Područje tehnike u koje spada izumThe technical field to which the invention belongs
Izum se odnosi na postupak i uređaj za sterilizaciju medicinskih uređaja i spada u područje proizvodnje medicinskih uređaja i aparata.The invention relates to the procedure and device for sterilization of medical devices and belongs to the field of production of medical devices and apparatus.
Tehnički problemTechnical problem
Tehnički problem koji se rješava izumom sastoji se u sljedećem: kako ostvariti postupak i uređaj za sterilizaciju medicinskih uređaja u smislu njihovog usavršavanja, tako da se izbjegnu nesterilne međuoperacije?The technical problem that is solved by the invention consists in the following: how to realize the procedure and device for sterilization of medical devices in terms of their improvement, so that non-sterile intermediate operations are avoided?
Stanje tehnikeState of the art
Medicinski uređaji, kao što su npr. medicinski filtri, posebno filtri za tretman s krvlju koji se uključuju u ekstrakorporalnom krvotoku (npr. dijalizatori), moraju biti na taj način u velikoj mjeri sterilizirani. Isto vrijedi i za sklopove koji nalaze primjenu kod sterilnih medikamenata.Medical devices, such as medical filters, especially blood treatment filters that are included in the extracorporeal blood stream (eg dialyzers), must be largely sterilized in this way. The same applies to assemblies that are used in sterile medicines.
U praksi je poznato, da se takvi medicinski uređaji steriliziraju jedan za drugim tj. u slijedećem postupku i takvi medicinski uređaji su za isporuku. Pojedinačni koraci vrše se izdvojeno prostorno jedan od drugog, tako da između pojedinačnih koraka nastaju nesterilni međukoraci, gdje se gubi sterilnost.In practice, it is known that such medical devices are sterilized one after the other, i.e. in the next procedure, and such medical devices are for delivery. Individual steps are carried out spatially separated from each other, so that non-sterile intermediate steps occur between individual steps, where sterility is lost.
Tako je na primjer kod DE 30 12 110A1 znanog postupka za umjetni bubreg, isti ispunjen za ljudsko tijelo neškodljivom tekućinom. Tada se tek zatvore priključci za bubrege. Sada se u jednom rezervoaru smješten umjetni bubreg postavi u autoklav i sterilizira u pari pod visokom temperaturom i pritiskom.Thus, for example, in DE 30 12 110A1, a known procedure for an artificial kidney, it is filled with a liquid that is harmless to the human body. Only then are the connections for the kidneys closed. Now the artificial kidney placed in one reservoir is placed in an autoclave and sterilized in steam under high temperature and pressure.
Tipični nedostaci ovakvog poznatog postupka su:Typical disadvantages of this known procedure are:
- potrebno je koristiti istezljive specijalne priključke odnosno komore za širenje, kako bi se moglo prihvatiti proširenje obujma pri sterilizaciji autoklavima;- it is necessary to use stretchable special connections, or chambers for expansion, in order to be able to accept the expansion of the volume during autoclave sterilization;
- priključci se mogu otkinuti;- the connections can be torn off;
- ne može se svaki tip umjetnog bubrega sterilizirati prema poznatom postupku sterilizacije;- not every type of artificial kidney can be sterilized according to the known sterilization procedure;
- kako se vrši sterilizacija umjetnih bubrega pri “mirujućoj tekućini”, ne mogu se isključiti gnijezda u mrtvim kutovima s toplotnim mostovima.- as the sterilization of artificial kidneys is carried out with "still liquid", nests in dead corners with thermal bridges cannot be excluded.
Daljnji korak učinjen je poznatim postupkom EP 0 198 100 A1, kod koga je umjetni ljudski organ, npr. umjetni bubreg u autoklavu sterilizira iznutra s pregrijanom vodom na temperaturu sterilizacije i izvana vrelom parom. Zatim se organ sa odgovarajućom hladnom sterilnom vodom ispire iznutra i zatim ohladi.A further step was taken by the known procedure EP 0 198 100 A1, in which an artificial human organ, for example an artificial kidney, is sterilized in an autoclave internally with superheated water to the sterilization temperature and externally with hot steam. Then the organ is washed inside with suitable cold sterile water and then cooled.
Bitan nedostatak poznatog postupka i pripadajućeg uređaja je taj, što se kod vađenja umjetnog organa iz autoklava u svrhu zatvaranja i pakiranja organa, gubi sterilitet.An essential drawback of the known procedure and the associated device is that, when the artificial organ is removed from the autoclave for the purpose of closing and packing the organ, sterility is lost.
Opis rješenja tehničkog problemaDescription of the solution to the technical problem
Tehnički problem za postupak prema izumu, riješen je sljedećim zahvatima: što se medicinski uređaj postavlja u sustav pod hermetičkim spajanjem oba priključka na dovodni i odvodni sustav u atmosferskim uvjetima, što sterilni medij prostrujava uređaj u sustavu za unaprijed određeno vrijeme, što je nakon sterilizacije za klice brtveno zatvaranje oba priključka u spojenom stanju bez otvaranja, i što se uređaj izuzima iz sustava kao sterilna jedinica sa zatvorenim priključcima.The technical problem for the procedure according to the invention is solved by the following measures: the medical device is placed in the system under hermetic connection of both connections to the supply and drainage system in atmospheric conditions, the sterile medium flows through the device in the system for a predetermined time, after sterilization for germs sealing both connections in the connected state without opening, and that the device is excluded from the system as a sterile unit with closed connections.
Tehnički problem kod uređaja riješen je na taj način, što ima najmanje jednu atmosferskom tlaku izloženu stanicu za stezanje za termporalno pod pritiskom brtven spajanje priključaka uređaja, pri čemu stanica za stezanje ima dovod i odvod, što je najmanje jedan cjevovod priključen od uređaja za sterilizaciju medija prema dovodu ka steznoj stanici, i najmanje jedan cjevovod koji je priključen na odvod stanice za stezanje, što ima organe za zatvaranje, posebno ventile za zatvaranje u cjevovodima, i što ima najmanje jedan uređaj za hermetičko zatvaranje od klica priključaka uređaja u priključenom stanju.The technical problem with the device is solved in this way, which has at least one clamping station exposed to atmospheric pressure for thermally under pressure sealing connection of the device's connections, where the clamping station has an inlet and outlet, which is at least one pipeline connected from the media sterilization device towards the inlet to the clamping station, and at least one pipeline that is connected to the outlet of the clamping station, which has closing means, especially valves for closing in the pipelines, and which has at least one device for hermetically sealing the device connections in the connected state.
Kod postupka i uređaja prema izumu vrši se sterilizacija tzv. “inline”, tj. svi zahvati se provode u istom sustavu u kome protječu i sredstva. Ovim je osigurano da ne mogu nastati nesterilni međuzahvati i da medicinski uređaji budu dostupni pacijentima koji su s najvećom sigurnošću sterilno zatvoreni.In the procedure and device according to the invention, the so-called sterilization is performed. "inline", i.e. all operations are carried out in the same system in which funds also flow. This ensures that non-sterile intermediate interventions cannot occur and that medical devices are available to patients that are sterilely sealed with the greatest safety.
Kao sterilna sredstva mogu doći u obzir uobičajena sredstva, kao npr. voda pod pritiskom ili vodena para najmanje temperature od 105°C, ovisno o podnošljivosti medicinskih uređaja. Za uređaje koji su hidrofobni, s prednošću se koristi otopina peroctene kiseline.Usual agents can be used as sterile agents, such as water under pressure or water vapor with a temperature of at least 105°C, depending on the tolerance of the medical devices. For devices that are hydrophobic, peracetic acid solution is preferably used.
Kod određenih uređaja u vezi s primijenjenim medijem za steriliziranje neophodan je zahvat ispiranja prije i/ili nakon sterilizacije. Kao tekućina za ispiranje nalazi prvenstveno primjena voda koja kod ispiranja nakon sterilizacije mora također biti sterilna.With certain devices, in connection with the applied sterilization medium, a rinsing procedure is necessary before and/or after sterilization. Water is primarily used as a rinsing liquid, which must also be sterile when rinsing after sterilization.
Kod zatvorenog sustava s vodom pod pritiskom ili vrelom parom kao medij za sterilizaciju može voda za ispiranje biti odvedena iz medija za sterilizaciju, npr. služi li još nepregrijana voda kao tekućina za ispiranje prije sterilizacije kao i ohlađena voda odnosno kondenzirana para kao tekućina nakon sterilizacije.In the case of a closed system with water under pressure or hot steam as a sterilization medium, the rinsing water can be diverted from the sterilization medium, e.g. if still unheated water serves as a rinsing liquid before sterilization, as well as cooled water or condensed steam as a liquid after sterilization.
Ovisno o medicinskom uređaju svrsishodno je, kod njegovog zatvaranja iste ostaviti napunjene sterilnom tekućinom ili uključiti zahvat sušenja sterilnim plinom, npr. zrakom koji je najmanje zagrijan na 100°C.Depending on the medical device, it is expedient to leave it filled with sterile liquid when closing it or to turn on the drying procedure with sterile gas, for example air heated to at least 100°C.
Ovisno o medicinskom uređaju dobivaju se različite mogućnosti kombinacija.Depending on the medical device, different combination options are available.
Kod hidrofilnih uređaja, npr. kuprofan - dijalizatora, postupak se provodi na taj način da se ispiranje provodi vrelom vodom, vrela voda se pod pritiskom na temperaturi sterilizacije pregrijava i s ovom vodom pod pritiskom u recirkulaciji pri sterilizaciji provodi se kao vrela sterilizacija, pri čemu se nakon toga protočna voda pod pritiskom ohladi na sobnu temperaturu a medicinski uređaj se pod sterilnim uvjetima zatvori.In the case of hydrophilic devices, e.g. cuprophan dialyzers, the procedure is carried out in such a way that the rinsing is carried out with hot water, the hot water under pressure is overheated at the temperature of sterilization and with this water under pressure in recirculation during sterilization, it is carried out as hot sterilization, whereby after that, the flowing water under pressure cools down to room temperature and the medical device is closed under sterile conditions.
Kod hidrofobnog medicinskog uređaja, npr. polisulfon - membranskog filtra, postupak se prednošću provodi tako, što se postupak ispiranja vrši vrelom vodom, zatim vodenom parom kao medijem za vrelu sterilizaciju i nakon toga se medicinski uređaj pod sterilnim uvjetima zatvori. Svrsishodno se uređaj nakon vrele sterilizacije ispire sterilnom vodom i nakon toga suši.In the case of a hydrophobic medical device, for example a polysulfone - membrane filter, the procedure is preferably carried out by rinsing with hot water, then steam as a medium for hot sterilization, and after that the medical device is closed under sterile conditions. After hot sterilization, the device is expediently rinsed with sterile water and then dried.
Alternativno ovom postupku s vodom pod pritiskom, može se postupak na taj način provesti, što se postupak ispiranja provodi s vrelom vodom, pa se nakon toga peroctenom kiselinom, pri sobnoj temperaturi u recirkulaciji vrši sterilizacija, pa se nakon toga medicinski uređaj ispire sterilnom vodom i nakon toga zatvori pod sterilnim uvjetima.As an alternative to this procedure with water under pressure, the procedure can be carried out in this way, the rinsing procedure is carried out with hot water, then sterilization is carried out with peracetic acid at room temperature in recirculation, and then the medical device is rinsed with sterile water and after that close under sterile conditions.
Odgovarajuće kombinacije postoje kod uređaja također.Corresponding combinations exist with the device as well.
Izum će biti bliže objašnjen na osnovi prikazanih primjera izvođenja na crtežima, s dijalizatorima kao medicinskim uređajima, pri čemu:The invention will be explained in more detail on the basis of the examples shown in the drawings, with dialyzers as medical devices, whereby:
sl. 1 prikazuje uređaj za sterilizaciju za dijalizatore pomoću vode pod pritiskom kao medija za sterilizaciju,Fig. 1 shows a device for sterilizing dialyzers using pressurized water as a sterilizing medium,
sl. 2 prikazuje komandnu tablu programskog upravljanja uređajem prema sl. 1,Fig. 2 shows the control panel of the program management of the device according to Fig. 1,
sl. 3 prikazuje izvađen detalj iz uređaja sa sl. 1 i sa alternativno prilagodivim rezervoarom za različite medije za sterilizaciju iFig. 3 shows a detail removed from the device from Fig. 1 and with an alternatively adjustable tank for different sterilization media and
sl. 3a prikazuje detalj uređaja sa sl. 1 s rezervoarom za sterilni zrak a za sušenje dijalizatora.Fig. 3a shows a detail of the device from Fig. 1 with a tank for sterile air and for drying the dialyzer.
Na sl. 1 prikazan uređaj za sterilizaciju služi za sterilizaciju regeneriranih celofan - dijalizatora pomoću vode pod pritiskom pri temperaturi od 121 °C.The sterilization device shown in Fig. 1 serves to sterilize regenerated cellophane dialyzers using pressurized water at a temperature of 121 °C.
Dijalizatori 2 - prvenstveno deset komada - koji se nalaze na brušenom limu od plemenitog metala, postavljaju se u stanicu 1 za stezanje i svojim otvorenim priključcima, prema krvi i strani dijalize, čvrsto se stegnu sa priključcima za ispiranje stanice 1 za stezanje. Prvenstveno se koristi priključna tehnika prema patentnoj prijavi P 38 25 573.Dialyzers 2 - primarily ten pieces - located on a ground sheet of precious metal, are placed in the clamping station 1 and with their open connections, towards the blood and dialysis side, tightly clamped with the flushing connections of the clamping station 1. Primarily, the connection technique according to patent application P 38 25 573 is used.
U rezervoaru 3 drži se sterilizirana voda temperature 123°C. Rezervoar 3 ima ventil 4 za napajanje vodom destiliranom kao i ventil 5 za odzračivanje rezervoara 3. Rezervoar 3 nalazi se pod povišenim pritiskom, kako voda pri zadanoj temperaturi ne bi ključala.Sterilized water at a temperature of 123°C is kept in tank 3. Reservoir 3 has valve 4 for supplying distilled water as well as valve 5 for venting reservoir 3. Reservoir 3 is under elevated pressure, so that the water does not boil at the given temperature.
Pomoću cirkulacione pumpe 6 izvlači se voda iz rezervoara 3. Dio I ukupnog protoka transportira se preko filtra 7 s veličinama pora od 10 um i preko ventila 8 do dijalizatora 2 koji se steriliziraju, dok se preko ventila 9 vraća u rezervoar 1. Drugi dio II ukupnog protoka vrele vode prolazi stalno preko izmjenjivača 10 topline i odatle nazad u rezervoar 3 i služi za održavanje konstantne temperature rezervoara 3.Using the circulation pump 6, water is extracted from the reservoir 3. Part I of the total flow is transported through the filter 7 with pore sizes of 10 μm and through the valve 8 to the dialyzer 2, which are sterilized, while through the valve 9 it is returned to the reservoir 1. The second part II of the total flow of hot water constantly passes through the heat exchanger 10 and from there back to the reservoir 3 and serves to maintain a constant temperature of the reservoir 3.
Stanica 1 za stezanje ima i ventil 11 koji je povezan s odvodom.Clamping station 1 also has a valve 11 which is connected to the drain.
Između filtra 7 i stanice 1 za stezanje za dijalizatore uključen je hladnjak 12 s ispred i iza priključenim ventilima 13, 14 u bajpasu. Na strani hlađenja, hladnjak 12 ima ventila 15, 16 za ulaz i izlaz rashladne vode (gradska odnosno cijevna vodovodna voda) kao i ventile 17, 18 za dovod i odvod zraka.Between the filter 7 and the clamping station 1 for the dialyzers, a cooler 12 is included with valves 13, 14 connected in front and behind in the bypass. On the cooling side, the refrigerator 12 has valves 15, 16 for the inlet and outlet of cooling water (city or piped water) as well as valves 17, 18 for the air inlet and outlet.
Sterilizacija se vrši u više zahvata.Sterilization is performed in several procedures.
1. Ulaganje dijalizatora:1. Inserting the dialyzer:
Sve kape za zatvaranje dijalizatora 2 toliko se odvrnu, da je osigurano potpuno zabravljivanje i brtvljenje. Kape za zatvaranje svakog dijelizatora - svaki dijalizator s dvije kape na strani za krv i dvije kape za stranu dijalizatora - imaju po jedan O-prsten i umetnuti zatvarač, čep (prema DE 38 25 573 A1). Nakon toga se dijalizatori postave u uređaj za prihvaćanje stanice 1 za stezanje, koji posjeduju cilindre za brtvljenje za zatvarače dijalizatora.All caps for closing the dialyzer 2 are unscrewed so that complete locking and sealing is ensured. The closure caps of each dialyzer - each dialyzer with two caps on the blood side and two caps on the dialyzer side - each have an O-ring and an inserted closure, plug (according to DE 38 25 573 A1). After that, the dialyzers are placed in the receiving device of the clamping station 1, which has sealing cylinders for the dialyzer closures.
2. Ispiranje:2. Rinsing:
Nakon postavljanja dijalizatora 2 u stanicu 1 za stezanje, otvaraju se ventili 5, 11, 13, 14; drugi ventili su zatvoreni. Dijalizatori 2 i hladnjak 12 ispiru se vrelom vodom od oko 98°C za određeno vrijeme (oko 4 minute), pri čemu voda za ispiranje doseže direktno u odvod čime se izbacuje cijeli sadržaj kružnog toka. Za vrijeme faze ispiranja raste temperatura zagrijavanja izmjenjivača 10 topline u drugom dijelu II ukupnog protoka.After placing the dialyzer 2 in the clamping station 1, the valves 5, 11, 13, 14 are opened; other valves are closed. The dialyzers 2 and the refrigerator 12 are rinsed with hot water of about 98°C for a certain time (about 4 minutes), whereby the rinsing water reaches directly into the drain, which throws out the entire contents of the circular flow. During the rinsing phase, the heating temperature of the heat exchanger 10 increases in the second part II of the total flow.
3. Steriliziranje:3. Sterilization:
Nakon završetka postupka ispiranja, nastaje - pri dalje otvorenim ventilima 13 i 14 pod istodobnim otvaranjem ventila 8 i 9 - zagrijavanje vode pod pritiskom na temperaturu sterilizacije od oko 123°C. Faza zagrijavanja tako se dimenzionira, da se nakon njenog isteka - oko 10 minuta - na svim mjernim mjestima najmanje pokaže temperatura od 121°C. Vrela voda se pomoću cirkulacijske pumpe 6 drži u stalnoj cirkulaciji preko filtra 7 i dijalizatora 2 nazad u rezervoar 3. Postupak sterilizacije uključujući zagrijavanje iznosi oko 30 minuta. Mora se pri tome utvrditi, da na svim mjernim mjestima za vrijeme čitavog trajanja sterilizacije vlada temperatura od 121°C.After the end of the rinsing process, with the further open valves 13 and 14 and the simultaneous opening of valves 8 and 9, the water is heated under pressure to a sterilization temperature of about 123°C. The heating phase is dimensioned so that after its expiration - about 10 minutes - a temperature of at least 121°C is shown at all measuring points. Using the circulation pump 6, the hot water is kept in constant circulation through the filter 7 and the dialyzer 2 back to the tank 3. The sterilization process including heating takes about 30 minutes. In doing so, it must be established that the temperature of 121°C prevails at all measuring points during the entire duration of sterilization.
4. Hlađenje:4. Cooling:
Nakon steriliazcije bit će voda pod pritiskom uključivanjem prethodno steriliziranog hladnjaka 12 pomoću ventila 15, 16 uz istodobno zatvaranje ventila 8, ohlađena na sobnu temperaturu i ohlađenom obliku transportiran preko dijalizatora koji su također ohlađeni na sobnu temperaturu. Naknadno hlađenje dijela za krv dijalizatora je pri tome nešto niže od dijela za dijalizu (25°C u odnosu na 20°C).After sterilization, the pressurized water will be cooled to room temperature by turning on the pre-sterilized cooler 12 using valves 15, 16 while simultaneously closing valve 8, and transported in a cooled form through the dialyzer, which is also cooled to room temperature. The subsequent cooling of the blood part of the dialyzer is slightly lower than the dialysis part (25°C compared to 20°C).
5. Zatvaranje i vađenje:5. Closure and removal:
Nakon hlađenja bit će dijalizator pneumatskim utiskivanjem zatvarača u kapu zatvarača automatski zatvoren i izvađen iz stanice 1 za stezanje otpuštanjem i vraćanjem cilindra za pridržavanje. Ohlađena sterilna voda ostaje u sterilnom dijalizatoru.After cooling, the dialyzer will be automatically closed by pneumatically pressing the closure into the closure cap and removed from the clamping station 1 by releasing and returning the holding cylinder. The cooled sterile water remains in the sterile dialyzer.
Upravljanje uređajem za sterilizaciju može se vršiti ručno ili preko biračkog prekidača vrste pogona, automatski. U ručnom pogonu ventili se pojedinačno upravljaju. U automatskom pogonu za upravljanje ventilima brine se programsko i vremensko temperaturno upravljanje. Takve vrste programskih pogona koji u tijelu upravljanja jedan za drugim vremenom i senzorski pojedinačne radne hodove, poznate su stručnjacima. Pripadajuća tabla za upravljanje ima raspored prema sl. 2 i sadrži sljedeće pokazne i upravljačke elemente, koji su na sl. 2 označeni slovom i koji su povezani pripadajućim senzorima odnosno upravljačkim dijelovima.Control of the sterilization device can be done manually or via the selector switch of the type of drive, automatically. In manual operation, the valves are controlled individually. Program and time temperature control is taken care of in the automatic valve control drive. Such types of program drives which in the control body one after the other time and sensor individual working moves, are known to experts. The corresponding control panel is arranged according to Fig. 2 and contains the following display and control elements, which are marked with a letter in Fig. 2 and which are connected to the corresponding sensors or control parts.
A digitalno pokazivanje temperatureAnd digital temperature display
B digitalno pokazivanje temperature rezervoaraB digital display of tank temperature
C pokazivač napunjenostiC charge indicator
D preklopnik prekidač za pokazivanje temperature za krv i dijalizatD switch switch for displaying temperature for blood and dialysate
F pisač za pritisak i temperaturuF printer for pressure and temperature
G kontrolne lampe za pumpeG control lamps for pumps
H regulator temperature zagrijavanjaH heating temperature controller
I preklopnik ručno - nula - automatika za pneumatske ventileAnd switch manually - zero - automatic for pneumatic valves
L prekidač za rezervnu pumpuL switch for backup pump
M prekidač za pumpuM pump switch
N taster “Start”N "Start" button
P “isključena nužda”P "excluded necessity"
Q svjetlosni signalizator programaQ program light indicator
R glavni prekidačR main switch
S taster “stezanje”With the "clamping" button
T taster “zabraviti”T key "forget"
U taster “izvaditi”In the "take out" button
Uvjeti i prilagođavanje sterilizacijskog uređaja u pogonu automatika odvija se kako slijedi:The conditions and adjustment of the sterilization device in the automatic drive are as follows:
Filtri za dijalizaciju, npr. deset komada, postave se u stanicu 1 za stezanje i aktiviranjem tastera S sa oznakom “stezanje” priključe na uređaj. Aktiviranjem tastera N “start” uključuje automatski tijek kretanja. Pojedinačni programski koraci - ispiranje, sterilizacija, hlađenje, zabravljivanje i vađenje - odvijaju se prema prilagođenom vremenu, jedno za drugim samostalno i programski upravljano.Filters for dialysis, for example ten pieces, are placed in the clamping station 1 and connected to the device by activating the S button labeled "clamping". By activating the N "start" button, it turns on the automatic flow of movement. The individual program steps - rinsing, sterilizing, cooling, locking and extracting - take place according to the adjusted time, one after the other independently and program-controlled.
Za vrijeme odvijanja programa, preko svjetiljki za signalizaciju pokazuju se pojedinačni programski koraci. Na digitalnim pokazivačima A pokazane su temperature svakog dijalizatora - pomoću preklopnika D naizmjenično strana krv i strana dijaliza - i na pisaču F isipuje se za dokumentaciju. Pri zasvjetljivanju sijalice “kraj” program je završen. Dijalizatori se mogu nakon pritiskivanja tastera T “zabravljivanje” i U “vađenje” izvaditi iz stanice za stezanje.While the program is running, the individual program steps are shown via the signaling lamps. The digital indicators A show the temperatures of each dialyzer - by means of the switch D alternately foreign blood and foreign dialysis - and on the printer F it is printed for documentation. When the "end" lamp lights up, the program is finished. The dialyzers can be removed from the clamping station after pressing the buttons T "locking" and U "removing".
Nakon što se ponovno stave novi dijalizatori u stanicu za stezanje, može se postupak ponoviti.Once new dialyzers are placed back into the clamping station, the process can be repeated.
U primjeru izvođenja prema sl. 1 bit će kuprofan - dijalizatorima korištena vrela, destilirana voda pod pritiskom, temperature najmanje 121°C kao medij za steriliziranje. Umjesto vode pod pritiskom može se primijeniti i 3 %tna peroctena kiselina pri sobnoj temperaturi kao medij za steriliziranje, pri čemu se tada dijalizatori nakon sterilizacije isperu sterilnom vodom od sterilnog medija.In the example of execution according to Fig. 1, hot, distilled water under pressure, temperature at least 121°C will be used as a sterilization medium for cuprophan dialyzers. Instead of water under pressure, 3% peracetic acid at room temperature can be used as a sterilization medium, in which case the dialyzers are washed with sterile water from the sterile medium after sterilization.
Tehnički je pri tome - kao što je na sl. 3 u detalju prikazano - svrsishodno, da se predvidi rezervoar 3, 19 za oba medija za sterilizaciju, koji su preko pripadajućih ventila 20, 21 alternativno uključivi. Rezervoar 3 s vrelom vodom može pri tome služiti kao izvor za sterilnu vodu za slobodno ispiranje dijalizatora nakon njihove sterilizacije peroctenom kiselinom iz rezervoara 19. Nakon ispiranja sterilnom vodom mogu se dijalizatori 2 sušiti, uključivanjem sterilnog zraka iz rezervoara 22, preko ventila 23, prema sl. 3a, ili sterilna voda ostaje u dijalizatoru odgovarajuće primjeru izvođenja sa sl. 1.Technically, as shown in detail in Fig. 3, it is expedient to provide a reservoir 3, 19 for both sterilizing media, which can alternatively be switched on via the associated valves 20, 21. Tank 3 with hot water can serve as a source for sterile water for free rinsing of dialyzers after their sterilization with peracetic acid from tank 19. After rinsing with sterile water, dialyzers 2 can be dried by turning on sterile air from tank 22, through valve 23, according to fig. 3a, or sterile water remains in the dialyzer corresponding to the embodiment shown in Fig. 1.
Kao medij za sterilizaciju je dalje primjenjiva vodena para, koja je tada prema shematskom prikazu na sl. 4, stavljena na raspolaganje bez ventila iz generatora 24 pare. Ovaj medij za sterilizaciju se prvenstveno primjenjuje kod dijalizatora 2 s polisulfon - membranama. Polisulfon je kako je poznato, hidrofoban i sadrži kao hidrofilirajuće sredstvo PVP (polivinil-pirolidon).Water vapor is also applicable as a sterilization medium, which is then, according to the schematic representation in Fig. 4, made available without a valve from the steam generator 24. This sterilization medium is primarily used in dialyzer 2 with polysulfone membranes. As is known, polysulfone is hydrophobic and contains PVP (polyvinyl-pyrrolidone) as a hydrophilizing agent.
Analogno prikazanom primjeru izvođenja na sl. 1 vrši se prvo ispiranje dijalizatora 2 vodom iz odgovarajućeg izvora, npr. kondenzatom iz generatora 24 pare preko voda 25. Nakon toga vrši se vrela sterilizacija vodenom parom preko vodova 26, kome je dodan kondenzator 27. Nakon sterilizacije bit će dijalizator 2 naknadno ispiran sterilnom vodom, npr. kondenzatom iz generatora 24 pare, radi ostranjivanja otopljenog PVP-a. Na kraju se dijalizator 2 suši sterilnim zrakom, koji je pripremljen odgovarajućim izvorom i priključen je uređaju npr. prema sl. 3a.Analogously to the design example shown in Fig. 1, the dialyzer 2 is first rinsed with water from a suitable source, for example, with condensate from the steam generator 24 through lines 25. After that, hot sterilization is performed with steam through lines 26, to which a condenser 27 is added. After sterilization the dialyzer 2 will be subsequently washed with sterile water, for example with condensate from the steam generator 24, in order to remove the dissolved PVP. Finally, the dialyzer 2 is dried with sterile air, which is prepared by a suitable source and is connected to the device, for example according to Fig. 3a.
Realizacija naprijed navedenih zahvata i previđenog upravljanja je na osnovi danih postupaka i uz navedeni primjer izvođenja stručnjaku ostvarljivo bez teškoća. Primjera radi, otpada pri tretiranju peroctenom kiselinom, prema sl. 2, kao medij za sterilizaciju na sobnoj temperaturi, faza hlađenja. U ovom slučaju ili nije predviđen hladnjak 12 ili isti ostaje isključen.Realization of the above interventions and overlooked management can be achieved without difficulty by an expert on the basis of the given procedures and with the given example of implementation. For example, waste when treated with peracetic acid, according to Fig. 2, as a medium for sterilization at room temperature, cooling phase. In this case, either the refrigerator 12 is not provided or it remains switched off.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE3936785ADE3936785C1 (en) | 1989-11-04 | 1989-11-04 | |
| YU205790AYU47805B (en) | 1989-11-04 | 1990-10-31 | PROCEDURE AND DEVICE FOR STERILIZATION OF MEDICAL DEVICES |
| Publication Number | Publication Date |
|---|---|
| HRP920408A2true HRP920408A2 (en) | 1995-04-30 |
| HRP920408B1 HRP920408B1 (en) | 1998-06-30 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP-2057/90AHRP920408B1 (en) | 1989-11-04 | 1992-09-21 | Process and appliance for sterilising medical appliences |
| Country | Link |
|---|---|
| HR (1) | HRP920408B1 (en) |
| Publication number | Publication date |
|---|---|
| HRP920408B1 (en) | 1998-06-30 |
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