Pharmaceutical Packaging Handbook

Name: Pharmaceutical Packaging Handbook
Brand: Taylor & Francis Inc
Price: 267.5 AUD
Availability: BackOrder

By: Edward Bauer

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Hardcover | 24 March 2009 | Edition Number 1

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Hardcover
604 Pages

Dimensions(cm)
24.13 x 15.88 x 3.81

Hardcover

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Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices. Supplying a thorough examination of the industry in size and scope, the book covers drug dosage forms, vaccines, biologically produced products, and medical foods.

Features:

Discusses how packaging is designed and integrated into the product development cycle
Provides an overview of the regulatory environment procedures
Describes the materials used to package pharmaceuticals, including glass, metal, plastics, flexible films, rubber, and elastomers
Examines new hybrids used for packaging
Explores the processing techniques used with the materials to produce pharmaceutical containers
Discusses some of the strengths and weaknesses of the processes used for container fabrication
Explains retort, aseptic, gas, and radiation sterilization of product
Reviews labeling and design for pharmaceuticals, including how labels are produced, materials used, and production techniques

Complete and straightforward, the book lists information in an easy to follow fashion, making it a complete standalone reference for anyone working in the pharmaceutical industry.

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Non-Fiction Medicine Other Branches of Medicine Pharmacology Science Biology, Life Sciences Engineering & Technology Industrial Chemistry & Manufacturing Technologies Industrial Chemistry Pharmaceutical Technology Industry & Industrial Studies Manufacturing Industries

Pharmaceutical Industries Technology in General Engineering in General Environmental Science

Preface	p. iii
Introduction to the Pharmaceutical Industry: An Overview	p. 1
Introduction	p. 1
General Aspects of Drug Packaging	p. 1
Brief History	p. 3
General Business Overview of the Pharmaceutical Industry	p. 6
General Industry Challenges and Trends	p. 9
The Evolution and Structure of the Pharmaceutical Business	p. 9
Therapecutic Areas of Concentration	p. 11
General Worldwide Pharmaceutical Trends	p. 12
Cost and Pricing Trends	p. 13
Generic Products	p. 13
OTC Products	p. 14
Definition of a Drug	p. 14
The Differences Between Pharmaceutical and Food Packaging	p. 15
Drug Regulations	p. 18
The Function of Packaging	p. 19
Trends in Pharmaceutical Packaging	p. 20
Current Trends in Packaging	p. 20
Influences Impacting Packaging	p. 21
Summary	p. 29
References	p. 29
Pharmaceutical Dosage Forms and Their Packaging Requirements	p. 31
Introduction	p. 31
Stability	p. 32
Chemical Change	p. 32
Thermal Protection	p. 36
Chemical Reactions	p. 37
Moisture Protection-Protecting the API from Hydrolysis	p. 38
Oxidation-Reactions with Oxygen	p. 40
Light Protection	p. 41
Mathematical Methods and Accelerated Methods for Assessing Shelf Life	p. 42
Purity and Sterility	p. 42
Drug Purity	p. 43
Quality Assurance	p. 44
Drug Sterility	p. 45
Drug Physiology	p. 48
Oral Administration of Drug Products-Gastrointestinal Methods	p. 48
Direct Injection of Drug Products	p. 50
Topical Administration of Drugs, Transdermal Methods	p. 51
Topical Administration	p. 51
Administration of Drugs through Mucus Membranes, Inhalation, and Nasal Administrations	p. 52
Rectal Administration of Drugs	p. 54
Dosage Forms of Drugs	p. 54
Solids	p. 55
Liquids	p. 75
Gases	p. 81
Summary	p. 90
Further Reading	p. 91
References	p. 91
Vaccines and Biologically Produced Pharmaceuticals	p. 93
Introduction	p. 93
Biologic Products	p. 94
Biologic Drugs	p. 95
Vaccines	p. 99
Types of Vaccines	p. 102
Summary	p. 109
Further Reading	p. 109
References	p. 109
Medical Foods	p. 111
Introduction	p. 111
History of Medical Foods	p. 112
Regulatory Requirements of Medical Foods	p. 113
Medical Foods	p. 114
Composition and Formulation of Medical Nutritional Products	p. 115
Nutritionally Complete Products	p. 117
Nutritionally Incomplete Products	p. 118
Formulas for Metabolic or Genetic Disorders	p. 118
Oral Rehydration Solutions	p. 118
Enteral Packaging	p. 118
Medical Food Administration to the Patient	p. 119
Tube Feeding	p. 120
Parenteral Nutrition	p. 121
Parenteral Formulations for Intravenous Feeding	p. 121
Infant Formulas	p. 124
Prenatal Nutritional Products	p. 127
Juvenile Nutritional Products	p. 127
Medical Foods; Legislative Overview and Regulations	p. 127
Infant Formula Regulation	p. 129
Manufacture of Infant Formula and Medical Nutritional Products	p. 130
Retort Processing	p. 131
Aseptic Processing	p. 133
Cold Aseptic Sterilization-Aseptic Filtration	p. 135
Aseptic Manufacturing Equipment	p. 137
Aseptic Package Sterilization	p. 138
Mechanical Processes	p. 139
Thermal Processes	p. 140
Irradiation Processes	p. 140
Chemical Processes	p. 140
Combination Processes	p. 141
Aseptic Packaging Systems	p. 141
Fill and Seal	p. 141
Erect, Fill, and Seal	p. 141
Form, Fill, and Seal	p. 141
Thermoform, Fill, and Seal	p. 142
Blow Mold, Fill, and Seal	p. 142
Bulk Storage and Packaging	p. 143
Basic Principles of Thermal Processing	p. 144
Thermobacteriology	p. 144
Heat Exchange/Heat Transfer	p. 147
Deaeration	p. 148
Aseptic Surge Tanks	p. 149
Processing Authority	p. 149
The U.S. FDA/CFSAN Grade A Pasteurized Milk Ordinance	p. 151
USDA Requirements	p. 152
Sterilization Technologies Under Development	p. 153
Future Trends	p. 154
Further Reading	p. 154
References	p. 154
The Regulatory Environment	p. 157
Introduction	p. 157
Stages in the Identification and Qualification of a Drug	p. 159
Drug Discovery	p. 160
Preclinical Testing	p. 161
Investigational New Drug Review	p. 162
Clinical Trials	p. 163
Clinical Trials	p. 163
Clinical Trials	p. 163
Clinical Trials	p. 164
FDA Approval	p. 165
Post-Marketing Surveillance and Phase IV Studies	p. 165
The Regulatory Arena	p. 166
The United States Food and Drug Administration	p. 167
A General Overview of the Drug Approval Process	p. 170
The Drug Packaging Approval Process	p. 171
Current Good Manufacturing Practices	p. 173
Validation	p. 174
Electronic Data Submission, Electronic Specifications Systems, Elimination of Paper Records 21 CFR Part 11 Electronic Records	p. 176
Change Control	p. 179
Structured Product Labeling: Enterprise Content Management, Digital Asset Management	p. 180
The United States Pharmacopeia-National Formulary	p. 183
The United States Pharmacopeia Dictionary	p. 185
Consumer Product Safety Commission	p. 185
Summary	p. 186
Further Reading	p. 186
References	p. 187
Pharmaceutical Packaging Materials	p. 189
Introduction	p. 189
Glass Pharamaceutical Packaging	p. 192
Glass Composition	p. 192
Types of Glass Used for Pharmaceutical Packaging	p. 195
Glass	p. 196
Glass	p. 197
Glass	p. 197
USP Designation NP Glass	p. 198
Glass as a Pharmaceutical Packaging Material	p. 198
Metal Pharmaceutical Packaging	p. 200
Tinplate	p. 201
Can Coatings for Tinplate and Aluminum Cans	p. 202
Aluminum	p. 202
Metals as Pharmaceutical Packaging Materials	p. 203
Aerosol Cans	p. 205
Plastic Pharmaceutical Packaging	p. 206
Plastics Overview and Definition	p. 206
Introduction to Plastics	p. 208
A Plastic Primer	p. 208
Polymer Descriptions	p. 212
Classes of Polymers	p. 216
Determinants of a Polymer's Properties	p. 218
Chemical Attributes of Polymers	p. 219
Chemical Bonding	p. 219
Molecular Shape and Intramolecular Forces	p. 222
Viscoelastic Behavior	p. 225
Physical Properties of Polymers	p. 227
Temperature Dependence on Reaction Rates	p. 228
Plastics as Drug Packaging Materials	p. 229
Density Differences/Consumer Preference for Plastic/Easy Handling	p. 230
Design Freedom	p. 231
Plastic Disadvantages	p. 231
Chemical Inertness/Strees Cracking/Additives/Electrical Properties	p. 231
Common Plastic Pharmaceutical Packaging Materials	p. 232
Polyethylene Polymers	p. 232
High-Density Polyethylene	p. 234
Low-Density Polyethylene	p. 235
Linear Low-Density Polyethylene	p. 235
Polyethylene Restrictions in Drug Packaging	p. 237
Other Ethylene Polymers	p. 238
Ethylene Vinyl Acetate	p. 238
Ethylene Acrylic Acid	p. 240
Ionomers	p. 241
Ethylene Vinyl Alcohol	p. 242
Polyvinyl Alcohol	p. 244
Polypropylene	p. 245
Catalyst Background for Ethylene and Propylene Polymers	p. 248
Polyvinyl Chloride	p. 249
Polyvinylidene Chloride Copolymers	p. 252
Fluoropolymers	p. 254
Polystyrene	p. 255
Other Styrene-Modified Copolymers	p. 257
Polyamides (Nylon)	p. 258
Polyester	p. 259
Polyethylene Terephthalate	p. 260
Amorphous PET	p. 263
Crystallized PET	p. 263
PET Films	p. 264
Glycol-Modified Polyester	p. 264
Polyethylene Naphthalate	p. 264
Polycarbonate	p. 265
Polyurethane	p. 266
Acrylonitrile Polymers	p. 267
Rubbers and Elastomers	p. 268
Summary	p. 271
Further Reading	p. 271
References	p. 271
Medical Device Packaging	p. 273
Introduction	p. 273
Regulation of Medical Devices	p. 273
Medical Device Definitions and Testing Standards	p. 276
510 (k) Pre-market Notification	p. 278
Pre-market Approval of a Medical Device	p. 279
Good Manufacturing Compliance (CGMP)	p. 280
Establishment Registration	p. 281
Medical Device Reporting	p. 282
Harmonization of Standards for Terminally Sterilized Medical Device Packaging-United States and Europe	p. 282
An Overview of a Package Validation	p. 285
Major Elements of a Package Validation	p. 288
Validation Testing, Process Sampling, and Validation Reporting	p. 289
Sample Size Testing	p. 290
Test Methods	p. 290
Distribution Testing	p. 291
Accelerated Aging	p. 292
ISO Standards	p. 293
References	p. 293
Container Fabrication	p. 295
Introduction	p. 295
Glass Containers	p. 297
Blow Molding of Glass Containers	p. 297
Annealing and Treating-Glass Finishing	p. 300
Tubular Glass Fabrication-USP Type I Glass	p. 303
Metal Containers-Cans	p. 305
Draw-Redraw Cans	p. 308
Draw and Iron Cans	p. 309
Welded Cans-Three-Piece Cans	p. 311
Metal Tubes	p. 314
Plastic Containers	p. 314
Bottles and Vials	p. 314
Thermoforming of Pharmaceutical Containers	p. 320
Blister Packaging	p. 320
Large Thermoformed Packages-Strip, Tray, and Clamshell Packages for Medical Devices	p. 327
Pouches	p. 330
Form, Fill, and Seal Bottles	p. 336
Plastic Tubes	p. 339
Laminated Tubes	p. 341
Summary	p. 342
Further Reading	p. 342
References	p. 342
Sterilization Technology	p. 345
Introduction	p. 345
Overview of Sterilization Requirements	p. 346
Heat Sterilization Techniques	p. 352
Sterilization Using Steam and Pressure (Autoclave)	p. 352
Sterilization by Boiling	p. 355
Dry Heat	p. 356
Other Heat Sterilization Methods	p. 356
Chemical Sterilization	p. 357
Eto Sterilization	p. 357
Other Chemical Sterilants	p. 365
Radiation Sterilization	p. 368
¿-Ray Sterilization	p. 368
X-Rays and Electron Beam (E-Beam) Sterilization	p. 373
UV Light	p. 375
Sterile Filtration	p. 376
Regulatory Overview	p. 376
Monitoring Sterilization Processes	p. 382
Mechanical, Chemical, and Biologic Indicators	p. 382
Summary	p. 384
References	p. 385
Container Closure Systems: Completing All Types of Filled Pharmaceutical Containers	p. 387
Introduction	p. 387
Closure Functions	p. 389
Protections	p. 390
Containment	p. 390
Complete and Positive Sealing	p. 390
Access (The Ability to Open and Close a Package Repeatedly and Safely)	p. 390
Consumer Communication	p. 391
Display	p. 391
Metering and Measuring	p. 392
Types of Closures	p. 393
Closures for Metal Cans	p. 393
Bottles and Jars	p. 393
Threaded Closures	p. 395
Friction-Fit Closures	p. 399
Crown Closures	p. 399
Snap-Fit Closures	p. 400
Press-on Vacuum Caps	p. 400
Vial Stoppers	p. 401
Flanged Plug Elastomeric Stoppers	p. 401
Flanged Hollow Plug with Cutouts for Lyophilized Products	p. 402
Flanged Elastomeric Plug with Plastic Overseal	p. 403
Metal Closure with and Elastomeric Disk	p. 403
Elastomeric Closure Performance	p. 403
Tube Closures	p. 405
Specialty Closures	p. 405
Dispensing Closures and Closures with Applicators	p. 406
Fitment Closures	p. 407
Spray and Pump Dispensers	p. 407
Single-Dose Closures	p. 408
Compliance (Adherence)	p. 409
Closure Liners	p. 410
Composition of Closure Liners	p. 411
Linerless Closures	p. 412
Child-Resistant Closures	p. 412
Child-Resistant Testing of Closures-An Overview	p. 417
Design of Child-Resistant Closures	p. 420
Combination Closures	p. 421
Aerosol Closures	p. 421
Non-reclosable Packages	p. 421
Pouches	p. 421
Tamper-Evident Packaging Closures	p. 422
Ease of Opening	p. 425
Capsule Problems	p. 425
Heat Sealing	p. 426
Peelable Seals	p. 429
Summary	p. 430
References	p. 430
Labels and Labeling	p. 433
Introduction	p. 433
History of Drug Labels	p. 435
Labeling Requirements	p. 435
Prescription Drug Labeling	p. 435
Label Information	p. 437
Drug Facts Labeling-OTC Pharmacentical Products	p. 443
NDC Number-The National Drug Code	p. 447
Label Construction	p. 448
Types of Labels	p. 448
Label and Package Printing	p. 454
Overview of Bar Code Administration: GSI Designations	p. 469
Universal Product Code Numbers	p. 470
The Global Trade Item Numbers	p. 472
Bar Codes	p. 474
GSI Standards Organization	p. 477
EAN International Article Numbering Association and UCC	p. 477
Two Dimensional Codes (2-D Data Matrix and other Matrix Codes)	p. 479
RSS Codes	p. 484
RSS-14	p. 485
RSS Limited	p. 486
RSS Expanded	p. 486
Composite Components of the Codes	p. 487
Composite Code A (CC-A)	p. 487
Composite Code B (CC-B)	p. 487
Composite Component C (CC-C)	p. 487
Code Category Overview	p. 488
Narrow-With Bar Code Symbologies	p. 488
Pulse-Width Modulated Bar Code	p. 489
Multi-Width Modular Codes	p. 489
References	p. 490
Issues Facing Modern Drug Packaging	p. 493
Introduction	p. 493
Compliance or Adherence to Drug Regimens	p. 496
Unit Dose Packaging	p. 501
Anticounterfeiting Packaging	p. 505
Detailed Product Information	p. 510
Transaction Details	p. 510
Environmental Issues	p. 511
Packaging and the Environment	p. 512
United States Recycling Programs	p. 516
Collection Methods for Recycling	p. 518
European Recycling Programs	p. 521
Plastic Packaging and the Environment	p. 523
Recycling Rates for Plastic Packaging	p. 523
U.S. Municipal Solid Waste: An Overview	p. 524
Infectious Waste	p. 524
Biodegradable Plastics	p. 525
Biodegradable Materials	p. 527
Starch-Based Plastics	p. 527
Lactic Acid Polymers	p. 528
Polyesters	p. 529
Other Biodegradable Polymers	p. 530
Naturally Occurring Biodegradable Polymers	p. 531
Other Pharmaceutical Packaging Issues	p. 532
References	p. 534
Glossary of Terms	p. 537
Bibliography	p. 561
Index	p. 565
Table of Contents provided by Ingram. All Rights Reserved.

Pharmaceutical Packaging Handbook

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