A few when sterilization of medical devices packs a design main demands (3)

iGrow Medical Marijuana: A California Growth Industry

(add above paragraphs. . . . . . )

4, scientific design stability test (Stability Testing)

Stability experiment also is the problem of a platitude to MDSP, the author has written special implied meaning to had discussed this task likewise, what need to make an explanation of course is below the connection between these a few nouns: Stability experiment (StabilityTesting) , ageing experiment (Aging Testing) with shelf life experiment (or call experiment of period of efficacy, shelf-lifeTesting) . Although the author not dare absurd makes conclusions, but be in in fact bound of medical devices, major view is to think these 3 show is same a concept, also having special product of course is exceptional.

The stability experiment of MDSP, or the past history that calls ageing the experiment, come from at ISO11607 series standard. The around in this standard in a few version, have a paragraph of such stated very clear words all the time: "Manufacturer should be in charge of a proof, of the product pack finally enduring long current with process of keep in storage in, did not damage or should be being packed only was not opened, and be store in what manufacturer appoints below the condition, in the period of efficacy that the product tags its pack Ying Wei to hold complete " , this paragraph of word should be the authoritative standard basis with product the directest ageing tests. But this standard just was mentioned should have ageing test in order to ensure the effectiveness of product period of efficacy, and the detail that did not allude how to have ageing test, after all this is a standard of general rule sex.

Analyse ageing test actually with very scientific point of view, discover this experiment is a system in fact not hard, mix complexly long sample conditioning process, with those tests that provide in ASTMD4332 sample adjustment process is in this is consistent substantially, the specific environment that makes sample good in the design namely issues those who pass proper time to adjust, the sample that passes specific conditioning to these again next has the test of the respect such as necessary physics, chemical, biology and mechanical function, in order to proves sample passes conditioning around to whether be put in the difference on of all kinds function. If use a simple word to come to those who summarize ageing test to change, that should be: Ageing experiment is long, of the system and the conditioning process that does not involve product function test.

It is OK that ageing experiment differs according to property cent is true ageing tests (Real Time Aging Testing) and accelerate ageing experiment (AcceleratedAgingTesting) , just as its name implies, former fall in normal temperature environment namely, perhaps saying is the buy of transfer to a lower level of current storage environment that anticipates in the product, till the period of efficacy till the design expires, in will pack complete product to be taken do relevant function test, mix with the result of this function experiment the result of sample function test before undertaking ageing tests undertakes contrast, is reasonable. And quickening ageing tests is to design a specific ageing experiment environment, achieve the goal that shortening greatly is very endless ageing experiment duration normally thereby, this specific environment and shorten associated sex exists between the scale of time.

Can see from this, true ageing tests is very simple, but the time of need is very long, the likelihood does not suit intense market competition to be opposite the requirement in respect of sex of effectiveness for a given period of time, often should use so quicken ageing tests, but true ageing experiment is indispensable, because its result just is the most accurate,mix authoritative, and the result that quickens ageing tests is only transfer, after result of true ageing tests comes out, still want result of referenced and true ageing tests finally.

And the acceleration to MDSP ageing experiment, what the author should state above all is this it is an ambiguous science, the chemical reaction that involves because of experimental itself too complication, and its theory basis still cannot get science so far continuously confirm authoritatively. As to its specific academic principle and design ask to wait, can refer to the author to was published at last year " information of Chinese medical devices " relevant article " experiment of the ageing of sterilization of medical devices that pack " , here no longer give uncecessary details!

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

About the topic of MDSP craft test and verify, almost the one pile that every industry public figure can speak him is distinctive opinion, this also enough sees this content is us this industry most the requirement of fundamental sex, the author also had article discussion to cross this part content last year.

But the reality that another nots allow to ignore is, if let the personage inside every course of study write according to the requirement of standard code oneself most think plan of sound MDSP craft test and verify, the metropolis that everybody writes the likelihood is different, and mutual between meeting difference is very big, and very much now the line of business of travel is entered first wife person seeks relevant documentation data to Internet, gotten result also is each not identical. All these showed course of study inside a very big challenge was encountered on this problem now, that is everybody think craft test and verify is packed to sterilization of medical devices for be must, but how be being designed and carry out go up to have very big difference each other however. And the about this problem view that author place gives out, also be the experience knowledge that is based on author individual purely, and the view of a few viewpoints that summarizes domestic and international person of the same trade and reach.

Of course, here same no longer give uncecessary details, the reader friend that have fun at can consult the author was published at last year " information of Chinese medical devices " relevant article " test and verify of the craft of sterilization of medical devices that pack " .

In the article finally, what must point out is, in fact at present MDSP all over the world the rational inside limits is talked (or standard) directive great progress is controlled in nearly 20 years namely, and in home it is the time that influences 5 years more, itself of together with MDSP is a thing that needs to consider a lot of course integratedly (include at least material, microbial wait for scientific class with mechanical automation) , so a lot of a lot things do not have complete determinism, what give out here, also be to be based on a few individual experience and knowledge, and consult home of a lot of international (especially international) the person of the same trade‘s view, will consult for everybody and discuss. If each reader has the place of different opinion, can send a letter will case deliberate!

Full text is over!
Wish everybody Happy New Year, the hope can compare quiet 2008 place 2009, not again so do sth over and over again ～ ～ !
Article \Randy alls rights reserved, do not reprint at will please!