Sterility, sterilisation and sterility assurance for pharmaceuticals: technology, validation and current regulations
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Oxford, UK
Woodhead Publishing Ltd.
2013
|
| Schriftenreihe: | Woodhead Publishing series in biomedicine
32 |
| Schlagworte: | |
| Online-Zugang: | FAW01 Volltext Volltext |
| Beschreibung: | Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivationIncludes discussion of medical devices, aseptically filled products and terminally sterilised productsDescribes bacterial, pyrogenic, and endotoxin risks to devices and products |
| Beschreibung: | 1 Online-Ressource (200 pages) Diagramme |
| ISBN: | 1907568387 9781907568381 9781306177085 1306177081 |
Internformat
MARC
| LEADER | 00000nmm a2200000zcb4500 | ||
|---|---|---|---|
| 001 | BV043216097 | ||
| 003 | DE-604 | ||
| 005 | 20220901 | ||
| 007 | cr|uuu---uuuuu | ||
| 008 | 151216s2013 |||| o||u| ||||||eng d | ||
| 020 | |a 1907568387 |9 1-907568-38-7 | ||
| 020 | |a 9781907568381 |c online |9 978-1-907568-38-1 | ||
| 020 | |a 9781306177085 |9 978-1-306-17708-5 | ||
| 020 | |a 1306177081 |9 1-306-17708-1 | ||
| 035 | |a (OCoLC)870639846 | ||
| 035 | |a (DE-599)BVBBV043216097 | ||
| 040 | |a DE-604 |b ger |e aacr | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-1046 | ||
| 082 | 0 | |a 615.19 |2 23 | |
| 084 | |a VX 8600 |0 (DE-625)147833:253 |2 rvk | ||
| 084 | |a XD 2100 |0 (DE-625)152542:12905 |2 rvk | ||
| 100 | 1 | |a Sandle, T. |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Sterility, sterilisation and sterility assurance for pharmaceuticals |b technology, validation and current regulations |c by T. Sandle |
| 264 | 1 | |a Oxford, UK |b Woodhead Publishing Ltd. |c 2013 | |
| 300 | |a 1 Online-Ressource (200 pages) |b Diagramme | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b c |2 rdamedia | ||
| 338 | |b cr |2 rdacarrier | ||
| 490 | 0 | |a Woodhead Publishing series in biomedicine |v 32 | |
| 500 | |a Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivationIncludes discussion of medical devices, aseptically filled products and terminally sterilised productsDescribes bacterial, pyrogenic, and endotoxin risks to devices and products | ||
| 650 | 7 | |a Sterilization |2 fast | |
| 650 | 4 | |a Sterilization | |
| 650 | 0 | 7 | |a Sterilisation |0 (DE-588)4057333-3 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Arzneimittel |0 (DE-588)4003115-9 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Sterilität |g Hygiene |0 (DE-588)4295343-1 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Medizinprodukt |0 (DE-588)4024018-6 |2 gnd |9 rswk-swf |
| 689 | 0 | 0 | |a Medizinprodukt |0 (DE-588)4024018-6 |D s |
| 689 | 0 | 1 | |a Arzneimittel |0 (DE-588)4003115-9 |D s |
| 689 | 0 | 2 | |a Sterilität |g Hygiene |0 (DE-588)4295343-1 |D s |
| 689 | 0 | |5 DE-604 | |
| 689 | 1 | 0 | |a Medizinprodukt |0 (DE-588)4024018-6 |D s |
| 689 | 1 | 1 | |a Arzneimittel |0 (DE-588)4003115-9 |D s |
| 689 | 1 | 2 | |a Sterilisation |0 (DE-588)4057333-3 |D s |
| 689 | 1 | |5 DE-604 | |
| 856 | 4 | 0 | |u http://www.sciencedirect.com/science/book/9781907568381 |x Verlag |3 Volltext |
| 856 | 4 | 0 | |u https://www.sciencedirect.com/science/book/9781907568381 |x Verlag |3 Volltext |
| 912 | |a ZDB-33-ESD |a ZDB-33-EBS | ||
| 940 | 1 | |q FLA_PDA_ESD | |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-028639121 | ||
| 966 | e | |u https://www.sciencedirect.com/science/book/9781907568381 |l FAW01 |p ZDB-33-ESD |q FAW_PDA_ESD_Kauf |x Verlag |3 Volltext | |
Datensatz im Suchindex
| _version_ | 1804175720673443840 |
|---|---|
| any_adam_object | |
| author | Sandle, T. |
| author_facet | Sandle, T. |
| author_role | aut |
| author_sort | Sandle, T. |
| author_variant | t s ts |
| building | Verbundindex |
| bvnumber | BV043216097 |
| classification_rvk | VX 8600 XD 2100 |
| collection | ZDB-33-ESD ZDB-33-EBS |
| ctrlnum | (OCoLC)870639846 (DE-599)BVBBV043216097 |
| dewey-full | 615.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.19 |
| dewey-search | 615.19 |
| dewey-sort | 3615.19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| format | Electronic eBook |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>03880nmm a2200577zcb4500</leader><controlfield tag="001">BV043216097</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20220901 </controlfield><controlfield tag="007">cr|uuu---uuuuu</controlfield><controlfield tag="008">151216s2013 |||| o||u| ||||||eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">1907568387</subfield><subfield code="9">1-907568-38-7</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9781907568381</subfield><subfield code="c">online</subfield><subfield code="9">978-1-907568-38-1</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9781306177085</subfield><subfield code="9">978-1-306-17708-5</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">1306177081</subfield><subfield code="9">1-306-17708-1</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)870639846</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV043216097</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">aacr</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-1046</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">615.19</subfield><subfield code="2">23</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">VX 8600</subfield><subfield code="0">(DE-625)147833:253</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">XD 2100</subfield><subfield code="0">(DE-625)152542:12905</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Sandle, T.</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Sterility, sterilisation and sterility assurance for pharmaceuticals</subfield><subfield code="b">technology, validation and current regulations</subfield><subfield code="c">by T. Sandle</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Oxford, UK</subfield><subfield code="b">Woodhead Publishing Ltd.</subfield><subfield code="c">2013</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">1 Online-Ressource (200 pages)</subfield><subfield code="b">Diagramme</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="490" ind1="0" ind2=" "><subfield code="a">Woodhead Publishing series in biomedicine</subfield><subfield code="v">32</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivationIncludes discussion of medical devices, aseptically filled products and terminally sterilised productsDescribes bacterial, pyrogenic, and endotoxin risks to devices and products</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Sterilization</subfield><subfield code="2">fast</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Sterilization</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Sterilisation</subfield><subfield code="0">(DE-588)4057333-3</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Arzneimittel</subfield><subfield code="0">(DE-588)4003115-9</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Sterilität</subfield><subfield code="g">Hygiene</subfield><subfield code="0">(DE-588)4295343-1</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Medizinprodukt</subfield><subfield code="0">(DE-588)4024018-6</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="689" ind1="0" ind2="0"><subfield code="a">Medizinprodukt</subfield><subfield code="0">(DE-588)4024018-6</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="1"><subfield code="a">Arzneimittel</subfield><subfield code="0">(DE-588)4003115-9</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="2"><subfield code="a">Sterilität</subfield><subfield code="g">Hygiene</subfield><subfield code="0">(DE-588)4295343-1</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="689" ind1="1" ind2="0"><subfield code="a">Medizinprodukt</subfield><subfield code="0">(DE-588)4024018-6</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="1"><subfield code="a">Arzneimittel</subfield><subfield code="0">(DE-588)4003115-9</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="2"><subfield code="a">Sterilisation</subfield><subfield code="0">(DE-588)4057333-3</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">http://www.sciencedirect.com/science/book/9781907568381</subfield><subfield code="x">Verlag</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://www.sciencedirect.com/science/book/9781907568381</subfield><subfield code="x">Verlag</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-33-ESD</subfield><subfield code="a">ZDB-33-EBS</subfield></datafield><datafield tag="940" ind1="1" ind2=" "><subfield code="q">FLA_PDA_ESD</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-028639121</subfield></datafield><datafield tag="966" ind1="e" ind2=" "><subfield code="u">https://www.sciencedirect.com/science/book/9781907568381</subfield><subfield code="l">FAW01</subfield><subfield code="p">ZDB-33-ESD</subfield><subfield code="q">FAW_PDA_ESD_Kauf</subfield><subfield code="x">Verlag</subfield><subfield code="3">Volltext</subfield></datafield></record></collection> |
| id | DE-604.BV043216097 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:20:47Z |
| institution | BVB |
| isbn | 1907568387 9781907568381 9781306177085 1306177081 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-028639121 |
| oclc_num | 870639846 |
| open_access_boolean | |
| owner | DE-1046 |
| owner_facet | DE-1046 |
| physical | 1 Online-Ressource (200 pages) Diagramme |
| psigel | ZDB-33-ESD ZDB-33-EBS FLA_PDA_ESD ZDB-33-ESD FAW_PDA_ESD_Kauf |
| publishDate | 2013 |
| publishDateSearch | 2013 |
| publishDateSort | 2013 |
| publisher | Woodhead Publishing Ltd. |
| record_format | marc |
| series2 | Woodhead Publishing series in biomedicine |
| spelling | Sandle, T. Verfasser aut Sterility, sterilisation and sterility assurance for pharmaceuticals technology, validation and current regulations by T. Sandle Oxford, UK Woodhead Publishing Ltd. 2013 1 Online-Ressource (200 pages) Diagramme txt rdacontent c rdamedia cr rdacarrier Woodhead Publishing series in biomedicine 32 Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivationIncludes discussion of medical devices, aseptically filled products and terminally sterilised productsDescribes bacterial, pyrogenic, and endotoxin risks to devices and products Sterilization fast Sterilization Sterilisation (DE-588)4057333-3 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf Sterilität Hygiene (DE-588)4295343-1 gnd rswk-swf Medizinprodukt (DE-588)4024018-6 gnd rswk-swf Medizinprodukt (DE-588)4024018-6 s Arzneimittel (DE-588)4003115-9 s Sterilität Hygiene (DE-588)4295343-1 s DE-604 Sterilisation (DE-588)4057333-3 s http://www.sciencedirect.com/science/book/9781907568381 Verlag Volltext https://www.sciencedirect.com/science/book/9781907568381 Verlag Volltext |
| spellingShingle | Sandle, T. Sterility, sterilisation and sterility assurance for pharmaceuticals technology, validation and current regulations Sterilization fast Sterilization Sterilisation (DE-588)4057333-3 gnd Arzneimittel (DE-588)4003115-9 gnd Sterilität Hygiene (DE-588)4295343-1 gnd Medizinprodukt (DE-588)4024018-6 gnd |
| subject_GND | (DE-588)4057333-3 (DE-588)4003115-9 (DE-588)4295343-1 (DE-588)4024018-6 |
| title | Sterility, sterilisation and sterility assurance for pharmaceuticals technology, validation and current regulations |
| title_auth | Sterility, sterilisation and sterility assurance for pharmaceuticals technology, validation and current regulations |
| title_exact_search | Sterility, sterilisation and sterility assurance for pharmaceuticals technology, validation and current regulations |
| title_full | Sterility, sterilisation and sterility assurance for pharmaceuticals technology, validation and current regulations by T. Sandle |
| title_fullStr | Sterility, sterilisation and sterility assurance for pharmaceuticals technology, validation and current regulations by T. Sandle |
| title_full_unstemmed | Sterility, sterilisation and sterility assurance for pharmaceuticals technology, validation and current regulations by T. Sandle |
| title_short | Sterility, sterilisation and sterility assurance for pharmaceuticals |
| title_sort | sterility sterilisation and sterility assurance for pharmaceuticals technology validation and current regulations |
| title_sub | technology, validation and current regulations |
| topic | Sterilization fast Sterilization Sterilisation (DE-588)4057333-3 gnd Arzneimittel (DE-588)4003115-9 gnd Sterilität Hygiene (DE-588)4295343-1 gnd Medizinprodukt (DE-588)4024018-6 gnd |
| topic_facet | Sterilization Sterilisation Arzneimittel Sterilität Hygiene Medizinprodukt |
| url | http://www.sciencedirect.com/science/book/9781907568381 https://www.sciencedirect.com/science/book/9781907568381 |
| work_keys_str_mv | AT sandlet sterilitysterilisationandsterilityassuranceforpharmaceuticalstechnologyvalidationandcurrentregulations |