VVH-TV News -- Lyme Disease: Medical Nightmare (Part 1)
Add above paragraphs!
5,
Sterilization of medical devices packs main demand of the system
In front a paragraph of main demand that those who discuss is material of pair of sterilization of medical devices that pack, this paragraph is discussed is systems of pair of sterilization of medical devices that pack below, or the main demand of system of asepsis protective screen, both distinction is former be aimed at package data yes, and what latter is aimed at is by former make the packing system that close.
5.1 suit with sterilization process photograph
When the material that pack is being told to ask basically in front, mention material to want to have sterilization process consistence, without doubt, the sterilization that forms by material packs a system, also should suit with expectant sterilization means appearance, this is the uniqueness of this kind of means that pack and characteristic, because pack the perfect combination of craft and sterilization craft,just be those who form this kind of sterilization to pack craft is all, this also got reflecting in its major nominally, must consider when the design packs a system so expect the sterilization craft demand to its, avoid to give the issue that currently holds the post ofHe Qian to be in!
The 5.2 craft that pack affirm (Validation)
The 3.3rd is in in front a fundamental that we mention sterilization of medical devices to pack is to emphasize security and successive stability, and the craft that pack affirms what undertake for this purpose just about!
About packing the specific definition that craft affirms, not be so easy it is clear to can be described, consulting after data of a lot of document, of wide extensive say, the course that craft test and verify is changed into a file by the explanation, namely those any mixing the element with successive relative stability and information file change security of the product craft that pack and quality and form report of test and verify so a process.
Accordingly here extend the meaning went out to pack craft to confirm plan (Validation Protocol) confirm a report with the craft that pack (ValidationReport) these two concepts, this is it is very important to be packed to sterilization of medical devices but very complex topic, the article is not done spread out discuss!
The ageing experiment of the 5.3 systems that pack (Aging Testing)
Ageing experiment can call stability experiment or experiment of period of efficacy again, ageing tests is a when the consideration wants in the design of sterilization of medical devices that pack main item, because to medical devices this kind of security asks very expensive product, the ageing test that the issue passes product period of efficacy to assure cannot be ignored, and the conclusion sex report of ageing experiment also can serve as refer orgnaization of relevant examine and verify, come with this as what state to product period of efficacy one supports sexual file.
The around in ISO11607 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 also is the code that has ageing tests according to!
Analyse ageing test actually with very scientific point of view, discover this experiment is a system in fact not hard, complex and long sample conditioning process, sample adjustment process is in this and those simple test 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, the whether is put on of all kinds function difference that in order to proves to sample passes conditioning around. 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 conditioning process.
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, the time that because it can shorten,laboratory needs, quicken a product to appear on the market, more important is, this kind of mode of operation and experimental result also are approved on code, of course, true ageing experiment also is indispensable!
Quickening ageing experiment itself 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. ASTMF1980 is the reference standard that accelerates ageing experiment, its main content includes guidance how to prepare to pack the information that quickens ageing test program and sex of a few correlation to state harmony bright etc, but do not involve program of true ageing test and the experimental method that a few particular judgement products pack function.
Experiment of imitate of environment of the 5.4 systems that pack
Environmental imitate experiment calls imitate to carry a test again, this is to detect whether the system that pack can endure the test of all sorts of current storage ambient conditions that think of beforehand or did not think of to be gone to by safe service till them ultimate consumer in the hand, of course, the packing system here, it is to point to normally agree with the assembly packaging system that current have enough to meet need carries an operation, for instance corrugated box, tray, this also included the system of asepsis protective screen that exists as inner packing system of course among them!
As to reference standard, what recommend in ISO 11607 is ISTA series imitate carriage experiment tests a level, ISTA is the abbreviate of International SafetyTransit Association, chinese interpreter carries association for international safety!
Unfinished to be continued!
Civil / Randy
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