EP0134896A2 - Récipient en matière synthétique pour du sang, produits sanguins et produits pharmaceutiques et leur application dans un système à sac - Google Patents

Récipient en matière synthétique pour du sang, produits sanguins et produits pharmaceutiques et leur application dans un système à sac Download PDF

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Publication number
EP0134896A2
EP0134896A2 EP84105742A EP84105742A EP0134896A2 EP 0134896 A2 EP0134896 A2 EP 0134896A2 EP 84105742 A EP84105742 A EP 84105742A EP 84105742 A EP84105742 A EP 84105742A EP 0134896 A2 EP0134896 A2 EP 0134896A2
Authority
EP
European Patent Office
Prior art keywords
bag
plastic
blood
polyvinyl chloride
plasticizer
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.)
Withdrawn
Application number
EP84105742A
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German (de)
English (en)
Other versions
EP0134896A3 (fr
Inventor
Wolfram H. Dr. Dipl.-Chem. Walker
Karlheinz Dr. Dipl.-Chem. Gänshirt
Manfred Netz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biotest Serum Institut GmbH
Original Assignee
Biotest Serum Institut GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Biotest Serum Institut GmbH filed Critical Biotest Serum Institut GmbH
Publication of EP0134896A2 publication Critical patent/EP0134896A2/fr
Publication of EP0134896A3 publication Critical patent/EP0134896A3/fr
Withdrawn legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers

Definitions

  • the invention relates to the plastic container for blood, blood components and liquid pharmaceutical preparations described in the claims and its use in a bag system.
  • the plastic container according to the invention can be used, for example, as a blood, plasma, transfusion or infusion bag for taking, storing, preserving or deep-freezing blood, blood plasma, cellular blood components or liquid pharmaceutical preparations, e.g. infusion solutions.
  • plastic containers of this type they must be transparent and flexible, they must be steam sterilizable or filled with aqueous blood stabilizer liquid Can be sterilized empty with ethylene oxide or radiation.
  • plastic from which such bags are usually made must be compatible with the blood, must not give off substances that are harmful to the blood or the patient, must not eliminate any substances from the blood, must not influence the blood's coagulation system, and must not have an adverse effect on the plasma and cellular substances in the blood such as erythrocytes, thrombocytes and leukocytes and must be tight against the penetration of microorganisms.
  • M an has mainly produced bags for the purposes mentioned above from plasticized polyvinyl chloride.
  • Polyvinyl chloride shows favorable properties such as transparency and light V ER- working properties. It is also available in various degrees of stiffness. Depending on its plasticizer content, it is flexible to firm and can be used for a wide variety of purposes.
  • the plasticized polyvinyl chloride which itself contains stabilizers and lubricants, has the disadvantage that when blood and plasma are stored in these bags, substantial amounts of these additives, e.g. the plasticizer and / or the stabilizer can be removed.
  • German utility model 76 31 615 a blood bag made of polyurethane film was described which contains no plasticizer and therefore for the storage of Blood and blood components is particularly suitable because no plasticizer can be removed.
  • a multiple bag system is known in which the different bags of the system consist of different plastics, the blood collection bag being made of a material that is at least 5% of a be agreed ester contains as a plasticizer, which leads to a reduction in plasma hemoglobin and thus to a reduction in hemolysis of erythrocytes when stored in the blood collection bag for 21 days.
  • the satellite bag should consist of a plastic that is free of a blood-extractable plasticizer.
  • blood extractable plasticizers include dioctyl phthalate and dioctyl adipate.
  • materials that contain practically no blood extractable plasticizer include polyester, ethylene-vinyl acetate copolymers, triethylhexyl mellitized plasticized polyvinyl chloride, and polyethylene.
  • a blood bag for storing platelet concentrates is known from EP-A 00 26 912 and US Pat. No. 4,280,497, the walls of which consist of soft polyvinyl chloride, the 30 to 50% tri-2-ethylhexyl trimellitate as plasticizer and additionally 3 Contains up to 5 % epoxidized vegetable oils for heat stabilization. With such a bag, a favorable platelet survival rate was found in vivo due to its high gas permeability.
  • a multiple bag system is known from EP-A 00 54 221, in which both bags consist of a plastic that is essentially free of plasticizers that can be extracted by blood.
  • plastics can ri-2-ethylhexyl as a plasticizer and about 3.5% epoxidized soybean oil and contains about 0.6% metal soaps as stabilizers made of soft polyvinyl chloride containing 30 to 50% of T or Made of polyurethane, polyester or polycarbonate and should have a CO 2 permeability of at least 3000 ml / m 2 / day.
  • a blood bag which contains 5 to 30% by weight of a first plasticizer, which is not extractable by blood, and 10 to 25% of a second plasticizer, which is made by blood at 4 ° C. and for 35 days Storage is extracted significantly, contains.
  • a plasticizer mixture of 17% tri-2-ethylhexyl trimellitate and 15% dioctyl phthalate is preferably used.
  • US Pat. No. 4,301,800 discloses a blood bag consisting of a plastic which is essentially free of blood-extractable plasticizers, and an insert made of a plastic mass which contains 5 to 70% of a blood-extractable plasticizer, namely Contains dioctyl phthalates or dioctyl adipates.
  • plastic containers for blood and blood components described so far were each geared to specific types of use and could be used, for example, either for storing platelet concentrates or for storing erythrocytes.
  • the invention has for its object to provide a plastic container or plastic bag that is universal for blood, blood components and liquid Pharmaceutical preparations can be used, ie in which both erythrocyte and thrombocyte concentrates as well as blood supplies, blood plasma and plasma preparations can be stored, the plasticizer extraction being reduced to a certain minimum by cellular and plasmatic blood components.
  • the plastic container consists of at least two plastic materials of different compositions, part of the container wall made of a first plastic material with high oxygen permeability and the other part of the container wall made of a second plastic material containing a component that improves the storage capacity of erythrocytes minimal extractability of this component consists of the second plastic material.
  • the plastic container according to the invention has properties which have not been achieved by the individual plastic materials used hitherto for the entire container wall, including the mixtures of plastics and plasticizers used hitherto, for example that the plastic container according to the invention is suitable both for storing erythrocytes and for storage is capable of platelet concentrates, while the W calibration wheeler extraction by cellular and plasmatic blood components at a certain minimum value is maintained, corresponding to a clinically acceptable hemolysis.
  • This plasticizer extraction can be simulated and determined using an aqueous alcoholic solution in accordance with the German standard for blood bags, DIN 58 361, part 4.
  • the evaluation can be carried out photometrically or by gas chromatography.
  • the minimum plasticizer extraction that is sufficient to press the hemolysis rate to a clinically acceptable value is, for example, about 5.8 mg dioctyl phthalate per 100 ml extraction solution according to DIN 58 361, part 4.
  • the plastic container according to the invention is preferably constructed as a bag from at least two foils of different compositions.
  • Fig. 1 shows a front view of a typical embodiment of a plastic container according to the invention in the form of a blood bag.
  • This bag contains puncture stubs (1), a break-off part (2) as well as a tube attachment (3), blood collection tube (5) with venous cannula (6) and transfer tube (4), blood bag walls (7) from the front and back (7a) or (7b ) and label (8).
  • Fig. 2 shows a side view of the same bag.
  • the walls of the plastic container or plastic bag according to the invention are preferably constructed from foils, the front and back of the bag consisting of different plastic formulations. .
  • the bag further components mentioned in Figure 1 can consist of the same material as eutel Wegseite Beutelvorder- or B; however, they can also be constructed from a further third recipe.
  • Plasticizers can be mono- or polyalkyl esters of mono- or polycarboxybenzenes, the first soft polyvinyl chloride containing a plasticizer with a molecular weight above 400 and the second soft polyvinyl chloride containing a plasticizer with a molecular weight below 400.
  • These alkyl esters can contain 6 to 10 carbon atoms, in particular 8 carbon atoms, in each alkyl group and can be present as mono-, di-, tri-, tetra-, penta- or hexa esters or also as mixed esters.
  • plasticizers having a molecular weight above 400 are the triester of Tricarboxybenzolen such Trioctylester of trimellitic acid, hemimellitic acid or trimesic acid, T RI and Tetraester of Tetracarboxybenzolen such Tetraoctylester the mellophanic acid, prehnitic or pyromellitic acid, and polyalkyl esters of penta-and Hexacarboxybenzol.
  • Preferred plasticizers of this D type are the trioctyl esters of tricarboxybenzenes, in particular trioctyl trimellitates, such as tri-2-ethyl hexyl trimellitate.
  • plasticizers with a molecular weight below 400, which can be extracted by cellular and plasmatic blood components and improve the storage capacity of erythrocytes, are the dialkyl esters of dicarboxybenzenes, for example the dioctyl esters of phthalic acid, terephthalic acid or isophthalic acid, in particular dioctyl phthalates, such as di-2 -ethylhexyl phthalate.
  • Usable plastic materials made of soft polyvinyl chloride for the plastic container according to the invention contain about 60 to 70% by weight of polyvinyl chloride, 30 to 40% by weight of the above plasticizers, about 2 to 10% of an epoxidized plasticizing oil such as epoxidized soybean oil and up to 2% of a lubricant , such as N, N'-dipalmitylethylenediamine and up to 1% of a stabilizer, such as zinc and / or calcium stearate.
  • an epoxidized plasticizing oil such as epoxidized soybean oil
  • a lubricant such as N, N'-dipalmitylethylenediamine
  • a stabilizer such as zinc and / or calcium stearate.
  • the plastic material with high oxygen permeability ie an oxygen permeability above about 700 ml / m 2 / day
  • the plastic material with high oxygen permeability can also be a polyurethane, polyester, polyolefin, for example polyethylene, thermoplastic polychlorinated polyethylene, Ethylene-vinyl acetate copolymer or polycarbonate and their copolymers and mixtures (polyblends) are used.
  • the walls of the plastic container according to the invention can have a material thickness or film thickness of 0.2 to 0.5 mm.
  • Another advantage of the plastic container according to the invention is that a certain quality effect can also be achieved by different material thicknesses of the bag front or 7 back.
  • the layer side of the bag which is intended for favorable gas permeability, can be set in such a way that the combination of plastic material and layer thickness leads to optimal gas permeability. Similar conditions apply to the extraction of the constituent (plasticizer) which improves the storage ability of erythrocytes from the second plastic material.
  • the behavior of the gas permeability of the bag can also be changed, for example, by adding a bag label to the front or back of the bag.
  • the plastic container according to the invention can be used as a plastic bag in a blood bag system, and it can be used both as a bag for storing whole blood and erythrocyte concentrates and as a satellite bag for storing platelet concentrates.
  • a conventional bag made of soft polyvinyl chloride and plasticized with dioctyl phthalate can also be used as a dispenser bag in such a bag system.
  • a plastic bag according to Fig. 1 was produced, which was suitable for storing erythrocyte concentrates as well as for storing platelet concentrates.
  • One side of the bag was made of a soft polyvinyl chloride film containing 37% di-2-ethylhexyl phthalate (DOP); the other side of the bag consisted of a soft polyvinyl chloride film with a content of 37% tri-2-ethylhexyltrimellitat (TOM).
  • the other plastic parts of the bag consisted of soft polyvinyl chloride with a content of 37% DOP.
  • the film thickness on both sides of the bag was 0.3 mm.
  • the bag had a nominal volume according to DIN 58 361, part 5 of 300 ml.
  • This bag (C) was compared in its properties to a known bag (A), both sides of which were made of soft polyvinyl chloride with a content of 37% DOP, and a known bag (B), whose both sides were made of soft polyvinyl chloride with a content passed 37% TOM.
  • the remaining plastic parts as well as the film thickness and the nominal volume corresponded to those of bag (C).
  • the comparison bag (A) is only of limited suitability for storing platelets due to its too low 0 2 permeability. It is also known that platelets or platelet concentrates in particular accumulate up to 10 times more plasticizers than blood or plasma. For this reason, it is not desirable to use a bag (A) for the required application.
  • the bag (B) has the disadvantage that it is not suitable for storing erythrocyte concentrates at the same time. As can be seen from the hemolysis rate of the erythrocytes, the extractable plasticizer content and the type of plasticizer, in the case described TOM, are not sufficient to depress the hemolysis rate to a clinically acceptable value.
  • the bag (C) according to the invention is suitable both for the storage of erythrocyte and platelet concentrates, the plasticizer extraction detected by blood or aqueous-alcoholic solutions being minimal at the same time.
  • the plasticizer extraction value determined for aqueous-alcoholic solutions is approximately half the value found for the bag (A).
  • the percentage increase in the rate of hemolysis after 31 days of storage shows that hemolysis is significantly below the value for bag (B) and is still within the clinically acceptable range, if one takes into account that with a starting value of approx. 15 - 18 mg% free hemoglobin after 31 days of storage this value is still below the generally clinically accepted value of 100 mg%. However, this value is significantly exceeded for bag (B).
  • a plastic bag according to FIG. 1 was produced, one side of the bag made of soft polyvinyl chloride with a content of 37% DOP and the other side of the bag made of a polyurethane with comparable flexibility.
  • the film thickness was 0.3 mm.
  • the remaining plastic parts and the nominal volume corresponded to those of the bag from Example 1. Properties comparable to those for the bag (C) from Example 1 were obtained.
  • a plastic bag was produced as shown in Fig. 1, 'one side of the bag made of soft polyvinyl chloride with a content of 37% DOP and the other side of the bag made of a soft polyvinyl chloride with a content of 37% tetra-2-diethylhexylpyromellitat.
  • the film thickness was 0.3 mm.
  • the remaining plastic parts and the nominal volume corresponded to those of the bag from Example 1. Properties comparable to those for the bag (C) from Example 1 were obtained.

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP84105742A 1983-05-25 1984-05-19 Récipient en matière synthétique pour du sang, produits sanguins et produits pharmaceutiques et leur application dans un système à sac Withdrawn EP0134896A3 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3318875 1983-05-25
DE19833318875 DE3318875A1 (de) 1983-05-25 1983-05-25 Kunststoffbehaelter fuer blut, blutbestandteile und fluessige arzneimittelzubereitungen und dessen verwendung in einem beutelsystem

Publications (2)

Publication Number Publication Date
EP0134896A2 true EP0134896A2 (fr) 1985-03-27
EP0134896A3 EP0134896A3 (fr) 1986-07-02

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EP84105742A Withdrawn EP0134896A3 (fr) 1983-05-25 1984-05-19 Récipient en matière synthétique pour du sang, produits sanguins et produits pharmaceutiques et leur application dans un système à sac

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EP (1) EP0134896A3 (fr)
DE (1) DE3318875A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6470057A (en) * 1987-08-19 1989-03-15 Hoechst Ag Plastic film having polar molecular radical
DE3915252A1 (de) * 1989-05-10 1990-11-15 Fresenius Ag Transparenter, flexibler beutel aus thermoplastischem kunststoff fuer die lagerung von thrombozytenkonzentraten
US20140016883A1 (en) * 2012-07-12 2014-01-16 Terumo Bct, Inc. Hybrid blood component storage bag and method of making such bag

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6133661A (ja) * 1984-02-02 1986-02-17 テルモ株式会社 医療用器具
DE3624319A1 (de) * 1986-07-18 1988-01-28 Wolff Walsrode Ag Verfahren zur herstellung von polyurethanfolien fuer blut- oder infusionsbeutel

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2439589A1 (fr) * 1978-10-26 1980-05-23 Baxter Travenol Lab Systeme de sacs pour le sang multiples ayant des portions sans plastifiant et permettant un taux de survie important des composants du sang
EP0026912A2 (fr) * 1979-10-09 1981-04-15 Cutter Laboratories, Inc. Récipient pour concentré de plaquettes de sang
US4301800A (en) * 1978-10-26 1981-11-24 Baxter Travenol Laboratories, Inc. Blood bags having an insert member
EP0051414A1 (fr) * 1980-10-31 1982-05-12 Baxter Travenol Laboratories, Inc. Poche pour le stockage de sang, et matériau le constituant
EP0054221A1 (fr) * 1980-12-15 1982-06-23 Miles Inc. Système de sacs multiples pour le sang, en plastique, substantiellement exempt de plastifiant susceptible à l'extraction par le sang
EP0114372A2 (fr) * 1982-12-27 1984-08-01 Miles Inc. Récipient pour le sang et les composants du sang

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2439589A1 (fr) * 1978-10-26 1980-05-23 Baxter Travenol Lab Systeme de sacs pour le sang multiples ayant des portions sans plastifiant et permettant un taux de survie important des composants du sang
US4301800A (en) * 1978-10-26 1981-11-24 Baxter Travenol Laboratories, Inc. Blood bags having an insert member
EP0026912A2 (fr) * 1979-10-09 1981-04-15 Cutter Laboratories, Inc. Récipient pour concentré de plaquettes de sang
EP0051414A1 (fr) * 1980-10-31 1982-05-12 Baxter Travenol Laboratories, Inc. Poche pour le stockage de sang, et matériau le constituant
EP0054221A1 (fr) * 1980-12-15 1982-06-23 Miles Inc. Système de sacs multiples pour le sang, en plastique, substantiellement exempt de plastifiant susceptible à l'extraction par le sang
EP0114372A2 (fr) * 1982-12-27 1984-08-01 Miles Inc. Récipient pour le sang et les composants du sang

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6470057A (en) * 1987-08-19 1989-03-15 Hoechst Ag Plastic film having polar molecular radical
JPH0523785B2 (fr) * 1987-08-19 1993-04-05 Hoechst Ag
DE3915252A1 (de) * 1989-05-10 1990-11-15 Fresenius Ag Transparenter, flexibler beutel aus thermoplastischem kunststoff fuer die lagerung von thrombozytenkonzentraten
US20140016883A1 (en) * 2012-07-12 2014-01-16 Terumo Bct, Inc. Hybrid blood component storage bag and method of making such bag
CN104507441A (zh) * 2012-07-12 2015-04-08 泰尔茂比司特公司 混合型血液成分储存袋以及制造该袋的方法
JP2015521946A (ja) * 2012-07-12 2015-08-03 テルモ ビーシーティー、インコーポレーテッド ハイブリッド血液成分保存バッグ及びその作製方法
US9440011B2 (en) 2012-07-12 2016-09-13 Terumo Bct, Inc. Hybrid blood component storage bag and method of making such bag
CN104507441B (zh) * 2012-07-12 2018-01-12 泰尔茂比司特公司 混合型血液成分储存袋以及制造该袋的方法

Also Published As

Publication number Publication date
DE3318875A1 (de) 1984-11-29
EP0134896A3 (fr) 1986-07-02

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Inventor name: WALKER, WOLFRAM H., DR. DIPL.-CHEM.

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Inventor name: NETZ, MANFRED