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Home > News > Real shot | Into Guangdong Jia Mei medical mask GMP purification workshop

Real shot | Into Guangdong Jia Mei medical mask GMP purification workshop

2020-06-01
The global outbreak of new coronavirus infection pneumonia continues to affect everyone's sensitive nerves. With the constant appeal of medical experts, people are paying more and more attention to masks. Today, the author takes everyone into the site of the 100,000-level dust-free production workshop in the industrial park, only guarantees each batch of products, and each piece reaches the goal of 100% pass rate when it is produced. Friends who are familiar with the classification of medical devices should know that medical devices are divided into three categories, and masks belong to the second category of medical devices. Whether it is a medical cup-type Protective Mask or a disposable Medical Mask, the production environment must be at 100,000 level (medical name: D-level clean Workshop) or above in a clean workshop. This is a national mandatory requirement, the production environment must be dust-free and standard, and masks with special requirements must be produced within the specified constant temperature and humidity range.


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What standards should the 100,000-level purification workshop meet?

Our production site must meet the maximum allowable number of dust particles ≥0.5 micron particles not exceeding 3.5 million, and ≥5 micron particles not exceeding 20,000. The maximum allowable number of microorganisms, the number of planktonic bacteria does not exceed 500 / m; the number of settled bacteria does not exceed 10 / dish. Differential pressure. The pressure difference between clean rooms of the same clean level should be the same. The pressure difference between adjacent clean rooms of different clean levels should be ≥5Pa, and ≥10Pa between clean rooms and non-clean rooms (mainly to ensure that air flows from clean areas to Clean area, avoid airflow backflow).

Employees strictly implement production process standards

Outside the gate of one of the workshops, it is the place where employees put on shoe covers and wear "mushroom hats". These two pieces of equipment seem inconspicuous, but the company has very strict requirements. In the production workshop, employees wear masks and coveralls. According to the operation manual, employees need to be "fully armed" during the production process. Only when they leave the workshop can they take off their protective clothing. Wear masks, disposable gloves, protective clothing and shoe covers, and enter the designated clean workshop to avoid mutual influence. This is not only a requirement for epidemic prevention, but also a production requirement.


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To ensure the safety and quality of the production of Protective Equipment According to the regulations, whether it is a N95 mask or a disposable medical mask, it must be produced in a purification workshop with a level of 100,000 or above, and must have microbiological laboratory testing capabilities and related physical and chemical testing capabilities. The automatic mask production line is composed of a mask body machine and an ear strap welding machine. The entire process flow includes: material receiving, material storage, material distribution, mask body processing, ear strap welding, and mask packaging. Whether it is an auxiliary area or a production line, it should meet the production requirements and the convenience of operation, minimize the return of materials and personnel, and each function must not cross each other; clean area and non-clean area, sterile operation area and non-sterile The operation area can be effectively separated.

Regarding the quality of the masks that users care about most, the implementation standard of the masks put into production by Guangdong Jia Mei Biotechnology this time is YY / T 0969-2013. What is YY / T0969-2013? It is the production standard of single-use Medical masks. There are clear marks on the outer packaging, which can be verified by the Jiangmen City Market Supervision Administration and can obtain production licenses. Zhongyue Jia Mei KN95 Mask: GB2626-2006 Here we will share with you the protection of Zhongyue Jia Mei KN95 level. The standard is 0.3 microns. The penetration efficiency of penetrating particles is 95%. Between 1 micron and 5 microns, so, for daily protection, this level of mask is completely enough. Even if it is to protect the virus spread by droplets in a closed space (in the hospital), the Zhongyue Jia Mei KN95 mask is enough.

After going to a special closed environment, such as a hospital, we can't make sure whether the condition of the person next to you is contagious. Therefore, the safest way is to wear a mask without a valve, to fundamentally prevent the possibility of a virus entering the mask when the valve opens when the valve is exhaled. In fact, the KN95 masks, disposable masks and protective-grade isolation suits launched by Guangdong Jia Mei Biotechnology are not considered to be cross-border. It is precisely because the development of a high-quality mask requires the same level of core technology and production environment, so it has accumulated a long-term foundation in the field of medical aesthetics and is fully equipped with professional mask manufacturing capabilities.
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