The protection of human contamination is an important part of clean environment maintenance. In the cleanroom environment, anti-static clean clothing is the key product for the protection of human contamination, and the performance of anti-static clean clothing directly affects the quality of the cleanroom environment. Therefore, the evaluation and verification of the performance of clean clothing have become a frequently discussed issue in the pharmaceutical industrial
In other industries, such as the electronics industry, the evaluation, and verification of the performance of clean clothing is much more active than that of the pharmaceutical industry.
The basic requirements of GMP on aseptic work clothes are described as follows:
- The selection of materials, style and wearing method of aseptic clothing should be consistent with the production operation and air cleanliness level requirements, and should not be mixed. The texture of the clean work clothes should be smooth, no static electricity, no shedding of fibers and particles.
- Aseptic work clothes should be able to cover all the hair, beard and feet, and be able to retain human shedding.
- The aseptic clothes used in different air cleanliness levels should be washed and sorted separately, disinfected or sterilized when necessary, and the additional particulate matter should not be brought in when washing and sterilizing the aseptic clothes, and the cleaning cycle of work clothes should be formulated.
- Clean work clothes are generally recommended to be washed, dried and sorted in the clean room (area).
The material selection of sterile clothing is now commonly used: superfine polyester filament + conductive fiber.
This fabric is not dusty, not dust-absorbing, with no particle shedding, good particle barrier, high density, high strength, high temperature resistance and other properties. Optional fabrics: 5mm strip type, 5mm grid, 2.5mm grid fabric conductive silk, its dustproof and anti-static effect is increasingly strong.
Aseptic clothing styles are: coat type, seperated type (jacket and pants type), one-piece (coverall, hooded coverall , hooded coverall with socks type).
The use cycle of clean work clothes, Midposi recommends.
121 ℃ autoclaving for 30 minutes, the number of cleaning up to 100 times, the use cycle is 1 to 2 years.
However, everyone needs to verify, verify the performance of clean clothes, verify the number of washable times.
Because the cleanroom clothes on the market are good or bad, the difference is still very big, including the use of different environments, the number of washable times can also be very different.
Evaluating the clean performance of anti-static clean clothes needs to be considered from “dust generation and dust filtration” two aspects.
1, clean clothing should not be dusty itself, in the production and design process should choose non-dusty fabrics and accessories, and in the cutting, sewing, and style design to reduce the possibility of dust and dust accumulation in clothing.
● Observe through a microscope whether the antistatic fibers added to the fabric will become a source of dust generation
● Microscopy to see if the fabric is woven with filament fibers
● Checking whether the garment fabric is less prone to dust
● Helmke roller test
In addition to these simple evaluation methods, IEST-RP-CC003.3 provides the Helmke roller test method to evaluate the dust generation index of antistatic clean clothing and fabrics from a scientific and quantitative point of view. The test method is to put the garment or consumables in the stainless steel roller tumbling and use the air particle counter to test the number of various specified size particles per cubic foot.
2、The dust filtration rate of anti-static clean clothing refers to the effect of anti-static clean clothing in blocking the outward diffusion of human particles. To judge the dust filtering property of anti-static clean clothing.
● Look at the linear density (D number) of the fiber used in the clothing fabric
● Check whether the cutting and sewing of the anti-static clean clothing meet the specifications
● Check whether the style of the garment is reasonable
● Look at the warp and weft density of the garment fabric
● Check the dust filtering effect, a certain concentration of dust is generated upstream, the concentration of particles passing through is detected downstream, and the dust filtering rate is calculated.
We have professional personnel to provide you with free consultation on cleanroom garments, welcome to contact our staff.
