Detailed flow of articles and personnel in the production workshop of medical mask clean room

First of all, Haili Heng Purification will introduce the classification of masks, which can be divided into the following three categories:

1. Common decorative mask

The masks are made of common cotton fabric and are mainly used for decoration and warmth. Cannot be used for novel coronavirus infection prevention. Ordinary clothing production companies can produce. It does not belong to the medical device, do not need to apply for "medical device production license.

2, labor protective mask

This kind of mask is mainly used to prevent dust and harmful gases in the process of labor production. Various dust masks on the market, PM2.5 masks and masks containing activated carbon layer all fall into this category. It belongs to the special labor protection articles, to new coronavirus infection may have certain protective effect, but is very limited, because the droplets are attached to the dust particles in the air flux may transmit the virus to produce the mask needs to have the special labor protection articles production license, but in September 2019 to cancel, strengthen the regulation of things later, do not need to apply for registration certificate and the medical equipment production license.

3. Medical masks

Medical masks fall into three categories.

(1) Medical surgical mask: it is generally composed of mask, setting piece, band and so on. It is generally made of non-woven material and plays an isolation role through filtering. Suitable for health care of the wearer in a general medical setting where there is no risk of fluids or spills. In this outbreak of novel coronavirus, it has a protective effect. The blue disposable masks commonly seen in pharmacies are medical surgical masks.

(2) Medical protective masks: masks made of one or more fabrics that have isolation effect on viral aerosols and virus-containing liquids. It still acts as a barrier to viral aerosols and virus-containing fluids. When removed, the outer surface of the mask is not in contact with the human body. N95, like the one used in this outbreak, is worn on the faces of people exposed to viral material in health facilities to prevent the spread of the virus from patients to health workers. It is suitable for the protection of medical personnel and related staff against airborne respiratory infectious diseases.

(3) Continuous positive pressure ventilation mask. Non-invasive ventilation support for chronic respiratory insufficiency, improved ventilation, sleep therapy, etc. This is not common and is only used for patients who need it.

The above three types of medical masks belong to Class II medical instruments.

Dust-free clean workshop

1. Logistics: from the initial selection of raw materials to the final molding of the inner package, the whole process must be dust-free and bacterial-free. The layout of the workshop should be reasonable, pay attention to the smooth process, the connection between the upper and lower processes is smooth, the transportation distance should be short and straight, and the roundabout and round-trip transportation should be avoided as far as possible.

The material flow process of the mask cleaning workshop is as follows:

2. Personnel: from changing clothes > BBB>nd washing disinfection/buffer BBB2 B>air >er disinfection BBB4 BBB5 cl>corr> BBB6 BBB7 each cle>orks>must be dust-free.

The following is the flow process of personnel in the mask cleaning workshop:

3. Mask Production Equipment:

The production of masks is usually automatic or semi-automatic.

Automatic equipment includes automatic flat mask machine, automatic folding mask machine, etc. Automatic equipment is more expensive.

Semi-automatic equipment includes mask forming machine, mask pressing machine, mask trimming machine, breathing valve punching machine (if breathing valve is available), nose bridge line fitting machine, ear belt spot welding machine, breathing valve welding machine (if breathing valve is available), packaging, sterilization, analysis (EO), finished products.