Microbial contamination control in parenteral manufacturing:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Dekker
2004
|
| Schriftenreihe: | Drugs and the pharmaceutical sciences
140 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXVI, 721 S. Ill., graph. Darst. |
| ISBN: | 0824753208 |
Internformat
MARC
| LEADER | 00000nam a2200000 cb4500 | ||
|---|---|---|---|
| 001 | BV019825464 | ||
| 003 | DE-604 | ||
| 005 | 00000000000000.0 | ||
| 007 | t | ||
| 008 | 050530s2004 ad|| |||| 00||| eng d | ||
| 020 | |a 0824753208 |9 0-8247-5320-8 | ||
| 035 | |a (OCoLC)56593313 | ||
| 035 | |a (DE-599)BVBBV019825464 | ||
| 040 | |a DE-604 |b ger |e rakddb | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-19 | ||
| 050 | 0 | |a RS199 | |
| 082 | 0 | |a 615.19 |2 22 | |
| 084 | |a VX 8300 |0 (DE-625)147825:253 |2 rvk | ||
| 245 | 1 | 0 | |a Microbial contamination control in parenteral manufacturing |c ed. by Kevin L. Williams |
| 264 | 1 | |a New York [u.a.] |b Dekker |c 2004 | |
| 300 | |a XXVI, 721 S. |b Ill., graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 1 | |a Drugs and the pharmaceutical sciences |v 140 | |
| 650 | 4 | |a Contamination | |
| 650 | 4 | |a Microbiologie - Technique | |
| 650 | 4 | |a Médicaments - Essais cliniques - Politique gouvernementale - États-Unis | |
| 650 | 4 | |a Drug Contamination |x prevention & control | |
| 650 | 4 | |a Drug Industry |x methods | |
| 650 | 4 | |a Microbiology | |
| 650 | 4 | |a Parenteral solutions |x Contamination | |
| 650 | 4 | |a Parenteral solutions |x Quality control | |
| 650 | 4 | |a Pharmaceutical Solutions |x standards | |
| 650 | 4 | |a Quality Control | |
| 700 | 1 | |a Williams, Kevin L. |e Sonstige |4 oth | |
| 830 | 0 | |a Drugs and the pharmaceutical sciences |v 140 |w (DE-604)BV000002008 |9 140 | |
| 856 | 4 | 2 | |m GBV Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013150654&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-013150654 | ||
Datensatz im Suchindex
| _version_ | 1804133329776148480 |
|---|---|
| adam_text | MICROBIAL CONTAMINATION CONTROL IN PARENTERAL MANUFACTURING EDITED BY
KEVIN L. WILLIAMS ELI LILLY AND COMPANY INDIANAPOLIS, INDIANA, U.S.A. M
A R C FC I M MARCEL DEKKER, INC. NEW YORK * BASEL CONTENTS PREFACE ///
CONTRIBUTORS V.VR PART I CONCEPTS AND FOUNDATIONS OF PARENTERAL
MANUFACTURING CONTAMINATION CONTROL 1. HISTORICAL AND EMERGING THEMES IN
PARENTERAL MANUFACTURING CONTAMINATION CONTROL J KEVIN L. WILLIAMS .1
INTRODUCTION I .2 THE BIRTH OF MICROBIOLOGICAL THEORY 2 .3 HISTORICAL
DEVELOPMENT AND REGULATION OF PARENTERAL DOSAGE FORMS 3 .4 FROM
ANTIBIOTICS TO BIOLOGIES 9 .5 CHANGING PERSPECTIVES ON CONTAMINANTS 16
.6 EMERGING APPROACHES TO FINDING AND IDENTIFYING CONTAMINANTS 20 VIII
CONTENTS 2. MICROBIAL CONTAMINATION HAZARD ANALYSIS IN STERILE PRODUCT
MANUFACTURING SIMON RUSMIN 2.1 AN OVERVIEW OF THE EVOLUTION AND
DIVERSIFICATION OF MICROORGANISMS - 2.1.1 THE FIRST BILLION YEARS:
EARTH S COOLING, FORMATION OF SOLID CRUST, THE FIRST ATMOSPHERE AND
LIQUID WATER 2.1.2 THE SECOND BILLION YEARS: FIRST LIVING ORGANISMS, THE
BACTERIA 2.1.3 THE THIRD BILLION YEARS: AGE OF PROKARYOTES AND OXYGENIC
PHOTOSYNTHESIS 2.1.4 THE FOURTH BILLION YEARS: THE AGE OF EUKARYOTES AND
SEXUAL REPRODUCTION 2.1.5 THE PAST BILLION YEARS: MULTICELLULAR
ORGANISMS AND THE GRAND PARADE 2.2 A VIEW OF MICROBES AND THEIR
RELATIONSHIP TO STERILE DRUG PRODUCT MANUFACTURING 33 2.3 THE
MICROBIOLOGICAL FUNCTION IN DRUG PRODUCT MANUFACTURING - 6 2.3.1 WHY
SHOULD THERE BE A DISTINCT MICROBIOLOGICAL FUNCTION? 2.3.2 WHAT DOES THE
MICROBIOLOGICAL FUNCTION DO IN A PHARMACEUTICAL COMPANY? 2.4
UNDERSTANDING PROCESS ANALYSIS 42 2.4.1 WHAT IS A PROCESS? 2.4.2 WHAT
ARE PROCESS FLOWS? 2.4.3 WHAT ARE THE PRINCIPLES OF IMPROVING QUALITY?
2.5 MICROBIAL CONTAMINATION HAZARD ANALYSIS STEP-BY-STEP -AN EXAMPLE 48
2.5.1 INITIATION AND TEAM ORGANIZATION 2.5.2 STUDY OF MANUFACTURING PLAN
& RELATED SOPS 2.5.3 OBSERVATION OF REAL OPERATIONS 2.5.4 TASK ANALYSIS
FOR MICROBIAL CONTAMINATION HAZARDS & CONTROL POINT SETUP 2.5.5
TRANSLATION OF CONTROL MEASURES INTO OPERATOR SKILLS THROUGH TRAINING
2.6 HAZARD ANALYSIS DISCUSSION AND CONCLUSION 52 CONTENTS J X 3.
OVERVIEW OF MODERN PARENTERAL PODUCTS AND PROCESSES 59 ARVIML K. BANSAL
3.1 PARENTERALS*GENERAL INTRODUCTION AND PRODUCT TYPES 59 3.2 DEMANDS ON
PARENTERAL PRODUCTS AND MANUFACTURING PROCESSES 60 3.3 PARENTERAL
MANUFACTURING PROCESSES 62 3.4 AREA DESIGN AND ENVIRONMENT CONTROL 63
3.5 FABRICATION OF BATCH 64 3.6 STERILITY ASSURANCE IN PARENTERAL
MANUFACTURING 64 3.6.1 TERMINAL STERILIZATION 3.6.2 NEW TECHNIQUES OF
TERMINAL STERILIZATION 3.7 ASEPTIC PROCESSING 68 3.7.1 ADVANCED ASEPTIC
PROCESSES AND ISOLATOR BARRIER TECHNOLOGY 3.7.2 BLOW FILL SEAL
TECHNOLOGY (BFS) 3.7.3 TERMINAL STERILIZATION OF BFS CONTAINERS BY
AUTOCLAVING 3.8 RECENT ISSUES IN STERILIZATION BY FILTRATION 75 3.9
STERILE PREFILLED SYRINGES (PFS)---MANUFACTURING AND TERMINAL
STERILIZATION PERSPECTIVES 75 3.10 PROCESS VALIDATION. HAZARD ANALYSIS
AND CRITICAL CONTROL POINTS (HACCP) 76 3.11 CONTINUOUS PROCESSING OF
PARENTERAL PRODUCTS 78 3.12 COMPUTER-CONTROLLED AUTOMATION OF UNIT
PROCESSES NO 3.13 PROCESSING OF BIOPHARMACEUTICAL PRODUCTS 80 3.13.1
STABILIZATION DURING FREE/E-DRYING OF PROTEIN FORMULATIONS 3.13.2
SPRAY-DRYING OF PROTEIN FORMULATIONS 3.13.3 ASSURING STERILITY OF
PROTEIN FORMULATIONS 3.13.4 STERILE FILTRATION OF PROTEIN FORMULATIONS
3.13.5 FUTURE TRENDS 3.14 PROCESSING OF PACKAGING COMPONENTS 83 3.14.1
RUBBER CLOSURES 3.14.2 WASHING 3.14.3 SILICONIZATION 3.14.4 CLEANING AND
STERILIZATION OF FLASTOMERIC CLOSURES 3.15 FUTURE TRENDS IN PARENTERAL
PROCESSIM: 86 T CONTENTS 4. THE ROLE OF USP IN THE MICROBIOLOGICAL
ASSESSMENT OF PARENTERAL MANUFACTURING 91 ROGER DABBAH AND DAVID PORTER
4.1 INTRODUCTION 4.2 THE USP ORGANIZATION 92 4.3 USP LEGAL
RECOGNITION AND USP RELATIONSHIP TO FDA 93 4.3.1 USP LEGAL RECOGNITION:
4.3.2 USP AND FEDERAL STATUTES 4.4 MICROBIOLOGICAL ASSESSMENT CONTINUUM
4 4.4.1 STEP 1 *ASSESSMENT OF RAW MATERIALS 4.4.2 STEP
2*MICROBIOLOGICAL ASSESSMENT CONTINUUM 4.4.3 STEP 3*MICROBIOLOGICAL
ASSESSMENT CONTINUUM 4.4.4 STEP 4 -MICROBIOLOGICAL ASSESSMENT CONTINUUM
4.4.5 STEP 5- MICROBIOLOGICAL ASSESSMENT CONTINUUM 4.4.6 STEP
6*MICROBIOLOGICAL ASSESSMENT CONTINUUM 5. STERILITY AND BIOINDICATORS
107 PATRICK J. MCCORMICK, CATHERINE J. FINOCCHARIO, AND JAMES J. KAISER
5.1 INTRODUCTION 1 7 5.2 STERILITY ASSURANCE 108 5.3 RESISTANCE
PERFORMANCE 09 5.3.1 POPULATION 5.3.2 D-VALUE 5.3.3 SURVIVAL/KILL TIME
5.4 SELECTION 112 5.4.1 TEST ORGANISM 5.4.2 FORMAT 5.5 PROCESS CHALLENGE
DEVICES 116 5.6 REGULATORY STATUS 117 5.7 QUALIFICATION OF BIOLOGICAL
INDICATORS H^ 5.8 APPLICATION 11 9 5.8.1 CYCLE DEVELOPMENT 5.8.2 CYCLE
VALIDATION 5.8.3 ROUTINE PROCESSING 5.8.4 INCUBATION TIMES 5.9 RAPID
READOUT BIOLOGICAL INDICATORS 124 5.10 CONCLUSION 125 APPENDIX 5.1
D-VALUE CALCULATIONS 129 CONTENTS XI PART II CONTROL OF CONTAMINANTS VIA
FACILITIES AND UTILITIES 6. BIOLOGICAL SAFETY CABINETS AND ISOLATORS
USED IN PHARMACEUTICAL PROCESSING 139 MARK CLAERBOUT 6.1 INTRODUCTION
139 6.2 DESIGN CONSIDERATIONS 140 6.2.1 PARTIAL BARRIER ENCLOSURES 6.2.2
FULL BARRIER ENCLOSURES (ISOLATORS) 6.2.3 ISOLATOR MATERIALS OF
CONSTRUCTION 6.2.4 ISOLATOR/OPERATOR INTERFACE 6.2.5 ISOLATOR ERGONOMICS
6.2.6 ISOLATOR VENTILATION 6.2.7 ISOLATOR INTEGRITY TESTING 6.2.8 RAPID
TRANSFER PORTS (RTPS) 6.3 COMMON LAB ISOLATOR REQUIREMENTS 150 6.4 LAB
ISOLATORS USED FOR STERILITY ASSURANCE 151 6.5 THE STERILITY TEST 151
6.6 ISOLATOR ROOM REQUIREMENTS 152 6.7 BIODECONTAMINATION EFFICACY 152
6.8 MICROBIOLOGICAL MONITORING OF STERILITY TESTING ISOLATORS 154 6.9
ISOLATOR CLEANING 154 6.10 CONCLUSION 154 7. DEVELOPING A PROCESS FOR
ASEPTIC FACILITY DESIGN AND VALIDATION 157 DIMITRI II IRCHANSK R 7.1
INTRODUCTION 157 7.2 DEFINING THE PROJECT 15 7.3 PRELIMINARY PROJECT
TEAM 158 7.4 DELIVERABLES FOR THE PRECONCEPTUAL PHASE 158 7.5 CONCEPTUAL
DESIGN 160 7.6 DEVELOPING THE PROJECT CORE TEAM 16(1 7.6.1 ARCHITECT
7.6.2 PROCESS ENGINEER 7.6.3 HVAC FNGMEER 7.6.4 MANUFACTURING
REPRESENTATIVE 7.6.5 QA REPRESENTATIVE VALIDATION XII CONTENTS 7.7
DEVELOPING THE BASIS OF DESIGN OR BOD 7.8 LEVERAGING THE EFFORT 7.8.1
LINING UP INTERNAL SUPPORT 7.8.2 EXTERNAL SUPPORT 7.9 THE DESIGN
QUALIFICATION PROCESS 7.9.1 Q7A GUIDE TO CGMP FOR API 7.9.2 ORANGE
GUIDE, ANNEX 15 7.10 EXAMPLE OF AN APPROACH TO DESIGN QUALIFICATION
7.10.1 USER REQUIREMENTS 7.10.2 SYSTEM CLASSIFICATION 7.10.3 TYING IT
TOGETHER 7.11 PRELIMINARY ENGINEERING 162 163 164 165 166 7. 7. 7. 7. 7.
7. 7. 7. 7 7.1 7.1 7.1 7.1 7.1 11 1 1 1 1 1 1 1 1 1 1 1 1 1 .1 2 .3 .4
.5 1.6 1.7 1.8 1.9 10 11 12 13 .14 ARCHITECTURE ENVIRONMENTAL HEALTH AND
SAFETY (EHS) PROCESS PROCESS MECHANICAL CIVIL STRUCTURAL ELECTRICAL
INSTRUMENTATION AND CONTROLS (I&C) BUILDING AUTOMATION SYSTEMS (BAS)
HVAC PROCESS PIPING PLUMBING MANUFACTURING REPRESENTATIVE QA
REPRESENTATIVE*VALIDATION 7.12 THE PROJECT FUNCTION 7.12.1 DETAILED
DESIGN 7.12.2 CONSTRUCTION 7.12.3 STARTUP, COMMISSIONING, AND VALIDATION
168 8. PHARMACEUTICAL WATER SYSTEMS: NEW ORIENTATIONS IN SYSTEM DESIGN
THEODORE H. MELTZER AND ROBERT C. LIVINGSTON 8.1 8.2 8.3 8.4 8.5
INTRODUCTION WATER PURITY STANDARDS ELECTRONIC RINSE WATER EMPHASIS ON
PRETREATMENTS SOURCE WATERS 8.5.1 MUNICIPAL CITY WATER 173 173 174 175
177 178 CONTENTS 8.6 PRETREATMENTS 179 8.6.1 CHLORINATION 8.6.2 REMOVAL
OF TRIHALOMETHANES 8.6.3 DEEP BEDS AND MULTIMEDIA FILTRATION 8.6.4
SOFTENING AND SOLUBILITY PRODUCT 8.6.5 SOFTENING OR DECHLORINATION FIRST
8.6.6 FUOSS EFFECT AND TOC ADSORPTION 8.7 CHLORINE REMOVAL 191 8.7.1
ACTIVATED CARBON 8.7.2 REDUCTIONS WITH SODIUM SULFITE 8.7.3 DESTRUCTION
BY ULTRAVIOLET LIGHT 8.7.4 REACTION WITH ION-EXCHANGE RESINS 8.8
CHLORAMINE REMOVAL 195 8.8.1 REMOVAL OF CHLORAMINES USUALLY MANAGED BY
ADSORPTION TO ACTIVATED CARBON 8.9 ORGANIC ENTITIES. TOC 196 8.10
ENDOTOXINS 197 8.11 ULTRAFILTRATION 198 8.12 PRINCIPAL PURIFICATIONS 198
8.12.1 DISTILLATION 8.12.2 ION-EXCHANGE 8.12.3 SILICA 8.13
COUNTERCURRENT OPERATIONS 201 8.13.1 HOT WATER SANITIZATIONS 8.13.2
ELECTRODEIONIZATION 8.14 REVERSE OSMOSIS 207 8.14.1 RO MEMBRANES 8.14.2
TANGENTIAL FLOW FILTRATION 8.14.3 REUSE OF REJECT WATER 8.14.4
CONCENTRATION POLARIZATION 8.14.5 THE PERMEATE STREAM 8.14.6 THE EXTENT
OF RECOVERY 8.14.7 DISCONTINUOUS RO OPERATIONS 8.14.8 SIZE OF RO UNIT
8.15 STORAGE CONDITIONS 213 8.16 CONCLUSION 213 9. AIRBORNE
CONTAMINATION CONTROL 215 LOTHAR GAIL AND DIRK STANISCHEUSKI 9.1
INTRODUCTION 215 9.2 CLEANROOM DESIGN AND OPERATION 217 XJV CONTENTS
9.2.1 PROCESSING CONCEPT 9.2.2 ZONING CONCEPT 9.2.3 CLEANROOM
SEGREGATION TECHNIQUES FOR STERILE PROCESSING 9.2.4 AIRFLOW SIMULATION
9.2.5 QUALIFICATION AND OPERATION 9.3 METROLOGY AND TEST METHODS 224
9.3.1 GENERAL 9.3.2 CLEANROOM CLASSIFICATION 9.3.3 INSTALLED FILTER
LEAKAGE TESTING 9.3.4 AIRFLOW 9.3.5 PRESSURE DIFFERENCE 9.3.6 RECOVERY
9.3.7 DOCUMENTATION 10. DISINFECTION PRACTICES IN PARENTERAL
MANUFACTURING 233 VIVIAN DENNV AND FREDERIC MARSIK 10.1 10.2 10.3 10.4
10.5 10.6 10.7 INTRODUCTION CURRENT REGULATORY ENVIRONMENT CHEMICAL
DISINFECTANTS- -ACTIVITY, MECHANISM OF ACTION. MECHANISM(S) OF
RESISTANCE 10.2.1 ALCOHOLS 10.3.2 ALDEHYDES 10.3.3 FORMALDEHYDE
(METHANAL) 10.3.4 GLUTARALDEHYDE (PENTANEDIAL) 10.3.5 ORTHO-PHTHALDEHYDE
(OPA) 10.3.6 HALOGENS 10.3.7 CHLORINE AND CHLORINE CONTAINING COMPOUNDS
10.3.8 IODINE (I 2 ) 10.3.9 PEROXYGEN COMPOUNDS 10.3.10 HYDROGEN
PEROXIDE (H 2 O : ) 10.3.11 PERACETIC ACID (CH^COOOH) 10.3.12 PHENOLICS
10.3.13 QUATERNARY AMMONIUM COMPOUNDS (QUAES OR QUATS) RESISTANCE TO
DISINFECTANTS SPORES AND DISINFECTANTS PRIONS AND DISINFECTANTS REASONS
FOR USING A DISINFECTANT 233 234 236 245 246 248 249 CONTENTS XV 10.8
WHAT TO CONSIDER WHEN CHOOSING A DISINFECTANT 249 10.9 IDENTIFYING THE
NUMBER AND TYPE OF MICROORGANISMS THAT NEED TO BE CONTROLLED 250 10.10
DETERMINING THE SPECIFICITY OF MICROBIAL ACTION OF COMMERCIALLY
AVAILABLE DISINFECTANTS 250 10.11 SURFACE AND DISINFECTANT COMPATIBILITY
250 10.12 SAFETY AND PRECAUTIONS 251 10.13 PHYSICAL AND ENVIRONMENTAL
FACTORS THAT INFLUENCE DISINFECTANT EFFICACY 251 10.13.1 PH 10.13.2
SURFACE SOILS 10.13.3 BIOFILMS 10.13.4 TEMPERATURE 10.13.5 CONCENTRATION
10.13.6 COMPATIBILITY OF DISINFECTANTS 10.13.7 ECONOMIC CONSIDERATIONS
10.14 PREPARATION OF DISINFECTANT SOLUTIONS 254 10.14.1 WATER 10.14.2
CONCENTRATION 10.14.3 TEMPERATURE 10.14.4 STERILE FILTRATION 10.14.5
STORAGE 10.14.6 EXPIRY DATE 10.15 QUALITY CONTROL OF DISINFECTANTS 256
10.16 METHODS FOR VALIDATION OF DISINFECTANT EFFICACY 257 10.16.1
EVALUATION OF DISINFECTANT EFFICACY CLAIMS 10.16.2 VALIDATION TEST
DEVELOPMENT AND EFFICACY PARAMETERS 10.17 APPLICATION OF DISINFECTANTS
FOR CONTAMINATION CONTROL 262 10.17.1 THE THREE-STEP DISINFECTION
PROCESS 10.17.2 APPLICATION TECHNIQUES 10.17.3 USING SANITIZERS IN
CONJUNCTION WITH DISINFECTANTS 10.17.4 ROTATION OF DISINFECTANTS 10.17.5
DISINFECTION PROGRAM DESIGN SCHEDULING FREQUENCY 10.18 DEVELOPING AND
IMPLEMENTING A DISINFECTION PROGRAM 2D6 10.18.1 STEPS THAT CAN BE TAKEN
TO DEVELOP A PROGRAM 10.19 PERSONNEL TRAINING AND DEMONSTRATION OF
COMPETENCY 2~3 10.19.1 TRAINING AND REGULATIONS XVI CONTENTS 10.19.2
DEVELOPING A TRAINING PROGRAM 10.19.3 DOCUMENTATION-DOCUMENTATION 10.20
SUMMARY 276 PART III MANUFACTURING PROCESS CONTROL OF CONTAMINANTS 11.
STERILE FILTRATION MAIK W. JORNITZ 11.1 11.2 11.3 11.4 11.5 1.6 11.2.2
11.2.3 11.2.4 11.7 INTRODUCTION TYPES OF FILTRATION 11.2.1 PREFILTRATION
MEMBRANE FILTRATION PREFILTER AND MEMBRANE FILTER COMPARISON CROSS-FLOW
FILTRATION MODUS OF FILTRATION 11.3.1 SIEVE RETENTION 11.3.2 ADSORPTIVE
SEQUESTRATION MEMBRANE FILTER MATERIALS 11.4.1 MANUFACTURING PROCESS
11.4.2 POLYMER DIFFERENCES FILTER CONSTRUCTIONS AND DESIGN 11.5.1 DISC
FILTERS 1.5.2 CARTRIDGE FILTERS 1.5.3 CAPSULE FILTERS FILTER VALIDATION
.6.1 GUIDELINES AND DOCUMENTS BACTERIA CHALLENGE TEST EXTRACTABLE TEST
CHEMICAL COMPATIBILITY TEST OTHER TESTS INTEGRITY TESTING 1.7.1
GUIDELINES AND DOCUMENTS BUBBLE POINT TEST DIFFUSIVE FLOW TEST PRESSURE
HOLD TEST WATER INTRUSION TEST MULTIPOINT DIFFUSION TEST 283 283 284 293
297 301 315 1.6.2 1.6.3 1.6.4 1.6.5 1.7.2 1.7.3 1.7.4 11.7.5 11.7.6 324
CONTENTS XVII 12. PROCESS DEVELOPMENT OF ALTERNATIVE STERILIZATION
METHODS 341 VOLKER SIGWARTH 12.1 INTRODUCTION 341 12.2 PROCESS
DEVELOPMENT-GENERAL 342 12.2.1 STEPS OF PROCESS DEVELOPMENT 12.3
PHYSICAL FACTORS AND VALIDATION 345 12.4 TARGET VALUE FOR STERILIZATION
EFFECT 354 12.4.1 BIOLOGICAL INDICATORS (BIS) 12.4.2 SURVIVAL TIME MODEL
OF MICROBIAL REDUCTION 12.4.3 D-VALUE DETERMINATION 12.4.4 SELECTION OF
BIOLOGICAL INDICATOR 12.4.5 SCREENING EXPERIMENT 12.4.6 SUITABILITY OF
BI 12.5 PROCESS-INFLUENCING FACTORS 379 12.5.1 HIOT SURFACE
DECONTAMINATION PROCESS 12.5.2 DESIGN OF EXPERIMENT. DOE 12.5.3 MAIN
EXPERIMENT 12.5.4 INTERPRETATION OF PROCESS 12.6 METHOD OF CYCLE
DEVELOPMENT AND PROCESS QUANTIFICATION 403 12.6.1 EXPERIMENT 0: REACTIVE
PATTERN RECOGNITION 12.6.2 CYCLE DEVELOPMENT 12.6.3 EXPERIMENT
1-BACTERIAL REDUCTION RATE ACHIEVED. QUANTITY (QL) 12.6.4 EXPERIMENT 2:
STABILITY OF DECONTAMINATION EFFECT. QUANTITY (Q2) 12.6.5 ESTIMATION OF
D-VALUE HI;M RKLLA . 12.6.6 EXPERIMENT 3: WORST-CASE STUDY. DURATION OF
DECONTAMINATION 12.6.7 EXPERIMENT 4. DETERMINATION OF PURGE TIME 12.6.8
EXPERIMENT 5. DETERMINATION OF D-VALUE 12.6.9 SUMMARY OF CYCLE
DEVELOPMENT METHOD 12.7 ADDITIONAL STUDIES 414 12.8 CONCLUSION 415 13.
TERMINAL STERILIZATION AND PARAMETRIC RELEASE 419 KLAUS HAHERER 13.1
ROLE AND SIGNIFICANCE OF THE STERILITY LEST IN THE RELEASE OF STERILE
PHARMACEUTICALS 419 XVIII CONTENTS 13.1.1 ROLE OF THE TEST 13.1.2
STATISTICAL SIGNIFICANCE OF THE TEST 13.1.3 PERFORMANCE AND CORRECTNESS
OF THE TEST 13.1.4 PERFORMANCE OF THE LABORATORY AND THE RATE OF FALSE
POSITIVES WITH IMPLICATIONS FOR THE REJECTION OF COMPLIANT PRODUCT
13.1.5 CONTRIBUTION OF THE STERILITY TEST TO STERILITY ASSURANCE FOR
PRODUCTS TERMINALLY STERILIZED IN THEIR SEALED CONTAINER BY A VALIDATED
STERILIZATION PROCESS 13.1.6 RISK CONSIDERATION FOR FAILURE OF TERMINAL
STERILIZATION PROCESSES AND SIGNIFICANCE OF THE STERILITY TEST FOR
FAILURE DETECTION 13.1.7 STERILITY TESTING AND RELEASE OF ASEPTICALLY
MANUFACTURED PRODUCT 13.2 BASIC CONSIDERATIONS FOR PARAMETRIC RELEASE
427 13.2.1 PRINCIPLE OF PARAMETRIC RELEASE 13.2.2 ELEMENTS NEEDED FOR
SAFE RELEASE OF STERILE PRODUCTS 13.2.3 ELEMENTS CONSIDERED FOR
PARAMETRIC RELEASE 13.2.4 PARAMETRIC RELEASE AND AUTOMATED MANUFACTURE
13.2.5 AVAILABILITY OF NEW TECHNOLOGIES AND PARAMETRIC RELEASE 13.2.6
ASEPTIC PROCESSING AND PARAMETRIC RELEASE 13.3 HISTORY OF PARAMETRIC
RELEASE AND PRESENT POSITIONS OF THE AUTHORITIES 433 13.3.1 SITUATION IN
THE UNITED STATES OF AMERICA 13.3.2 SITUATION IN EUROPE 13.3.3 SITUATION
IN JAPAN 13.3.4 THE POSITION OF OFFICIAL REFERENCE LABORATORIES 13.3.5
POSITIONS OF PHARMACEUTICAL MANUFACTURERS 13.4 THE FUTURE OF PARAMETRIC
RELEASE 444 13.4.1 UNDECIDED MANUFACTURERS 13.4.2 CRITICISM OF THE
POSITIONS OF THE AUTHORITIES 13.4.3 NEED FOR A RISK-BASED APPROACH 14.
RAW MATERIAL CONTAMINATION CONTROL 449 LISA GONZALES 14.1 INTRODUCTION
449 14.2 RAW MATERIAL REQUIREMENTS FOR GMP 450 CONTENTS XIX 14.3
INCOMING INSPECTION OF RAW MATERIALS PROGRAM 451 14.4 QUALIFICATION OF
SUPPLIERS 454 15. ENDOTOXIN: WORST-CASE PARENTERAL PYROGEN 461 KEVIN L.
WILLIAMS 15 15 15 15 .1 - .3 .4 INTRODUCTION ENDOTOXIN NOMENCLATURE
AND AS A PYROGEN STRUCTURE OVERVIEW WHV THE PARENTERAL FOCUS ON
CLASSIFICATION ENDOTOXIN ? 461 462 463 466 15.5 CONTAMINATION CONTROL
PHILOSOPHY IN PARENTERAL MANUFACTURING 471 15.6 DEVELOPING AN ENDOTOXIN
CONTROL STRATEGY FOR DRUG SUBSTANCES EXCIPIENTS 473 BET STANDARDIZATION
477 ORIGIN AND IMPORTANCE OF LAL 482 LAL DISCOVERY 483 HEMOLYMPH
COAGULATION IN LIMULUS AND TACHYPLEUS 485 PROMINENT LAL TESTS 487 METHOD
DEVELOPMENT AND VALIDATION THE IMPORTANCE OF A GOOD TEST 492 RESOLVING
TEST INTERFERENCES 500 SETTING ENDOTOXIN SPECIFICATIONS 500
DEPYROGENATION VALIDATION 503 ENDOTOXIN REMOVAL IN PHARMACEUTICAL
MANUFACTURING PROCESSES 512 THE FUTURE AND ENDOTOXIN TESTING 513 THE
WHOLE BLOOD PYROGEN TEST 518 16. SCREENING ACTIVE PHARMACEUTICAL
INGREDIENTS AND F.XCIPIENTS FOR ENDOTOXIN 531 JAMES F. COOPER 16.1
OVERVIEW 16.2 REGULATORY DOCUMENTS FOR THE BET 16.3 ENDOTOXIN ALERT
LEVELS (EAL) FOR APIS 16.4 SYNERGISTIC EFFECT OF ENDOLOXIN WITH OTHER PV
LOGONS 16.5 ENDOTOXIN LIMITS FOR STERILE PHARMACY COMPOUNDING 16.6
ENDOTOXIN LIMITS FOR EXCIPIENTS 16.7 INTERFERENCE TESTING FOR APIS AND
EXCIPIENTS 15.7 15.8 1 15 15 15 15 15 15 15 15 15 5.9 .10 .11 .12 .13
.14 .15 .16 .17 .18 CONTENTS 17. VIRAL AND PRION CLEARANCE STRATEGIES
FOR BIOPHARMACEUTICAL SAFETY HAZEL ARANHA 17.1 BIOPHARMACEUTICAL
MANUFACTURING: GENERAL CONSIDERATIONS 17.2 SOURCES OF VIRAL CONTAMINANTS
^43 17.3 VIRUS DETECTION METHODS 545 17.4 REGULATORY CONSIDERATIONS: A
RISK-BASED APPROACH 547 17.5 HOW MUCH VIRAL CLEARANCE IS ENOUGH ? 548
17.6 VIRUS CLEARANCE METHODS 549 17.6.1 GENERAL CONSIDERATIONS 17.6.2
VIRAL CLEARANCE METHODS DISCUSSION 17.6.3 PROCESS VALIDATION FOR VIRAL
CLEARANCE 17.6.4 PROCESS ANALYSIS AND EVALUATION OF PROCESSES TO
VALIDATE FOR VIRAL CLEARANCE 17.6.5 VIRAL CLEARANCE STUDIES: SCALING
CONSIDERATIONS AND IDENTIFICATION OF CRITICAL PARAMETERS 17.7 TECHNICAL
ASPECTS OF STUDY DESIGN 17.7.1 CHOICE OF PANEL OF TEST VIRUSES 17.7.2
VIRUS-STOCK-RELATED CONSIDERATIONS 17.7.3 IMPORTANCE OF ADEQUATE
CONTROLS IN VIRUS STUDY DESIGN 17.8 CONSIDERATIONS IN DATA
INTERPRETATION AND ESTIMATING VIRAL CLEARANCE 17.9 VIRAL CLEARANCE
VALIDATION STUDIES: PITFALLS AND CAUTIONS 8 17.10 PRIONS 559 17.11
ETIOLOGY OF PRION DISEASES 561 17.12 MODE OF PRION TRANSMISSION ^ 17.13
PRION DETECTION METHODS 564 17.14 PRION CLEARANCE: A RISK-BASED APPROACH
566 17.14.1 RISK MINIMIZATION 17.14.2 SOURCING 17.14.3 RISK MANAGEMENT
17.14.4 PRION CLEARANCE METHODS 17.15 PROCESS CLEARANCE EVALUATION:
CONSIDERATIONS AND DESIGN ISSUES 570 17.15.1 SPIKING AGENTS 17.15.2
RELEVANCE OF THE SPIKING AGENT 17.15.3 DETECTION METHODS USED IN PROCESS
CLEARANCE EVALUATION STUDIES CONTENTS 17.16 CONSIDERATIONS IN DATA
INTERPRETATION AND ESTIMATING PRION CLEARANCE 572 17.17 CONCLUSION 572
PART IV SAMPLING, MONITORING, AND IDENTIFYING CONTAMINANTS 18.
STATISTICAL SAMPLING CONCEPTS 585 HEW A SARANADASA 18.1 INTRODUCTION 585
18.2 POISSON PROBABILITY DISTRIBUTION 586 18.2.1 EXAMPLE 18.3 THE LIMIT
OF QUANTITATION 589 18.4 LIKELIHOOD OF NOT DETECTING AN ORGANISM 589
18.5 HYPERGEOMETRIC DISTRIBUTION 592 18.6 LOT-BY-LOT ACCEPTANCE SAMPLING
ATTRIBUTES 594 18.7 OPERATING CHARACTERISTIC CURVE 595 18.8 METHOD OF
DESIGNING A SAMPLING PLAN 596 18.8.1 COMPUTATION STRATEGY 18.8.2 EXAMPLE
18.8.3 INSPECTION LEVELS 18.8.4 EXAMPLE 18.9 VARIABLE TYPE SAMPLING
PLANS 602 18.9.1 EXAMPLE 18.10 MIL STANDARD PLANS FOR VARIABLE TYPE 603
18.10.1 EXAMPLE 18.11 COMMON TYPES OF STATISTICS 605 18.11.1 EXAMPLE 19.
ENVIRONMENTAL MONITORING 609 JOHN LDH ISON. PETRU FSSWEIN. LOTHAR DAIL.
AND I IRICH PTLUGMACHCR 19.1 INTRODUCTION 60 ) 19.2 MICROBIOLOGICAL
MONITORING 6|N 19.2.1 REQUIREMENTS AND PROCEDURES 19.2.2 TEST
PROCEDURES. TEST PROGRAM. LIMITS, AND DATA EVALUATION 19.2.3 ROUTINE
ENVIRONMENTAL MONITORING PRO;- 1 11 CONTENTS XXII 19.2.4 WATER
SAMPLES 19.2.5 BIOBURDEN SAMPLES 19.2.6 GAS SAMPLES 19.2.7
IDENTIFICATION OF CONTAMINANTS 19.3. PANICULATE MONITORING AND OTHER
PARAMETERS 621 19.3.1 PURPOSE OF PANICULATE MONITORING 19.3.2 TEST
METHODS AND EQUIPMENT FOR PANICULATE MONITORING 19.3.3 RESULTS AND
DEVIATIONS 19.3.4 OTHER ENVIRONMENTAL PARAMETERS 19.4 OVERALL
PERFORMANCE OF ENVIRONMENTAL MONITORING 6 19.5 OVERALL QUALITY
ASSESSMENT OF ENVIRONMENTAL MONITORING DATA 62 20. PREVENTION AND
TROUBLESHOOTING OF MICROBIAL EXCURSIONS 625 ELAINE KOPIS SARTAIN 20.1
INTRODUCTION 625 20.2 FACILITIES DESIGN 626 20.3 PERSONNEL MANAGEMENT
20.4 CLEANING AND SANITIZATION PROGRAMS ^ 20.5 CONCLUSION 633 21.
SIMULATION OF ASEPTIC MANUFACTURE **35 NIGEL A. HALLS 21.1 INTRODUCTION
* 35 21.2 SIMULATION: ITS PURPOSE 636 21.3 PLACEBOS 638 21.4 PROCESS
SIMULATION 640 21.4.1 SIMULATION OF AQUEOUS LIQUID ASEPTIC FILLING
PROCESSES 21.4.2 SIMULATION OF LYOPHILIZATION PROCESSES 21.4.3 WHAT
SHOULD AND WHAT SHOULD NOT BE SIMULATED? 21.4.4 SIMULATION OF SOLID
DOSAGE FORM ASEPTIC FILLING PROCESSES 21.4.5 SIMULATION OF PROCESSES
INVOLVING ASEPTIC BULK COMPOUNDING BEFORE FILLING CONTENTS 21.4.6
SIMULATION OF ASEPTIC MANUFACTURE OF STERILE SOLID ACTIVE PHARMACEUTICAL
INGREDIENTS 21.5 MICROBIOLOGICAL CONTROLS 655 21.5.1 STERILITY AND
GROWTH SUPPORT CONTROLS 21.5.2 CONTROLS INTENDED TO EXPOSE INCIDENTAL OR
LABORATORY CONTAMINATION 21.5.3 ENVIRONMENTAL MONITORING AND MEDIA FILL
OBSERVATION 21.6 INCUBATION OF SIMULATION TRIALS 660 21.7 APPLICATION
663 21.7.1 SIMULATION TRIALS IN VALIDATION OF ASEPTIC- PROCESSES 21.7.2
SIMULATION TRIALS IN VALIDATION OF ASEPTIC PROCESSES FOR MANUFACTURE OF
STERILE APIS 21.7.3 PERIODIC SIMULATION TRIALS IN ROUTINE OPERATION 22.
STANDARD METHODS OF MICROBIAL IDENTIFICATION 677 MYRON SASSER 22.1
INTRODUCTION 677 22.2 BIOCHEMICAL TEST-BASED IDENTIFICATION 67S 22.2.1
BASIC PREMISES 22.2.2 METHODOLOGY 22.2.3 MANUAL BIOCHEMICAL-TEST SYSTEMS
22.2.4 AUTOMATED BIOCHEMICAL-TEST SYSTEMS 22.3 FATTY ACID BASED
IDENTIFICATION 680 22.3.1 BASIC PREMISES 22.3.2 METHODOLOGY 22.4 FACTORS
TO CONSIDER IN CHOICE OF SYSTEM FOR IDENTIFICATION OF BACTERIA 681 22.5
CONCLUSION 683 23. RAPID METHODS OF MICROBIAL IDENTIFICATION 685 LUIS
JIMENEZ 23.1 INTRODUCTION 685 23.2 ATP BIOLUMINESCENCE 686 23.3 DIRECT
VIABLE COUNTS (DVC) 692 XXIV CONTENTS 23.4 FLOW CYTOMETRY 693 23.5
IMPEDANCE 694 23.6 PCR TECHNOLOGY 695 23.7 IMMUNOASSAYS 698 23.8
CRITERIA FOR VALIDATING RAPID METHODS 702 23.9 CONCLUSION 704 INDEX
709
|
| any_adam_object | 1 |
| building | Verbundindex |
| bvnumber | BV019825464 |
| callnumber-first | R - Medicine |
| callnumber-label | RS199 |
| callnumber-raw | RS199 |
| callnumber-search | RS199 |
| callnumber-sort | RS 3199 |
| callnumber-subject | RS - Pharmacy |
| classification_rvk | VX 8300 |
| ctrlnum | (OCoLC)56593313 (DE-599)BVBBV019825464 |
| 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 | Book |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01712nam a2200445 cb4500</leader><controlfield tag="001">BV019825464</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">00000000000000.0</controlfield><controlfield tag="007">t</controlfield><controlfield tag="008">050530s2004 ad|| |||| 00||| eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">0824753208</subfield><subfield code="9">0-8247-5320-8</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)56593313</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV019825464</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rakddb</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-19</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">RS199</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">615.19</subfield><subfield code="2">22</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">VX 8300</subfield><subfield code="0">(DE-625)147825:253</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Microbial contamination control in parenteral manufacturing</subfield><subfield code="c">ed. by Kevin L. Williams</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">New York [u.a.]</subfield><subfield code="b">Dekker</subfield><subfield code="c">2004</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">XXVI, 721 S.</subfield><subfield code="b">Ill., graph. Darst.</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">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="490" ind1="1" ind2=" "><subfield code="a">Drugs and the pharmaceutical sciences</subfield><subfield code="v">140</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Contamination</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Microbiologie - Technique</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Médicaments - Essais cliniques - Politique gouvernementale - États-Unis</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drug Contamination</subfield><subfield code="x">prevention & control</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drug Industry</subfield><subfield code="x">methods</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Microbiology</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Parenteral solutions</subfield><subfield code="x">Contamination</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Parenteral solutions</subfield><subfield code="x">Quality control</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Pharmaceutical Solutions</subfield><subfield code="x">standards</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Quality Control</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Williams, Kevin L.</subfield><subfield code="e">Sonstige</subfield><subfield code="4">oth</subfield></datafield><datafield tag="830" ind1=" " ind2="0"><subfield code="a">Drugs and the pharmaceutical sciences</subfield><subfield code="v">140</subfield><subfield code="w">(DE-604)BV000002008</subfield><subfield code="9">140</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">GBV Datenaustausch</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013150654&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Inhaltsverzeichnis</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-013150654</subfield></datafield></record></collection> |
| id | DE-604.BV019825464 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T20:06:59Z |
| institution | BVB |
| isbn | 0824753208 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-013150654 |
| oclc_num | 56593313 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM |
| owner_facet | DE-19 DE-BY-UBM |
| physical | XXVI, 721 S. Ill., graph. Darst. |
| publishDate | 2004 |
| publishDateSearch | 2004 |
| publishDateSort | 2004 |
| publisher | Dekker |
| record_format | marc |
| series | Drugs and the pharmaceutical sciences |
| series2 | Drugs and the pharmaceutical sciences |
| spelling | Microbial contamination control in parenteral manufacturing ed. by Kevin L. Williams New York [u.a.] Dekker 2004 XXVI, 721 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 140 Contamination Microbiologie - Technique Médicaments - Essais cliniques - Politique gouvernementale - États-Unis Drug Contamination prevention & control Drug Industry methods Microbiology Parenteral solutions Contamination Parenteral solutions Quality control Pharmaceutical Solutions standards Quality Control Williams, Kevin L. Sonstige oth Drugs and the pharmaceutical sciences 140 (DE-604)BV000002008 140 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013150654&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Microbial contamination control in parenteral manufacturing Drugs and the pharmaceutical sciences Contamination Microbiologie - Technique Médicaments - Essais cliniques - Politique gouvernementale - États-Unis Drug Contamination prevention & control Drug Industry methods Microbiology Parenteral solutions Contamination Parenteral solutions Quality control Pharmaceutical Solutions standards Quality Control |
| title | Microbial contamination control in parenteral manufacturing |
| title_auth | Microbial contamination control in parenteral manufacturing |
| title_exact_search | Microbial contamination control in parenteral manufacturing |
| title_full | Microbial contamination control in parenteral manufacturing ed. by Kevin L. Williams |
| title_fullStr | Microbial contamination control in parenteral manufacturing ed. by Kevin L. Williams |
| title_full_unstemmed | Microbial contamination control in parenteral manufacturing ed. by Kevin L. Williams |
| title_short | Microbial contamination control in parenteral manufacturing |
| title_sort | microbial contamination control in parenteral manufacturing |
| topic | Contamination Microbiologie - Technique Médicaments - Essais cliniques - Politique gouvernementale - États-Unis Drug Contamination prevention & control Drug Industry methods Microbiology Parenteral solutions Contamination Parenteral solutions Quality control Pharmaceutical Solutions standards Quality Control |
| topic_facet | Contamination Microbiologie - Technique Médicaments - Essais cliniques - Politique gouvernementale - États-Unis Drug Contamination prevention & control Drug Industry methods Microbiology Parenteral solutions Contamination Parenteral solutions Quality control Pharmaceutical Solutions standards Quality Control |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=013150654&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000002008 |
| work_keys_str_mv | AT williamskevinl microbialcontaminationcontrolinparenteralmanufacturing |