With the growing competition, medical device manufacturers need to seize any opportunity to enhance the competitive advantage. Packaging is one of the areas that are often overlooked. Understanding and thinking of ways to meet the needs of customers is very critical. Master packaging technology, international packaging standards, green planning and design for the user needs can help manufacturers to expand market share.
With the continuous development of medical technology, packaging technology must be developed, to protect the medical innovation, and to deal with the new challenges of technological progress. Due to advances in biotechnology, pharmaceuticals, biotechnology and nanotechnology, the integration of the other. One of the fastest developing areas is the combination of pharmaceutical and medical instruments.
According to medical packaging bag of research results, in 2004 the world's pharmaceutical and medical instruments of the composite product market value of about $5400000000, is expected to be 13.3% of the annual growth rate continued to rise, to 2010 is expected to reach $11500000000. One of the most important compound is the drug eluting stent, which is expected to grow at a rate of 11.5% per year by 2010.
TIR22:2007 focuses on the specific application details of the packaging engineer. It can provide in-depth details of the design and development of the packaging system, but not after the design of the packaging engineer to provide help. In many small and medium manufacturing companies, product development engineers also need to be responsible for packaging.
This is committed to the integration of the ISO11607:2006 Committee faced with many obstacles, a clear description of the medical packaging related terms is one. To establish a platform for international recognition, the work is very important. Thus, the following 4 key terms are defined. These definitions can greatly promote the correct use of ISO11607:2006 and TIR22:2007, as follows:
Packaging system. Combination of sterile barrier systems and protective packaging. Protective packaging. Used to protect the sterile barrier system and content, making it the structure of the material that is protected from damage. Pre forming sterile barrier system. Sterile barrier system assembled in bagging and finally before sealing part of the use of. Sterile barrier system. To prevent the entry of microorganisms and to allow the product to use in a sterile condition of the smallest packaging structure. For specific surgical instruments, the load in the special guard bag in the tray may be the user's favorite packaging.
Medical device packaging engineer most of the ISO11607:2006 and TIR22:2007 as packaging development canon. Medical device packaging engineer for design, material selection, sterilization, production, packaging, testing, documentation, audit and supplier certification of any decision made by the ISO11607 as a benchmark.