As a medical plastic processing process, the main principle of medical blister packaging is to heat and soften safe plastic hard sheets, use vacuum adsorption on the surface of the mold, cool and form them, and use them for medical outer packaging. Medical packaging blister boxes, as a sterile barrier system, are increasingly being accepted by more and more medical devices, and Laiya Technology is particularly favored for their strong stability in medical blister packaging.

1. Raw material selection

The selection of raw materials is the foundation of ensuring quality, from particles to vacuum molded products, its requirements are far higher than food grade and industrial grade. The selection of medical grade blister boxes must meet the ROHS requirements, as well as the requirements of IS010993 "Biological Evaluation of Medical Devices" and ISO11607 "Packaging of Final Sterilized Medical Devices", in order to achieve a complete sterile barrier system and microbial barrier function.

Currently, there are various types of food packaging materials produced in China, with mixed quality and many safety hazards. Especially when industrial PVC replaces PETG and RPET (a recycled PET material) instead of APET, a large amount of harmful substances will precipitate after high-temperature molding and sterilization, containing painful substances, resulting in the original life-saving equipment becoming a "killing" tool. Therefore, we need to carefully choose the materials used. Currently, medical PETG mainly includes Eastman 6763 in the United States and SKS2008 in South Korea.

2. Structural design of vacuum box

Before design and development, comprehensive factors such as raw material selection, packaged devices, sterilization methods, and clean opening by medical personnel should be fully considered. And it is necessary to ensure the ability of sterile medical device packaging to maintain a sterile level within its validity period. Therefore, details such as the design of edge width, hand tearing position, and clamping method need to be considered during the design phase.

3. Selection of blister molds

Medical vacuum boxes use aluminum alloy molds, and there are many types of aluminum materials available. However, in terms of overall mold processing accuracy and various performance, 6061 is a better aluminum material. This aluminum material is processed into a mold by CNC. Due to the aluminum inner core, it is easy to achieve thermal balance, and cold water is used around to cool the mold quickly, providing the production efficiency of the blister box. Due to the aluminum inner core, it is easy to achieve thermal balance, and cold water is used around to cool the mold quickly, increasing the speed of production and the smoothness of the blister box. Due to the high cost of the aluminum mold and the generally long service life, Martin Medical Packaging promises customers that the aluminum mold can be used for up to 10 years, And it can maintain high accuracy during repeated production. There are many master molds made of gypsum powder on the market, with a layer of copper plating on the outer surface. The accuracy and appearance of the finished product are not to mention, and the cleanliness cannot meet the requirements of medical device packaging. The quality of the mold production of the blister box directly affects the detailed effect of the finished product, so it is recommended to choose it carefully.

4. Requirements for dust-free production environment

Laiya Technology's ISO13485:2016 system coexistence management. There are very high requirements for the cleanliness level of medical vacuum boxes. (For example, the initial contamination bacteria and insoluble particles of medical vacuum boxes need to be controlled within a certain level), especially for the packaging of Class III medical devices.

5. Blister forming equipment

Has a customer ever asked about the difference between positive and negative pressure integrated molding machines and negative pressure molding machines? Generally speaking, experienced manufacturers know that positive and negative presses are commonly used in the dry food packaging industry because of their large production capacity, single structure, and high efficiency requirements. Although some food tray products feel hard when touched by hand, their impact resistance is relatively poor and they are prone to stress deformation. A greater risk is due to its pursuit of efficiency. Although there is a heating knife in the punching section, it still cannot avoid cutting edges and flocs, and the dissolved substances during the forming process and the dust caused by the chain piercing material may directly fall into the shell, causing poor appearance.

Furthermore, because it is automatically stacked after production, it is easy to cause scratches. These are difficult to detect through the lamp inspection table. If the automatically stacked products are dismantled for full inspection, it is easy to cause secondary scratches and affect the quality.

As is well known, the characteristics of medical device packaging are a large variety and small quantity, but with extremely high requirements, emphasizing detail control and risk prevention. Negative pressure molding has high flexibility and flexibility, and the upper and lower molds are also very convenient. The key is that personnel monitoring during the process can reduce the occurrence of many defects. Therefore, there is still a significant difference in the molding conditions between it and food packaging.

6. Final product packaging verification

As mentioned above, there are strict regulatory requirements for testing the biocompatibility, physical and chemical properties, sterilization adaptability, heat sealing performance with the cover material, and transportation methods of raw materials. A complete medical packaging verification plan should include but not be limited to: bacterial resistance test, material toxicology test, and cover material peeling strength test, leakage test, initial contamination bacteria and particle detection of the plastic box, aging test of the plastic box, sterilization residue and sterility test, stacking and transportation simulation test. Choosing a medical packaging manufacturer that meets the requirements requires comprehensive consideration from multiple aspects, and cannot be decided solely based on price factors.

Regarding the high standard and strict requirements for medical vacuum boxes, in addition to the conventional requirements mentioned above, some companies also have personalized requirements for card positions, sealing, etc. If you need to learn more information, please privately write to the official website of Laiya Technology!