Validation of pharmaceutical processes: sterile products
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York u.a.
Dekker
1999
|
| Ausgabe: | 2. ed., rev. and exp. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | 1. Aufl u.d.T.: Validation of aseptic pharmaceutical processes |
| Beschreibung: | XII, 840 S. Ill., graph. Darst. |
| ISBN: | 0824793846 |
Internformat
MARC
| LEADER | 00000nam a2200000 c 4500 | ||
|---|---|---|---|
| 001 | BV013943513 | ||
| 003 | DE-604 | ||
| 005 | 20011004 | ||
| 007 | t | ||
| 008 | 011004s1999 ad|| |||| 00||| eng d | ||
| 020 | |a 0824793846 |9 0-8247-9384-6 | ||
| 035 | |a (OCoLC)39982679 | ||
| 035 | |a (DE-599)BVBBV013943513 | ||
| 040 | |a DE-604 |b ger |e rakwb | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-19 | ||
| 050 | 0 | |a RS199.S73 | |
| 082 | 0 | |a 615/.19 |2 21 | |
| 245 | 1 | 0 | |a Validation of pharmaceutical processes |b sterile products |c ed. by Frederick J. Carleton .. |
| 250 | |a 2. ed., rev. and exp. | ||
| 264 | 1 | |a New York u.a. |b Dekker |c 1999 | |
| 300 | |a XII, 840 S. |b Ill., graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 500 | |a 1. Aufl u.d.T.: Validation of aseptic pharmaceutical processes | ||
| 650 | 4 | |a Stérilisation | |
| 650 | 2 | |a Stérilisation - Méthode | |
| 650 | 7 | |a Stérilisation |2 ram | |
| 650 | 4 | |a Techniques pharmaceutiques - Normes | |
| 650 | 4 | |a Techniques pharmaceutiques - Qualité - Contrôle | |
| 650 | 7 | |a Technologie pharmaceutique - Normes |2 ram | |
| 650 | 7 | |a Technologie pharmaceutique - qualité contrôle |2 ram | |
| 650 | 2 | |a Technologie pharmaceutique | |
| 650 | 4 | |a Pharmaceutical technology |x Quality control | |
| 650 | 4 | |a Pharmaceutical technology |x Standards | |
| 650 | 4 | |a Quality Control | |
| 650 | 4 | |a Sterilization | |
| 650 | 4 | |a Sterilization |x methods | |
| 650 | 4 | |a Technology, Pharmaceutical | |
| 700 | 1 | |a Carleton, Frederick J. |e Sonstige |4 oth | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009540495&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-009540495 | ||
Datensatz im Suchindex
| _version_ | 1804128788327432192 |
|---|---|
| adam_text | Contents
Preface v
Contributors xi
INTRODUCTION
1. Why Validation? 1
Robert G. Kieffer and Joseph D. Nally
2. Organizing for Validation 17
Ronald J. Simko
3. Validation and Facility Design 31
J. Robert Adamson
SUPPORT AND UTILITY SYSTEMS
4. Calibration and Certification 59
Robert E. Bremmer
5. Design, Installation, and Calibration of Thermocouple Measuring Systems 101
Clarence A. Kemper
6. Qualification and Change Control 131
Bohdan M. Ferenc
7. Monitoring of Nonviable Particles 151
Alvin Lieberman
8. Viable Environmental Microbiological Monitoring 197
Pamela D. Deschenes
vii
viii Contents
9. Validation of Environmental Control Systems Used in Parenteral Facilities 217
Franco De Vecchi
10. Validation of Utilities 261
Barry D. Garfinkle
11. The Validation of Pharmaceutical Water Systems 279
Theodore H. Meltzer
STERILIZATION, SANITIZATION, AND STERILITY ASSURANCE
12. Microbiology of Sterilization Processes 353
Timothy J. Leahy, Kerry L. Roche, and Maura R. Christopher
13. F, D, and Z Values 381
John Shirtz
14. Validation of Steam Sterilization in Autoclaves 413
Phil DeSantis
15. Steam Sterilization in Place Technology and Validation 451
James P. Agalloco
16. Dry Heat Sterilization and Depyrogenation 483
Laurie B. Colman and Gayle D. Heffernan
17. Validation of Gas Sterilization 527
David F. Bekus
18. Validation of Radiation Sterilization Processes 541
John F. Reger
19. Validation of Sterilizing Grade Filters 555
John McGrath and Richard Levy
20. Validation of Unique Filtration Processes 585
Carole S. Genovesi
21. Disinfectants 617
James D. Wilson
22. Cleaning and Sanitization of Cleanrooms and Materials 645
Anne Marie Dixon
23. Validation of Aseptic Processing 669
James P. Agalloco and James E. Akers
Contents ix
STERILE PRODUCT MANUFACTURING
24. Component Preparation Processes 703
Dominic A. Ventura and Stephen W. Goodsir
25. Validation of Lyophilization 721
Edward H. Trappier
26. Validation of Packaging Operations 751
Charles S. Levine
27. Retrospective Validation 791
James P. Agalloco
28. Regulatory Aspects of Validation 807
Ralph Badagliacca
29. Process Control and Quality Systems for a Changing World 821
James E. Akers
Index 831
|
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| callnumber-raw | RS199.S73 |
| callnumber-search | RS199.S73 |
| callnumber-sort | RS 3199 S73 |
| callnumber-subject | RS - Pharmacy |
| ctrlnum | (OCoLC)39982679 (DE-599)BVBBV013943513 |
| 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 219 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| edition | 2. ed., rev. and exp. |
| format | Book |
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| id | DE-604.BV013943513 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:54:48Z |
| institution | BVB |
| isbn | 0824793846 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-009540495 |
| oclc_num | 39982679 |
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| owner_facet | DE-19 DE-BY-UBM |
| physical | XII, 840 S. Ill., graph. Darst. |
| publishDate | 1999 |
| publishDateSearch | 1999 |
| publishDateSort | 1999 |
| publisher | Dekker |
| record_format | marc |
| spelling | Validation of pharmaceutical processes sterile products ed. by Frederick J. Carleton .. 2. ed., rev. and exp. New York u.a. Dekker 1999 XII, 840 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier 1. Aufl u.d.T.: Validation of aseptic pharmaceutical processes Stérilisation Stérilisation - Méthode Stérilisation ram Techniques pharmaceutiques - Normes Techniques pharmaceutiques - Qualité - Contrôle Technologie pharmaceutique - Normes ram Technologie pharmaceutique - qualité contrôle ram Technologie pharmaceutique Pharmaceutical technology Quality control Pharmaceutical technology Standards Quality Control Sterilization Sterilization methods Technology, Pharmaceutical Carleton, Frederick J. Sonstige oth HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009540495&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Validation of pharmaceutical processes sterile products Stérilisation Stérilisation - Méthode Stérilisation ram Techniques pharmaceutiques - Normes Techniques pharmaceutiques - Qualité - Contrôle Technologie pharmaceutique - Normes ram Technologie pharmaceutique - qualité contrôle ram Technologie pharmaceutique Pharmaceutical technology Quality control Pharmaceutical technology Standards Quality Control Sterilization Sterilization methods Technology, Pharmaceutical |
| title | Validation of pharmaceutical processes sterile products |
| title_auth | Validation of pharmaceutical processes sterile products |
| title_exact_search | Validation of pharmaceutical processes sterile products |
| title_full | Validation of pharmaceutical processes sterile products ed. by Frederick J. Carleton .. |
| title_fullStr | Validation of pharmaceutical processes sterile products ed. by Frederick J. Carleton .. |
| title_full_unstemmed | Validation of pharmaceutical processes sterile products ed. by Frederick J. Carleton .. |
| title_short | Validation of pharmaceutical processes |
| title_sort | validation of pharmaceutical processes sterile products |
| title_sub | sterile products |
| topic | Stérilisation Stérilisation - Méthode Stérilisation ram Techniques pharmaceutiques - Normes Techniques pharmaceutiques - Qualité - Contrôle Technologie pharmaceutique - Normes ram Technologie pharmaceutique - qualité contrôle ram Technologie pharmaceutique Pharmaceutical technology Quality control Pharmaceutical technology Standards Quality Control Sterilization Sterilization methods Technology, Pharmaceutical |
| topic_facet | Stérilisation Stérilisation - Méthode Techniques pharmaceutiques - Normes Techniques pharmaceutiques - Qualité - Contrôle Technologie pharmaceutique - Normes Technologie pharmaceutique - qualité contrôle Technologie pharmaceutique Pharmaceutical technology Quality control Pharmaceutical technology Standards Quality Control Sterilization Sterilization methods Technology, Pharmaceutical |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009540495&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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