Sterile Packaging


  Paper+Film●In the 121 ℃ discharge pressure steam sterilizer for 20 minutes, or in 132 ℃ ~ 134 ℃ in the vacuum pressure steam sterilizer 4 ~ 6 minutes.Observe the instructions of sterilization and discoloration on the paper to indicate that the sterilization process is completed.

 ●Or placed in ethylene oxide sterilization chamber,After epoxy ethane concentration to 600 + 50 ml/l, temperature 50 ℃, humidity 65% ~ 80%, 3 hours sterilization.Observe the instructions of sterilization and discoloration on the paper to indicate that the sterilization process is completed.

  Application: hospital supply room is used for sterilization package of medical instruments.

Quality Technical Requirements

1.    Including materials must be effective against microorganisms/bacteria  ASTM F-1608

2.    Must adapt to promised sterilization methods ISO11134ISO11135ISO11137

3.   Maintain products sterility.Packaging should not have the opportunity to be contaminated by air, fiber breakage, dust and other foreign matter, microbial invasion(ASTM D- 2019).Therefore, packaging needs to be ensured:

  --Including material without damage.

--Sealing integrity, suitable peeling strength(ASTM F88), no penetration(ASTM

F1929:1998), no blasting(ASTM F-1150 / ASTM F-2054), stripping clean(EN868-5)

4.   Including materials or packaging shall be suitable for subsequent processing;

When making materials, the loss of particles must be minimized.For example,fiber, sheet, ink off, dust(ASTM D-2019).

5.   When the package is opened, there should be a clear indication that it has been opened;

 After opening the package, there should be no arbitrary resealing.(Prevent packaging from opening and closing after being contaminated)

6.   Open position and direction should be identified;

  It should be easy to open and the position should be convenient for the user to open

7.      It have to be able to identify the product(The printed marks shall conform to the laws and regulations of medical devices.Includes materials that have a transparent side and can see the products inside.)

 Put the instrument which will be in final sterilization into the packaging bag.  After being sealed, the microorganism on the instrument inside the bag can be killed by physical or chemical method, and the device inside the bag can be kept in a sterile state within the specified period of validity.Include the following functions:

  --Suitable for the corresponding sterilization process

  --Protect the device and keep it in an acceptable condition

  --It has bacteria resistance and can keep the sterility and integrity of the instrument before use

  --It can be opened aseptically to use the instrument

  -- Identify and use the product correctly

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