11

2020

-

12

After visiting the sterile workshop for medical devices, I finally understand why medical beauty masks are so expensive.

What does GMP Class 10,000 mean? Ordinary skincare product production workshops are only required to reach Class 300,000, and this is not even a mandatory regulation. However, medical skincare products must meet the requirement of being within Class 100,000, which means there is a limit on the number of particles per cubic meter of space. Therefore, the smaller this number, the higher the cleanliness level of the production environment. Medical beauty masks are not classified as skincare products; they are considered "medical devices," commonly referred to as "medical device numbers." These masks are produced under strict GMP (Good Manufacturing Practice) standards with a medical device production license.


This sterilized blue hooded, one-piece clean suit can only be seen inGMPa class 10,000 cleanroom.~Sterile rubber gloves, shoe covers, medical masks, with cuffs and pant legs secured, fully wrapping the skin, hair, and clothing, and when necessary, wearing goggles to reduce the risk of fiber or particle shedding during production.

 

 

GMPWhat does class 10,000 mean? The production workshop for ordinary skincare products only requires a class 100,000 standard,30and this is not a mandatory regulation, while medical skincare products must meet the standard of10within class 10,000, which means the upper limit of particle count per cubic meter of space, so the smaller this number, the higher the cleanliness level of the production environment.

 

 

The National Food and Drug Administration periodically releases product sampling results, one of which is the total bacterial count, reflecting the hygiene status of the production environment. Masks with an unqualified total bacterial count not only raise concerns about the hygiene of the production process but also require the addition of a large amount of preservatives to ensure the product does not deteriorate. Long-term use of such masks can easily damage the skin barrier, causing redness, itching, and allergic infections....continuous issues.

 

 

Medical beauty masks do not belong to skincare products; they are"medical devices," which we commonly refer to as "device number," and are masks produced under a medical device production license, strictly followingGMP(Good Manufacturing Practice) standards.

 

 

GMPThat isGood Manufacturing Practiceabbreviated, which means "product production quality management standards" in Chinese, or "excellent manufacturing standards." In simple terms, it is the standard for producing items that can remain on the human body, quite impressive, right?~

 

 

Medical beauty masks are developed and produced for sensitive skin with damaged barriers. The higher the air cleanliness in the production workshop, the fewer particles in the air, the lower the chance of product contamination, and the corresponding reduction in the requirement for preservatives, meaning the amount of preservatives added to the masks will be less than that in cosmetic masks, making the overall product gentler and more suitable for"sensitive periods."

 

 

Medical beauty masks are produced in a sterile environment, which includes not only a purified production workshop but also medical-grade raw materials. For example, the purified water used in the masks is not sourced externally; the company is equipped with a fully automatic purified water system that delivers purified water through stainless steel pipes to various water points, ensuring a continuous and stable supply of purified water while eliminating the risk of contamination during procurement and transportation.

 

 

Medical-grade raw materials, sterile workshops, fully automated production lines, terminal irradiation sterilization, yes, our Haibeiyan medical beauty masks are produced in such a sterile environment, which is difficult for other ordinary masks to achieve.~In terms of production specifications and safety, medical beauty masks are indeed very impressive!

 

Jiangsu Haizhi Biopharmaceutical Co., Ltd. specializes inOEM/ODMOEM and private label, main products and services: masksoemprocessing, liquid band-aidoemprocessing, mouthwashoemprocessing, private label processing, etc. Providing one-stop private label processing services.