Part I: Shanghai Capalito to carry out a special research on clean clothes.
Part II: Shanghai Capalito provides relevant suggestions and explanations for the cleaning requirements of clean production area and dressing area in GMP.
The third part: Detail requirements of work clothes in the personnel clean production area in GMP. With reference to Shanghai Captial Liton, the reasons for the importance of clean clothes and the characteristics of clean clothes are given, and the higher standards of Captial quality clean clothes are shown.
The fourth part: Shanghai Capelliton clean clothing for a long time to provide customers with efficient service, has become a leader in the human clean protective equipment industry.

In recent years, electronic, pharmaceutical and bioengineering industries have developed rapidly, and closely related supporting industries have also flourished. With the arrival of the epidemic, the need for human clean protective equipment is more urgent. Because our country does not have national standard in terms of dust-free performance testing in related to clean clothes, some are good and some are bad in the market. Capalito conducted a special study on clean clothing by referring to the "Good Practice for Drug Manufacturing Quality Management" and the "Standard Operating Process Guidance for Aseptic Dressing" independently prepared in October 2012.

GMP in clean production area and dressing area clean requirements

Clean clothing is an important protective tool to prevent pollution brought by human body in clean production process. The performance of clean clothing can directly affect the environmental quality of clean room. Therefore, the evaluation and verification of the performance of clean clothing has become a frequently discussed issue in the pharmaceutical industry. Before discussing the performance and validation of clean clothes, first understand the changing area and clean clothes related knowledge and use specifications.

Article 34 Personnel entering the production area shall change their clothes in accordance with the regulations. The material, style and way of wearing the work clothes should be suitable for the job and the air cleanliness level.
Article 35 Personnel entering the clean production area shall not make up and wear accessories.
Article 197 Measures shall be taken as far as possible in the course of production to prevent contamination and cross-contamination, such as:
(1) producing drugs of different varieties in separate areas;
(2) Adopting the staged mode of production;
(3) To set up the necessary air lock room and exhaust air; There should be differential pressure control in areas with different air cleanliness levels;
(4) The risk of pollution caused by re-entry of untreated or inadequately treated air into the production area shall be reduced;
(5) In the production area where cross-contamination is easy to occur, the operators shall wear special protective clothing for the area;

Our new version of GMP has clear provisions for purifying the dressing area. Accordingly, the personnel dressing channel entering the production area of the clean room should be equipped with appropriate dressing facilities according to the production nature, product characteristics, product requirements for environmental level, etc., and its air distribution, pressure difference and monitoring devices should be reasonably designed to meet the requirements of drug GMP for cleaning and dressing. Usually the following factors must be considered: dressing room setup, dressing grading, dressing area differential pressure, about dressing area differential pressure detection, and exit channel setup.
Based on the industrial process summarized over the years, Capelliton recommends the following typical changing layouts:

Note: For powerful drugs, due to the small allowable exposure in the air, in order to prevent the air flow containing drugs in the production area from leaking out through the dressing room passage, the air lock at the end of dressing is designed in a positive pressure way, and a special exit air lock is set in the dressing passage. The exit channel is partitioned according to the controlled ungraded zone (CNC), and the air is filtered through the high efficiency filter. There is a certain number of air changes and pressure difference, and the adjacent room is designed with negative pressure to prevent the possibility of particles being carried out of the dressing area by the air flow during the stripping process. The changing setting of strong sterile drugs adds a sterile underwear room for wearing.

Note: In order to prevent the interference of the air in the ordinary area outside, the air pressure is kept increasing from the first to the third. There is a high efficiency filter in the dressing room, and there is a certain number of air changes, which are considered according to the control ungraded area (CNC). Added exit channel design.

Note: The air lock at the end of the changing process is designed in a positive pressure way, and a special exit channel is set in the changing channel. The exit channel is divided according to the controlled non-graded zone (CNC), and the air is filtered through the high efficiency filter with a certain number of air changes and pressure difference. The relative stripping room is designed with negative pressure to prevent the possibility of particles being carried out of the changing area by the air flow during the stripping process.

Detail requirements for work clothes in clean production areas in GMP

The layout of the dressing area is very important for the clean production area, so the selection and use of clean clothes should be ensured.
Article 24 The work clothes and their quality shall be in conformity with the requirements of the production operation and the cleanliness level of the operation area, and the style and way of wearing shall be able to meet the requirements of protecting the products and personnel. The dress code for each clean area is as follows:
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.
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.
Level A/B clean areas: All hair, beard and other relevant areas should be completely covered with a hood tucked into the collar, a mask should be worn to prevent the release of droplets, and protective goggles should be worn if necessary. Rubber or plastic gloves that are sterilized and free of particulate matter (e.g. 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.
Work clothes should be sterilized one-piece work clothes that do not shed fibers or particles and can retain particles emitted by the body.
Article 26 The work clothes used in the clean area shall be cleaned and disposed of in such a way as to ensure that they do not carry pollutants and pollute the clean area. The work clothes should be cleaned and sterilized in accordance with the relevant operating procedures. It is best to set up the laundry room separately.
Article 16 Personnel entering the production area should change clothes and wash hands; The material selection, style and way of wearing the work clothes entering the clean area should meet the requirements of the general principles; Personnel engaged in toxic and harmful operations to the human body shall wear protective clothing according to regulations. Their special work clothes and the work clothes of other operators shall be washed and sorted separately to avoid cross contamination.

Five features of Garber clean clothes
Personnel and materials entering the clean room will bring external pollutants into the room, especially personnel themselves are an important source of pollution. According to relevant foreign data reports, the source analysis of dust in clean rooms is shown in the following table, and the source of dust from personnel factors accounts for 35%. The sample analysis of clean room air also found that the main pollutants were human skin particles, fabric fibers of clothing and particles of the same nature in the outdoor atmosphere. It can be seen that in order to obtain the air cleanliness required by the production environment, the purification of personnel and materials is very necessary.

Correct aseptic dressing is the most important and high-risk operation for personnel to enter the aseptic production operation area. Correct aseptic dressing operation process can effectively prevent viruses, bacteria, dust particles, fibers and other high-risk pollutants from contaminating the clean area or sterile area. Improper dressing operation will cause these pollutants to be brought into the clean area along with the surface of clean clothes or the leakage of protection, resulting in a decrease in the cleanliness of the clean area, and may even cause serious quality problems for drugs or food.
The requirement for clean clothing is very high, especially for class A/B clean areas. According to the five characteristics of clean clothes provided by Capelliton, five characteristics of high-quality clean clothes are obtained:
1. Less fiber shedding.
2. Electrostatic charge generated in friction can dissipate rapidly in a short time.
3. The hot and humid gas emitted by the human body can also volatilize rapidly through the surface of clothing.
4, human dust particles are not easy to discharge through the gap to the clean area.
5, fiber and auxiliary materials can withstand 121 degrees Celsius high temperature and humid heat sterilization, not easy to aging, shrinkage, fracture, fall off, can greatly extend the life of clean products.
On this basis, Capelliton is the best quality clean clothes. Gabor clean clothes not only have excellent performance of cleanliness, barrier, anti-static and other basic properties, but also ensure durability and safety and comfort in place:
1, cleanliness: no dust, no fiber.
2, barrier: exquisite fabric, low dust penetration rate, can effectively block 0.5 micron particle size above particles, effectively control the human body's own pollution to the clean environment, but also to prevent harmful substances in the environment to human harm.
3, anti-static: the use of high quality raw materials manufacturing, has good anti-static performance, fast dissipation of static electricity during operation, effectively control the dust adhesion, so as to protect the quality and safety of products; In addition, it can prevent the harm of alternating current to the human body.
4, durability: The use of high quality filament fiber, excellent tensile and anti-aging properties, products can be used for about 100 times under the condition of 121 degrees Celsius humid heat sterilization.
5, safety and comfort: the selected raw materials are high quality raw materials, part of the main materials are imported pharmaceutical grade raw materials, and through special treatment, to meet the needs of pharmaceutical grade certification, and wear comfortable and breathable.