Introduction to Medical Device Sterilization Packaging (MDSP)
Time: 2018-09-04
Summary:First of all, let's explain the concept of "MDSP" clearly. Based on the understanding and analysis of the latest updated authoritative standard ISO11607 of MDSP in the world (note: it is the 2006 version, EN868 series has been unified into the latest ISO11607 version, and the GB19633-2005 standard has not had time to update synchronously), the author thinks that MDSP can still be divided into two parts: primary packaging and auxiliary packaging, but the new standard gives a clear and unified title, and the primary packaging is called "sterile barrier system (SterileBa"
MDSP Overview
First of all, let's explain the concept of "MDSP" clearly. Based on the understanding and analysis of ISO 11607, the latest updated authoritative standard for MDSP in the world (note: it is the 2006 version, EN 868 series has been unified into the latest ISO 11607 version, and the GB19633-2005 standards have not yet been updated synchronously), the author thinks that MDSP can still be divided into two parts: initial packaging and auxiliary packaging, but the new standard gives a clear and unified title, the initial packaging is called "Sterile Barrier System (SBS)", the auxiliary packaging is called "protective packaging (Protective Packaging)", and the packaging products and materials before the realization of SBS function are very strictly defined as "pre-formed sterile barrier system (Performed Sterile Barrier System, PSBS)". It should be noted that because the concepts of SBS and PSBS were only put forward in the latest version of ISO 11607, there is no unified or authoritative name when it is translated into Chinese. The Chinese names mentioned above that correspond to the two are translated by the author himself.
As the name implies, the sterile barrier system (SBS) is a sterile packaging system that directly contacts the medical device product and constitutes a microbial barrier. There is no doubt that it is the core part of MDSP. Protective packaging is mainly about the product in its life cycle of storage, circulation process of protection, convenience, traceability and packaging costs of some packaging, involving cartons, plastic bags, labels, bar codes, printing, pallets and containers and other content.
Although the strength of protective packaging such as cartons is not enough, it will also affect the realization of SBS functionality (for example, the damage of cartons will lead to the failure of SBS packaging in some bags), and the label focuses on another problem that MDSP pays great attention to-traceability (Note: the country has specially issued relevant label requirements for the food, drug and medical device industries; new RFID tags are also in full swing in related industries in the United States), but considering the limited space, this article only discusses SBS (including PSBS) in MDSP.
Common SBS in industrial production mainly includes bag type (Pouch & Bag), Form-Fill-Seal type (FFS) and hard blister box-lid material type (Tray Lid). SBS used for disinfection in hospitals may also have roll-shaped paper bag (Reel Bag).
Bag type SBS can be divided into paper-poly bag (Paper-Poly Pouch), paper bag (Paper Bag), plastic bag (Poly Bag), Tyvek bag (Tyvek-Pouch), header bag (Header Bag), window bag (Vent Bag), etc. according to the degree of commonness. The Chinese names provided by the author are for reference only. The paper used here is medical grade wrapping paper with good air permeability. There are many kinds of plastic films used, mainly LDPE, HDPE, PET/PE, PA/PE, and special linear tear film (Liner Tear Film). Among them, linear tear film is very innovative. Only several leading companies in the world have this technology and use it on window bags (Vent Bag). Bag SBS products are widely used in MDSP, from disposable devices such as syringes and catheters to high-end implantable devices, and their cost varies greatly depending on the materials used and packaging purposes.
FFS SBS consists of two parts: top material (Top Web) and bottom material (Bottom Web). Among them, the materials used for the top material mainly include Tyvek with or without glue, medical ventilation paper, films with special easy peeling coating, etc. The substrate is mainly soft plastic forming films with various structures, the more common structures in China are PP/PE, PA/PE, Surlyn/EVA/Surlyn. The first structure is polypropylene composite film, which is economical and practical. The nylon film in the second structure has high strength and puncture resistance. The Surlyn layer in the last structure can increase the flexibility of the composite film, has good formability and beautiful appearance. The biggest advantage of FFS class SBS is a high degree of automation, high efficiency, and low cost, but it is not suitable for complex structures or high-demand device packaging.
Key words:
Yangzhou Tuobo Plastic Industry Co., Ltd
E-mail:tuoboxisu@126.com
Address: Dinghuo Town, Jiangdu District, Yangzhou City
Mobile website QR code
Business License