Sources of contamination in medicinal products and medical devices:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Oxford
Wiley-Blackwell
2013
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XIX, 571 S. Ill., graph. Darst. 28 cm |
| ISBN: | 9780470487501 047048750X |
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| 245 | 1 | 0 | |a Sources of contamination in medicinal products and medical devices |c Denise Bohrer |
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| 653 | |a Microbial contamination. | ||
| 653 | |a Pharmaceutical technology--Standards. | ||
| 653 | |a Pharmaceutical industry--Quality control. | ||
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Datensatz im Suchindex
| _version_ | 1804150114636267520 |
|---|---|
| adam_text | Titel: Sources of contamination in medicinal products and medical devices
Autor: Bohrer, Denise
Jahr: 2013
CONTENTS
PREFACE xv
ACKNOWLEDGMENTS xix
1 Introduction 1
Reference 6
2 Directives for Contamination Control 7
PART I CHEMICAL CONTAMINATION 17
3 Raw Materials 19
3.1 Water 19
3.2 Inorganic Impurities 27
3.3 Organic Impurities 32
3.3.1 By-products 32
3.3.2 Genotoxic Impurities (GTIs) 35
3.3.3 Degradation Products 39
3.4 Additives 52
3.5 Residual Solvents 58
Concluding Remarks 63
References 65
4 Medicinal Gases and Volatile Anesthetics 70
4.1 Medicinal Gases 70
4.2 Volatile Anesthetics cSO
Concluding Remarks 93
References 94
ix
X
5 Diagnostic Imaging Agents
5.1 Radiopharmaceuticals
5.1.1 Technetium-Based Products
5.1.1.1 Production of Mo-99
5.1.1.2 Generation of Tc-99m
5.1.1.3 Labeling Procedures
5.1.2 Iodine-Based Products
5.1.3 Fluorine-Based Products
5.1.3.1 [18F]FDG Production and Labeling
5.1.3.2 Species Formed during [180]H20
Irradiation
5.1.3.3 Residual Solvents and Components
Used in the Labeling
5.1.3.4 Radiolysis Products Generated by
Elevated Activity of the Labeled
Compound
5.2 Contrast Agents
5.2.1 Gadolinium-Based Products
5.2.2 Iodine-Based Products
5.2.3 Barium Sulfate
Concluding Remarks
References
6 Containers
6.1 Glass Containers
6.2 Plastic Containers
6.2.1 Polymer Formation
6.2.2 PVC Containers
6.2.3 Other Plastic Containers
6.3 Metal Containers
Concluding Remarks
References
7 Closures
Concluding Remarks
References
8 Delivery Systems and Filters
8.1 Delivery Systems Made of PVC
8.2 Delivery Systems Made of Other Plastic Materials
8.3 Filters
Concluding Remarks
References
CONTENTS
96
98
100
100
103
107
113
125
127
128
137
140
143
143
158
172
176
177
185
185
199
199
203
215
220
223
223
228
256
256
259
260
275
282
287
287
CONTENTS
xi
9 Medical Devices 290
9.1 General Use Devices 293
9.1.1 Medical Gloves 294
9.1.2 Syringes 294
9.2 Extracorporeal Circuits 300
9.3 Devices for Administration of Aerosolized Drugs 307
9.4 Reprocessed Medical Devices 308
9.5 Tissue Substitutes 309
9.5.1 Skin Substitutes and Surgical Dressings 310
9.5.2 Hard Tissue Substitutes 310
9.5.3 Soft Tissue Substitutes 311
Concluding Remarks 313
References 313
PART II PHYSICAL CONTAMINATION 317
10 Particulate Matter 319
Concluding Remarks 345
References 345
PART III MICROBIOLOGICAL CONTAMINATION 349
11 Microbiological and Endotoxin Contamination 351
11.1 Water 355
11.2 Raw Materials 361
11.3 Sterile Products 367
11.3.1 Single-and Multiple-Dose Products 368
11.3.2 Parenteral Nutrition (PN) 371
11.3.3 Propofol 378
11.3.4 Ophthalmic Products 384
11.4 Medicinal Gases 393
11.5 Medical Devices 394
11.5.1 Syringes 395
11.5.2 Endoscopes 398
11.5.3 Other Devices 401
11.6 Biofilms 406
11.7 Dialysis Circuits 407
11.8 Nosocomial Infections 413
Concluding Remarks 420
References 422
xii
CONTENTS
PART IV MISCELLANEOUS 433
12 Contamination from Sterilization Procedures 435
12.1 Residuals from Radiation Sterilization 437
12.1.1 Radiolysis of Water 438
12.1.2 Effect of Ionizing Radiation on Drug Products 439
12.1.3 Polymers in Drug Delivery 440
12.1.3.1 Polylactide (PLA) and
Poly(lactide-co-glycolide) (PLGA) 443
12.1.3.2 Collagen 448
12.1.3.3 Cellulose and Other Polysaccharides 448
12.1.3.4 Alginate 450
12.1.4 Radiolysis of Selected Nondrug Components 450
12.1.4.1 Residual Solvents 450
12.1.4.2 Monosaccharides 451
12.1.4.3 Starch 451
12.1.5 Effect of Ionizing Radiation on Materials Used in
Packaging and in Medical Devices 454
12.1.5.1 Ultra-High-Molecular-Weight
Polyethylene (UHMWPE) 456
12.1.5.2 Polyurethane (PU) 458
12.1.5.3 Silicone 464
12.1.5.4 Polyamide (PA) 464
12.1.5.5 Poly(methyl methacrylate) (PMMA) 466
12.1.5.6 Polytetrafluoroethylene (PTFE) 468
12.1.5.7 Polyvinyl Chloride (PVC) 468
12.1.5.8 Polyethylene (PE) 470
12.1.5.9 Polypropylene (PP) 473
12.1.5.10 Polyethylene Terephthalate (PET) 478
12.1.5.11 Polystyrene (PS) 478
12.1.5.12 Polysulfone (PSf) 478
12.1.5.13 Ethylene Vinyl Acetate (EVA) 480
12.1.5.14 Multilayer Materials 482
12.2 Heat Sterilization 483
12.3 Residuals from Chemical Disinfection and
Sterilization Agents 486
12.3.1 Ethylene Oxide (EtO) 487
12.3.2 Peracetic Acid and Hydrogen Peroxide 494
12.3.3 Formaldehyde 497
Concluding Remarks 503
References 504
13 Biotechnological Products 512
13.1 DNA and HCP Residuals 516
13.2 Viruses and Mycoplasma 516
CONTENTS xiii
13.3 Endotoxin 518
13.4 Protein Degradation 522
13.5 Protein Aggregation 524
Concluding Remarks 530
References 530
Appendix Polymeric Materials: Components, Additives,
Extractables, and Degradation Products 533
References 553
INDEX
555
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| spelling | Bohrer, Denise Verfasser aut Sources of contamination in medicinal products and medical devices Denise Bohrer Oxford Wiley-Blackwell 2013 XIX, 571 S. Ill., graph. Darst. 28 cm txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Microbial contamination. Pharmaceutical technology--Standards. Pharmaceutical industry--Quality control. HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=025763410&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Bohrer, Denise Sources of contamination in medicinal products and medical devices |
| title | Sources of contamination in medicinal products and medical devices |
| title_auth | Sources of contamination in medicinal products and medical devices |
| title_exact_search | Sources of contamination in medicinal products and medical devices |
| title_full | Sources of contamination in medicinal products and medical devices Denise Bohrer |
| title_fullStr | Sources of contamination in medicinal products and medical devices Denise Bohrer |
| title_full_unstemmed | Sources of contamination in medicinal products and medical devices Denise Bohrer |
| title_short | Sources of contamination in medicinal products and medical devices |
| title_sort | sources of contamination in medicinal products and medical devices |
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