We all know that people are the biggest source of pollution in the clean environment where pharmaceutical factories work. At this time, clean clothes and other equipment are needed to isolate and protect people from the environment. In addition to the high requirements for the cleanliness performance of the clean clothes itself, it is also necessary to determine the pollution particles attached to the inside and outside of the clothing.
Cite four commonly used methods of measurement, namely: microscope method, counting method, rotating drum method (roller method) and vibration test method (vibration method).
We introduce in detail the steps for these four measurement methods:
1. Microscope method: The test probe is equipped with a filter diaphragm, directly connected to the suction metering pump, and the amount of air passing through is 28L/min. During the test, the air is passed through the test cloth, and the dust particles contained in the air are captured on the test filter membrane, and the number of dust particles is counted by observation with a 400-fold microscope. Read the number of particles 0.5-5 and above 5 on the filter membrane. A 3.08mm grid is printed on the filter membrane, and the number of particles in a grid can be read.
2. Counting method: let air pass through the test cloth, and measure the size and number of dust particles with a particle counter. Place the sample on a table with a metal mesh, and use a sampler (replaced with a 47mm filter holder) to contact and attract, and the amount of air passing through is 28L/min.
3. Roller barrel method: Put the sample in a rotating barrel with side openings and rotate, sample the dust particles from the barrel, and determine the cleanliness level after measuring the number of particles with a particle counter. The size of the rotating drum is 43cm×33cm, and there are 4 blades on the inside of the barrel, and the speed of the barrel is 10 revolutions per minute.
4. Vibration method: Put the sample in a small chamber, generate particles through vibration and twist, and measure with a particle counter. At the same time, the particles with a large particle size (above 25) are trapped on the filter membrane and the number of particles is read. The air volume is 3.5 feet/minute (0.099m/mim), and the vibration frequency is 150 times/minute.
In addition, my country currently does not have a national standard for dust-free performance testing of clean clothes. You can refer to the Japanese Industrial Standard JIS-B-9923 and the American IES Standard RP-CC-003-87-T studied by the Special Committee of the Japan Air Cleaning Association.
For the evaluation of cleanliness performance, each industry can differentiate and use it according to the clean room standard specified in the international standard ISO/TC209, combined with their own cleanliness level. For more information about clean clothes, add WeChat ID: shjiabo, welcome to join the Jiabo clean clothes lecture hall.
The first paragraphs
The human body is the largest source of mobile pollution in a clean area: The pollution source comes from the body's own surface, all the harmful substances that can be emitted or shed by the wearable equipment, and the harmful substances contained in the gas exhaled by the human body (coughing, sneezing).
There are two main categories:
1. Organic harmful substances: bacteria, viruses, dander, hair, human secretions, etc. carried by the human body.
2. Inorganic harmful substances: clothing microfibers, dust particles (elements: potassium, chlorine, phosphorus, sodium, calcium, carbon, nitrogen, sulfur, iron, titanium, aluminum)
Example: Statistics on the types of bacteria in the clean room
The Second paragraphs
Goals to be achieved by human body cleansing protective equipment:
1.Prevent the particles or fibers produced by the clean clothes and other equipment from being brought into the clean area or aseptic area with the clean personnel due to material and production process problems.
2.Prevent clean personnel from bringing clean equipment contaminated by the outside into the clean area or aseptic area.
3.Prevent viruses, bacteria or other harmful micro-particles from the surface of the cleansers' bodies, and micro-pollutants in the exhaled air from penetrating the outer surface of clean clothes and other equipment to invade the clean area.
4.Prevent harmful substances in the controlled environment from injuring the personal safety and health of clean personnel by penetrating the barriers of clean clothing and other equipment.
The Third paragraphs
The configuration method of human body clean protection equipment:
1.Clean personnel wear equipment including: clean bags, tops, pants, or coveralls, masks, clean shoes, work hats, protective goggles, protective gloves, etc.
2.Different industries or different levels of clean areas need to be equipped with different configurations of clean equipment:
1) D-level areas or areas with lower cleanliness levels, with hats, coats, trousers, shoes, masks, gloves, etc.
2) A/ In areas with high cleanliness levels such as Class B and C clean areas (Class 10, Class 100, Class 1000), it is generally necessary to wrap the entire body with one-piece caps, masks, goggles, gloves, high-tube shoes, etc. among them, the high cleanliness The protective equipment worn by the cleansers in the high-level area should not have exposed body parts. The quality requirements of human body clean protection equipment:
1.Clean work clothes and other supporting products require that their materials are free of fiber shedding, no balling, uninterrupted silk, permanent anti-static, non-adhesive particles, and good filtering performance.
2. It is resistant to aging, washing, abrasion and has good resistance to high temperature, humidity and heat sterilization; all items to be sterilized must withstand disinfection and sterilization at a high temperature of 121°C.
3. The fabric should be soft, comfortable and breathable (under the premise that it is not dust-proof).
4. In addition to the style that meets the requirements of the corresponding clean area configuration, the details require no pockets, no belts, tight seams, smooth texture, and elastic cuffs and trousers (depending on the configuration).
The Fourth paragraphs
Wear the human body clean and protective equipment correctly:
1.The appropriate equipment size should be selected for each person to wear to ensure that it is close to the body, comfortable and easy to operate at work.
2.According to the requirements of different industries and regions, formulate corresponding SOP rules for changing clothes, and strictly operate and manage in strict accordance with the changing procedures.
3.Clean personnel should try to avoid large movements or operations during the production operation, their hands should not be crossed on their chests, and they should not lean on any objects including walls.
The Fifth paragraphs
Properly manage human body cleansing protective equipment:
1. Work clothes should be numbered and dedicated for special use. To prevent cross-contamination, they should not be mixed.
2. Formulate correct equipment cleaning and sterilization procedures, including cleaning frequency, time, sterilization frequency and time, and make compliance records. Clean clothes that are damaged, defibered, or have reached the end of their service life, should be scrapped in time.
3.Each shift is cleaned, dried, folded and put into their own clean clothes bag or underwear bag in the laundry room of the corresponding clean area. If sterilization is required, sterilize the clean bag together with the equipment on the inside. After cleaning and sterilizing, put it in the wardrobe in the specified area for storage for easy access.
4.Clean equipment used in different regional levels shall be cleaned, dried, sterilized and stored separately, and marked to ensure that no cross contamination occurs.
5.The clean clothes and equipment after cleaning and sterilization should be used within the valid period of the verification, otherwise they need to be re-sterilized before they can be used. The clean clothes after sterilization should be regularly checked for bacteria and recorded.
6.Use purified water or water for injection to clean, and add a proper proportion of special cleaning agent, the cleaning agent is a non-ionic surfactant.
[Pharmaceutical protective clean clothing element one]: cleanliness
It is not difficult to understand literally, just like we manufacture medicines, from its raw materials, to ingredients, to the manufacturing process, the entire manufacturing management process, to the final assured medicine. The manufacturing process and manufacturing principles of clean protective clothing are also the same. Due to the particularity of the environmental level of the pharmaceutical industry, all products in this environment will have the same strict requirements, such as whether they meet the cleanliness requirements of this level, While protecting the human body from pollution, whether the protective product itself is dust-proof, dust-tight, and dust-free; in addition, is it possible to make the product sterile through some sterilization gloves?
In response to the above requirements, clean protective equipment will have many high requirements from the selection of materials and auxiliary materials: First, the fabric must be woven with chemically synthesized filament fibers. If you use filament fibers to weave natural fibers such as cotton and hemp, because they are short fibers, it is easy to produce particles at the ends of the fibers, so they cannot be used in clean rooms. In addition, since the fibers spun from recycled chips contain a certain proportion of recycled materials, there are more impurities in them, which will increase the dust of the fabric, so it cannot be used in a clean room. Clean clothes must use anti-static fibers, and incorrect selection of anti-static fibers may cause pollution. At present, there are two common anti-static fibers-surface carburized anti-static fiber and composite spinning type anti-static fiber. The surface carburized anti-static fiber is coated on the surface of the substrate because of its conductive ingredients, which is susceptible to washing and friction, which will increase the amount of dust generated by the fabric. It cannot be used in a clean room environment. The composite spinning type anti-static fiber is fully mixed with the conductive component and the molten matrix material, and then composited with the matrix material through the special spinneret hole to form a fiber, so it is wear-resistant and washable, and is not easy to generate dust. If the surface of the anti-static fiber is rough and has light-transmitting spots, and it can be judged as a surface carburized anti-static fiber, it cannot be used to make clean clothes. The warp and weft density of the fabric is an index reflecting the degree of tightness of the fabric. The higher the warp and weft density, the smaller the gap of the fabric, and the better the dust filter rate at this time. The dust filter rate is also another important indicator of the cleanliness performance of clean clothes.
The second is the auxiliary materials. There are many auxiliary materials that make up the clean clothes, such as zippers, elastics, snaps, sewing threads, etc.; for the auxiliary materials, we need to do several checks to see if the auxiliary materials generate dust; whether the auxiliary materials have high temperature sterilization performance (usually 121 Degree of heat and humidity sterilization).
Furthermore, check whether the cutting and sewing of the clean clothes meet the specifications. Improper cutting and sewing will increase the amount of dust generated by the clean clothes. This is because the edges of the garment pieces will emit particles. Therefore, the clean clothes require the use of rolls. Edge, three-folding, piping, or four-folding, etc. are used to process the connection of the pieces. And for the exposed burrs to be hot-melted, some high-grade clean clothes also require laser cutting of the fabric to reduce dust.
Finally, check whether the style of clothing is reasonable. The design of clean clothing requires that it is not easy to accumulate dust, including: reducing clothing wrinkles; pen holders must not be back covered; reducing unnecessary accessories (such as pockets). In addition, the design of clothing styles should not be too loose, which can reduce clothing friction and control dust generation. When evaluating a clean suit, these requirements should also be used as assessment indicators.
[Pharmaceutical protective clean clothing elements two]: anti-static
Anti-static property (The content includes: Does the clean clothing of pharmaceutical companies need anti-static property? What are the effects if improper use? How is anti-static processing? How to test anti-static performance?)
In addition to the product's sensitivity to static electricity, most clean rooms require that the environment be in constant temperature and humidity conditions for a long time. The static electricity generated in the clean room is more difficult to eliminate, and the static control performance of the clean clothing is particularly important. There are two main ways to ensure the electrostatic performance of clean clothes. One is to choose fabrics with good anti-static properties. The other is to ensure the overall electrical connectivity of the clothing and to be well grounded when wearing it.
There are usually three antistatic processing methods for fabrics: ①The fabric is finished with an antistatic finishing agent; ②The fiber grafting modification for the purpose of improving the moisture absorption of the fabric, the blending and interweaving of hydrophilic fibers; ③Blend spinning or inlaid weaving Anti-static fiber. Three different processing methods bring different effects. The mechanism of the first two methods is to increase the moisture regain and hydrophilicity of the fabric, reduce the insulation, to accelerate the leakage of static electricity, so in a dry environment or after multiple washings, the effect is either not durable or not significant, generally only Applied to fabrics for general clothing. Only the third method can last.
Efficiently solve the static electricity problem of textiles, so it is currently widely used in the production of anti-static work clothes. The resistance, amount and method of the anti-static fiber determine the anti-static performance of the fabric. In the case of a certain area, the greater the amount of anti-static fiber added, the better the anti-static performance of the fabric. According to the electrostatic sensitivity level of the clean room, different added amount of fabrics can be selected. The anti-static fiber is generally black or gray, so the appearance of the interwoven anti-static fiber is generally black stripes or grids.
Inspection method: Use scissors to cut the fabric along the edge of the black conductive fiber, and separate the black conductive fiber. Use a magnifying glass to observe whether there are one or more thick fibers in it. Use a surface resistance tester to measure the separation. The electrical resistance of the conductive fiber. By removing a few in a row, it can be basically judged whether each black thread in the fabric contains conductive fibers.
In addition, as mentioned in the previous article, the surface carburized anti-static fiber is not suitable for use in a clean room environment due to its own characteristics. Therefore, it is necessary to pay attention to judgment during inspection. After adding anti-static additives to the fabric, the electrostatic performance is not ideal and not lasting, because the additives themselves are also a kind of macromolecular organic compounds, which will pollute the clean room environment, so they cannot be used in the clean room.
To ensure the electrical continuity of the whole clean clothes, conductive sewing threads must be used; for some clean clothes with particularly high static electricity requirements, conductive tapes must be used in the splicing parts of the fabric, and conductive ribs must be used at the cuffs and feet; Add a grounding point to the appropriate position of the clothing. The use of these auxiliary materials is an intuitive basis for judging the electrostatic performance of clean clothes.
[Pharmaceutical protective clean clothing element three]: Durability
The utility of the clean clothes decreases with the use time. To ensure the durability of the clean clothes performance, it is not only beneficial to reduce the frequency of replacement of the clean clothes and reduce the production cost, but more importantly, it can prevent the failure of the clean clothes during the service life. Harm to production. The durability of clean clothes needs to be considered in terms of durability of clean performance and durability of electrostatic performance. The main indicator of cleaning performance and durability is the level of pilling of the fabric, which reflects the changes in the surface of the fabric after rubbing for a certain period of time under the specified procedure. In clothing with a low level of friction and pilling, the fibers are easily broken and pilled during use, and particles are generated, which pollute the clean room environment. The breakage of the fibers will cause the partial filtration efficiency of the clean clothing to decrease, which cannot meet the requirements of dust filtration.
Several common problems: 1. The quality of the anti-static fiber and the silk. The quality of the yarn is caused by uneven tension control. The conductive yarn floating on the surface is easily broken, and then falls off from the fabric, which affects the conductivity and damages the cleanliness. 2. Use the hook of the hook and loop fastener to rub the fixed position of the garment, observe and compare the friction and fluffing of the two garments, and you can also preliminarily judge the fluffing and pilling of the clean clothes fiber; 3. The fabric with longer floating length , Due to the small traction between the fibers, it is easy to fuzz and pilling; 4. Fabrics with insufficient warp and weft density are also prone to fuzz and pilling; 5. On high-grade clean clothes, you should use as little hook and loop as possible, and metal buttons can be used To adjust the tightness.
[Four elements of pharmaceutical protective clean clothing]: comfort
Due to the particularity and importance of the products produced by the pharmaceutical factory, it has a cleanliness requirement for the workshop. Objects other than people can be sterilized, isolation and other measures can be used for risk control, but the human body cannot be sterilized. Only effective protective equipment and a reasonable dressing process can be used to achieve isolation and isolation to control pollution risks. . Therefore, in a specific environment, in addition to considering risk control, humanization must also be considered when armed with layers of arms. The basic comfort of clothing is lost. A clean garment with perfect function is also a huge burden for the wearer. Therefore, clean clothing should have a certain degree of air permeability and moisture permeability to avoid the stuffy feeling when wearing; in the style design, the freedom of movement after wearing the clothing should be considered as much as possible; at the same time, the fabric should be careful to avoid excessive light transmission. Generally speaking, improving the dust filterability of clean clothes comes at the expense of air permeability and moisture permeability. Therefore, the air permeability and moisture permeability of clean clothes must be controlled within a certain range, and the air permeability should be maintained at 3～120 l/dm2*min. On the premise of ensuring clean performance, to improve the air permeability and moisture permeability of the fabric, we can consider using a new type of moisture-absorbing and sweat-wicking fiber, but this will increase the production cost of clothing.
Regarding the evaluation of clean room clothing, there is currently a lack of unified standards and methods, but no matter what method is used for evaluation and testing, they cannot do without [cleanliness performance (high temperature resistance)], [static performance], [durability] and [Comfort], these four basic elements of clean room clothing!
The human body is the largest source of mobile pollution in a clean area. Aseptic dressing is the first and critical step before entering the aseptic operation area. Improper operation will bring microorganisms, dust particles, fibers and other substances into the aseptic area, causing cross-contamination. The complete standard aseptic dressing operation process training generally takes several hours or tens of hours, and can only pass after careful assessment and verification, which shows its importance. Employees must keep in mind the following basic judgment principles when performing aseptic changing operations.
1. Any item without a reliable sterilization process is regarded as "bacteria". Personnel cannot be sterilized, so it is regarded as "bacteria".
2. After a reliable sterilization process, it becomes "sterile". But this aseptic state is time-limited. Those that have passed the time limit are regarded as "bacteria".
3. Aseptic products are regarded as "bacteria" upon contact with "bacteria". Need to be re-sterilized.
4. When "sterile" encounters "bacteria", it is also regarded as "bacteria".
5. A scientifically designed "aseptic dressing process" is the guarantee for the implementation of the concept of aseptic dressing.
1. Hands and gloves: Bare hands are always bacteria-infected, even spraying disinfectant will not work. When wearing sterile gloves, bare hands should not touch the outer surface of the glove, only the inner surface. The inner surface of the glove becomes "bacterial" when it touches the bare hand, and the outer surface of the glove is in a "sterile state". Gloves are broken during work or come into contact with any "non-sterile" objects, which means "bacteria".
2. Head and face: For the human body, the head is the easiest to pollute the external clean area, especially the eyes and respiratory organs are easy to fall off or excrete pollutants. In addition to strengthening the protection of the head, it is also necessary to avoid touching the head with hands wearing sterile gloves as much as possible, thereby destroying the "sterile" state of the gloves. When the aseptic dressing operation is completed, all protections of the whole body must be neatly in place and no exposed.
3. Wear aseptic one-piece clean clothes: This is the most critical moment for aseptic changing. This locker room is a special zone, part of which is a "bacterial zone" and part of a sterile zone. First of all, when a person stands in the "bacteria zone", take a set of one-piece clean clothes. Pay attention that the hands can only touch the inner surface of the clean clothes. Aseptic surface meets the aseptic surface is the most basic principle of the whole dressing process. Reach in one foot first, and step on the "sterile field" after putting it on. When dressing, the outer surface of the other trouser leg and sleeve must not touch any other surfaces, including walls, floors, and the human body, otherwise the "sterile" state will be lost. The coveralls must be replaced again. Put the worn foot on the "sterile area" and put on the other foot. After putting on, step on the "sterile area" and put on the sleeves. When dressing, the outer surface of the sleeve must not touch any other surfaces, including walls, floors and the human body, otherwise it will lose its "sterile" state. The coveralls must be replaced again. If there is no mistake in dressing, after entering the "sterile area", it is not allowed to return to the "bacterial area".
4. Put on the sterile clothes and enter the work room. The door of the room should not be equipped with a handle so that the personnel can push it open with the elbow. It is best to open and close the door automatically to ensure that the sterile gloves are "sterile." The handle touched by many people is a potential source of contamination.
5. When working or not working, put your hands on your chest. Don't support it on other facilities, and don't sag. The human body cannot lean on any objects to avoid contamination of clean clothes.
6. When operating in a clean area or aseptic area, clean personnel should not move or operate significantly, otherwise it will cause serious pollution.
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