Used for packaging of medical device products, it can be sterilized, can provide acceptable microbial barrier performance, can protect the product before and after sterilization, and can maintain the sterile environment inside the system within a certain period of time after sterilization. system.

　　I. Overview

　　1. Structure composition: bag or blister.

　　2. Bags: mainly paper-plastic bags and paper-paper bags.

　　3. Blister box: heat-sealed medical coated paper outside the blister box composed of blister material PET, or PP, or PETG. At present, most of them are DuPont Tyvek blister cover material Tyvek coated paper.

　　4. Target: Medical equipment manufacturers and hospitals are the main ones.

　　5. Sealing form: hot press sealing machine seal and double-sided adhesive self-reflex adhesive seal

　　6. Packaging principle: the device is loaded, sealed, sterilized, and the bag can be stored for 1-5 years through the principle of sterilization factor to achieve the barrier effect of medical sterilization packaging bags.

　　7. Suitable sterilization methods: EO ethylene oxide, high temperature and humid steam, Gamma cobalt 60 ray irradiation, plasma, etc.

　　Ⅱ. Function:

　　Put the device to be terminally sterilized into the packaging bag. After being sealed, the microorganisms on the device in the bag can be killed by physical or chemical methods, and the device in the bag can be kept in the specified period of validity. Sterile state. It can include the following functions

　　1. It can be adapted to the corresponding sterilization process;

　　2. Protect the device and keep it under an acceptable use condition;

　　3. With bacteria barrier properties, the sterility and integrity of the device can be maintained before use;

　　4. It can be opened aseptically to use the instrument;

　　5. Identify and use the product correctly.

　　Ⅲ. Quality and technical requirements:

　　1. Including materials that must effectively block microorganisms.

　　2. Must adapt to the promised sterilization method ISO17665\ISO11135\ISO11137.

　　3. Maintain the sterility of the product. The packaging must not be exposed to air pollution, fiber breakage, dust and other foreign objects, and microorganisms invade. Therefore, packaging needs to ensure:

　　--Including that the material is not damaged;

　　--The sealing is complete and peeling strength.

　　4. Including materials or packaging should be suitable for subsequent processing.

　　The material must minimize the shedding of particles, such as fibers, flakes, ink shedding, and dust.

　　5. After the package is opened, there should be obvious traces showing that it has been opened.

　　After the unsealing of the package is opened, there should not be any resealability to prevent the package from being contaminated and then closed again.

　　6. The opening position and direction should be marked.

　　Should be easy to open, and the opening position should be convenient for the user to open

　　7. The product must be identifiable.

　　The printing mark should meet the requirements of medical device laws and regulations, including materials with one side transparent, and the internal products can be seen.

　　Ⅳ. Sterilization packaging of medical devices-chemical indicators and printing inks

　　1. Sterilization and discoloration chemical indicator

　　The product is similar to printing ink, and the processing principle is the same as printing ink, and it is usually printed on the outside of the packaging bag. The principle is that under specific sterilization conditions, the indicator ink changes from the initial color to the preset color. The function is to visually indicate whether the sterilized product has passed and meets the prescribed sterilization conditions. Sterilization and discoloration chemical indicators are divided into water-based and oily.

　　2. Printing ink

　　It is usually divided into water-based and oil-based. Based on the quality requirements of medical products, medical packaging usually uses water-based environmentally friendly ink. The ink should pass the ISO10993 biocompatibility test, and the content of heavy metals meets the relevant requirements.

　　Five, medical device sterilization packaging-the principle of conventional manufacturing process

　　1. Dialysis Paper

　　→Hydrolysis of wood pulp→netting, rolling, drying and refined paper→winding→slitting→packing. (The main difference between self-adhesive and non-self-adhesive paper is that chemical raw materials are infiltrated on the surface of the paper during the paper forming process)

　　2. Composite film (composite machine)

　　→With selected material pellets→blown film or cast film forming material→composite of two or more preselected films.

　　3. Blown film co-agent or casting co-agent film (blowing machine or casting machine)

　　→Two or more cohesive soluble granules→Multi-layer blown film or multi-layer casting co-agent forming film material→Rewinding→Slitting→Packaging.

　　4. Laminating (Laminating Machine)

　　→On the paper or its substrate, the plastic particles are dissolved at high temperature through the coating equipment, and then poured on the substrate through the micro holes of the adjustable thickness die, and then cooled to form.

　　5. Coating material (coating machine)

　　→ on paper or other substrate, by the anilox roll, the pre-dissolved hot melt pressure by the pressure roll mode is switched to move on a substrate, then dried to solidify.