What is the initial packaging of medical devices
The definition of sterilization packaging of medical devices should be understood as: for the packaging of medical devices, it can be sterilized, sterilized (such as clean opening), and can provide acceptable microbial barrier performance, The packaging system that protects the product before and after sterilization and maintains the sterile environment inside the system within a certain period (marked limited period). Because this concept usually does not include the protective packaging system outside (buffer packaging and collective packaging, etc.), the sterilization packaging system of medical devices can also be called "sterile barrier system"
There are three types of sterilization packaging for medical devices
Soft blister forming filling heat sealing packaging system: this kind of packaging can be divided into two types according to the thickness of the base material of the forming part: flexible and semi-rigid. The base material of this kind of packaging can be thermoformed into a pre-designed shape through the adjustment of temperature, vacuum and pressure on the specific blister packaging equipment, and then it can be hot closed with the corresponding top material to form a three-dimensional forming packaging system that meets the requirements. The characteristics of this kind of packaging are: high automation, high efficiency, low cost of single packaging, good matching of packaging system and content shape, etc., but it involves equipment and mold investment, and has certain requirements for output. It is usually used in class I and class II medical equipment products with large output, such as various syringes, gauze pieces, surgical clothes and medical catheter intubation, and simple three Class a medical devices, such as intravenous indwelling needle, etc
Hard blister - cover material packaging system: this kind of packaging uses all kinds of molding blister boxes to directly heat seal with all kinds of cover materials suitable for heat sealing and pre cut in shape, while the so-called hard blister is more related to the thickness of sheet materials used for blister forming, usually between 0.4 and 1.2mm, and the materials involved are mainly PVC, PP, PE, APET and PETG from the low end to the high end
All kinds of bag packaging systems: such as teweiqiang, paper plastic bags, head bags, middle seals, paper bags, aluminum foil composite bags with tyyek and other products, more styles may be produced according to the actual situation, in a word, it is difficult to fully summarize the types and application scope. In China, these products, such as head bag and middle seal bag, are welcomed by many medical equipment enterprises because of the special design of the ventilation window, which saves the material cost.
The basic principle of sterilization packaging of medical devices
In order to design a reasonable sterilization packaging system for medical devices, the following basic principles need to be followed:
1. "Package" is a part of the product: the package here refers to "sterile barrier system". The failure of sterile barrier system means the failure of medical device products, and the potential risk may be greater, because such failure is usually more difficult to detect or more easily ignored.
Of course, the external protective packaging system is also very important, but its failure is relatively explicit, and will not bring catastrophic consequences, so it can not rise to the height of a part of the product.
Therefore, for the product or designer in the medical device industry, we should pay special attention to this point and focus on the packaging design of the product, because this is also a part of the product design.
2. Emphasize the safety and continuous stability of packaging:
Because of the particularity of medical devices, the safety of their packaging is directly related to the life safety of the patients using the devices (of course, some low-end medical devices may not have such serious consequences). In this era of life supremacy, no one can ignore this point. As for the continuous stability of packaging quality, this is a problem to be considered after the premise of sterilization packaging safety has been met. In fact, this is also a requirement to meet the absolute safety of packaging. In addition to the quality management system standards designed by the industry at home and abroad for decades, generally speaking. Scientific and strict packaging process confirmation is also a limited method to ensure the continuous and stable packaging quality.
Basic requirements for sterilization packaging materials of medical devices
The commonly used sterilization packaging materials for medical devices include medical packaging paper, non-woven fabric, all kinds of plastic films, hard plastic boxes and aluminum-plastic composite materials. Although the materials are diverse, the basic requirements for them can be summarized as follows:
Basic performance: including basic physical and mechanical performance indexes, such as air permeability, barrier, various mechanical strength, etc.; chemical performance such as environmental stability, solvent resistance, etc.; optical performance such as transparency and haze, etc.; and other performance related to sterilization process such as high temperature resistance and radiation resistance, etc;
Microbial barrier: for the materials used for sterilization packaging of medical devices, this requirement is undoubtedly to be met, because the prerequisite for the establishment of "sterile barrier system" is that the packaging materials and the sealing systems formed by different packaging materials through specific processes (usually heat sealing) must be able to block microorganisms. In this concept, packaging materials can be divided into porous materials and non porous materials. In common sterilization packaging materials, medical packaging paper and teweiqiang belong to the former, while all kinds of polymer composite films, rigid plastic boxes and other composite materials belong to the latter;
Adapt to the sterilization process: the reason why we always emphasize the difference between the sterilization packaging of medical devices and other packaging is that the packaging system must go through a pre-designed sterilization process after the completion of the sealing process. Of course, we also need to consider the applicability of the packaging materials to the sterilization process. The common sterilization processes have different requirements on the materials, such as the ring The sterilization of oxyethane requires that the materials constituting the packaging system have at least certain air permeability.
As for the specific definition of packaging process validation, it is not so easy to describe clearly. Broadly speaking, process validation is interpreted as a documented process, which is to document the factors and information related to the packaging process safety and quality continuous stability of any product to form a validation report.