A few when sterilization of medical devices packs a design main demands (one)

Medical School Pathology, Chapter 1a

Hasty a year, will go again suddenly, the end of the year, want or stick the article that writes this year piece come out, taste for everybody read!

The first part: Sterilization of medical devices packs the main demand of the design

.The author ever had written sterilization of a few concerned medical devices two years to pack afore (Medical Device SterilizationPackaging, MDSP of the following abbreviation) relevant article, for instance a few omnibus overviews, home reachs experiment of test and verify of international current situation, craft, ageing (or call stability the experiment) , particular certain property test, but a few fundamental that did not involve concerned MDSP design, accordingly the article undertakes with respect to this task a few discuss, of course these are author individuals only see, be not is absolutely and correct, if which reader feels the viewpoint in the article is worth deliberate, can consider to discuss deep again together with the author, after all, to MDSP, the theory that there is special authority inside whole world limits at present consults directly for everybody, more technical theory points accumulate summary slowly in practice.

So are those things just the main demand in current MDSP design? It is the one part that we want a MDSP to regard product of the medical devices that be packed as of course above all, and be absent to pack what it regards a product as merely alone, got at this o‘clock in ISO11607-2006 the directest reflect, in this MDSP is concerned on international at present in the most authoritative standard, be absent even pack call ‘ pack ‘ , and change say ‘ system of asepsis protective screen (SterileBarrierSystem) ‘ , nod at this point so in light of, pack the medical devices to needing sterilization for, the effect that have is different from really pack at fast consumable (food, medicines and chemical reagents and cosmetic and so on) wait with industrial product. Accordingly the product to industry of medical devices is developed or the technology designs staff for, want special attention this a little bit, should consider the packing design of the product mainly, because this also is the one part of product oneself design.

It is demand of the security that pack next, because of medical devices kind the characteristic of the product, of the life safety that the safety that its pack was the patient that matters to use appliance directly (the product of medical devices of a little low of course end can not have so serious consequence possibly) , in the time with this consummate life, do not have a person to be able to ignore this. And the absolutely security that should achieve sterilization to pack, the professional company that there is experience inside advisory course of study or personage, choose what be proved to be qualification to pack material, enough and the experimental design that has scientific basis and strict experimental operation, consult to be considered as correct historical experience and experimental data to wait, should be considered inside.

Finally is the quality that pack the requirement of successive stability, this is the requirement that in the sterilization security that pack this major premise has satisfied falls, the issue that should consider next again, in fact this also is to satisfy a requirement that packs absolutely security. Come according to a few years domestic and international industry experience summary, generally speaking test and verify of scientific and strict the craft that pack is to ensure the quality that pack is successive the effective method of stability, also be so far only method.

The 2nd part: How to satisfy these basic requirements

After the main demand that knew MDSP is designed, how should satisfy these basic requirements so? With the author at present humble see, should have a few more the following:

1. Experimental method admits really (Test Method Validation)

2. The product is familial (Product Family) with worst circumstance (the definition of WorstCase) and apply

3. Scientific design packs systematic performance experiment (Packaging System PerformanceTesting)

4. Scientific design stability test (Stability Testing)

5. The test and verify of the craft that pack (Packaging Process Validation)

Still possibly of course the method satisfies those basic requirements of MDSP, here author does not discuss in extend the meaning, below these gets the self-identity inside course of study quite at present to MDSP designs that talk about above only simply to mention want a place.

One, experimental method admits really

Because,occurrence of this bit is in fact MDSP all over the world inside limits for it is a newer science, very much to its thing is current inside course of study in still be being discussed, dominant standard ISO11607 every 3 be about to update to 5 years (note: At present the version of ISO11607 was 2006 of version, ever some version include to was mixed 1997 2003 two version; And according to the plan, the version of next 2011 ISO11607 can be promulgated formally in order to replace present edition) explained this is nodded adequately, the experimental method that this brought about a lot of specific aim is not long-tested or absolutely and correct, and a lot of be in at present him business circles ‘ creation ‘ experimental method, although be returned at present,be not collected formally to be in standard and so on, but test result is actually same also however, the person that can pass experimental use comes from me or search lab of tripartite independence to confirm the effectiveness of experimental method, will get final self-identity.

Collect the standard in list of ISO11607-2006 appendix B some now in fact, also be to pass such way to be accepted finally by industry, be adopted to be official standard, be like ASTMF1929 typically, also namely color of toluene amine Lan Ran sinks a test.

How should undertake experimental method admits really so? Actually main avenue still is passed and have similar standard experiment method (to MDSP, generally speaking, its are of all kinds function experiment is OK know exactly about sth is planted the method will examine, pack integrality experiment for instance) will contrast, look both right same the experimental result that approves sample is consistent; If experimental result has difference, whether is this difference inside the limits that can be accepted etc.

Want of course the experimental method that him seek devises becomes an industry to test a level, so the tripartite lab that entrusts authority will have a test and the effectiveness of result of comparative analysis test cannot be avoided surely, the author believes, this is in home, return at present very few, come true very hard also truly. And to manufacturer of medical devices (MedicalDeviceManufacturer, MDM of the following abbreviation) for, can not bring the profit of what materiality so, instead can have suspicion of classified of leak company technology. The sterilization that is upper reaches packages data or systematic supplier often stems from commercial interest (the method that establishs good industry reputation to perhaps regard a kind of market as promotion for instance) consideration, meeting attempt does this kind of work, the typical Dupont company that is like the United States is its subordinate Tyvek brand and a series of accords with sterilization to pack a requirement test methods of the design, some already standard of translate into ASTM, be like ASTMF1608 typically, about porous material microbial cut off standard of a test, and the take time that rises in view of ASTMF1608 operation is arduous costly, developed an ASTM F2638-07 of new congener test method again at present.

Unfinished to be continued!
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