Requirements for Medical Sterilization Paper-Plastic Packaging Pouches

What are the requirements for medical sterile paper-plastic packaging pouches

Sterile paper-plastic packaging pouch

+ plastic laminated film, used for packaging medical devices to be sterilized, is the initial inner packaging of the product. Generally, the paper of a sterile paper-plastic packaging pouch needs to be printed with relevant information about the manufacturer or the product of the medical device.

According to regulations, the printing area shall not exceed

50%. It is also known as sterile packaging pouch, sterilization packaging pouch, medical reagent packaging pouch and medical paper-plastic pouch.

Medical packaging pouches made of medical laminated film can be respectively suitable for

EO ethylene oxide and high-temperature steam, such as high-temperature steam sterilization or hospital medical device sterilization, and can be used to hold items to be sterilized.

For high-temperature sterilization, it is not advisable to use

colorless and transparent medical laminated film of PET (polyester)/PE (polyethylene), because PE itself cannot withstand high temperatures and its adhesive cannot withstand high temperatures either, so it is not recommended to use PET (polyester)/CPP (polypropylene) for irradiation sterilization, because irradiation will age and embrittle CPP and may also precipitate harmful halides.

Generally, in a clean workshop, such as a Class 100,000 purification workshop, the product is put into the pouch. Then, the pouch is sealed with a heat sealer and placed in a carton for sterilization. Then, due to the different materials, the sterility shelf life is generally divided into

1 year, 3 years and 5 years, all of which have undergone aging verification. This ensures that the medical supplies in the pouch are sterile before transportation and storage, until a hospital nurse opens it, so that it can be sterilized directly.

: By utilizing the semi-permeability and antibacterial properties of the packaging material, sterilizing gas such as EO ethylene oxide or steam can penetrate to achieve a sterilization effect, preventing bacteria from entering the sterile paper-plastic packaging pouch again. Under storage, transportation and shelf-life conditions that meet the requirements, the pouch is ensured to remain sterile until the sterile paper-plastic packaging pouch is opened. The sterile state of the product is maintained. The packaging must not be invaded by air contamination, fiber breakage, dust and other foreign matter and microorganisms. Therefore, the packaging should ensure that the packaging material is not damaged; it is completely sealed, with appropriate peel strength, non-permeable, non-bursting and clean peeling.

——This article is reprinted from China Packaging Network (pack.cn). Original link: http://news.pack.cn/show-379024.html