Medical Sterilization Paper-Plastic Pouches: Key Requirements for Printing, Material Selection and Sterilization Methods

What are the key requirements for medical sterilization paper-plastic packaging pouches?

Sterilization paper-plastic pouch

+ plastic laminated film is used to package medical devices awaiting sterilization and serves as the product's primary inner packaging. Typically, the paper side of a sterilization paper-plastic pouch must be printed with relevant information about the medical device manufacturer or the product.

Under applicable rules, there is a clear ceiling for the printing area:

It must not exceed 50%. These pouches are also called sterile packaging pouches, sterilization packaging pouches, medical reagent packaging pouches or medical paper-plastic pouches.

Medical packaging pouches made from medical laminated film can be matched respectively with

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

For high-temperature sterilization, one type of material is not advisable:

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

Usually, in a clean workshop such as a Class 100,000 purification workshop, the product is placed into the pouch. The pouch is then sealed with a heat sealer, packed into a carton and sterilized. Depending on the material, sterility shelf life is generally classified as

1 year, 3 years or 5 years, all supported by aging verification. This helps ensure the medical supplies inside the pouch remain sterile before transport and storage, until a hospital nurse opens it, so it can be sterilized directly.

By leveraging the semi-permeability and antibacterial properties of the packaging material, sterilizing gas such as EO ethylene oxide or steam can penetrate to achieve sterilization while preventing bacteria from re-entering the sterilization paper-plastic pouch. Under compliant storage, transport and shelf-life conditions, the pouch remains sterile until the sterilization paper-plastic pouch is opened. The product's sterile state is maintained. The packaging must not be invaded by air contamination, fiber breakage, dust, other foreign matter or microorganisms. Therefore, the packaging should ensure the material is not damaged; it must be fully sealed, have suitable peel strength, be impermeable, resist bursting and peel cleanly.

Source: China Packaging Network (pack.cn), original link: http://news.pack.cn/show-379024.html