Sterile barrier system test manufacturer considers sterile barrier The system has the function of blocking microorganisms of sterile medical devices under specific conditions. Typically, packaging on the inside that comes into contact with the product is used to sterilize specific pathogens for sterile medical devices. Sterile barrier systemTypes include: DisposableSterile barrier system, achieve sterile barrier function through airtight packaging; or disposable reusable packaging materials, achieve sterile barrier function through airtight packaging; reusableSterile barrier systemValve or filterable The components of the device achieve the sterile barrier function.

Sterile barrier system test manufacturer thinksSince medical devices are sterilized after packaging, the packaging materials and/or system should be able to withstand the sterilization process and meet the conditions required for sterilization in packaging. For sterile medical device manufacturers, the design and material selection of sterile packaging should take into account the specific characteristics, intended use, validity period, transportation and storage conditions of the medical device, and should be compatible with the sterilization process to meet the requirements of sterilization, packaging content Basic requirements for material protection and sterilization medium discharge.

Sterile barrier system test manufacturer thinksThe basic requirements of aseptic packaging mainly include the following aspects:

(1) The integrity of the packaging. Includes seal integrity and seal integrity;

(2) Stability of packaging materials. Maintain the stability of mechanical and chemical properties of packaging materials within the validity period, and maintain the integrity of the aseptic packaging system;

(3) Biocompatibility of packaging materials . Sterile barrier system test manufacturer thinksBecause the packaging material is in direct or indirect contact with the device during use, it must meet the relevant biocompatibility;

(4) Compatibility of sterilization process. It is required that in different sterilization processes, the packaging integrity will not be affected due to sterilization reasons;

(5) Requirements for convenience, cleanliness and openness . Sterile barrier system test manufacturer thinksThe process of taking out the instrument should be simple and convenient. The cleanliness has high requirements on the material itself and the heat sealing of the material, so the mechanical strength of the material must be qualified, and the heat sealing strength should not be too high.

Sterile barrier system test manufacturer thinksFactors affecting the packaging design of sterile medical devices There are many factors to consider in the process of designing and developing sterile medical device packaging. The goal of medical device packaging is to sterilize the device, provide sterility protection prior to use, and maintain its level of sterility so that the device can ultimately be used sterile. The main influencing factors are:

(1) The natural attributes of the equipment product itself. Such as equipment material, hardness, size and shape, center of gravity, edges and corners, surface characteristics, service life, rearrangement ability, etc.

(2) Protection requirements for instruments. Such as sensitivity to temperature, humidity, light, oxygen and vibration.

(3) Sterilization method used. Sterile barrier system test manufacturer thinksKnowledge of the chosen sterilization method can help in selecting the appropriate type of sterile barrier material. The selected material must be compatible with and able to withstand the sterilization process. For example, gas sterilants often employ porous sterilization barrier materials.

(4) Requirements for transportation and storage environment. Sterile barrier system test manufacturer thinksWhen designing, we had to consider how the device would be conveyed and transported during the shipping process. The requirements of the equipment storage environment must also be comprehensively evaluated, and the layout of the equipment on site is also a factor that needs to be considered.