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Medical Device Sterile Packaging In China (二)

Packaging process verification For most people involved in packaging related work, "packaging process verification" should be a very strange term, because it is not a theoretical vocabulary, so there is no such term in the textbooks of general universities or vocational and technical schools. To be precise, the word "packaging process" is not mentioned. "Verification" itself should be a typical term in the industrial field. The common industrial fields are IT semiconductor industry, pharmaceutical industry and  medical device industry . It can be seen that “validation” is a rigorous term and is therefore used in some industries where process safety and stability are very high. The packaging industry has not always been an industry that is very sensitive to safety or stability, so there are fewer people in the industry who know "validation." However, when the package is considered together with the packaged contents contained therein, the packaged...

medical device sterillizatation packaging in china (一)

1.Market situation At present, the market size of China's MDSP industry is about 500 million US dollars, which includes both materials and equipment, but the majority of materials. However, some of the MDSP materials used cannot contribute to the domestic MDSP market boom, that is, those that are produced abroad and ordered to be shipped back to China for high-fidelity printing and then sold back to the international market.  This situation usually occurs in the packaging of some internationally renowned medical device companies, whether it is self-production or OEM by other companies, this part of the sales of about 10 million to 20 million US dollars.Since 2003, international companies engaged in MDSP business have officially entered the Chinese market, such as the US high-end rubber and bag products supplier Bemis, Oliver and high-end hard blister supplier Prent activities, Canada Alcan (to acquire domestic The well-known flexible packaging company Baobo entered the Chinese MDSP...

The Condition of MDSP Industry In the USA

There are now two specialized agencies on MDSP in the United States,( All are ngos), One is the SPMC commission, part of the American flexible packaging association (FPA), This is an organization for enterprises, although it was established as early as 1994 (at that time, there was no initiative on MDSP in China). But so far there are only eight members, Alcan   、 Amcor   、 Beacon Convertors   、 Oliver   、 Bemis Perfecseal   、 Rollprint   、 Technipaq and Tolas. But so far there are only eight members, The author has contact with 6 companies except Beacon and Technipaq, and the two companies that are not in contact with the small print education have not yet entered the Chinese market. This is enough to explain that the industry does not need too many competitors. If the followers do not have the technical or cost advantages, they will face the outcome of being eliminated. Among the eight companies mentioned above, Tolas is a CTF that was disguised from...

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 t...

biological monitoring method for sterilization of pressure steam in the supply room

A biological monitoring method for sterilization of pressure steam in the supply room 1. Place the   biological indicato r  i n the center of the standard test package and place the test package in the designated place for sterilization.2. Wear gloves, open the test bag and take out the sterilized biological indicator, indicating the sterilization time and location.Three indicators, containing the ampoule crowded broken, in the constant temperature incubator (56 ℃ to + / - 1 +), at the same time, a comparison of  biological indicators  indicate the time in cultivating box, 24 hours later to see the results.Four, the result decides, the positive control group culture positive (yellow) negative test group culture negative (purple) decides for the sterilization is qualified, otherwise is unqualified.5. Put the biological indicators of the positive control group into the high-pressure steam sterilizer for sterilization, and then put them into the medical garbage can. B. ...

The advantages of Tyvek for medical

Tyvek  was discovered by Jim White, a researcher at dupont, by accident.In 1955, Jim White discovered in his laboratory that a White polyethylene fluff was coming out of the tube.After inspection, it was found that this material has some very interesting properties, so I made a plan to develop a new material. One year later, I submitted a patent application for high-strength yarn polyethylene material, and after several years of development and improvement, I tried the new results on book covers, labels and specific clothing materials.The brand was registered in 1965 and was not mass-produced until 1967, when it was introduced into the medical packaging industry in 1972. The process composition of tevtron: Material ------ is HDPE fiber; Process -- flash - spinning - laying - bonding into a sheet Some features: Waterproof, breathable and resistant to bacteria, can still maintain flexibility and high strength at -73 degrees;Contraction begins at 118 degrees;It starts melting at 135 d...

Medical Sterilization Packaging bag

For the packaging of the products of the  medical devices , sterilization of the products, and the sterile operation, which is a sterile operation, to provide acceptable microorganism, to protect and to  sterilize the product  and to sterilize the product and to keep the system within a certain period of time to maintain the system's sterile environment. It is suitable for sterilization ETO ethylene oxide, high temperature wet steam, gamma-60 radiation, plasma, formaldehyde, etc. Blister box The blister material PET, or PP, or PETG, etc., is heat-sealable medical coated paper, which is currently more than one Tyvek adhesive paper) object Medical equipment manufacturers and hospitals. The sealing form Hot sealing machine and double-sided adhesive sealing reflexive buckle adhesive closure   Quality standard International ISO11607; The European Union is EN868; China for GB/T19633 Packaging principle Through the principle of sterilization fac...