The Summarization of “MDSP”
First, let's clarify the conception of MDSP. Based on the international MDSP latest update of the authoritative standard ISO 11607 understanding and analysis of scanning. MDSP, can be divided into the early packing and affiliate of two parts, only in the new standard is given a clear and unified appellation, wrap the early called "Sterile Barrier System (Sterile Barrier System, referred to as" SBS ")" The attached Packaging is called "Protective Packaging (Protective Packaging)" development, and very strict rules on the implementation of SBS function before Packaging products and materials for "preformed Sterile Barrier System (Performed Sterile Barrier System, PSBS)". Since the concepts of SBS and PSBS were proposed in the latest version of ISO 11607, there is no unified or authoritative name for them when they are translated into Chinese.
As the name implies, the pre-press aseptic barrier system (SBS) is a sterile packaging system that is in direct contact with medical device products and constitutes a microbial barrier. It is undoubtedly a core part of MDSP.Protective packaging is mainly about the protection, convenience, traceability and packaging cost of products in the storage and circulation process within their life cycle, involving cartons, plastic bags, labels, bar codes, printing, pallets and containers.
Although the strength of the carton and other protective packaging is not enough also affects the SBS functional implementation (such as some of the bag inside the carton damage will cause the type of SBS packing crushed and failure), and label of MDSP very pay attention to another problem - traceability (note: the country has for food, medicines and medical equipment industry specifically introduced related label requirements;New RFID tags are also gaining popularity in the United States (ticket printing).
The SBS commonly used in industrial production includes Pouch & Bag, form-fill-seal (FFS) and hard plastic box-cover Lid. The SBS used for sterilization in hospitals may also contain Reel Bag.
Bag type of SBS a common degree and can be divided into paper-plastic Bag (Paper - Poly real Pouch), Paper Bag, Paper Bag), plastic and plastic Bag (Poly real Bag), Tyvek Tyvek Bag (Tyvek - Pouch), immediate Bag (Header Bag), window bags (Vent Bag), etc., three behind the current domestic haven't standard Chinese translation of the film coating, the Paper used here are the permeability is good medical grade wrapping Paper, there are many kinds of plastic film,LDPE, HDPE, PET/PE, PA/PE, and special Liner Tear films are the main ones, among which Liner Tear films are very innovative. Only a few leading international companies have this technology, which is used in the window bags.Bag SBS products have a wide range of USES in MDSP, ranging from disposable devices such as the lowest end syringe and catheter to high-end implantable devices, etc. The cost varies greatly with the use of materials and packaging purposes.