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Definition of BFE: The ability of  packaging materials  to resist bacterial penetration, ie bacterial filtration efficiency. The material was evaluated for performance by parameters of bacterial filtration efficiency. No material can block bacteria into the package 100%, so BFE can reach more than 95%, which is a good result. BFE also changes under different air pressure conditions. Microbial aerosol test The experimental methods are clearly defined in AAMI ST77 and ISO 11607. There is no clear requirement for the design of the cabin of an aerosol cabinet for testing aerosols. The aerosol cabinets used in different laboratories are not the same, but they work basically the same way. Under normal circumstances, the size of the aerosol cabinet is one cubic meter. The aerosol can be continuously injected into the micro-organized aerosol through the circulation device, and the specific pressure is maintained. The rigid container or the whole package of the sterile package is place...

Medical packaging  materials are also known as "SBS"  Sterile Barrier System , or "sterile barrier system."   basic requirements 1. The formation of a sterile barrier system requires the following requirements: 2. The sterilization medium should be able to effectively penetrate the medical packaging materials. 3. In the sterile barrier system, the sterilization medium can be effectively sterilized. 4. Medical packaging materials should be able to protect the surgical instruments inside the package. 5. Medical packaging materials should be able to discharge the sterilization medium. 6. The sterile barrier system formed by medical packaging materials should be able to ensure its sterility. From the time of sterilization to the time of opening, the inside should always be sterile. Related standards 1.ISO 11607-1, 11607-2 2.EN 868 series standard 3.ASTM-various experimental methods 4.AAMI ST77 The above standards are currently the most commonl...

Sterilizer bags  have become the most breathable sterile barrier system and are widely used in articles that require full penetration of steam to sterilize, such as gauze, cotton, wood products, fiber products, etc., and these items are destroyed by using paper-sterilization bags. Bacteria, due to poor gas permeability, easy to dry is not thorough, wet pack or burst bag. At the same time, the whole paper bag is an environmentally friendly product and does not need to pass the EU's environmental directive requirements. The specific requirements can be found in YY0698-3 2009. It should be specially pointed out that the wholesale wrapping paper bag for hospitals is different from the paper bag for food. The whole paper bag for hospitals is bonded with structural adhesive, which has the performance of resisting water and high temperature, and the back seal is lapped. It is guaranteed that in the steam sterilization, the paper and paper seals are perpendicular to the direction of the fo...

Aseptic bag, a high-tech  new packaging material produced by using polyethylene pellets as raw material in ause.  Sterilizer bags  are widely used in aseptic solid bulk drugs, aseptic pharmaceutical excipients, aseptic preparations, etc. due to their sterility, non-toxicity, excellent low temperature resistance, good chemical stability and electrical insulation properties. Transshipment and temporary storage, as well as transit packaging of sterile rubber plugs from cleaning to filling line processes. In addition, in the food industry, the aseptic bag can also be combined with cardboard and aluminum foil to form a packaging container for food. The weight of the aseptic bag accounts for about 20% of the entire package, and mainly blocks liquid leakage and microbial attack. clean environment by blown film, cutting, heat sealing, vacuum packaging, sterilization and other processes. Production environment and process According to the new GMP standard, the production environme...

The  bowie dick test  is named after the surnames of developers J. H. Bowie and J. Dick. Originally this test was used to evaluate the vacuum process of single deep vacuum sterilizers, also known as high vacuum sterilizers. It is a diagnostic test for a sterilizer vacuum system. In particular, the test can assess an inadequate vacuum condition, meaning that air is not completely removed from the sterilizer cabinet or air leaking from the door gasket is left in the sterilizer cabinet. This residual air prevents the penetration of steam into the contents of the sterilizer cabinet during the steam exposure phase of the sterilization process.  This diagnostic test used an autoclave tape to form a cross pattern on a piece of paper (St. Andrews cross). These  sterilization indicator tapes  are coated with chemical indicator lines. The paper is placed in the middle of a linen interwoven fabric having a folded layer of 29 to 36. The wrapped test package was placed above...

Generally referred to as "medical wrap", " sterilization pouches ", "sterilizer bags", "medical wrap,sterile packaging", etc., according to ISO-11607 and EN-868, the initial packaging used for medical equipment to be sterilization pouches is. In ISO-11607:2006, it is called SBS (Sterile barrier systems), which is named as “sterile barrier system” in the medical device packaging industry standard being developed by the Chinese Food and Drug Administration (SFDA). standard Internationally used ISO-11607 terminally sterilized medical wrap, and EN-868 medical materials sterile packaging materials and systems. Domestic use GB/T 19633 (transcription ISO-11607) and the State Food and Drug Administration SFDA is developing a new medical sterile packaging industry standard YYiT "terminally sterilized medical device packaging materials" (transcription EN-868 parts 2 to 10). Internationally, ISO-11607 and EN-868 are being gradually integrated. ISO...

First you need to make a definition of this packaging system. This packaging system is a combination of all the external factors that constitute the protection of the target body - medical device products. A packaging system is mainly completed through the steps of packaging material selection, packaging structure (or form) design, packaging process execution and packaging experiment inspection. For medical device  sterilization packaging systems , based on their specificity on the performance requirements of the packaging (mainly requiring systemic inhibition and ability to withstand the various types of sterilization methods that will be used in advance), this system can be divided It consists of two parts, the  Sterile Barrier System  (SBS), which belongs to the category of the inner packaging system, and the Protective Packaging System (PPS), which belongs to the outer packaging system. Relatively reorganized, SBS is more critical because its failure means absolute fa...