JPS63111878A - Sterilization of semipermeable membrane module - Google Patents
Sterilization of semipermeable membrane moduleInfo
- Publication number
- JPS63111878A JPS63111878A JP61259365A JP25936586A JPS63111878A JP S63111878 A JPS63111878 A JP S63111878A JP 61259365 A JP61259365 A JP 61259365A JP 25936586 A JP25936586 A JP 25936586A JP S63111878 A JPS63111878 A JP S63111878A
- Authority
- JP
- Japan
- Prior art keywords
- semipermeable membrane
- membrane module
- sterilization
- cellulose
- polyhydric alcohol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000012528 membrane Substances 0.000 title claims description 82
- 230000001954 sterilising effect Effects 0.000 title claims description 29
- 238000004659 sterilization and disinfection Methods 0.000 title description 16
- 238000000034 method Methods 0.000 claims description 34
- 229920002678 cellulose Polymers 0.000 claims description 22
- 239000001913 cellulose Substances 0.000 claims description 19
- 150000005846 sugar alcohols Polymers 0.000 claims description 19
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 8
- 235000011187 glycerol Nutrition 0.000 claims description 4
- 239000012510 hollow fiber Substances 0.000 description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 8
- 238000000502 dialysis Methods 0.000 description 7
- 230000005251 gamma ray Effects 0.000 description 6
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 5
- 230000006866 deterioration Effects 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 4
- 239000007789 gas Substances 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 3
- 238000004388 gamma ray sterilization Methods 0.000 description 3
- 239000011261 inert gas Substances 0.000 description 3
- 239000001301 oxygen Substances 0.000 description 3
- 229910052760 oxygen Inorganic materials 0.000 description 3
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 description 2
- 229920001747 Cellulose diacetate Polymers 0.000 description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 239000012153 distilled water Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 229910052757 nitrogen Inorganic materials 0.000 description 2
- 238000000108 ultra-filtration Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- GUTLYIVDDKVIGB-OUBTZVSYSA-N Cobalt-60 Chemical compound [60Co] GUTLYIVDDKVIGB-OUBTZVSYSA-N 0.000 description 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 239000001856 Ethyl cellulose Substances 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- 229910052786 argon Inorganic materials 0.000 description 1
- 230000005587 bubbling Effects 0.000 description 1
- 229920002301 cellulose acetate Polymers 0.000 description 1
- 229920006217 cellulose acetate butyrate Polymers 0.000 description 1
- 229920001727 cellulose butyrate Polymers 0.000 description 1
- 229920003086 cellulose ether Polymers 0.000 description 1
- 239000004020 conductor Substances 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 229940105990 diglycerin Drugs 0.000 description 1
- GPLRAVKSCUXZTP-UHFFFAOYSA-N diglycerol Chemical compound OCC(O)COCC(O)CO GPLRAVKSCUXZTP-UHFFFAOYSA-N 0.000 description 1
- 229910001873 dinitrogen Inorganic materials 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 150000002170 ethers Chemical class 0.000 description 1
- 235000010944 ethyl methyl cellulose Nutrition 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000001307 helium Substances 0.000 description 1
- 229910052734 helium Inorganic materials 0.000 description 1
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 229920003087 methylethyl cellulose Polymers 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229910052754 neon Inorganic materials 0.000 description 1
- GKAOGPIIYCISHV-UHFFFAOYSA-N neon atom Chemical compound [Ne] GKAOGPIIYCISHV-UHFFFAOYSA-N 0.000 description 1
- QJGQUHMNIGDVPM-UHFFFAOYSA-N nitrogen group Chemical group [N] QJGQUHMNIGDVPM-UHFFFAOYSA-N 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000005416 organic matter Substances 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000001012 protector Effects 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000001223 reverse osmosis Methods 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Landscapes
- External Artificial Organs (AREA)
Abstract
(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。(57) [Abstract] This bulletin contains application data before electronic filing, so abstract data is not recorded.
Description
【発明の詳細な説明】
［産業上の利用分野］
この発明は半透膜モジュールの滅菌方法に関するもので
ある。さらに詳しく一τうと、たとえばセルロース誘導
体からなる半透膜を用いたモジュールを滅菌する方法に
関する。DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] This invention relates to a method for sterilizing a semipermeable membrane module. More specifically, the present invention relates to a method for sterilizing a module using a semipermeable membrane made of, for example, a cellulose derivative.
［従来の技術およびその問題点］
従来、たとえば′ｆ−透膜を用いて構成され、人工Ｕ器
として使用される半透膜モジュールの滅菌方法としては
、γ線滅菌法、エチレンオキサイドガス滅菌法（以下、
ＥＯＧ滅菌法と言う、）、蒸気滅菌法などが知られてい
た。[Prior art and its problems] Conventionally, methods for sterilizing a semipermeable membrane module constructed using, for example, an 'f-permeable membrane and used as an artificial U device include a gamma ray sterilization method and an ethylene oxide gas sterilization method. (below,
The EOG sterilization method (EOG), steam sterilization method, etc. were known.
前記γ線滅菌法には、さらに、乾式と湿式とがある。The gamma ray sterilization method further includes a dry method and a wet method.
前記乾式γ線滅菌法は、滅菌物を乾燥状態または多価ア
ルコール等を含浸させた状態でγ線を照射する方法であ
り、前記湿式γ！ｉ１Ｍ菌法は、たとえば半′Ｘ！ｉ膜
モジュールの中に蒸留水、イオン交換水、ＲＯ水（逆浸
透膜で癌過することによりイオン、有機物等を除去した
精製水）、生理食塩水等を充填して、γ線を照射する方
法である。The dry gamma ray sterilization method is a method in which a sterilized object is irradiated with gamma rays in a dry state or in a state impregnated with polyhydric alcohol, etc. The i1M bacterium method, for example, is half'X! Fill the i-membrane module with distilled water, ion-exchanged water, RO water (purified water from which ions, organic matter, etc. have been removed by passing through a reverse osmosis membrane), physiological saline, etc., and irradiate it with gamma rays. It's a method.
一般にセルロース誘導体は、γ線に対して弱い素材であ
り、γ線の照射によりその物理化学的性質の劣化が著し
いと考えられている。このγ線照射によるセルロース誘
導体の劣化を防ＩＦする方法として、セルロース系半透
膜を飽和含水率以上の湿温状態に保持しつつγ線照射を
行なう方法が提案されている（特公昭５５−２３６２０
号公報参照）、シかし、この方法でも、セルロース誘導
体の劣化が完全に抑制される訳ではない。In general, cellulose derivatives are materials that are sensitive to gamma rays, and it is believed that irradiation with gamma rays significantly deteriorates their physicochemical properties. As a method for preventing the deterioration of cellulose derivatives due to γ-ray irradiation, a method has been proposed in which γ-ray irradiation is carried out while the cellulose semipermeable membrane is kept in a humid temperature state with a saturated water content or higher (Japanese Patent Publication No. 1983-1993-1). 23620
However, even with this method, the deterioration of the cellulose derivative is not completely suppressed.
また、乾式γ線照射法では、セルロース系誘導体からな
る半透膜は、γ線照射による劣化の程度が著しく、γ線
照射後セルロース系誘導体の半透膜からの溶出物の増大
および強度の低下が大きい。In addition, in the dry γ-ray irradiation method, semipermeable membranes made of cellulose derivatives are significantly degraded by γ-ray irradiation, and after γ-ray irradiation, eluates from the semipermeable membranes of cellulose derivatives increase and strength decreases. is large.
前記蒸気滅菌法は、セルロース誘導体からなる゛ト透膜
に適用すると、同誘導体が耐熱性に乏しいことから、半
透膜の形態を変化させその性能を低下させることがある
。したがって、セルロース誘導体からなる半透膜に対し
て、蒸気滅菌法は、多くの場合、採用されていない。When the steam sterilization method is applied to semipermeable membranes made of cellulose derivatives, the semipermeable membrane may change its form and deteriorate its performance because the derivatives have poor heat resistance. Therefore, steam sterilization is not often used for semipermeable membranes made of cellulose derivatives.
結局、セルロース誘導体からなる半透膜に対して多く採
用されるのは、ＥＯＧ滅菌法である。Ultimately, the EOG sterilization method is often employed for semipermeable membranes made of cellulose derivatives.
しかしながら、ＥＯＧＭ！ｉ法による場合には、エチレ
ンオキサイドガスが半透膜中に残留するおそれがあり、
万一、大王臓器に用いられている半透膜に同ガスが残留
していると生体に！！影響を及ぼすという問題がある。However, EOGM! When using the i method, there is a risk that ethylene oxide gas will remain in the semipermeable membrane.
In the unlikely event that the same gas remains in the semi-permeable membrane used in the Great King's organ, it will infect living organisms! ! There is the problem of influence.
［発明の目的］
この発明の目的は、前記問題点を解消し、セルロース誘
導体からなる半透膜の物理化学的性質を損ねることなく
確実な滅菌効果を有し、かつ生体にＳ影響を及ぼすおそ
れのない半透膜モジュールの滅菌方法を提供することで
ある。[Objective of the Invention] The object of the present invention is to solve the above-mentioned problems, to have a reliable sterilization effect without impairing the physicochemical properties of a semipermeable membrane made of a cellulose derivative, and to eliminate the possibility of S affecting living organisms. An object of the present invention is to provide a method for sterilizing a semipermeable membrane module without the need for sterilization.
［前記１１的を達成するためのｐ段］
前記目的を達成するために、この発明者らが鋭、α研究
を重ねた結果、セルロース誘導体からなる半透膜に特定
の処理を施し、特定の雰囲気下にγ線滅菌することによ
り、たとえば半透膜の溶出物のより一層の低減を図り、
強度等の低下を防Ｉヒすることができる、半透膜モジュ
ールの優れた滅菌方法を見い出してこの発明に到達した
。[Step P for achieving the above-mentioned 11th objective] In order to achieve the above-mentioned objective, the inventors have conducted extensive research, and as a result, a semipermeable membrane made of a cellulose derivative is subjected to a specific treatment, and a specific By sterilizing with gamma rays in an atmosphere, for example, we can further reduce eluates from semipermeable membranes.
The present invention was achieved by discovering an excellent method of sterilizing semipermeable membrane modules that can prevent deterioration of strength, etc.
すなわち、前記問題点を解決するためのこの発１１１１
の１段は、セルロース誘導体から形成した半透膜を用い
た半透膜モジュールの滅菌方法において、前記半透膜に
多価アルコールを含浸させると共にこの：ｔ−ａＳを実
質的に無水状態とし、次いで実質的に無酸素の乾燥雰囲
気下にγ線滅菌することを特徴とする半透膜モジュール
の滅菌方法である。That is, this issue 1111 to solve the above problem
In the first step of the method for sterilizing a semipermeable membrane module using a semipermeable membrane formed from a cellulose derivative, the semipermeable membrane is impregnated with a polyhydric alcohol and the :t-aS is made substantially anhydrous; This is a method for sterilizing a semipermeable membrane module, which is then sterilized with gamma rays in a substantially oxygen-free dry atmosphere.
この発明における半透膜モジュールは、透析装置に使用
される。この透析装置とは、透析膜あるいは限外濾過膜
等の膜素材を使用する透析装置、および限外濾過装置等
を指称する。具体的には、たとえば人工腎臓、人工肝臓
などの目的で使用される生体用透析装置などが挙げられ
る。型式としては、この半透膜モジュールは、中空糸型
透析装置に好適に適用されるものである。勿論、他の型
式の透析装置などに使用されるものであっても良い。The semipermeable membrane module in this invention is used in a dialysis device. This dialysis device refers to a dialysis device that uses a membrane material such as a dialysis membrane or an ultrafiltration membrane, an ultrafiltration device, and the like. Specifically, examples include biological dialysis equipment used for purposes such as artificial kidneys and artificial livers. As a type, this semipermeable membrane module is suitably applied to a hollow fiber type dialysis device. Of course, it may also be used in other types of dialysis equipment.
前記半透膜モジュールは、セルロース誘導体を用いて形
成される半透膜を備えるものである。The semipermeable membrane module includes a semipermeable membrane formed using a cellulose derivative.
前記セルロース誘導体としては、たとえセルロースアセ
テート、セルロースブチレート等のセルロースエステル
系化合物、メチルセルロース、エチルセルロース等のセ
ルロースエーテル系化合物などの一種またはこれらの混
合物などが挙げられる。Examples of the cellulose derivative include cellulose ester compounds such as cellulose acetate and cellulose butyrate, and cellulose ether compounds such as methyl cellulose and ethyl cellulose, or a mixture thereof.
これらの中でも、セルロースアセテートなどのセルロー
スエステル系化合物が好ましく、特にセルロースジアセ
テートが好ましい。Among these, cellulose ester compounds such as cellulose acetate are preferred, and cellulose diacetate is particularly preferred.
前記半透膜は、通常、中空糸繊維、あるいはシート状物
、フィルム状物として使用されるのであるが、゛ト透膜
モジュールに好適な半透膜は、中空繊維である。The semipermeable membrane is usually used in the form of hollow fiber, sheet-like material, or film-like material, but the semipermeable membrane suitable for the permeable membrane module is hollow fiber.
この発明に係る方法で重要なことは、半透膜モジュール
中の半透膜を、先ず、多価アルコールで含浸すると共に
その半透膜を実質的に無水の状態とすることである。What is important in the method according to the present invention is that the semipermeable membrane in the semipermeable membrane module is first impregnated with a polyhydric alcohol and the semipermeable membrane is rendered substantially anhydrous.
前記多価アルコールは、半透膜の親木化は勿論、滅菌時
あるいは保存時の際の半透膜の保護として作用するもの
であれば特に制限がなく、たとえば、グリセリン、ジグ
リセリン、トリグリセリン、エチレングリコール、フロ
ビレングリコールなどを例示することができる。The polyhydric alcohol is not particularly limited as long as it acts not only as a parent for the semipermeable membrane but also as a protector for the semipermeable membrane during sterilization or storage, such as glycerin, diglycerin, and triglycerin. , ethylene glycol, flobylene glycol, and the like.
これら各種の多価アルコールの中でも、安定性および安
全性の観点より検討すると、グリセリンなどが好ましい
。Among these various polyhydric alcohols, glycerin and the like are preferred from the viewpoint of stability and safety.
多価アルコールを半透膜に含浸し、実質的に無水状態と
するのは、要するに、半透膜に無水状態の多価アルコー
ルで膜の保護および親木化を十分に行なうためである。The reason why the semipermeable membrane is impregnated with polyhydric alcohol to make it substantially anhydrous is to sufficiently protect and parent the semipermeable membrane with the anhydrous polyhydric alcohol.
したがって、この多価アルコールの半透膜に対する含浸
量は、膜の保護および親木化に必要な１分な量と言うこ
とができるのであるが、通常、半透膜の単位重量当り、
０．１〜１０倍であり、好ましくは０．５〜５倍である
。Therefore, the amount of polyhydric alcohol impregnated into the semipermeable membrane can be said to be the amount necessary for protecting and parenting the membrane, but usually per unit weight of the semipermeable membrane,
It is 0.1 to 10 times, preferably 0.5 to 5 times.
また、多価アルコールを含浸させる操作としては、半透
膜を多価アルコールに浸漬する方式であっても良いし、
ディスポーザブル！！！半透膜モジュールであれば、デ
ィスポーザブル容器内に多価アルコールをたとえばポン
プで送り込み、ディスポーザブル容器内の半透膜に多価
アルコールを含浸させるような方式であっても良い。Further, the operation of impregnating the polyhydric alcohol may be a method of immersing the semipermeable membrane in the polyhydric alcohol,
Disposable! ! ! In the case of a semipermeable membrane module, a method may be used in which polyhydric alcohol is pumped into the disposable container, and the semipermeable membrane in the disposable container is impregnated with the polyhydric alcohol.
また、この無水状態の多価アルコールを半透膜にト分に
含浸させることができれば、実質的に無水状態にする方
法には特に制限があるわけではなく、たとえば、半透膜
を前記多価アルコールに含浸させた後にこの半透膜を加
熱乾燥あるいは減圧乾燥しても良く、また場合により、
実質的に無水状態の多価アルコールを半透膜に接触、含
浸させるだけでも良い。Furthermore, as long as a semipermeable membrane can be impregnated with this anhydrous polyhydric alcohol, there is no particular restriction on the method of making the semipermeable membrane substantially anhydrous. After being impregnated with alcohol, this semipermeable membrane may be dried by heating or under reduced pressure.
The semipermeable membrane may be simply brought into contact with and impregnated with substantially anhydrous polyhydric alcohol.
いずれにしても、水分含有Ｉツが５重量％以下であれば
、実質的な無水状態と言い得る。In any case, if the water content is 5% by weight or less, it can be said to be substantially anhydrous.
水分含有量が５虫呈％を超えると、半透膜の物理的化学
的な劣化が大きくなって好ましくない。If the water content exceeds 5%, the semipermeable membrane will undergo significant physical and chemical deterioration, which is undesirable.
次に、この発明で重要なことは、多価アルコールを十分
に含浸させた半透膜を、実質的に無酸素の乾燥雰囲気下
にγ線減菌することである。Next, what is important in this invention is to sterilize the semipermeable membrane sufficiently impregnated with polyhydric alcohol by gamma rays in a substantially oxygen-free dry atmosphere.
ここで、実質的に無酸素の状態とは、多価アルコールを
含浸させた半透ＩＩ！２ア雰囲気中の酸素分圧が、２
ｍ ｍ Ｈｇ以下である場合が挙げられる。酸素分圧が
２ｍｍＨｇを超えると、γ線照射時に酸素ラジカルによ
る半透膜の劣化が著しくなる。Here, the substantially oxygen-free state means semi-transparent II! impregnated with polyhydric alcohol! 2A The oxygen partial pressure in the atmosphere is 2
For example, it may be less than mm Hg. When the oxygen partial pressure exceeds 2 mmHg, the deterioration of the semipermeable membrane due to oxygen radicals becomes significant during γ-ray irradiation.
実質的に無酸素、乾燥状態とするための操作としては、
たとえば、ｒｌ’ ｍ Ｉｇ！モジュールを収納する滅
菌バッグ内を高真空あるいは減圧にし、要すれば不活性
気体を刃入することが挙げられる。Operations to achieve a substantially oxygen-free and dry state include:
For example, rl' m Ig! The inside of the sterilization bag in which the module is housed may be brought to a high vacuum or reduced pressure, and if necessary, an inert gas may be introduced into the bag.
また、半透膜モジュールがディスポーザブル型であれば
、ディスポーザブル容器内に乾燥不活性ガスを所定時間
流し続けるだけでも良いであろう。Furthermore, if the semipermeable membrane module is a disposable type, it may be sufficient to simply continue to flow dry inert gas into the disposable container for a predetermined period of time.
この不活性気体としては、たとえば、ヘリウム、ネオン
、アルゴンなどの島ガス類や窒素ガスなどが挙げられる
。材料の入手の容易性、価格の低廉性などを考慮すると
、これらの中でも、窒素が好ましい。Examples of this inert gas include island gases such as helium, neon, and argon, and nitrogen gas. Among these, nitrogen is preferable in consideration of the ease of obtaining the material and the low cost.
γ線の照射は１通常、コバルト６０照射装置により行な
われる。Irradiation with gamma rays is usually performed using a cobalt-60 irradiation device.
γ線の照射が、照射強度および照射時間は、線源の大き
さ、被照射物との距離、被照射物の密度等により相違す
るが、通常の減菌５ ｒ、；は、２〜３Ｍｒａｄ程度で
ある。The irradiation intensity and irradiation time of gamma rays vary depending on the size of the radiation source, the distance to the irradiated object, the density of the irradiated object, etc., but the normal sterilization time is 2 to 3 Mrad. That's about it.
照射のｙｂ様としては、連続照射であっても良いし、ま
た間欠的に照射しても良い。The yb type of irradiation may be continuous irradiation or may be irradiated intermittently.
［発明の効果］
この発明によると、セルロース、通導体からなる半透膜
を用いたモジュール中の！ｆ−透膜にたとえば強度の低
ド、溶出物の増大のような物理化学的損傷をかえること
なく、γ線照射による滅菌を効率的に行なうことができ
る滅菌方法を提供することができる。[Effects of the Invention] According to this invention, in a module using a semipermeable membrane made of cellulose and a conductor! It is possible to provide a sterilization method that can efficiently sterilize an f-permeable membrane by irradiation with gamma rays without causing physicochemical damage such as low strength or increased eluate.
〔実施例］
（実施例１〜４．比較例１〜４）
ポリカーボネート製の円筒状ケース（直径５０ｍ ｍ
、長さ２１５ ｍｍ）の内部に、半透膜としてセルロー
スジアセテートの中空糸状繊維束１５．５ｇを充填する
と共にその中空糸状繊維束の両端をポリウレタンで固定
することにより、半透膜モジュールを作成した。[Example] (Examples 1 to 4. Comparative Examples 1 to 4) Polycarbonate cylindrical case (diameter 50 mm
, 215 mm in length) was filled with 15.5 g of hollow fiber bundles of cellulose diacetate as a semipermeable membrane, and both ends of the hollow fiber bundles were fixed with polyurethane to create a semipermeable membrane module. did.
この円筒状ケース内の半透膜に、グリセリン４２ｇを含
浸させた後、ＩＴｏｒｒ巾で減圧乾燥した。The semipermeable membrane in this cylindrical case was impregnated with 42 g of glycerin, and then dried under reduced pressure using an ITorr width.
このときの中空糸状繊！ｌ東の含水率を第１表に示す。Hollow fiber at this time! Table 1 shows the moisture content of l East.
次いで、この半透膜モジュールの滅菌バッグ内を真空に
した半透膜モジュール、滅菌バッグ内を窒素ｌ換した半
透膜モジュール、比較例として滅菌バッグ内に空気を入
れた半透膜モジュール、モジュール内に蒸留水を充填し
た半透膜モジュールをそれぞれ調製した。Next, a semipermeable membrane module in which the inside of the sterilization bag of this semipermeable membrane module was evacuated, a semipermeable membrane module in which the inside of the sterilization bag was replaced with nitrogen, and a semipermeable membrane module in which air was put in the sterilization bag as a comparative example, and a module. Semipermeable membrane modules each filled with distilled water were prepared.
そして、半透膜モジュールに、γ線を、第１表に示す線
量で照射した。Then, the semipermeable membrane module was irradiated with gamma rays at the doses shown in Table 1.
γ線の照射後に、半透膜モジュールから中空糸状繊維束
を取り出して、透析型人工？Ｖ臓装２１承認基準に従っ
て中空糸状繊維束の溶出物試験をし、また繊維束の強度
保持率を算出した。After irradiation with gamma rays, the hollow fiber bundle is taken out from the semipermeable membrane module to create a dialysis-type prosthesis? The hollow fiber bundle was subjected to an eluate test in accordance with the V-Zou 21 approval standard, and the strength retention rate of the fiber bundle was calculated.
結果を第１表に示す。The results are shown in Table 1.
第１表からも明らかなように、゛ト透膜モジュールにお
けるセルロース誘導体からなる半透膜を。As is clear from Table 1, the semipermeable membrane made of cellulose derivative in the permeable membrane module.
多価アルコールを含浸してこれを乾燥した後に。After impregnating with polyhydric alcohol and drying this.
水分とｌｖ末とを実質的に存在しない状態で、γ線を照
射した半透膜モジュール中の半透膜は、比較例の半透膜
モジュール中の半透膜に比べて、ｐＨ１泡立ち、外Ｖ＆
等の項目において著しい改善が観察され、透析型人工腎
臓！ｊｔ置装認基準を満足するものである。The semipermeable membrane in the semipermeable membrane module that was irradiated with γ rays in the substantial absence of moisture and lv powder had a pH 1 level of bubbling and exudation, compared to the semipermeable membrane in the semipermeable membrane module of the comparative example. V&
Significant improvements were observed in items such as dialysis-type artificial kidney! It satisfies the JT equipment certification standards.
しかも、γ線の照射によっても、実施例の半透膜は１強
度の低下がなく、溶出量も少なくて高い安全性を備えた
ものと言える。Furthermore, even when irradiated with gamma rays, the semipermeable membrane of the example did not exhibit a single drop in strength, and the amount of elution was small, so it can be said that it has a high level of safety.
Claims (3)
透膜モジュールの滅菌方法において、前記半透膜に多価
アルコールを含浸させると共にこの半透膜を実質的に無
水状態にし、次いで実質的に無酸素の乾燥雰囲気下にγ
線滅菌することを特徴とする半透膜モジュールの滅菌方
法。(1) In a method for sterilizing a semipermeable membrane module using a semipermeable membrane formed from a cellulose derivative, the semipermeable membrane is impregnated with polyhydric alcohol and rendered substantially anhydrous; γ in an oxygen-free dry atmosphere
A method for sterilizing a semipermeable membrane module, which method comprises sterilizing a semipermeable membrane module.
記特許請求の範囲第１項に記載の半透膜モジュールの滅
菌方法。(2) The method for sterilizing a semipermeable membrane module according to claim 1, wherein the cellulose derivative is a cellulose ester.
の範囲第１項または第２項に記載の半透膜モジュールの
滅菌方法。(3) The method for sterilizing a semipermeable membrane module according to claim 1 or 2, wherein the polyhydric alcohol is glycerin.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61259365A JPS63111878A (en) | 1986-10-30 | 1986-10-30 | Sterilization of semipermeable membrane module |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61259365A JPS63111878A (en) | 1986-10-30 | 1986-10-30 | Sterilization of semipermeable membrane module |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPS63111878A true JPS63111878A (en) | 1988-05-17 |
Family
ID=17333100
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP61259365A Pending JPS63111878A (en) | 1986-10-30 | 1986-10-30 | Sterilization of semipermeable membrane module |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS63111878A (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0288074A (en) * | 1988-09-27 | 1990-03-28 | Teijin Ltd | Manufacture of blood treating device |
| JP2001205057A (en) * | 2000-01-27 | 2001-07-31 | Toyobo Co Ltd | Hollow fiber membrane |
| WO2006041124A1 (en) * | 2004-10-15 | 2006-04-20 | Nipro Corporation | Blood purification device and blood purification device package |
| WO2006068124A1 (en) * | 2004-12-22 | 2006-06-29 | Toyo Boseki Kabushiki Kaisha | Hemopurifier package and process for producing the same |
| WO2006104082A1 (en) * | 2005-03-28 | 2006-10-05 | Toyo Boseki Kabushiki Kaisha | Packaged module for blood purification and method of sterilizing the same |
| US9056280B2 (en) | 2004-10-15 | 2015-06-16 | Nipro Corporation | Method for sterilizing blood purifier and blood purifier package |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS59192373A (en) * | 1983-04-18 | 1984-10-31 | 東洋紡績株式会社 | Pasturization of osmosis apparatus |
| JPS59211459A (en) * | 1983-05-17 | 1984-11-30 | 帝人株式会社 | Pasturization of blood treating device |
-
1986
- 1986-10-30 JP JP61259365A patent/JPS63111878A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS59192373A (en) * | 1983-04-18 | 1984-10-31 | 東洋紡績株式会社 | Pasturization of osmosis apparatus |
| JPS59211459A (en) * | 1983-05-17 | 1984-11-30 | 帝人株式会社 | Pasturization of blood treating device |
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0288074A (en) * | 1988-09-27 | 1990-03-28 | Teijin Ltd | Manufacture of blood treating device |
| JP2001205057A (en) * | 2000-01-27 | 2001-07-31 | Toyobo Co Ltd | Hollow fiber membrane |
| WO2006041124A1 (en) * | 2004-10-15 | 2006-04-20 | Nipro Corporation | Blood purification device and blood purification device package |
| US9056280B2 (en) | 2004-10-15 | 2015-06-16 | Nipro Corporation | Method for sterilizing blood purifier and blood purifier package |
| US9987409B2 (en) | 2004-10-15 | 2018-06-05 | Nipro Corporation | Blood purifier and blood purifier package |
| US10137234B2 (en) | 2004-10-15 | 2018-11-27 | Nipro Corporation | Method for sterilizing blood purifier and blood purifier package |
| WO2006068124A1 (en) * | 2004-12-22 | 2006-06-29 | Toyo Boseki Kabushiki Kaisha | Hemopurifier package and process for producing the same |
| JPWO2006068124A1 (en) * | 2004-12-22 | 2008-06-12 | 東洋紡績株式会社 | Blood purifier package and method for producing the same |
| US9067178B2 (en) | 2004-12-22 | 2015-06-30 | Nipro Corporation | Blood purifier package and process for manufacturing the same |
| US9987408B2 (en) | 2004-12-22 | 2018-06-05 | Nipro Corporation | Blood purifier package and process for manufacturing the same |
| WO2006104082A1 (en) * | 2005-03-28 | 2006-10-05 | Toyo Boseki Kabushiki Kaisha | Packaged module for blood purification and method of sterilizing the same |
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