Single-use technology: a practical guide to design and implementation
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Berlin
De Gruyter
[2019]
|
| Ausgabe: | 2nd edition |
| Schriftenreihe: | De Gruyter STEM
|
| Schlagworte: | |
| Online-Zugang: | http://www.degruyter.com/search?f_0=isbnissn&q_0=9783110640557&searchTitles=true Inhaltsverzeichnis |
| Beschreibung: | VIII, 146 Seiten Illustrationen, Diagramme |
| ISBN: | 9783110640557 |
Internformat
MARC
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| 100 | 1 | |a Lopes, Adriana |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Single-use technology |b a practical guide to design and implementation |c Adriana G. Lopes, Andrew Brown |
| 250 | |a 2nd edition | ||
| 264 | 1 | |a Berlin |b De Gruyter |c [2019] | |
| 300 | |a VIII, 146 Seiten |b Illustrationen, Diagramme | ||
| 336 | |b txt |2 rdacontent | ||
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Datensatz im Suchindex
| _version_ | 1804180123107196928 |
|---|---|
| adam_text | CONTENTS
PREFACE
*
V
1
1.1
1.1.1
1.1.2
1.1.3
1.1.4
1.1.5
1.1.6
1.1.7
1.1.8
INTRODUCTION
*
1
BENEFITS
AND
LIMITATIONS
OF
SINGLE-USE
TECHNOLOGY
*
4
IMPROVED
PROCESS
FLEXIBILITY
*
4
INCREASED
SPEED
OF
IMPLEMENTATION
*
4
COST
SAVINGS
*
5
INCREASED
PRODUCT
SAFETY
*
5
TECHNICAL
LIMITATIONS
*
6
COST
INCREASES
*
6
INCREASED
COMPLEXITY
*
6
DEPENDENCE
ON
SUPPLIERS
*
7
REFERENCES
*
7
2
STRATEGIES
FOR
IMPLEMENTATION
OF
SINGLE-USE
TECHNOLOGY:
A
RISK-
AND
SCIENCE-BASED
APPROACH
*
9
2.1
2.2
2.3
A
RISK-
AND
SCIENCE-BASED
APPROACH
*
11
IMPLEMENTATION
PLAN
*
14
RISK-ASSESSMENT
TOOLS
TO
SUPPORT
IMPLEMENTATION
*
17
REFERENCES
*
18
3
3.1
3.2
3.3
FEASIBILITY
ASSESSMENT
OF
SINGLE-USE
TECHNOLOGY
AND
SUPPLIERS
*
19
TECHNICAL
FEASIBILITY
*
19
BUSINESS
ASSESSMENT
*
25
SELECTION
OF
A
SUPPLIER
OF
SINGLE-USE
TECHNOLOGY
*
33
REFERENCES
*
38
4
4.1
4.2
4.3
4.4
SPECIFICATIONS
AND
DESIGN
OF
SINGLE-USE
TECHNOLOGY
*
39
FRAMEWORK
FOR
THE
DESIGN
PROJECT
*
40
DESIGN
CHOICES
AND
RISK
*
43
SPECIFICATION
*
47
DESIGN
VERIFICATION
*
49
REFERENCES
*
50
5
5.1
5.1.1
5.1.2
5.1.3
5.2
VALIDATION
*
53
QUALIFICATION
OF
MATERIALS
AND
ASSEMBLIES
*
54
INTEGRITY
-----
57
COMPATIBLY
-----
57
STERILITY
AND
CLEANLINESS
*
57
PROCESS
QUALIFICATION
*
58
VIII
*
CONTENTS
5.2.1
INSTALLATION
QUALIFICATION
AND
OPERATIONAL
QUALIFICATION
-
WATER
OR
BUFFER
RUNS
*
60
5.2.2
5.2.3
5.3
PROCESS
SIMULATION
-
MEDIA
FILLS
*
61
PERFORMANCE
QUALIFICATION
-
API
STREAM
*
61
CONTINUOUS
IMPROVEMENT
OF
PROCESSES
*
62
REFERENCES
*
63
6
6.1
6.1.1
6.1.2
6.1.3
6.1.4
6.1.5
6.2
6.2.1
6.2.2
6.2.3
6.2.4
6.3
6.3.1
6.3.2
6.3.3
6.4
6.4.1
6.4.2
6.4.3
CASE
STUDIES
*
65
CASE
STUDY
1:
SINGLE-USE
BAG
SYSTEMS
*
66
MATERIAL
SELECTION
-----
66
RISK
ASSESSMENT
FOR
EXTRACTABLES
AND
LEACHABLES
*
68
PROFILES
OF
EXTRACTABLES
AND
LEACHABLES
*
70
SPECIFICATION
AND
DESIGN
*
73
QUALIFICATION
OF
FINAL
BAG
ASSEMBLY
*
77
CASE
STUDY
2:
SINGLE-USE
BIOREACTOR
*
83
SELECTION
OF
SINGLE-USE
BIOREACTOR
TECHNOLOGY
*
84
SPECIFICATION
AND
DESIGN
OF
SINGLE-USE
BIOREACTORS
*
88
RISK
ASSESSMENT
OF
THE
SINGLE-USE
BIOREACTOR
PROCESS
*
101
QUALIFICATION
OF
SINGLE-USE
BIOREACTORS
*
101
CASE
STUDY
3:
TANGENTIAL-FLOW
FILTRATION
*
104
SELECTION
OF
TECHNOLOGY
FOR
TANGENTIAL-FLOW
FILTRATION
*
105
SPECIFICATION
AND
DESIGN
*
107
RISK
ASSESSMENT
TO
SUPPORT
DESIGN
OF
A
SYSTEM
*
115
CASE
STUDY
4:
FORMULATION
AND
FILL-FINISH
-----
124
SELECTION
OF
FILL-FINISH
TECHNOLOGY
*
125
RISK
ASSESSMENT
OF
FILL-FINISH
*
125
QUALIFICATION
OF
FILL-FINISH
OPERATIONS
*
128
REFERENCES
*
133
ABBREVIATIONS
*
135
APPENDIX
1
SCORING
TABLES
*
137
APPENDIX
2
RISK
RATING
AND
PRIORITY
NUMBER
*
139
INDEX
*
141
|
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| discipline | Chemie / Pharmazie |
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| id | DE-604.BV045933043 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T08:30:45Z |
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| institution_GND | (DE-588)10095502-2 |
| isbn | 9783110640557 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-031315438 |
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| owner_facet | DE-29T |
| physical | VIII, 146 Seiten Illustrationen, Diagramme |
| publishDate | 2019 |
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| series2 | De Gruyter STEM |
| spelling | Lopes, Adriana Verfasser aut Single-use technology a practical guide to design and implementation Adriana G. Lopes, Andrew Brown 2nd edition Berlin De Gruyter [2019] VIII, 146 Seiten Illustrationen, Diagramme txt rdacontent n rdamedia nc rdacarrier De Gruyter STEM Biopharmazie (DE-588)4006890-0 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf Einwegprodukt (DE-588)4745574-3 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 s Biopharmazie (DE-588)4006890-0 s Einwegprodukt (DE-588)4745574-3 s DE-604 Brown, Andrew Verfasser aut Walter de Gruyter GmbH & Co. KG (DE-588)10095502-2 pbl Erscheint auch als Online-Ausgabe, PDF 9783110640588 Erscheint auch als Online-Ausgabe, EPUB 9783110640670 X:MVB http://www.degruyter.com/search?f_0=isbnissn&q_0=9783110640557&searchTitles=true DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=031315438&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Lopes, Adriana Brown, Andrew Single-use technology a practical guide to design and implementation Biopharmazie (DE-588)4006890-0 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd Einwegprodukt (DE-588)4745574-3 gnd |
| subject_GND | (DE-588)4006890-0 (DE-588)4045699-7 (DE-588)4745574-3 |
| title | Single-use technology a practical guide to design and implementation |
| title_auth | Single-use technology a practical guide to design and implementation |
| title_exact_search | Single-use technology a practical guide to design and implementation |
| title_full | Single-use technology a practical guide to design and implementation Adriana G. Lopes, Andrew Brown |
| title_fullStr | Single-use technology a practical guide to design and implementation Adriana G. Lopes, Andrew Brown |
| title_full_unstemmed | Single-use technology a practical guide to design and implementation Adriana G. Lopes, Andrew Brown |
| title_short | Single-use technology |
| title_sort | single use technology a practical guide to design and implementation |
| title_sub | a practical guide to design and implementation |
| topic | Biopharmazie (DE-588)4006890-0 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd Einwegprodukt (DE-588)4745574-3 gnd |
| topic_facet | Biopharmazie Pharmazeutische Technologie Einwegprodukt |
| url | http://www.degruyter.com/search?f_0=isbnissn&q_0=9783110640557&searchTitles=true http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=031315438&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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