[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.
in conclusion
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!
