Since the first surgical operation in Babylon, Cuba, 4000 years ago, human beings have taken measures to prevent infection. However, statistics from Europe in the late 19th century also showed that 60% of cases died directly due to postoperative infection.
According to the Centers for Disease Control and Prevention (CDC), there are about two million patients affected by iatrogenic infection in the national acute disease medical institutions, and the annual medical expenses directly used for these patients are about 4.5 billion US dollars. Today, human beings pay a huge price for this, and gradually understand a truth & mdash; & mdash; we should put an end to all kinds of possible infection channels and reduce the probability of infection. The study also showed that & ldquo; one third of iatrogenic infections can be prevented through infection control procedures in tissues & rdquo;.
(I) overview of medical packaging: if there is no package that meets the sterile requirements, the best product is zero. ”
The scope of medical packaging includes "medical" and "instrument". The two types of packaging are strictly different in supervision and application. There are also differences between "need to sterilize" and "don't need to sterilize" in the packaging of devices, which are differentiated in management and application.
There are two conceptual operations in the packaging of devices to be sterilized & mdash; & mdash; & ldquo; factory sterilized packaging & rdquo; and & ldquo; hospital sterilized packaging & rdquo;.
Medical packaging can be classified conceptually, which can play a fundamental role in promoting the sustainable development and research of packaging materials, as well as in the integrity, safety, usability and standardization of sterilization packaging; it can also play a constructive role in avoiding the lack of bacteria free performance of products due to the use of inappropriate packaging materials, in standardized manufacturing, and in the use of standards Function.
(II) compatibility of materials and sterilization
In the introduction of ISO 11607-1; 2006, the importance of medical device packaging design is expressed as follows: & ldquo; the process of designing and developing the final sterilized medical device packaging is a complex and hard work & rdquo;. And the complexity of packaging design is described as follows: & ldquo; the ultimate goal of medical device packaging design is that the material can adapt to sterilization, and the product can be protected after sterilization, and should be kept sterile when using & rdquo;.
Therefore, the packaging that meets the aseptic requirements is the inevitable choice of medical equipment manufacturers, and the idea of adapting to the sterilization technology is the highest guarantee of medical equipment products. Otherwise, the packaged products may become lethal weapons.
At present, the sterilization methods are mainly ethylene oxide and formalin, high temperature steam wet and dry sterilization, gamma ray irradiation, and low temperature plasma sterilization. The adaptation of the product itself to sterilization and the period of validity of its use, as well as the adaptation to sterilization methods, are selective. For example, biological products cannot be heated, PP plastics cannot be irradiated, liquid products cannot be permeated, plasma low-temperature sterilization cannot use plant fibers, species & hellip; & hellip;, all of which require that the sterilization method should be determined first while designing the packaging The mode of bacteria should be based on the appropriate materials, and the requirements of preservation should be considered. Combined with the production and processing technology, the expected sterilization effect and the purpose of aseptic preservation and barrier protection can be achieved.
Iso11607-1:2006 the selection of suitable materials for the final medical device packaging system is affected by the interrelationship shown in the figure below.
The interrelation of materials influencing the packaging system selection of final sterilized medical devices
(III) production and application of gluing process
The requirement to ensure aseptic opening is to peel off without fiber shedding. To solve this requirement, the first step is to apply glue. The main raw material of the glue is hot-melt glue. When the hot-melt glue is applied to the paper, it has an impact on the air permeability, so the grid coating process is used to solve the air permeability requirement. The hot-melt adhesive coating of the grid, due to its peeling free of paper scraps, processing temperature, pressing pressure and the tolerance of the selection of binding materials, has fully played its advantages, and has a profound impact on the opening of medical packaging requirements: "iron firmly, tear open, no fiber". Due to the continuous improvement of sterilization packaging requirements, the hot-melt adhesive coating is insufficient
1. The hot-melt adhesive is sensitive to temperature. In the temperature state of ethylene oxide sterilization, the package may be broken and the sterilization fails due to the weakening of the bonding strength due to temperature.
2. During transportation or storage, the change of scalding strength may be caused by temperature, resulting in package breaking and sterilization failure.
3. Due to the temperature, there will be adhesions with some contents.
4. In the process of hot-melt adhesive coating, non-alcoholic solvent is used to reduce the safety factor.
5. It does not exclude the possibility of collagen residue into the bag when the sterilization gas enters and exits for many times.
6. The packaging of hot melt adhesive is not suitable for high temperature sterilization.
The technology of hot melt adhesive coating opens a way for aseptic packaging to peel off non paper scraps. With the continuous improvement of sterilization packaging requirements, the above deficiencies are constantly made up and improved in the application. The appearance of frame gluing technology can make up for the deficiency of hot-melt adhesive coating technology to the greatest extent, and effectively guarantee and solve the problems of air permeability, residue, package breaking and adhesion. However, due to the processing technology and cost, the frame coating process is limited in the conditions of mass production, which can not be fully promoted, or can not meet more products.
So the coating of water-soluble adhesive appears. The solvent used for the water-based adhesive is alcohol or water, which is non-toxic and does not reduce the peel strength of the bonding due to temperature. It is safer for the product and makes up for the shortage of the hot-melt adhesive coating
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