SI24551A - The sterilization packaging made from termo contractible material - Google Patents

The sterilization packaging made from termo contractible material Download PDF

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Publication number
SI24551A
SI24551A SI201300365A SI201300365A SI24551A SI 24551 A SI24551 A SI 24551A SI 201300365 A SI201300365 A SI 201300365A SI 201300365 A SI201300365 A SI 201300365A SI 24551 A SI24551 A SI 24551A
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SI
Slovenia
Prior art keywords
packaging
sterilization
barrier
weld
thermally
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SI201300365A
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Slovenian (sl)
Inventor
Kozin Peter
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Kozin Peter
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Publication date
Application filed by Kozin Peter filed Critical Kozin Peter
Priority to SI201300365A priority Critical patent/SI24551A/en
Priority to SI201400396A priority patent/SI24533B/en
Priority to US15/034,591 priority patent/US10010637B2/en
Priority to PCT/SI2014/000063 priority patent/WO2015069196A2/en
Priority to EP14824154.0A priority patent/EP3066030B1/en
Publication of SI24551A publication Critical patent/SI24551A/en

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Abstract

Sterilizacijska embalaža izdelana iz termo skrčljivega materiala, značilna po tem, da se skrči z uporabo toplotne energije postopka sterilizacije, z namenom učvrstitve primarne sterilizacijske ovojnine. Med samo sterilizacijo, ki poteka pri povišani temperaturi, se embalaža skrči in na ta način stisne in učvrsti ovoj klasične sterilizacijske ovojnine. Z zatesnitvijo in skrčenjem je v veliki meri izločen človeški faktor, kakor tudi potreba po uporabi rizičnih lepilnih trakov, s čimer je zadoščeno zahtevamnorme ISO-11607. Pomembno inovacijo pri izdelavi embalaže predstavlja postopek vzdolžnega ultrazvočnega varjenja, dveh termo skrčljivih plasti, z vmesnim trakom termo stabilnega materiala, z namenom, da se ojača zvar, a ga je vendar mogoče z lahkoto odtrgati in s tem odpreti embalažo. Različica embalaže je lahko izdelana v kombinaciji z bariernem slojem na tak način, da barierni material zagotavlja bariero pred prodorom mikroorganizmov, termo skrčljiv material pa predstavlja mehansko zaščito bariernegasloja in na ta način, termo skrčljiva embalaža predstavlja samostojni sistem sterilizacijskega pakiranja.The sterilization packaging is made of thermally shrinking material, characterized in that it is shrinkable using the thermal energy of the sterilization process in order to strengthen the primary sterilization packaging. During self sterilization, which takes place at an elevated temperature, the packaging shrinks and thus compresses and consolidates this classic sterilization package. By sealing and shrinking, the human factor is largely eliminated, as well as the need to use high-risk adhesive tapes, thus meeting the requirements of the ISO-11607 standard. An important innovation in the production of packaging is the process of longitudinal ultrasonic welding, two thermal shrinkable layers, with an intermediate strip of thermally stable material, in order to reinforce the weld, but it can easily be ripped off and thus open the packaging. The packaging version can be made in combination with the barrier layer in such a way that the barrier material provides a barrier against the penetration of microorganisms, and the thermal shrinkable material represents the mechanical protection of the barrier enamel, and in this way the thermally shrink packaging is an independent sterilization packaging system.

Description

Po mednarodni klasifikaciji je izum razvrščen v razred GO ID 13/04,According to the international classification, the invention is classified in class GO ID 13/04,

Izum spada na področje embalaže, in sicer sterilizacijske embalaže, natančneje na področje embalaže za pakiranje kirurških instrumentov.The invention relates to the field of packaging, namely sterilization packaging, more specifically to the field of packaging for packaging surgical instruments.

Povsem konkretno, izum predstavlja embalažo v obliki rokava, izdelanega iz termo skrčljivega materiala, ki se skrči z uporabo toplotne energije med postopkom sterilizacije in s tem učvrsti sterilizacijski ovoj, vendar ne prepreči prodora sterilizacijskega medija v notranjost paketa.More specifically, the invention is a sleeve-shaped package made of a thermo-shrinkable material that shrinks by the use of heat during the sterilization process, thereby tightening the sterilization wrap, but does not prevent the sterilizing medium from penetrating the package.

Kot postopek, za sterilizacijsko pakiranje težjih enot, kirurških instrumentov, običajno imenovanih seti ali mreže, se najpogosteje uporablja dvoslojno ovijanje v pole sterilizacijskega papirja ali kakšnega drugega sterilizacijskega materiala. Za zavarovanje proti odvitju omenjenih paketov, se sedaj uporabljajo posebni lepilni trakovi, obstojni pri pogojih v sterilizacijskem postopku.As a process, two-layer wrapping in sheets of sterilizing paper or other sterilizing material is most commonly used for the sterilization packing of heavier units, surgical instruments, commonly referred to as sets or nets. To protect against unwinding of the said packages, special adhesive tapes resistant to the conditions of the sterilization process are now used.

Klasično ovijanje, kot najpogosteje uporabljeno pakiranje v fleksibilno sterilizacijsko embalažo, ima izrazito prednost pred ostalimi načini sterilizacijskega pakiranja, zaradi sorazmerno velikih dimenzij, ki ob razvitju predstavljajo pokrivalo delovne površine in s tem zaščito sterilnega delovnega polja. Največja slabost klasičnega ovijanja je sorazmerno zahteven postopek ročnega ovijanja in s tem zelo izrazita prisotnost človeškega faktorja. Slabost klasičnega ovijanja je tudi uporaba lepilnih trakov, ki se v pogojih sterilizacije velikokrat odlepijo, pri čemer se sterilizacijski paketi razpočijo, prav tako pa jih je tudi težko odlepiti na kraju uporabe, pri čemer je aseptičnost vprašljiva.Classic wrapping, as the most commonly used packaging in flexible sterilization packaging, has a distinct advantage over other methods of sterilization packaging, due to its relatively large dimensions, which, when developed, represent the cover of the work surface and thus protect the sterile working field. The biggest disadvantage of classic wrapping is the relatively demanding manual wrapping process and thus the very presence of the human factor. The disadvantage of classic wrapping is also the use of adhesive tapes that often peel off under sterilization conditions, with the sterilization packs cracking and also difficult to peel off at the point of use, leaving asepticism questionable.

S klasičnim ovijanjem ni možno zadostiti zahtevan norme ISO-11607, ki predpisuje nadzor parametrov pakiranja sterilnih izdelkov.With the standard wrapping it is not possible to meet the required standard ISO-11607, which prescribes control of the packaging parameters of sterile products.

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Embalaža je izdelana v obliki rokava primernih dimenzij, ki ga končni uporabnik odreže na dolžino, primerno sterilizacijskemu paketu in navleče preko klasično zavitega paketa, preden se paket vloži v sterilizator z namenom sterilizacije. Med samo sterilizacijo, ki poteka pri povišani temperaturi se skrči in na ta način stisne in učvrsti ovoj klasične sterilizacijske ovojnine. Z zatesnitvijo in skrčenjem je v veliki meri izločen človeški faktor, kakor tudi potreba po uporabi rizičnih lepilnih trakov, s čimer je zadoščeno zahtevam norme ISO-11607.The packaging is made in the form of a sleeve of appropriate dimensions, cut by the end-user to a length appropriate to the sterilization package and pulled over a classically wrapped package before being placed in the sterilizer for sterilization purposes. During the sterilization process itself, which takes place at elevated temperature, it shrinks and thus compresses and strengthens the wrapping of the classic sterilization package. Sealing and shrinking largely eliminates the human factor as well as the need to use high-risk adhesive tapes, thus meeting the requirements of ISO-11607.

Material, iz katerega je narejena embalaža, prenese vse faze sterilizacijskega postopka. Prodor sterilizacijskega medija je zagotovljen z zarezovanjem termo skrčljivega materiala. Na začetku sterilizacijskega postopka se material skrči, pri čemer se zareze relativno razprejo in omogočijo neoviran prodor sterilizacijskega medija, med procesom sterilizacije.The packaging material undergoes all stages of the sterilization process. The penetration of the sterilizing medium is ensured by cutting the shrinkage material. At the beginning of the sterilization process, the material shrinks, with slots relatively open and allowing unobstructed penetration of the sterilizing medium during the sterilization process.

Za lažjo aseptično prezentacijo na mestu uporabe je rokavu dodan eden ali več vzdolžnih trakov, ki jih s potegom odtrgamo in na ta način odpremo sterilni paket za nadaljnje odvijanje in prezentacijo.To facilitate aseptic presentation at the site of use, one or more longitudinal strips are added to the sleeve, which are torn off to open a sterile package for further unwinding and presentation.

Različica embalaže je lahko izdelana v kombinaciji z bariemim slojem na tak način, da barierni material zagotavlja bariero pred prodorom mikroorganizmov. Termo skrčljiv material predstavlja mehansko zaščito bariemega sloja in na ta način, termo skrčljiva embalaža, predstavlja samostojni sistem sterilizacijskega pakiranja.The packaging version may be made in combination with the barium layer in such a way that the barrier material provides a barrier against the penetration of microorganisms. The thermo-shrinkable material represents the mechanical protection of the barium layer and thus, the thermo-shrinkable packaging, represents a stand-alone sterilization packaging system.

Kombinacija je lahko izdelana z laminiranjem, zvarjanjem ali katerim drugim postopkom kombiniranja materialov, na način, da zagotavlja popolno bariero pred prodorom mikroorganizmov.The combination may be made by laminating, welding or any other process of combining materials in such a way as to provide a complete barrier against the penetration of microorganisms.

Pomembno inovacijo, pri izdelavi embalaže, predstavlja postopek vzdolžnega ultrazvočnega varjenja dveh termo skrčljivih plasti z vmesnim trakom termo stabilnega materiala, z namenom, da se ojača zvar, a ga je vendar mogoče z lahkoto odtrgati in s tem odpreti embalažo. Robni zvar embalaže predstavlja zvar treh plasti, in sicer; zgornja termo skrčljiva plast, vmesna termo stabilna plast in spodnja termo skrčljiva plast. Pri takšni kombinaciji materialov, se pojavi izrazito močan zvar v prečni smeri, ki omogoča dobro stiskanje in učvrstitev paketa, vendar je izrazito občutljiv na cepilni efekt v vzdolžni smeri, kar se izkoristi pri odpiranju embalaže, ko se s potegom enega konca traku, odtrga vzdolžni var embalaže in na ta način embalažo aseptično odpre.An important innovation in the manufacture of packaging is the process of longitudinal ultrasonic welding of two thermally shrinkable layers with an intermediate strip of thermally stable material, in order to strengthen the weld, but it can be easily torn off and thus open the packaging. The edge weld of the packaging is a three-layer weld, namely; upper thermo-shrinkage layer, intermediate thermo-stable layer and lower thermo-shrinkage layer. With such a combination of materials, a particularly strong transverse weld occurs, allowing for good compression and tightening of the package, but is extremely sensitive to the splitting effect in the longitudinal direction, which is used when opening the packaging when torn off one end of the strip var packaging and aseptically opening the packaging.

Claims (4)

Patentni zahtevkiPatent claims 1. Sterilizacijska embalaža izdelana iz termo skrčljivega materiala, značilna po tem, da se skrči z uporabo toplotne energije postopka sterilizacije, z namenom učvrstitve primarne sterilizacijske ovojnine.1. Sterilization packaging made of a heat shrinkable material, characterized in that it shrinks using the thermal energy of the sterilization process in order to secure the primary sterilization package. 2. Embalaža po zahtevku 1 izdelana v kombinaciji z bariemim materialom na način, da zagotavlja bariemi material bariero, pred prodorom mikroorganizmov v notranjost sterilnega paketa, z namenom tako, da embalaža predstavlja samostojni sistem sterilizacijskega pakiranja.Packaging according to claim 1, made in combination with barrier material in such a way as to provide a barrier material with a barrier, prior to the penetration of microorganisms into the interior of the sterile package, in order that the package represents a separate sterilization packaging system. 3. Postopek izdelave embalaže z ultrazvočnim varjenjem, z uporabo vmesnega traku termo stabilnega materiala med dvema plastema termo skrčljivega materiala, z namenom doseganja velike trdnosti zvara v prečni smeri in enostavnega odpiranja embalaže z cepitvijo in odtrganjem v vzdolžni smeri vara.3. A method of manufacturing packaging by ultrasonic welding using an intermediate strip of thermally stable material between two layers of thermally shrinkable material, with a view to achieving high strength of the weld in the transverse direction and easy opening of the packaging by splitting and tearing in the longitudinal direction of the weld. 4. Postopek odpiranja termo skrčljivega sterilnega paketa z odtrganjem zvara ojačanega s termo stabilnim materialom, v vzdolžni smeri vara, z izkoriščanjem cepilnega efekta.4. The process of opening a thermally shrinkable sterile package by tearing away a weld reinforced by a thermally stable material, in the longitudinal direction of the weld, by utilizing a splitting effect.
SI201300365A 2013-11-05 2013-11-05 The sterilization packaging made from termo contractible material SI24551A (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
SI201300365A SI24551A (en) 2013-11-05 2013-11-05 The sterilization packaging made from termo contractible material
SI201400396A SI24533B (en) 2013-11-05 2014-10-27 Heat-shrunk defensible packaging, particularly for use in the processof sterilization
US15/034,591 US10010637B2 (en) 2013-11-05 2014-11-03 Thermally shrinkable wrapper, in particular for use in sterilization process
PCT/SI2014/000063 WO2015069196A2 (en) 2013-11-05 2014-11-03 Thermally shrinkable wrapper, in particular for use in sterilization process
EP14824154.0A EP3066030B1 (en) 2013-11-05 2014-11-03 Thermally shrinkable wrapper, in particular for use in sterilization process

Applications Claiming Priority (1)

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SI201300365A SI24551A (en) 2013-11-05 2013-11-05 The sterilization packaging made from termo contractible material

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SI24551A true SI24551A (en) 2015-05-29

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