What are the prerequisites for the production of medical silicone products?

Many people are looking for factories that can produce medical silicone products, but they don’t know how to judge what standards are qualified suppliers of medical silicone products. Today Li Yong’an is here to talk about the qualification standards for everyone.

The first thing is to look at the product standards. If the product is a first-class medical device, the requirements for suppliers are not so strict. If it is a second or third-class medical product, then it is necessary to choose a supplier of medical silicone products carefully.

One: ISO13845 medical qualification

This is a mandatory requirement, because to obtain this qualification, the factory’s production environment and control procedures must meet the standards and will be reviewed every six months. This qualification is the threshold for medical silicone products.

silicone products

Two: material requirements

Materials need to have three and six standards. If the product only contacts the skin for external use, then three standards are required. Including: skin toxicity, skin sensitization, skin irritation. If it comes into contact with blood, six items are required, including: skin toxicity, skin irritation, skin sensitization, hemolysis, in vitro cytotoxicity, USP Class VI.

The three items and the six items are also divided into material brands and origins. There are domestic and imported products. The models of each brand are different, but the physical property table is the same. There are also solid silica gel and liquid silica gel. These two are also different models and physical property tables for the three items and six items of the standard. The physical property tables for the standard are the same, but the solid and liquid states are different in molding methods. At present, more and more Medical silicone products are produced from liquid silicone materials.

silicone products  factory

Three: production environment

Many manufacturers claim that they are Class 10 dust-free workshops, but in fact they do not meet the standards. They need to be randomly inspected by a third-party organization to purify particles in the air. The 100,000-level dust-free workshop has very strict control over the workshop. Employees must wear dust-proof clothing to work, and they must be fully disinfected before entering the workshop. It is fully sealed and managed, so it is difficult for customers to visit inside.


Four: Production procedure

The procedures for medical silicone products must all be operated in a dust-free workshop. Gloves must be worn throughout the operation according to the production operation instructions, and the products will be packaged in time after they are produced. Medical silicone products must be sterilized. At present, many factories do not have this sterilization workshop, so the client will basically package all the products before sterilization.


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