Medical Device Packaging Sealing Bursting Tester

During the sterilization or transportation storage process, there may be a pressure difference between the inside and outside of the sterilization packaging. If the equipment is loaded too tightly or the peeling strength of the sterilization bag slightly decreases, it may lead to potential leakage and explosion risks. This article elaborates on the testing methods for sealing of medical device open sterilization packaging through the interpretation of GB/T19633-2005 and ASTM F 1140 standards.
ZYY-08AMedical Device Packaging Sealing Bursting TesterStandard interpretation: Medical device sterilization packaging generally refers to the part that directly contacts the product and forms a microbial barrier, mainly consisting of paper plastic bags, plastic bags, dialysis paper bags, and other types. Due to the special nature of the contents inside, this type of packaging not only has the basic performance of packaging, but also needs to meet higher requirements for sterilization and aseptic operations. It also has a microbial barrier function to prevent microorganisms from entering and provide aseptic protection. After sterilization, it can maintain a sterile environment inside the packaging system for a certain period of time.
Among the current packaging testing standards, GB/T19633-2005 "Packaging for terminally sterilized medical devices" is a standard for various performance aspects of medical device sterilization packaging. This standard is equivalent to adopting ISO 11607:2003 "Packaging for terminally sterilized medical devices", which specifies the requirements for disposable materials and reusable containers used for packaging of terminally sterilized medical devices. At the same time, it proposes basic requirements for evaluating the performance of sterile medical device packaging, involving the physical, chemical, toxicological properties of packaging materials, microbial barriers, and the sealing/closure, integrity, aging performance of formed packaging. These performance requirements ultimately aim to ensure the microbial isolation of sterilization packaging. However, during the sterilization or transportation storage process, there may be a pressure difference between the inside and outside of the sterilization packaging. If the equipment is loaded too tightly or the peeling strength of the sterilization bag decreases, it may lead to potential leakage and explosion risks. So the microbial isolation effect of the entire sterilization bag will be greatly weakened. This reflects the importance of testing the sealing/closure performance of molded packaging.
GB/T19633-2005 "Packaging for terminally sterilized medical devices" stipulates that sealing strength is one of the evaluation indicators for sealing/closure, and provides two testing methods: tensile sealing strength test and burst/creep pressure test. The former measures the strength of the packaging seal by stretching a section of the sealed part. This method cannot be used to measure the connectivity or other sealing properties of the joint, but can only measure the tearing force of the seal between materials. The latter evaluates the overall minimum sealing strength of the packaging by applying pressure to the entire packaging to the point of rupture (bursting) or to a known critical value and maintaining it for a period of time (creep). The specific testing method and process for the burst/creep pressure test are not detailed in this standard. According to the standard "Specific testing process and requirements can be equivalent to ASTM F 1140", the test can be conducted by referring to ASTM F 1140 "Standard Test Method for Internal Pressure Resistance of Medical Non Suppressed Packaging".
ZYY-08A produced by Jinan Ruilaibo Intelligent Technology Co., LtdMedical Device Packaging Sealing Bursting TesterDesigned and developed according to the above standards, it meets multiple standard requirements and is a cost-effective equipment for testing the sealing performance of medical device sterilization packaging in China. The instrument has a high degree of intelligence, a beautiful and elegant design, and a human-computer interaction interface that increases the operator's good experience, which is highly recognized by the market. Jinan Ruilaibo Intelligent Technology Co., Ltd. looks forward to your inquiry.