Peracetic acid-ethanol treatment of allogeneic avital bone tissue transplants--a reliable sterilization method
Based on the European Standard EN 1040, the validation guidelines of the German Federal Institute for Drugs and Medical Devices and CPMP guidelines we tested the antimicrobial effectiveness of a peracetic acid-ethanol sterilization procedure (PES) in allogenic avital bone transplants. Delipidated hu...
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| Veröffentlicht in: | Annals of transplantation 2003, Vol.8 (2), p.34-42 |
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| container_title | Annals of transplantation |
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| creator | Pruss, Axel Göbel, Ulf B Pauli, Georg Kao, Moujahed Seibold, Michael Mönig, Hans-Joachim Hansen, Arne von Versen, Rüdiger |
| description | Based on the European Standard EN 1040, the validation guidelines of the German Federal Institute for Drugs and Medical Devices and CPMP guidelines we tested the antimicrobial effectiveness of a peracetic acid-ethanol sterilization procedure (PES) in allogenic avital bone transplants.
Delipidated human bone spongiosa cubes (15 x 15 x 15 mm) served as tissue. Three enveloped viruses (human immunodeficiency virus type 2, pseudorabies virus, bovine virus diarrhoea virus) and three non-enveloped viruses (hepatitis A virus, poliovirus, porcine parvovirus) were used. The reduction of virus infectivity was measured as TCID50/ml in neutralized supernatants and bone homogenates. Staphylococcus aureus. Enterococcus faecium, Pseudomonas aeruginosa. Bacillus subtilis. Clostridium sporogenes, Mycobacterium terrae. Candida albicans, Aspergillus niger as well as spores of Bacillus subtilis were tested additionally. PES led to a reduction of virus titres by more than 4 log10. Only HAV showed a reduction below 4 log10 (2.87) with residual infectivity. After including a delipidating step for HAV-infected cells, a reduction of over 7 log10 HAV titre was found. For viable bacteria, fungi and spores a titre reduction below the detection level (5 log10) was achieved after an incubation time of 2 hours.
The peracetic acid-ethanol procedure proved to be a reliable method for the sterilization of human bone transplants (layer thickness < or = 15 mm). However, additional safety measures (anamnestic informations, infectious serology, HIV-/HBV-/HCV-PCR in case of multiorgan donors) should be taken. |
| format | Article |
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Delipidated human bone spongiosa cubes (15 x 15 x 15 mm) served as tissue. Three enveloped viruses (human immunodeficiency virus type 2, pseudorabies virus, bovine virus diarrhoea virus) and three non-enveloped viruses (hepatitis A virus, poliovirus, porcine parvovirus) were used. The reduction of virus infectivity was measured as TCID50/ml in neutralized supernatants and bone homogenates. Staphylococcus aureus. Enterococcus faecium, Pseudomonas aeruginosa. Bacillus subtilis. Clostridium sporogenes, Mycobacterium terrae. Candida albicans, Aspergillus niger as well as spores of Bacillus subtilis were tested additionally. PES led to a reduction of virus titres by more than 4 log10. Only HAV showed a reduction below 4 log10 (2.87) with residual infectivity. After including a delipidating step for HAV-infected cells, a reduction of over 7 log10 HAV titre was found. For viable bacteria, fungi and spores a titre reduction below the detection level (5 log10) was achieved after an incubation time of 2 hours.
The peracetic acid-ethanol procedure proved to be a reliable method for the sterilization of human bone transplants (layer thickness < or = 15 mm). However, additional safety measures (anamnestic informations, infectious serology, HIV-/HBV-/HCV-PCR in case of multiorgan donors) should be taken.</description><identifier>ISSN: 1425-9524</identifier><identifier>PMID: 14626574</identifier><language>eng</language><publisher>United States</publisher><subject>Bacteria - isolation & purification ; Bacterial Physiological Phenomena ; Bone and Bones - microbiology ; Bone and Bones - virology ; Bone Transplantation - standards ; Disinfectants ; Ethanol ; Humans ; Peracetic Acid ; Spores, Bacterial ; Sterilization - methods ; Tissue Donors ; Transplantation, Homologous - standards ; Viruses - isolation & purification</subject><ispartof>Annals of transplantation, 2003, Vol.8 (2), p.34-42</ispartof><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,4024</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14626574$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pruss, Axel</creatorcontrib><creatorcontrib>Göbel, Ulf B</creatorcontrib><creatorcontrib>Pauli, Georg</creatorcontrib><creatorcontrib>Kao, Moujahed</creatorcontrib><creatorcontrib>Seibold, Michael</creatorcontrib><creatorcontrib>Mönig, Hans-Joachim</creatorcontrib><creatorcontrib>Hansen, Arne</creatorcontrib><creatorcontrib>von Versen, Rüdiger</creatorcontrib><title>Peracetic acid-ethanol treatment of allogeneic avital bone tissue transplants--a reliable sterilization method</title><title>Annals of transplantation</title><addtitle>Ann Transplant</addtitle><description>Based on the European Standard EN 1040, the validation guidelines of the German Federal Institute for Drugs and Medical Devices and CPMP guidelines we tested the antimicrobial effectiveness of a peracetic acid-ethanol sterilization procedure (PES) in allogenic avital bone transplants.
Delipidated human bone spongiosa cubes (15 x 15 x 15 mm) served as tissue. Three enveloped viruses (human immunodeficiency virus type 2, pseudorabies virus, bovine virus diarrhoea virus) and three non-enveloped viruses (hepatitis A virus, poliovirus, porcine parvovirus) were used. The reduction of virus infectivity was measured as TCID50/ml in neutralized supernatants and bone homogenates. Staphylococcus aureus. Enterococcus faecium, Pseudomonas aeruginosa. Bacillus subtilis. Clostridium sporogenes, Mycobacterium terrae. Candida albicans, Aspergillus niger as well as spores of Bacillus subtilis were tested additionally. PES led to a reduction of virus titres by more than 4 log10. Only HAV showed a reduction below 4 log10 (2.87) with residual infectivity. After including a delipidating step for HAV-infected cells, a reduction of over 7 log10 HAV titre was found. For viable bacteria, fungi and spores a titre reduction below the detection level (5 log10) was achieved after an incubation time of 2 hours.
The peracetic acid-ethanol procedure proved to be a reliable method for the sterilization of human bone transplants (layer thickness < or = 15 mm). However, additional safety measures (anamnestic informations, infectious serology, HIV-/HBV-/HCV-PCR in case of multiorgan donors) should be taken.</description><subject>Bacteria - isolation & purification</subject><subject>Bacterial Physiological Phenomena</subject><subject>Bone and Bones - microbiology</subject><subject>Bone and Bones - virology</subject><subject>Bone Transplantation - standards</subject><subject>Disinfectants</subject><subject>Ethanol</subject><subject>Humans</subject><subject>Peracetic Acid</subject><subject>Spores, Bacterial</subject><subject>Sterilization - methods</subject><subject>Tissue Donors</subject><subject>Transplantation, Homologous - standards</subject><subject>Viruses - isolation & purification</subject><issn>1425-9524</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kM1KxDAYRbtQnHH0FSQrd4UmzU-7lME_GNCFrsuX9ItG0qQmqaBPb0Vdnc3hcLlH1ZZyJupeML6pTnN-axophGhPqg3lkkmh-LYKj5jAYHGGgHFjjeUVQvSkJIQyYSgkWgLexxcM-CN9uAKe6BiQFJfzsiJByLOHUHJdA0noHWiPJBdMzrsvKC4GMq3lOJ5VxxZ8xvM_7qrnm-un_V19eLi9318d6pkyXmrGQVvNuhGl7rSllvIG-l4xGHvoWdcY1bEeUI3GtCgMmEYyVLSjzFrJdLurLn-7c4rvC-YyTC4b9OtKjEseFG17SYVaxYs_cdETjsOc3ATpc_h_qP0GrRhkTw</recordid><startdate>2003</startdate><enddate>2003</enddate><creator>Pruss, Axel</creator><creator>Göbel, Ulf B</creator><creator>Pauli, Georg</creator><creator>Kao, Moujahed</creator><creator>Seibold, Michael</creator><creator>Mönig, Hans-Joachim</creator><creator>Hansen, Arne</creator><creator>von Versen, Rüdiger</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>2003</creationdate><title>Peracetic acid-ethanol treatment of allogeneic avital bone tissue transplants--a reliable sterilization method</title><author>Pruss, Axel ; Göbel, Ulf B ; Pauli, Georg ; Kao, Moujahed ; Seibold, Michael ; Mönig, Hans-Joachim ; Hansen, Arne ; von Versen, Rüdiger</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p124t-24abfb28de6b8bf1f140a9972ad9a9280c7829ae7dcc3e5cac062e71812ff62b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Bacteria - isolation & purification</topic><topic>Bacterial Physiological Phenomena</topic><topic>Bone and Bones - microbiology</topic><topic>Bone and Bones - virology</topic><topic>Bone Transplantation - standards</topic><topic>Disinfectants</topic><topic>Ethanol</topic><topic>Humans</topic><topic>Peracetic Acid</topic><topic>Spores, Bacterial</topic><topic>Sterilization - methods</topic><topic>Tissue Donors</topic><topic>Transplantation, Homologous - standards</topic><topic>Viruses - isolation & purification</topic><toplevel>online_resources</toplevel><creatorcontrib>Pruss, Axel</creatorcontrib><creatorcontrib>Göbel, Ulf B</creatorcontrib><creatorcontrib>Pauli, Georg</creatorcontrib><creatorcontrib>Kao, Moujahed</creatorcontrib><creatorcontrib>Seibold, Michael</creatorcontrib><creatorcontrib>Mönig, Hans-Joachim</creatorcontrib><creatorcontrib>Hansen, Arne</creatorcontrib><creatorcontrib>von Versen, Rüdiger</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pruss, Axel</au><au>Göbel, Ulf B</au><au>Pauli, Georg</au><au>Kao, Moujahed</au><au>Seibold, Michael</au><au>Mönig, Hans-Joachim</au><au>Hansen, Arne</au><au>von Versen, Rüdiger</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Peracetic acid-ethanol treatment of allogeneic avital bone tissue transplants--a reliable sterilization method</atitle><jtitle>Annals of transplantation</jtitle><addtitle>Ann Transplant</addtitle><date>2003</date><risdate>2003</risdate><volume>8</volume><issue>2</issue><spage>34</spage><epage>42</epage><pages>34-42</pages><issn>1425-9524</issn><abstract>Based on the European Standard EN 1040, the validation guidelines of the German Federal Institute for Drugs and Medical Devices and CPMP guidelines we tested the antimicrobial effectiveness of a peracetic acid-ethanol sterilization procedure (PES) in allogenic avital bone transplants.
Delipidated human bone spongiosa cubes (15 x 15 x 15 mm) served as tissue. Three enveloped viruses (human immunodeficiency virus type 2, pseudorabies virus, bovine virus diarrhoea virus) and three non-enveloped viruses (hepatitis A virus, poliovirus, porcine parvovirus) were used. The reduction of virus infectivity was measured as TCID50/ml in neutralized supernatants and bone homogenates. Staphylococcus aureus. Enterococcus faecium, Pseudomonas aeruginosa. Bacillus subtilis. Clostridium sporogenes, Mycobacterium terrae. Candida albicans, Aspergillus niger as well as spores of Bacillus subtilis were tested additionally. PES led to a reduction of virus titres by more than 4 log10. Only HAV showed a reduction below 4 log10 (2.87) with residual infectivity. After including a delipidating step for HAV-infected cells, a reduction of over 7 log10 HAV titre was found. For viable bacteria, fungi and spores a titre reduction below the detection level (5 log10) was achieved after an incubation time of 2 hours.
The peracetic acid-ethanol procedure proved to be a reliable method for the sterilization of human bone transplants (layer thickness < or = 15 mm). However, additional safety measures (anamnestic informations, infectious serology, HIV-/HBV-/HCV-PCR in case of multiorgan donors) should be taken.</abstract><cop>United States</cop><pmid>14626574</pmid><tpages>9</tpages></addata></record> |
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| ispartof | Annals of transplantation, 2003, Vol.8 (2), p.34-42 |
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| subjects | Bacteria - isolation & purification Bacterial Physiological Phenomena Bone and Bones - microbiology Bone and Bones - virology Bone Transplantation - standards Disinfectants Ethanol Humans Peracetic Acid Spores, Bacterial Sterilization - methods Tissue Donors Transplantation, Homologous - standards Viruses - isolation & purification |
| title | Peracetic acid-ethanol treatment of allogeneic avital bone tissue transplants--a reliable sterilization method |
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