Medical Sterile Packaging Bag
For the packaging of the products of the medical devices, sterilization of the products, and the sterile operation, which is a sterile operation, to provide acceptable microorganism, to protect and to sterilize the product and to sterilize the product and to keep the system within a certain period of time to maintain the system's sterile environment.
It is suitable for sterilization
ETO ethylene oxide, high temperature wet steam, gamma-60 radiation, plasma, formaldehyde, etc.
The blister material PET, or PP, or PETG, etc., is heat-sealable medical coated paper, which is currently more than one
Tyvek adhesive paper)
Medical equipment manufacturers and hospitals.
The sealing form
Hot sealing machine and double-sided adhesive sealing reflexive buckle adhesive closure
International ISO11607; The European Union is EN868; China for GB/T19633
Through the principle of sterilization factor, it can be preserved for 1-5 years to achieve the blocking effect of medical sterilization packaging bag
The proposed final sterilization equipment into the sack, after sealing, through physical or chemical method, bag body instrument to kill microorganisms, and the prescribed period, keeping the equipment inside the bag in a sterile state. The following functions may be specifically included
-- applicable to the corresponding sterilization process;
- protection equipment, keep the equipment in the use of an acceptable conditions;
- bacterial barrier properties that preserve the sterility and integrity of the instrument prior to use;
-- can be opened aseptically to use the device;
- identify and use product correctly.
Quality and technical requirements
1. The material including the material must be effectively blocked from microorganism/bacteria ASTM f-1608
2. The committed sterilization mode must be adapted to iso 11134: iso 11135 / iso 11137
3. Keep the product sterile. The package is not capable of being contaminated with air, damaged fibers, foreign objects such as dust, and the opportunity for microbial invasion (ASTM d-2019). Therefore, the packaging needs to be assured:
That includes no damage to the materials;
The seal is full, dissection intensity (ASTM F88), no infiltration (ASTM, 1998), no explosion (ASTM, f-1150 / ASTM f-2054), defoliation (en868-5).
4. The material or package shall be suitable for subsequent processing.
Materials must be manufactured to minimize the shedding of particles, such as fibers, flakes, ink shedding, dust. (ASTM D - 2019.
5. After the package is opened, there should be obvious marks indicating that it has been opened;
After opening the opening opening of the package, there should be no arbitrary re-sealing. (prevent the package from being contaminated and then recombine)
6. The open position and direction shall be marked;
Should be easy to open, and the opening position should be convenient for the user to open (EN980)
7. The product must be able to identify products (the marking shall be in compliance with the requirements of the legal regulations of the medical device, including materials which are transparent to one side of the material, which can be seen within the product) en 980
Sterilization package for medical equipment - chemical indicator and printing ink
1. The sterilization color changing chemical indicator is similar to printing ink, processing principle and printing ink, which is usually printed in or on the outside of the package. The principle is in the specific conditions of sterilization, indicator printing ink from the initial color into a preset color. The function is to make it intuitively clear that the sterilization products are passing through and meet the required sterilization conditions. The chemical indicator for discoloration is water and oil, and the difference is that the water is not heavy metal.
2. Printed ink, generally split into water and oil, based on the quality requirements of medical products, the medical packaging usually USES an aqueous cycle-type ink, which shall be tested by ISO10993 biocompatibility, according to IEC 62321:2008, US EPA 3052:1996
Principle of manufacturing process
The wood is hydrolyzed, the top of the net, the roll pressure, the dry, processed paper, the cutting, the cutting, the wrapping. The main difference between self-adhesive and non-self-adhesive paper is that in the process of making paper, it's the surface of the paper that is forming chemicals on the surface of the paper.
Composite film (composite machine)
The material, the pellets, and the flow of the laminated film or the flow of the laminated film to the second floor or the multi-formed primary membrane.
Film blowing copolymer or film casting copolymer (film blowing machine or film casting machine)
And two phase viscosity solution of the above material grain and multi-layer blown film or more layers were agent forming the membrane material - winding - cutting and packing.
Drenching film (drenching machine)
In which a plastic particle is dissolve at a high temperature through a film for that film and then is leach onto the base material through a fine hole of an adjustable thickness, and then cooled to form.
The coating material (coating machine)
In the paper or other substrate, through the roller, the pre-dissolved hot sols through the pressure roller pressure transfer to the substrate, and then drying solidification.