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Preface: This is one is the article that the professional magazine inside industry of appliance of a medicine of American writes, promise the end of the year to give them the manuscript originally, it is good to pull the ability at the beginning of this year May to write all the time later give they, should publish on the periodical August, text is below:
Sterilization of medical devices is packed belong to a burgeoning development domain, can say to burgeoning industry is belonged to inside limits all over the world, in and still be in ceaseless accumulation be being summed up, the development in home especially slow. The article is based on the author‘s knowledge and experience summary, generalized sterilization of design medical devices to pack the respect that should note.
1,
Sterilization of medical devices packs brief introduction
The definition that sterilization of medical devices packs should understand for: Use at medical devices kind of the product pack, can have sterilization to its, can undertake aseptic manipulation (like clean open) , can offer acceptability microbial cut off function, sterilization around can make protect and can be after sterilization inside proper time to the product (tagged period of efficacy) the packing system that maintains environment of systematic interior asepsis. Because this concept does not include the protection outside to pack a system normally (amortize is packed and the part such as assembly packaging) , so sterilization of medical devices packs what the system also can say to be " system of asepsis protective screen (SterilizationBarrier System, SBS) " (the standard appellation according to ISO11607-2006) .
About the form that sterilization of medical devices packs, have 3 kinds as follows roughly:
1.1 soft suck model to shape - fill - heat seals the system that pack (Form-Fill-Seal, FFS) : This kind is packed according to shape bottom material of the part (BottomWeb) ply can be divided again for withy model (Flexible) and half hard model (Semi-rigid) two kinds, the material end its is in specific suction passes temperature on the model equipment that pack, suck vacuum to spend and of pressure adjust and heat shapes become the figure that has designed beforehand, mix relevant top material (TopWeb) heat closes, form those who accord with a requirement is stereo shape the system that pack. This kind of characteristic that pack is: Automation degree tall, efficiency is tall, individual what the low, system that pack and content substance appearance cooperate the cost that pack is good wait, but involve equipment and mould investment, have particular demand to crop, use in crop dimensions normally very big one, product of 2 kinds of medical devices, be like all sorts of injector, gauze piece, operation garment and medical and tracheal spile, and 3 kinds of simple medical devices, be like vein typically to leave buy needle to wait!
Those who look a bag appliance and corresponding sterilization way is different, top money and bottom material all have multiple choice, do not do here discuss in detail!
1.2 suck model box forcedly - lid material packs a system (Tray-LidSystem) : This kind is packed is to use of all kinds shape box suction model is direct with all sorts of those who sealed suiting that heat up, appearance is pressed reduce the lid ability that has cut beforehand (Lid) heat is sealed, and alleged suck model forcedly, criterion more it is with the sheet that is used at sucking model to shape ply is concerned, it is normally between 0.4-1.2mm, and the material that involves, from low end to high end basically PVC, PP, PE, PS, PET, PETG and PC wait, mix with PS, PET especially among them PETG these 3 kinds of material are commonly used; Because PVC involves security and environmental protection issue, have the tendency that is washed out gradually; PP and PE material of these two kinds of groovy high polymer, in view of the physical machinery of the oneself after shaping function is restricted, be in what this domain uses also is not very much; Because PC criterion is exalted the reason of cost, seldom counting a few domain application only, typical if need dry hot sterilization (DryHeat Sterilization) circumstance. This kind suck model box forcedly general outside buy, undertake heating up sealing in manufacturer of medical devices and lid material next, common heat heat seals equipment can.
Its typical application domain is 2, 3 kinds of high end are embedded medical devices, if orthopaedics product, heart and vessels intervenes kind of product, surgery is embedded kind of appliance, also apply in a few integrated kind of operation bag!
System of 1.3 of all kinds bag pack a system (Pouch/BagSystem) : Include of all kinds Pouch, if defend strong bag especially (Tyvek Pouch) , paper model bag (Paper-PolyPouch) etc, coming directly towards Vent Bag of pocket of bag Header Bag, window, breathe freely in the paper bag of envelope Center-seal Pouch, paper, aluminum foil that takes Tyvek is compound the product such as bag, more forms, the likelihood designs production according to actual condition, anyhow is very difficult complete and Baconian its sort and applied limits! In home, in these products, such as coming directly towards bag, window bag and breathe freely in the product such as envelope is opposite as a result of its the special design that shows fanlight mouth, managing the cost of material, get the welcome of enterprise of a lot of medical devices.
Here is even special the thing that point out, manufacturers of a lot of medical devices also use pure PE bag to pack annulus oxygen ethane (EO) the injector of sterilization and tracheal kind of foundation sex product of medical devices, say strictly, this means that pack cannot classify packs a domain to sterilization of medical devices, because they are put in very big risk, the country also is publishing relevant policy to check the problem of this respect. But the consideration that stems from cost, thinking the application of this respect returns complete completely ban at present is inconvenient.
2,
The relevant code that sterilization of medical devices packs standard
The code that packs about sterilization of medical devices standard, current, what worth while discussion is below these two: ISO11607 and EN868, of course these two belong to category of level of general rule sex, covered again inside them a lot of pack a system about sterilization of medical devices the relevant test standard of particular test method, basically be the standard such as ASTM and ISO!
ISO11607 shares 3 version so far, it is 1997 edition, 2003 edition are mixed respectively 2006 edition, also can seeing sterilization of medical devices packs this domain from here is new inside limits all over the world, according to the program, next version should be rolled out inside 5 years after 2006.
Newest 2006 edition, promulgate formally in April 2006, two parts are comprised, the first part basically is about packing material, asepsis to cut off the system is mixed of the system that pack, the craft that the 2nd part basically told about sterilization of concerned medical devices to pack affirms (Validation, similarly hereinafter) problem, pack asepsis so affirm with the craft that pack by design of the system that pack content of this two large principal part distinguishs came. More important is, in this version, absorb formally incorporated the EN868 standard system of European popularity, cancelled the system of general rule sex that EN868-1 conflicts this each other already, absorb optionally incorporated EN868-2 arrives - 10 these 9 are mixed about specific data of the product child standard, this also was proclaiming in fact the sterilization of medical devices with unified whole world packs a standard to was born 2006 eventually, already ISO11607-2006.
About EN868 this standard, standard of sex of this general rule also promulgates its original EN868-1 1997, ever since - 2 to - 10 are in as accessary standard ever since make up a few years slowly in time write development to rise, but as a whole the criterion that this fits sterilization to pack manufacturer to control material and production like more, is not the is used at coaching sterilization packs a system check mark that for medical devices manufacturer designs one allows, and this standard is done not have all the time fore-and-aft update, it is redo only some transverse child of the standard patulous!
What what I hope is, discuss concerned medical devices when us later when sterilization packs a standard, need to pay close attention to ISO11607 only this one standard! As to our country, 2005 coequal cited ISO11607-2003 as recommend sexual GB GB/T19633-2005, also doing the work that updates ISO11607-2006 translate into edition GB/T19633 all the time at present!
Unfinished to be continued!
Civil / Randy
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