Sterilization pouch description
November 25 , 2020

sterilization pouch

Abstract: This article contains instructions on how to use sterilization pouches. Their intended use, packaging, sealing, sterilization methods, opening and storage condition are explained in detail.

Subtitle:intended use; packaging; sealing; sterilization methods; package opening; storage


The self-sealing pouch is made of transparent PET / PP high temperature composite film and medical dialysis paper. It does not need to be sealed with a professional sealing machine. It meets the requirements of ISO11607 and EN868-5, and is suitable for high temperature steam (STEAM) and ethylene oxide (EO) sterilization methods. Using water-based non-toxic ink, to meet the requirements of ISO11140-1 standard, color change after sterilization is accurate and clear. medical sterilization pouches are intended for use at Hospital, Dental clinic and laboratory’s sterilization, medical device factory, nail&beauty supply, piercing tattoo supply and family high temperature etc.


The pouch should only be filled between 5% and 80% of the packing volume to allow proper air evacuation when using steam sterilizers.


After removing the protective strip, you need to Load the articles to be sterilized into this article. Then tear off the bottom isolation strip, fold inwards along the dotted line and press hard.

Self Sealing Sterilization Pouch

4. Sterilization Methods

self-sealing sterilization pouches are designed to be used at steam and ethylene oxide sterilizers.

Please refer to the following recommendations for steam sterilization cycle. Ensure that the volume of the sterilized item is between 5% and 80% of the volume of the sterilizer. When using 121℃ steam sterilization, the sterilization time is around 20-30 minutes; When using 132 ° C steam sterilization, the sterilization time is 4 minutes. After steam sterilization, the color of external indicator will change from blue to gray or black.

Please refer to the following recommendations for ETO sterilization cycle, The ethylene oxide concentration is 800 to 1000 mg / L, and the relative temperature is 55 ° C to 60 ° C. When the relative humidity is 60% to 80%, the sterilization duration is 6 hours. After ETO processed, the color of external indicator will change from pink to brown or yellow.


Because of the unique design of the sterilization pouches, the contents can be clearly seen to prevent errors through the transparent film. Inspect package for damage, moisture, or any sign of potential contamination prior to opening and again after opening but before use of contents. Do not use contents if these conditions are present, as sterility could be compromised. Reprocess the contents using an unprocessed pouch if any of these conditions are noted.


After sterilization, please use the sterilized instruments immediately. If not used, please store in a cool, dry, ventilated, and non-corrosive gas environment. The storage location of the medical sterilization pouch should be clean, dust free places. Store at room temperature below 25˚C and relative humidity below 60%. The shelf life of a properly processed pouch is event related and dependent upon proper handling and storage. If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years from the date of manufacture.

Armed with the knowledge of correct use of sterilization pouches will assist with safe and successful reprocessing and sterilization of instruments.

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