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What are the sterilization requirements for medical packaging bags?

Source: Author:Jiangsu Huoli Packaging Materials CO.,LTD Addtime:2020-01-23 00:00:00 Click:

The medical packaging bag is composed of paper + plastic composite film, which is used to treat the packaging of sterilized medical devices, and belongs to the initial internal packaging of the product. The relevant information of the manufacturer or product of the medical device is generally printed on the paper surface of the packaging bag.


According to EN868-5, the printing area shall not exceed 50%. Alias has sterilization bag, disinfection bag, medical reagent bag, medical paper plastic bag.


The medical packaging bag of the medical composite film can be suitable for: EO ethylene oxide, high temperature STEAM, such as the hospital to the medical equipment high temperature steam disinfection or sterilization used to hold the items to be sterilized.


It is not suitable to use PET(polyester)/PE(polyethylene) colorless transparent medical composite film during high temperature sterilization, because PE itself is not resistant to high temperature, glue is not resistant to high temperature, radiation sterilization is not recommended to use PET(polyester)/CPP(polypropylene). Because of irradiation

Irradiation has aging embrittlement effect on CPP and may precipitate harmful halides.Commonly used DuPont Tyvek™ 1073B, 1059B, 2FS™

Generally, the product is put into a bag in a clean workshop such as a 100,000-level purification workshop, and then the bag is sealed with a heat sealer and put into a carton, and then the sterilization cabinet is sterilized, and then the product is generally processed

The shelf life of different bacteria of the materials is generally divided into 1 year, 3 years, and 5 years, all of which have been verified by aging, so as to ensure that the medical products in the bag are sterile products without sterilization before transportation and storage until the final hospital nurse opens them.

You can just use it.


Principle of action:

The semi-permeability and bacteriostasis of packaging materials are used to achieve sterilization effect by transmitting EO ethylene oxide or steam and other sterilizing gases to prevent bacteria from entering the packaging bag again. Ensure that within the required storage, transportation, and validity period,

The inside of the bag is kept sterile until it is opened.

Maintain product sterility. Packaging should not be air pollution, fiber damage, dust and other foreign objects, microbial intrusion opportunities. Therefore, the packaging should ensure that:

Packing materials are intact;

Complete sealing, suitable stripping strength, no penetration, no blasting, clean stripping.

Must adapt to the promise of the sterilization ways ISO11134 / ISO11135 / ISO11137


Note:


Shall not be used twice, damaged shall not be used.