Here is an example of one of them:
Definition of medical device pouches:
Packaging systems used for the packaging of medical device-type products, which can be sterilized, which can be aseptically operated (e.g., clean-open), which can provide acceptable microbial barrier properties, which can protect the product before and after sterilization, and which can be used to maintain the system for a certain period of time (labeled expiration date) after sterilization. Packaging systems that provide an internally sterile environment.
Medical device pouches can be suitable for sterilization:
ETO ethylene oxide, high-temperature moist steam, gamma cobalt 60 irradiation, plasma, formaldehyde and so on.
Structural components: bags or blister boxes
Bags: paper-plastic bags and paper-paper bags are mainly (paper-plastic bags are mostly U.S. paper, French paper, British paper; paper-paper bags for domestic paper)
Blister boxes: blister materials PET, or PP, or PETG and other blister boxes outside the heat sealing medical adhesive coated paper, the current DuPont Tyvek blister cover Tyvek coated paper). (
Object: medical device manufacturers and hospitals are mainly.
Sealing form: hot pressure sealing machine sealing and double-sided adhesive self-buckling adhesive sealing
Quality standards: international ISO11607; the European Union for the EN868; China's GB/T19633
Packaging principle: loaded into the device, sealing, sterilizing, bag sterilization through the principle of bacterial barrier factor can be preserved for 1-5 years to achieve the barrier of the sterilized medical packaging bags. Role
Functional role: the instruments to be ultimately sterilized into the bag, after sealing, can be physically or chemically, the bag of microorganisms on the instruments killed, and can be in the stipulated period of validity, to maintain the instruments in the bag in a sterile state. Specifically, the following functions may be included
adapting to the appropriate sterilization process;
protecting the instrument to maintain the instrument in an acceptable condition for use;
having bacterial barrier properties to maintain the sterility and integrity of the instrument prior to use;
being able to be opened aseptically for use of the instrument;
correctly identifying and using the product.
Medical device packaging bags quality technical requirements:
1, including the material must be effective barrier to microorganisms / bacteria ASTM F-1608
2, must be adapted to the commitment of the sterilization method ISO11134 \ISO11135 \ISO11137
3, to maintain the product's aseptic state. Packaging can not have been airborne contamination, fiber breakage, dust and other foreign matter, microbial invasion opportunities (ASTM D- 2019). Therefore, the packaging needs to ensure:
Including no damage to the material;
Integrity of sealing, peel strength (ASTMF88) appropriate, no penetration (ASTM:1998), no burst (ASTMF-1150 / ASTM F-2054), peel clean (EN868-5).
4, including the material or packaging should be suitable for processing;
Materials must be manufactured in a way that minimizes the shedding of particles, such as fibers, flakes, ink shedding, dust. (ASTM D-2019
5. After the package is opened, there should be obvious signs that it has been opened;
There should be no arbitrary resealing of the package after the sealing port is opened. (Prevent the package from being opened by the contamination and then re-closed)
6, should mark the opening position and direction;
Should be easy to open, and the opening position should be convenient for the user to play open (EN980)
7, must be able to recognize the product (printed mark should be in line with the requirements of the medical device laws and regulations, including the material has a side of the material transparent material, you can see the product inside) EN980
Medical device bags of chemical indicators and printing ink
1, sterilized color-changing chemical indicators, the product is similar to the printing ink, the processing principle of the same printing ink, usually printed on the inside or outside of the bag. The principle is that under specific sterilization conditions, the indicator printing ink from the initial color into a pre-set color. Function is to visually indicate whether the sterilized product after and in accordance with the specified sterilization conditions. Sterilization color change chemical indicator is divided into water-based and oil-based, the difference is that water-based does not contain heavy metals.
2, printing ink, usually divided into water-based and oil-based, based on the quality requirements of medical products, medical packaging is usually used in water-based ring-packed ink, the ink should be through the ISO10993 biocompatibility test, the content of heavy metals in line with the requirements of the IEC 62321:2008, the US EPA 3052:1996
Conventional manufacturing of medical device packaging pouches Process Principle
Dialysis Paper
→Wood Pulp Hydrolysis→Web Spreading, Rolling, Drying Refined Paper→Winding→Slitting→Packaging. (The main difference between self-adhesive and non-self-adhesive paper is that in the papermaking and molding process, the surface of the paper infiltrated with chemical materials)
Laminating film (laminating machine)
→Matching and selecting the material particles→Blowing or casting into the film material→Two-layer or more pre-selected into the film composite.
Blown film **** agent or cast **** agent film (blown film machine or casting machine)
→Two or more kinds of adhesive soluble material particles→Multi-layer blown film or multi-layer cast **** agent molding film material→winding→slitting→packaging.
Laminating (Laminating Machine)
→On paper or its substrate, plastic particles are dissolved at high temperatures by laminating equipment, and then dripped onto the substrate through the micro holes of the adjustable thickness die head, and then cooled and molded.
Coating Material (Coating Machine)
→On paper or other substrates, through anilox rollers, the pre-dissolved hot sol is transferred to the substrate by means of pressure roller pressure, and then dried and solidified.