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China's medical equipment sterilization packaging status and related considerations (7)

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【Abstract】 talked about the performance of medical equipment sterilization packaging system test, first of all need to do a definition of this packaging system. I believe that the packaging system is the main component of all the target - the protection of medical device products external factors, a packaging system is mainly through the choice of packaging materials, packaging structure (or form) design, packaging, packaging and other experimental test carry out.
First of all need to do a definition of this packaging system. I believe that scanning, the packaging system is composed of all the main target - the external protection of medical device product portfolio, a packaging system is mainly through the choice of packaging materials, packaging structure (or form) design, packaging, packaging and implementation of laboratory tests and other tests The steps are completed.
For the medical device sterilization packaging system, based on its packaging performance requirements of the particularity (mainly requires the system of bacteria and can withstand pre-designed will be used in various types of sterilization), but also the system points (SBS) in the context of the internal packaging system and the Protective Packaging System (PPS) of the outer packaging system. Relatively speaking, reorganization, SBS is more critical, because it means that the failure of the absolute failure of the entire packaging system; and if the PPS does not meet the intended purpose of the design does not necessarily mean that the entire or bulk packaging system failure, And the failure to find such a packaging method is very simple and very low cost. In fact, it seems that medical device sterilization packaging systems and barrier-sensitive packaging systems (such as special food packaging and pharmaceutical packaging) as other packaging, can be divided into internal packaging systems and packaging systems, this and ordinary Industrial packaging is not the same, and very focused on the packaging of household electrical appliances and electronic packaging products are not the same.
Functional requirements and test methods for internal packaging systems
The Sterile Barrier System (SBS), the internal packaging system for sterilized medical devices, must meet three functional requirements in terms of functional integrity, including packaging integrity, packaging protection and convenience / Cleaning Openness (Cleaning Peel), the following are the three functional requirements and the corresponding experimental methods were discussed.
1. Requirements for completeness
For medical device sterilization packaging, the composition of a sealing system to ensure that all kinds of harmful microorganisms barrier is the foundation, is also necessary. This barrier may be very common in the field of flexible packaging made of paper and plastic, but for Chinese medical printing companies that require sterilization, there is often a contradiction when considering the expected sterilization methods, because Sterilization of ethylene oxide (EtO) is the most popular sterilization method in the country due to its low cost and general adaptability to the material. However, this sterilization method has proposed the packaging integrity One challenge: It requires packaging to be ventilated carton cartons, because ethylene oxide also through the sealed packaging system into the inside to kill the micro-organisms within the packaging system.
Thus, in order to satisfy the requirement of the sterilization method of the ethylene oxide type, the materials of the selected inner packaging system must satisfy the function of gas permeation and bacteriostasis at the same time. Therefore, it is necessary to select a material with a sufficiently small porosity and a certain Mechanical strength of the material, the so-called porous material. Of course, variable data printing, the pores are slightly smaller than the diameter of harmful microorganisms, so as to effectively prevent the entry of microorganisms. At present, the commonly used porous materials include non-woven materials from DuPont Tyvek, as well as the hygiene and pore size strict requirements of medical grade packaging paper, the medical packaging paper, there are a number of companies can provide. It is noteworthy that labels, these porous materials do not have a good direct processing performance to form a complete internal barrier system, they need to go through such as glue and other surface processing means to obtain and other materials are processed together The performance of a barrier system. Printing education
On the other hand, porous breathable materials constitute only part of the internal packaging system, the other part depending on the form of packaging can be different types of different types of polymer film, plastic boxes and other combinations of print, they are usually through various types of heat sealing Is processed into a complete internal packaging system to achieve the barrier microbial function into the package.
The inspection of the inner packaging system is complete, in accordance with the existing standards, generally refer to ASTM F1929-1998, that "toluidine blue dye solution penetration test." Prior to this special printing, based on EN868-1 Rhodamine solution penetration test has also been popular in the country (estimated at present domestic application is still very wide), but the US FDA suspected of its potential carcinogen and disabled. ASTM F1929 gives a solution of toluidine blue dye solution formulation, but the specific experimental methods of operation are not given in this standard, but must be noted that this method of operation is still very skillful book reviews, need to undergo a simple training To master, but the overall difficulty of the experiment is not.
In order to meet the γ-ray, electron beam sterilization methods such as high-energy packaging design of sterile systems, because there is no air permeability requirements, no longer need to use porous packaging materials, but the integrity of the internal packaging system Requirements, or the same color management, then you can use the differential pressure method for sealing packaging system leak detection methods to check, there are many non-domestic and international standards to reference, relatively easy to operate some. Moreover, this type of sealing material is generally polymer plastic materials, the use of melting between the layers of material Shanghai Guanghua heat sealing, the probability of leakage than the adhesive bonding method is much lower, which is a good point. software
2. Relevant protective requirements
Protection requirements are relatively easy to understand relative to integrity requirements. The primary function of a package is to protect the product before it evolves into additional functionality such as sales and ease of use. Therefore, both the inner packaging system and the outer packaging system Hanahuanhua, its protective requirements in essence is the same, but in the composition of the form is different.
For the protection requirements of the inner packaging system, it is required that the packaging material itself has a certain mechanical strength, but also requires a combination of different materials constitute the packaging system should have a certain strength, and usually this combination is through the various Fuji Xerox, commonly used in the heat of the way, including common heat, high frequency heat and ultrasonic heat and so on.
The mechanical strength of the material itself is easy to determine, in general, as long as the detection of tensile strength, puncture strength, notch tear strength, bursting strength and other conventional mechanical properties can be approximate data, and commonly used materials, such as All kinds of composite films, Tyvek and medical wrapping paper, their mechanical properties of these indicators is also very easy to query.
Material combination of heat sealing strength control is more complex on-demand printing, because to consider the mechanical properties of the material itself, adhesive composition and properties, heat sealing and heat sealing equipment and other factors, so in order to directly give a generally applicable heat intensity range is Challenging, this must be combined with the product and the historical experience of the past data can be.
Heat seal strength is too large or too small will cause problems. The excessive heat seal strength can easily cause the material to tear the packaging container in the heat-sealed area, especially when the heat-sealing strength is greater than the tensile strength of the material itself and the heat-sealing strength of the material Elongation and not big enough, such as medical packaging materials, and Tyvek type material because of its excellent mechanical strength and rarely tearing phenomenon; the second is not easy to open the use of packaging for convenient medical products for potential customers, That is, the pressure in the operation of a very large physician or the body is very weak and unattended patients CTF, is very attractive to them to buy one of the key points, and excessive heat sealing strength will open a product packaging becomes Very difficult, or can not be opened in the right way. If the heat seal strength is too small, it will obviously cause insufficient protection, and the product will fall from the inner packaging system and thus can not be adequately protected in the actual circulation. software
Summed up the experience and many years of product packaging heat sealing intensity data inkjet printing, the author believes that the heat intensity is generally controlled at 0.80-8.00N / 15mm more reasonable (except for extreme cases), below this range, will cause inadequate protection; In this range, paper-like sheet will appear tearing and scraps of paper published in the network, which can not meet the requirements of clean tear, thin film and Tyvek class materials, although there will not tear problem, but open to spend effort , Is not conducive to convenient opening.
3. Requirements for convenience / clean openability
Convenient / clean open requirement is a more subjective and also have a certain degree of difficulty requirements, it is subjective because the judge when there is no quantitative indicators can refer to the screen, and open the packaging system standards and even now can not qualitative to Out, so there will be different people to open the same batch of product packaging and draw different conclusions.
Convenient / clean open requirements on the composition of the packaging system of the material itself and the heat between the different materials have high requirements, so the mechanical strength of the material to be qualified, heat sealing strength of the heat can not be too high, this point in front of the Packaging protection requirements described in the description of India equipment, will not repeat them here.
It should also be noted that the convenience / clean open sex is developed in the medical device sterilization packaging industry attaches great importance to a packaging performance requirements, especially in April 2006 updated ISO11607-2006 after the official publication. However, this requirement in the domestic medical device sterilization packaging industry has been ignored, in the domestic industry regulations, the author only in DuPont participated in some of the technical seminars to hear someone formally mentioned the request. Packaging security
DuPont's Tyvek material is a good choice to solve the convenience / clean-up requirement, aside from cost considerations, although this assumption is not very practical since no manufacturing industry will consider material cost issues , While in China, the low-end manufacturing costs as the main means of competition in the packaging and printing countries, the cost is particularly important. But it must be pointed out that the use of paper packaging is difficult to completely solve the problem of clean opening, especially when the length and breadth of the internal packaging system size exceeds a certain limit. With the introduction of new standards, and now Europe and the United States more and more critical of the requirements of this, the domestic manufacturers should pay attention to this.
Functional requirements and test methods for outer packaging systems
Next to talk about the packaging system performance test requirements. The overwrap system is more typical of the protective packaging system manuscript, and more specifically, it refers primarily to the cushioning transport packaging system, which protects the interior packaging system.
In the packaging system components, the most important is the corrugated boxes and various types of industrial cardboard boxes, or less commonly used metal and wooden containers, such as Corey, supplemented by a variety of typical buffer packaging materials accessories, such as air cushion film, All kinds of foam plastic and paper buffer materials. In most cases this packaging system is very simple, is a reasonable calculation of a reasonable design of the appropriate strength of the corrugated box, or a little more complicated, in the packaging inside plus a packaging and packaging machinery, usually micro-corrugated paper Boxes or ordinary cardboard boxes and so on. In the disposable packaging of medical equipment products, the need to use wooden boxes or metal boxes and add some of the necessary buffer material accessories are rare, this situation often appears in the large electrical and electronic equipment packaging, At this point they usually do not need sterilization, that is, only as a buffer transport package scanning, and disposable medical equipment sterilization packaging is a very different from the two packaging. Embossing
So how to test the effectiveness of this packaging system? That is, how to use experimental methods to determine the packaging design is in line with the intended target, to ensure that the product packaging system can withstand the flow of storage environment conditions of the test until they are safe to reach the hands of the final consumer. Taking into account the complexity of the flow of the environment, the small company's engineering and technical personnel are unable to obtain and design simulation of the simulation of the circulation environment to test the product packaging system can withstand the test of the circulation, and therefore often refer to the relevant analog circulation Transport experimental program dairy packaging, to be mentioned here, two more authoritative reference worthy of the experimental program is the ISTA series and ASTM D4169.
The ISTA family of transport packaging experiments was prepared and presented to the industry by the ISTA (the International Transport Safety Association), a member of the ISTA, which includes companies that frequently deal with a variety of challenging products such as FedEx, UPS and other large logistics companies and HP and other large consumer electronics companies, with their own over the years in all types of transport environment in the accumulation of transport experience and the existence of various types of transport links in the shock, vibration and other harmful factors accumulated information, The preparation of these experimental programs for the ISTA accumulated a good data Fuji Xerox, so these experimental programs have considerable authority. Of course, some large companies in the field of engineering technology is very powerful, and their product circulation and transportation links are more special, they generally design their own products to simulate the flow of experimental programs.
ISTA has a total of seven series of standards, each series of standards followed by a number of specific sub-programs of several dairy packaging, so ISTA a total of dozens of different experimental programs to deal with various types of products, packaging systems, transport experiments. For a one-time medical device packaging system, because it is relatively simple, generally refer to the ISTA 1,2 and 3 in the three series, including a series of general simulation of domestic transport, 2 and 3 series simulation of international transport other packaging, The 3 series of simulated environment and slightly harsh, so 2 series is the most commonly used in international transport of the experimental program. Metal packaging
The whole experiment process consists of the following concrete steps: (1) adjustment of ambient temperature; (2) control of environmental regulation; (3) FCL compression experiment; (4) vibration of fixed time and frequency; (2) ⑤1 point 3 Leng 6 surface a total of 10 times the drop impact, which drop height have a specific method to determine; ⑥ fixed time and frequency of vibration. Specific experimental parameters for each step are not given here because the experimental parameters need to be reprogrammed according to the characteristics of the packaging system of the particular product and the intended circulation environment, where the duration of the vibration, for example, needs to be calculated.
At present, ISTA series of rigorous laboratory experiments are not many, while the medical equipment packaging system to do the transport experiment is very rare, of course, the transport experiment is not a must, because in accordance with medical equipment off A basic principle of the packaging of bacteria is that it can only carry out the transportation experiments of the worst-case (ie, the Worst Case State Book Review, which can be the most severe, hardest, most irregularly dimensioned). If it passes, it can be deduced that the packaging systems of those products, which prove to be better than they are, can also pass the transport experiment, thus reducing the number of experiments and thus reducing the cost of the experiment and shortening the project cycle,
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