them.
The training should include basic knowledge of hygiene and microbiology. Untrained external personnel (such as external construction personnel or maintenance personnel) should be given special detailed guidance and supervision when they need to enter the clean area during production.
Access to production and quality control areas should be limited. When unavoidable, visitors should be instructed on personal hygiene, changing clothes, etc. Persons suffering from infectious diseases, skin diseases, skin wounds, and persons with potential adverse effects on the quality and safety of drugs are not allowed to enter the production area for operation or quality inspection. Unauthorized personnel shall not enter the production operation area.

The control of human hygiene
The control of personal hygiene includes the development of personal hygiene habits and the control of personal health.
1. Develop personal hygiene habits. For drug production personnel, human hands are the most important tools used in the work, while human face and hair are the parts most exposed to the production environment. If you do not develop good personal hygiene habits, even if the work site again strict cleaning and disinfection measures, it is difficult to improve the health of people. Therefore, it is very important for pharmaceutical workers to develop good hygiene habits, such as frequent bathing, frequent hairdressing, frequent changing of clothes, frequent washing of hands, frequent cutting of nails, and keep clean.
2. Control of personal health. Due to the particularity of drug production, employees who have direct contact with drugs (materials) are required not to have wounds on their bodies, or to suffer from infectious diseases or other diseases that may contaminate drugs, including skin diseases. It is necessary to have a physical examination before taking the job.

Control of changing requirements
1. Dress code in the workplace:
-- The right dress size
-- Do not mix clothing categories (disposable vs. non-disposable)
-- Wear undamaged clothing
-- Don't wear jewelry
-- No makeup
-- No nail polish (including fake nails)
Don't wear a watch

2, according to the requirements of different clean areas, wear different clothes, changing requirements are also different. Personnel, Chapter VII of Draft Appendix 1 of the EU GMP Guide, specifies the changing requirements for each level of cleanliness.
Level A/B clean areas: Special sterile clean clothing should be worn, and all hair (including beard) related areas should be fully covered and separated from other clean clothing with a hood tucked into the collar. Sterilized face mask and sterilized protective goggles (such as goggles) should be worn to cover all facial skin to prevent the shedding of droplets and particles. Rubber or plastic gloves that are sterilized and free of powder (such as talc) should be worn, and foot covers that are sterilized or sterilized should be worn, with pant legs tucked into foot covers and cuffs tucked into gloves. The clothes should not shed fibers and particles and can retain particles from the body. Clean clothing should be packed and folded so that operators do not touch the outer surface during changing.
Grade C clean area: Hair, beard and other relevant parts should be covered and masks should be worn. You should wear a one-piece suit that tights at the wrist or a work suit that separates your pants, and appropriate shoes or shoe covers. Clothing should not shed fibers or particles.
Grade D clean area: Hair, beard and other relevant parts shall be covered. Appropriate work clothes and shoes or shoe covers should be worn. Appropriate measures should be taken to avoid contaminants brought outside the clean zone.
Gloves should be worn when performing activities defined by CCS as having a risk of contamination in Class C and D areas.
For the changing video, you can ask the Garber staff for the "Aseptic Changing Standard Operation Guide" video textbook. This video by Capelliton independent research and development design, is the first domestic launch.

Aseptic contamination control is an important measure to ensure the quality and safety of drugs, and human is the biggest pollution source, so the control of human pollution is particularly important. That concludes this series of articles on staff training, hygiene, and behavior. Thank you for your continued interest.