I Need Medical Attention
Add above paragraphs!
3,
The fundamental that sterilization of medical devices packs
The author thinks, pack a system to design a sterilization of reasonable medical devices, need to abide by a few more the following fundamental:
3.1 " pack " the one part that is a product: Here packing is to point to " system of asepsis protective screen " , because invalidation of system of asepsis protective screen means be no longer in force of product of medical devices namely, and hide the risk is possible bigger, because this is planted,invalidation is aware of more not easily normally or be ignored more easily.
Of course, explicit protection packs a system (Protective PackagingSystem) very important also, just its lose effectiveness is relative for be dominance, and won‘t bring disastrous consequence, still cannot rise so " the one part of the product " such height!
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.
3.2 " the system packs first " ＝ " system of asepsis protective screen " : This is nodded and the a bitth be mutual echo, and be in ISO11607-2006 concerns medical devices this on international at present got in the most authoritative standard the directest reflect, it is direct before in version " the system is packed first (PrimaryPackaging) " , redefine is ‘ system of asepsis protective screen (Sterile BarrierSystem) ‘ , this also is the most primitive provenance of this concept!
Of course, those who be based on descriptive setting and circumstance is different, in a lot of moment everybody or meeting mix these two concepts use or use at the same time, but what should write down sincerely is, the domain is packed in sterilization of medical devices, these two concepts are identical, consistent, the much in the article " pack " what the concept points to actually is " system of asepsis protective screen " !
The 3.3 security that emphasize packing and successive stability: 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.
As to emphasize packing quality 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, besides observe the quality management that ISO13485 designs this set for industry of medical devices only strictly besides systematic level, generally speaking, the scientific and strict craft that pack affirms also is the effective method that ensures the quality that pack is stabilized continuously.
4,
Sterilization of medical devices packs the main demand of material
The sterilization of medical devices that convention uses packs material to include medical treatment wrapping paper, mix without the Tyvek that spin cloth, of all kinds plastic film suck model box and aluminous model forcedly composite material, although material is of diversity, but OK to its main demand roughly when is reduce as follows:
4.1 foundations function: Comprise index of main physical machinery function, for instance permeability, cut off gender, of all kinds mechanical intensity; Chemical function is able to bear or endure like environmental stability, dissolvent fight a gender to wait; Optical function is like diaphaneity and haze to wait; Return some other a few be like high temperature resistant, be able to bear or endure the concerns with sterilization craft function of irradiation and so on;
4.2 microbial cut off quality: For the data that packages to be being used at sterilization of medical devices, this bit of requirement does not need doubt wants to be satisfied, because " system of asepsis protective screen " the premise condition that establish is the material that pack adopts specific technology with the different material that pack (it is hot normally) the sealed system that form all wants to be able to cut off microbial! On this concept, can be cent of the material that pack poriferous profile expects (PorousMaterial) with blame much pass material (Non-PorousMaterial) , common sterilization packages data in, medical wrapping paper and Tyvek belong to former, and of all kinds high polymer sucks model box and other composite material compound film, forcedly to belong to latter;
4.3 with adaptability of sterilization process photograph: all the time the different point that sterilization of intensity medical devices is packed and other packs, packing a system to pass a sterilization technology that has designed beforehand even after finishing sealed craft at its, this also should consider what to use itself of the material that pack to be opposite of course the adaptability of sterilization craft, technology of common a few kinds of sterilization is not same to the requirement of material, for instance vapour of annulus oxygen ethane (EO) in the material that sterilization asks to make the system that pack most at least has a kind to have certain permeability; Irradiation sterilization (Gamma) with electron beam sterilization (E-Beam) all packing data that ask to make the system that pack can bear fight irradiation ray handle and unapt ageing is fragile crack; And commonner the sterilization of high temperature vapour at the hospital (Steam) ask all all packing material that make the system that pack can bear fight proper high temperature, it is normally 121 - the buy of environmental transfer to a lower level of 136 15 - 30 minutes. Still have the sterilization kind of a few other of course, here has not been done how to discuss!
4.4 avirulent sexes: To the data that medical treatment domain uses, avirulent sex should be the basiccest it seems that, this kind of avirulent sex can behave two respects, the first respect is microbial with medical domain, such as is microbial of and so on of noxiousness of consistence, cell, related need microbial will prove with medical experiment, this is nodded more it is the exterior gelatinize component that is aimed at a few material that pack, the gelatinize component that as usual uses at Tyvek and medical treatment wrapping paper needs a proof this a little bit!
The 2nd respect is engineering field, more expression are material itself component simple, do not contain any component that have potential risk, mix in convention appoint the material below sterilization environment stable, do not decompose not the dissension, appliance face that does not change potential and harmful material to arrive to be packed, this bit criterion more is aimed at material matrix itself!
Unfinished to be continued!
Civil / Randy
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