Environmental monitoring for cleanrooms and controlled environments:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York [u.a.]
Informa Healthcare
2007
|
| Series: | Drugs and the pharmaceutical sciences
164 |
| Subjects: | |
| Online Access: | Publisher description Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | xi, 230 p. Ill., graph. Darst. 24 cm |
| ISBN: | 0824723597 9780824723590 |
Staff View
MARC
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| 245 | 1 | 0 | |a Environmental monitoring for cleanrooms and controlled environments |c ed. by Anne Marie Dixon |
| 264 | 1 | |a New York [u.a.] |b Informa Healthcare |c 2007 | |
| 300 | |a xi, 230 p. |b Ill., graph. Darst. |c 24 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
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| 490 | 1 | |a Drugs and the pharmaceutical sciences |v 164 | |
| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Environnement - Surveillance | |
| 650 | 4 | |a Environmental monitoring | |
| 700 | 1 | |a Dixon, Anne Marie |e Sonstige |4 oth | |
| 830 | 0 | |a Drugs and the pharmaceutical sciences |v 164 |w (DE-604)BV000002008 |9 164 | |
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Record in the Search Index
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| adam_text | ENVIRONMENTAL MONITORING FOR CLEANROOMS AND CONTROLLED ENVIRONMENTS
EDITED BY ANNE MARIE DIXON (. ARSON ( IT . XCVAIJTJ. I . INFORMA
HEALTHCARE CONTENTS FOREWORD N A N E T T E LONDEREE .... /// PREFACE
.... V CONTRIBUTORS .... XI 1. THE BEHAVIOR OF PARTICLES IN CLEANROOMS 1
DAVID S. ENSOR AND KARIN K. FOARDE INTRODUCTION .... 3 PHYSICAL
PROPERTIES OF PARTICLES .... 5 SOURCES OF PARTICLES IN CLEANROOMS .... 7
PARTICLE MECHANICS .... 10 FILTRATION .... 16 AIR SAMPLING IN CLEANROOMS
.... 18 CLEANROOM DYNAMICS .... 21 SUMMARY .... 24 REFERENCES .... 25 2.
THE APPLICATION OF THE NEW INTERNATIONAL STANDARDS ORGANIZATION
CLEANROOM STANDARDS 29 RICHARD A. MATTHEWS THE INTERNATIONAL STANDARDS
.... 31 GUIDELINES .... 31 W O R K I N G G R O U P S .... 32 D O C U M E
N T S A N D THEIR TITLES .... 33 ISO PROJECT STAGES A N D ASSOCIATED D O
C U M E N T S .... 33 SPECIFIC INFORMATION O N EACH STANDARD .... 33 S U
M M A R Y .... 41 REFERENCE .... 41 3. CLEANROOM CERTIFICATION AND
PARTICULATE TESTING 43 DAVID BRANDE INTRODUCTION .... 45 HIGH-EFFICIENCY
PARTICULATE AIR FILTERS .... 45 PHARMACEUTICAL INTRODUCTION .... 46 VII
CONTENTS AIR VOLUMES .... 47 PRACTICAL APPLICATION .... 49 AIRFLOW
PATTERNS .... 50 PRACTICAL APPLICATION .... 50 PRESSURE .... 51 FILTER
INTEGRITY .... 52 PRACTICAL APPLICATION .... 53 BLEEDTHROUGH .... 56
ROOM CLASSIFICATION .... 56 PRACTICAL APPLICATION .... 58 CONCLUSION
.... 60 4. MONITORING OF AIRBORNE VIABLE PARTICLES * 1 BENGT LJUNGQVIST
AND BERIT REINMIILLCR INTRODUCTION .... 63 SAMPLING EFFICIENCY .... 63
BIOLOGICAL EFFICIENCY .... 65 AIR SAMPLING .... 65 POINTS TO CONSIDER
.... 67 SUMMARY .... 68 REFERENCES .... 70 5. MICROBIAL SURFACE
MONITORING SCOTT SNTTON INTRODUCTION .... 73 TYPES OF MONITORING M E T
H O D S .... 77 EFFICACY OF M E T H O D S .... 81 ACCURACY/PRECISION OF
M E T H O D S .... 85 THE ROLE OF MICROBIAL IDENTIFICATION .... 86 THE
POTENTIAL OF R A P I D MICROBIOLOGY .... 87 CONCLUSIONS .... 88
REFERENCES .... 89 6. PROCESS SIMULATIONS (MEDIA FILLS) ANNE MARIE DIXON
BACKGROUND .... 95 CONTAMINATION SOURCES .... 96 THE PROCESS OF
DEVISING, EXECUTING, AND ASSESSING MEDIA FILLS .... 97 CASE STUDY ....
109 SUMMARY .... 109 CONCLUSIONS .... 110 CONTENTS JX FURTHER READING
.... ILL REFERENCES .... ILL 7. WATER MONITORING 113 ANNE MARIE DIXON
AND KAREN ZINK MCCIILLOUGH INTRODUCTION .... 115 STANDARDS .... 115
VALIDATION .... 115 SAMPLING .... 117 ROUTINE MONITORING .... 119
INVESTIGATIONS .... 120 INCOMING WATER .... 122 PRETREATMENT .... 123
WATER GENERATION .... 123 WATER DISTRIBUTION .... 123 SAMPLE PROCUREMENT
.... 125 SAMPLE TESTING .... 126 FURTHER READING .... 127 REFERENCES
.... 127 8. BACTERIAL ENDOTOXIN TESTING 129 KAREN ZINK MCCULLOUGH
INTRODUCTION .... 131 THE QUALITY SYSTEM .... 133 RISK . . . / 134
HAZARD AND CCP ANALYSIS .... 135 APPLYING THE PRINCIPLES OF RISK
MANAGEMENT TO THE CONTROL OF ENDOTOXIN CONTAMINATION IN PARENTERALS ....
137 PEELING THE ARTICHOKE: DETERMINATION OF CCPS IN THE LABORATORY
PERFORMANCE OF THE BET ASSAY .... 156 SUMMARY .... 173 ABBREVIATIONS AND
ACRONYMS .... 175 GLOSSARY .... 176 REFERENCES .... 177 9. FAULT TREE
ANALYSIS OF THE UNITED STATES PHARMACOPEIA STERILITY TEST 1S1 KAREN ZINK
MCCULLOUGH AND AUDRA ZAKZESKI INTRODUCTION .... 183 RISK .... 184
CONTENTS THE STERILITY TEST FAILURE CASE STUDY .... 185 TEST METHOD ....
187 ORGANISM INDENTIFICATION .... 193 MATERIALS TRANSPORT .... 196
EQUIPMENT .... 198 ENVIRONMENT .... 200 TECHNIQUE .... 208 THE CHECKLIST
.... 210 REFERENCES .... 214 APPENDIX 1: THE STERILITY TEST*BIG MOVING
PARTS .... 215 APPENDIX 2: THE STATISTICS OF ENDOTOXIN AND STERILITY
TESTING .... 221 INDEX .... 225
|
| adam_txt |
ENVIRONMENTAL MONITORING FOR CLEANROOMS AND CONTROLLED ENVIRONMENTS
EDITED BY ANNE MARIE DIXON (.'ARSON ( IT\. XCVAIJTJ. I \ \. INFORMA
HEALTHCARE CONTENTS FOREWORD N A N E T T E LONDEREE . /// PREFACE
. V CONTRIBUTORS . XI 1. THE BEHAVIOR OF PARTICLES IN CLEANROOMS 1
DAVID S. ENSOR AND KARIN K. FOARDE INTRODUCTION . 3 PHYSICAL
PROPERTIES OF PARTICLES . 5 SOURCES OF PARTICLES IN CLEANROOMS . 7
PARTICLE MECHANICS . 10 FILTRATION . 16 AIR SAMPLING IN CLEANROOMS
. 18 CLEANROOM DYNAMICS . 21 SUMMARY . 24 REFERENCES . 25 2.
THE APPLICATION OF THE NEW INTERNATIONAL STANDARDS ORGANIZATION
CLEANROOM STANDARDS 29 RICHARD A. MATTHEWS THE INTERNATIONAL STANDARDS
. 31 GUIDELINES . 31 W O R K I N G G R O U P S . 32 D O C U M E
N T S A N D THEIR TITLES . 33 ISO PROJECT STAGES A N D ASSOCIATED D O
C U M E N T S . 33 SPECIFIC INFORMATION O N EACH STANDARD . 33 S U
M M A R Y . 41 REFERENCE . 41 3. CLEANROOM CERTIFICATION AND
PARTICULATE TESTING 43 DAVID BRANDE INTRODUCTION . 45 HIGH-EFFICIENCY
PARTICULATE AIR FILTERS . 45 PHARMACEUTICAL INTRODUCTION . 46 VII
CONTENTS AIR VOLUMES . 47 PRACTICAL APPLICATION . 49 AIRFLOW
PATTERNS . 50 PRACTICAL APPLICATION . 50 PRESSURE . 51 FILTER
INTEGRITY . 52 PRACTICAL APPLICATION . 53 BLEEDTHROUGH . 56
ROOM CLASSIFICATION . 56 PRACTICAL APPLICATION . 58 CONCLUSION
. 60 4. MONITORING OF AIRBORNE VIABLE PARTICLES * 1 BENGT LJUNGQVIST
AND BERIT REINMIILLCR INTRODUCTION . 63 SAMPLING EFFICIENCY . 63
BIOLOGICAL EFFICIENCY . 65 AIR SAMPLING . 65 POINTS TO CONSIDER
. 67 SUMMARY . 68 REFERENCES . 70 5. MICROBIAL SURFACE
MONITORING ' SCOTT SNTTON INTRODUCTION . 73 TYPES OF MONITORING M E T
H O D S . 77 EFFICACY OF M E T H O D S . 81 ACCURACY/PRECISION OF
M E T H O D S . 85 THE ROLE OF MICROBIAL IDENTIFICATION . 86 THE
POTENTIAL OF R A P I D MICROBIOLOGY . 87 CONCLUSIONS . 88
REFERENCES . 89 6. PROCESS SIMULATIONS (MEDIA FILLS) ANNE MARIE DIXON
BACKGROUND . 95 CONTAMINATION SOURCES . 96 THE PROCESS OF
DEVISING, EXECUTING, AND ASSESSING MEDIA FILLS . 97 CASE STUDY .
109 SUMMARY . 109 CONCLUSIONS . 110 CONTENTS JX FURTHER READING
. ILL REFERENCES . ILL 7. WATER MONITORING 113 ANNE MARIE DIXON
AND KAREN ZINK MCCIILLOUGH INTRODUCTION . 115 STANDARDS . 115
VALIDATION . 115 SAMPLING . 117 ROUTINE MONITORING . 119
INVESTIGATIONS . 120 INCOMING WATER . 122 PRETREATMENT . 123
WATER GENERATION . 123 WATER DISTRIBUTION . 123 SAMPLE PROCUREMENT
. 125 SAMPLE TESTING . 126 FURTHER READING . 127 REFERENCES
. 127 8. BACTERIAL ENDOTOXIN TESTING 129 KAREN ZINK MCCULLOUGH
INTRODUCTION . 131 THE QUALITY SYSTEM . 133 RISK . . . / 134
HAZARD AND CCP ANALYSIS . 135 APPLYING THE PRINCIPLES OF RISK
MANAGEMENT TO THE CONTROL OF ENDOTOXIN CONTAMINATION IN PARENTERALS .
137 PEELING THE ARTICHOKE: DETERMINATION OF CCPS IN THE LABORATORY
PERFORMANCE OF THE BET ASSAY . 156 SUMMARY . 173 ABBREVIATIONS AND
ACRONYMS . 175 GLOSSARY . 176 REFERENCES . 177 9. FAULT TREE
ANALYSIS OF THE UNITED STATES PHARMACOPEIA STERILITY TEST 1S1 KAREN ZINK
MCCULLOUGH AND AUDRA ZAKZESKI INTRODUCTION . 183 RISK . 184
CONTENTS THE STERILITY TEST FAILURE CASE STUDY . 185 TEST METHOD .
187 ORGANISM INDENTIFICATION . 193 MATERIALS TRANSPORT . 196
EQUIPMENT . 198 ENVIRONMENT . 200 TECHNIQUE . 208 THE CHECKLIST
. 210 REFERENCES . 214 APPENDIX 1: THE STERILITY TEST*BIG MOVING
PARTS . 215 APPENDIX 2: THE STATISTICS OF ENDOTOXIN AND STERILITY
TESTING . 221 INDEX . 225 |
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| index_date | 2024-07-02T18:57:41Z |
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| institution | BVB |
| isbn | 0824723597 9780824723590 |
| language | English |
| lccn | 2006049725 |
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| owner | DE-19 DE-BY-UBM |
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| physical | xi, 230 p. Ill., graph. Darst. 24 cm |
| publishDate | 2007 |
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| publisher | Informa Healthcare |
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| series | Drugs and the pharmaceutical sciences |
| series2 | Drugs and the pharmaceutical sciences |
| spelling | Environmental monitoring for cleanrooms and controlled environments ed. by Anne Marie Dixon New York [u.a.] Informa Healthcare 2007 xi, 230 p. Ill., graph. Darst. 24 cm txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 164 Includes bibliographical references and index Environnement - Surveillance Environmental monitoring Dixon, Anne Marie Sonstige oth Drugs and the pharmaceutical sciences 164 (DE-604)BV000002008 164 http://www.loc.gov/catdir/enhancements/fy0703/2006049725-d.html Publisher description GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016144026&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Environmental monitoring for cleanrooms and controlled environments Drugs and the pharmaceutical sciences Environnement - Surveillance Environmental monitoring |
| title | Environmental monitoring for cleanrooms and controlled environments |
| title_auth | Environmental monitoring for cleanrooms and controlled environments |
| title_exact_search | Environmental monitoring for cleanrooms and controlled environments |
| title_exact_search_txtP | Environmental monitoring for cleanrooms and controlled environments |
| title_full | Environmental monitoring for cleanrooms and controlled environments ed. by Anne Marie Dixon |
| title_fullStr | Environmental monitoring for cleanrooms and controlled environments ed. by Anne Marie Dixon |
| title_full_unstemmed | Environmental monitoring for cleanrooms and controlled environments ed. by Anne Marie Dixon |
| title_short | Environmental monitoring for cleanrooms and controlled environments |
| title_sort | environmental monitoring for cleanrooms and controlled environments |
| topic | Environnement - Surveillance Environmental monitoring |
| topic_facet | Environnement - Surveillance Environmental monitoring |
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