Industrial Pharmacy
Handbook of Topical Antimicrobials: Industrial Applications in Consumer Products and Pharmaceuticals
This reference examines laboratory techniques and FDA and industry perspectives on medical, food service, and consumer product applications of antimicrobials. It offers methods to conduct investigations of effectiveness that simulate use of consumer, food, and medical antimicrobials in real-world conditions and environments, validate neutralizing systems, develop reliable and functional antimicrobial products, and prevent infection, disease, and contamination. Additional topics include the importance of customer-valued quality attributes, such as low skin irritation and ease of use, label claims, regulatory procedures, and quality control, and clinical simulation protocols.
Table of contents :
Cover......Page 1
HANDBOOK OF TOPICAL ANTIMICROBIALS INDUSTRIAL APPLICATIONS IN CONSUMER PRODUCTS AND PHARMACEUTICALS......Page 2
ISBN-13: 9780824707880......Page 3
PREFACE......Page 4
CONTENTS......Page 6
CONTRIBUTORS......Page 9
PART I OVERVIEW......Page 11
A. SOCIETAL REQUIREMENTS......Page 12
C. PERSONAL OBJECTIVE ATTRIBUTES......Page 13
II. A CHRONIC PROBLEM: REDUCTIONISM......Page 14
IV. HEALTHCARE CONTINUUM MODEL......Page 15
B. SOCIETAL REQUIREMENTS......Page 16
C. CULTURAL REQUIREMENTS......Page 17
A. PERSONAL OBJECTIVE......Page 18
D. PERSONAL SUBJECTIVE......Page 19
B. SOCIETAL REQUIREMENTS......Page 20
A. PERSONAL OBJECTIVE......Page 21
C. CULTURAL REQUIREMENTS......Page 23
D. PERSONAL SUBJECTIVE......Page 24
C. CULTURAL REQUIREMENTS......Page 25
REFERENCES......Page 26
CHAPTER 2 FOOD AND DRUG ADMINISTRATION PERSPECTIVE ON TOPICAL ANTISEPTIC DRUG PRODUCT DEVELOPMENT......Page 28
II. FDA REGULATORY PROCESS......Page 29
A. DEVELOPMENT OF EFFICACY STANDARDS FOR OTC TOPICAL ANTISEPTIC DRUG PRODUCTS......Page 30
A. IN VITRO AND TIME KILL KINETIC STUDIES......Page 46
B. CLINICAL SIMULATION STUDIES......Page 49
C. NEUTRALIZATION......Page 50
D. RESISTANCE TO ANTISEPTICS......Page 52
IV. CONCLUSIONS......Page 54
REFERENCES......Page 55
I. INTRODUCTION......Page 58
II. BACKGROUND......Page 59
IV. GENERAL POPULATION PRODUCTS: ANTIMICROBIAL HANDWASH AND ANTIMICROBIAL BODYWASH......Page 61
B. PUBLIC HEALTH IMPORTANCE......Page 62
C. ANTIMICROBIAL HANDWASHES......Page 64
D. FOODHANDLER HANDWASH......Page 67
E. HEALTHCARE PERSONNEL HANDWASH......Page 69
F. SURGICAL PRODUCTS: PREOPERATIVE SKIN PREPARATIONS AND SURGICAL SCRUBS......Page 71
V. EFFECTIVENESS TEST METHODS......Page 72
C. REDUCTION OF TRANSMISSION DURING PRESURGICAL/ SURGICAL, PREINJECTION PROCEDURES (SURGICAL SCRUB, PREOP PREP)......Page 74
REFERENCES......Page 75
PART II TOPICAL ANTIMICROBIALS......Page 80
I. ANTISEPSIS AND THE DEVELOPMENT OF IODINE ANTIMICROBIALS......Page 85
II. THE BIOCHEMISTRY OF POVIDONE-IODINE......Page 87
III. MECHANISM OF ACTION OF PVP-I AS AN ANTIMICROBIAL......Page 88
VI. CLINICAL USES OF PVP-I, GENERAL CONSIDERATIONS......Page 89
VII. PVP-I FOR PROPHYLACTIC PREOPERATIVE SKIN DECONTAMINATION......Page 93
IX. PVP-I AS A PROPHYLACTIC DISINFECTANT OF SUPERFICIAL ABRASIONS AND LACERATIONS......Page 94
X. PVP-I FOR MICROBIAL CONTAMINATION CONTROL OF ULCERS AND BURNS......Page 95
XI. COMPARISON OF PVP-I TO OTHER GENERAL ANTISEPTICS......Page 96
XII. AVOIDING ANTIBIOTICS WITH PVP-I......Page 97
A. PVP-I FUNCTION IN THE PRESENCE OF ORGANIC SUBSTANCES......Page 98
B. PVP-I AND WOUND REPAIR......Page 99
C. LOCAL IRRITATION AND SYSTEMIC TOXICITY......Page 100
XIV. CONCLUSION......Page 101
REFERENCES......Page 102
I. INTRODUCTION......Page 107
II. CHEMICAL DIVERSITY OF QACS......Page 108
III. CHEMICAL PROPERTIES OF QACS......Page 110
V. BENZETHONIUM CHLORIDE......Page 111
VII. CHEMICAL STRUCTURE AND MECHANISM OF QAC ANTIMICROBIAL ACTIVITY......Page 112
VIII. EFFECTS OF FORMULA COMPOSITION AND QAC ACTIVITY......Page 115
IX. SPECTRUM OF QAC ACTIVITY......Page 116
X. EXAMPLE OF BROAD-SPECTRUM ANTIMICROBIAL ACTIVITY FOR A BEC TOPICAL PRODUCT......Page 117
REFERENCES......Page 122
I. CHLORHEXIDINE GLUCONATE......Page 125
A. ANTIMICROBIAL ACTION......Page 126
A. SURGICAL SCRUB FORMULATIONS......Page 127
B. PREOPERATIVE SKIN PREPARATION......Page 128
C. HEALTHCARE PERSONNEL HANDWASH......Page 129
REFERENCES......Page 130
I. ALCOHOLS......Page 131
IV. ALCOHOLS FOR SKIN DEGERMING......Page 132
V. TRANSIENT MICROORGANISMS......Page 133
VI. RESIDENT SKIN MICROORGANISMS......Page 134
VII. ALCOHOLS USED TO PREVENT INFECTIONS......Page 136
REFERENCES......Page 137
PART III PRODUCT APPLICATIONS......Page 139
I. INTRODUCTION......Page 140
II. INFECTION......Page 141
IV. MULTIPLICATION......Page 142
V. IMMUNE SYSTEM......Page 143
VII. PHYSICAL FACTORS......Page 144
IX. ADHERENCE......Page 145
X. SPREAD......Page 146
REFERENCES......Page 147
CHAPTER 9 NOSOCOMIAL INFECTION......Page 148
I. PHYSIOLOGICAL SUSCEPTIBILITY OF A PATIENT TO AN INFECTIOUS OPPORTUNISTIC MICROORGANISM......Page 149
II. VIRULENCE OF AN INFECTION-CAUSING MICROORGANISM......Page 150
IV. COMMON NOSOCOMIAL INFECTIONS......Page 151
V. SURGICAL SITE INFECTIONS......Page 152
VII. ANTIBIOTIC-RESISTANT MICROORGANISMS......Page 153
IX. PREOPERATIVE SKIN PREP......Page 154
X. PRECATHETERIZATION PREPS......Page 156
XI. PERIPHERAL VENOUS CATHETERS......Page 157
XVI. PREINJECTION/ PHLEBOTOMY SKIN PREPS......Page 158
XVII. HEALTHCARE PERSONNEL HANDWASH......Page 159
REFERENCES......Page 160
CHAPTER 10 POSTSURGERY INFECTION......Page 163
I. INFECTION......Page 164
III. EXOGENOUS ETIOLOGY......Page 165
A. LENGTH OF HOSPITALIZATION......Page 166
C. LENGTH OF SURGICAL PROCEDURE......Page 167
E. PRESENCE OF OTHER INFECTION......Page 168
A. PATIENT PREOPERATIVE PREPS......Page 169
C. SURGICAL SCRUB WASH......Page 170
REFERENCES......Page 171
I. INTRODUCTION......Page 173
II. MICROBIOLOGY OF ANTISEPTIC BODY WASHES......Page 177
III. PERFORMANCE AND REGULATORY ASPECTS OF ANTIMICROBIAL BODY WASHES......Page 179
IV. CONCLUSIONS......Page 183
REFERENCES......Page 184
I. INTRODUCTION......Page 187
III. COLONIZATION......Page 190
IV. DRUG RESISTANCE......Page 192
REFERENCES......Page 193
CHAPTER 13 FULL-BODY SHOWER WASH: EFFICACY EVALUATION OF A 4% CHLORHEXIDINE GLUCONATE......Page 195
I. METHODS......Page 196
II. RESULTS......Page 198
III. DISCUSSION......Page 200
REFERENCES......Page 201
I. INTRODUCTION......Page 203
II. WHERE THE BACTERIA ARE......Page 204
REFERENCES......Page 222
I. INTRODUCTION......Page 227
II. MICROBIOLOGY OF HAND ASEPSIS-RELATED TO BRUSHLESS SCRUBBING......Page 234
III. CURRENT PROGRESS TOWARDS BRUSHLESS TECHNOLOGIES......Page 236
IV. CONCLUSIONS......Page 242
REFERENCES......Page 243
A. TYPES OF ORGANISMS......Page 246
B. ANTIMICROBIAL COMPOUNDS......Page 247
C. RELATIONSHIP BETWEEN INFECTION AND SOAPS......Page 248
B. HEALTH CARE PERSONNEL HANDWASH EVALUATIONS......Page 249
C. MODIFIED CADE HANDWASH PROCEDURE......Page 250
E. OPTIMAL EVALUATION DESIGN......Page 251
A. EXPERIMENTAL DESIGNS......Page 253
B. QUANTITATIVE RESEARCH DESIGNS......Page 254
REFERENCES......Page 256
PART IV FOOD......Page 257
A. MICROORGANISMS OF CONCERN......Page 258
B. ETIOLOGY OF INFECTIOUS DISEASE......Page 259
A. BARRIER GLOVES......Page 260
III. RECOMMENDATIONS AND COMMENTS......Page 261
IV. BEHAVIORAL ASPECTS......Page 262
A. SHARED VALUES......Page 263
C. INTEGRATION......Page 264
B. RECOMMENDATIONS AND COMMENTS......Page 265
C. CONTROL CHART METHODOLOGY......Page 266
E. USING THE CONTROL CHARTS......Page 268
G. MEAN CHART CONSTANT/ RANGE CHART SHIFTING......Page 270
REFERENCES......Page 271
II. METHODS......Page 273
A. MEDICAL LITERATURE......Page 274
B. MICROBIOLOGY LITERATURE......Page 277
C. FOOD INDUSTRY LITERATURE......Page 278
IV. DISCUSSION......Page 279
REFERENCES......Page 280
I. INTRODUCTION......Page 292
A. MATERIALS......Page 293
B. GLOVE JUICE SAMPLING METHOD......Page 294
A. PHASE 1......Page 298
REFERENCES......Page 302
I. INTRODUCTION......Page 303
II. MATERIALS AND METHODS......Page 304
C. PRETEST PERIOD......Page 305
D. PRACTICE WASH......Page 306
H. GLOVE JUICE SAMPLING PROCEDURE......Page 307
J. STATISTICAL ANALYSIS......Page 308
V. OPTIONAL SKIN IRRITATION......Page 309
A. SKIN IRRITATION EVALUATIONS......Page 310
REFERENCES......Page 311
PART V CONSUMER PRODUCTS......Page 313
II. THE HEALTHCARE PERSONNEL HANDWASH TEST......Page 314
A. INOCULATING HANDS TWICE WITH BACTERIA......Page 316
B. INOCULATING HANDS WITH A LARGE VOLUME......Page 317
C. EXTRACTION EFFICIENCY AND CROSS-CONTAMINATIONOF HANDS DURING THE WASH......Page 318
D. WASH AND RINSE TIMES......Page 319
F. SUBUNGUAL AREAS AS RESERVOIRS FOR BACTERIA......Page 321
A. SOURCE OF CONTAMINATION......Page 325
B. HANDWASHING HABITS......Page 328
REFERENCES......Page 329
II. CONSUMER DATA THAT SUPPORT DEVELOPMENT OF NEW METHODS......Page 331
B. SOURCES OF CONSUMER CONTAMINATION......Page 332
III. PROMISING METHODS FOR ASSESSING THE BENEFITS OF HANDWASHING IN CONSUMERS......Page 337
B. QUANTITATIVE MICROBIAL RISK ASSESSMENT......Page 338
C. SUMMARY......Page 339
A. USE OF AGAR PLATES TO ASSESS POTENTIAL FOR TRANSFER PRE- AND POST-WASH......Page 340
B. MEAL PREPARATION TEST......Page 342
C. POTENTIAL OF HANDS TO CAUSE CROSS-CONTAMINATION......Page 343
E. CONSUMER REALISTIC RESIDUAL EF.CACY TEST......Page 345
F. CONTINUED METHOD DEVELOPMENT......Page 347
V. SUMMARY......Page 348
REFERENCES......Page 349
CHAPTER 23 IMPORTANCE OF SKIN CARE ATTRIBUTES IN DEVELOPING TOPICAL ANTIMICROBIALS......Page 352
I. IMPORTANT FUNCTIONS......Page 353
II. SUCCESSFUL PRODUCT DEVELOPMENT......Page 354
REFERENCES......Page 358
I. INTRODUCTION......Page 360
III. PROPOSED NEUTRALIZER SYSTEM......Page 361
IV. STATISTICAL ANALYSIS......Page 362
B. TEST MICROORGANISM(S)......Page 366
C. PROCEDURES......Page 367
D. DATA COLLECTION......Page 368
VI. CONCLUSION......Page 369
REFERENCES......Page 370
I. INTRODUCTION......Page 372
A. GENERAL TEST CRITERIA......Page 373
B. SPECIFIC TEST CRITERIA......Page 374
A. GENERAL TEST CRITERIA: IN VITRO TEST REQUIREMENTS......Page 375
B. SPECIFIC TESTING CRITERIA......Page 378
IV. PROPOSITION OF A NEW REQUIREMENT FOR POSP TESTS—THE REQUIREMENT OF METHOD VALIDATION......Page 379
A. METHODOLOGY VALIDATION USING SPORE CHALLENGE......Page 380
B. EFFICACY ESTIMATE USING CHEMICAL ANALYSIS......Page 382
A. GENERAL TEST CRITERIA......Page 383
B. SPECIFIC TEST CRITERIA......Page 384
A. GENERAL TEST CRITERIA: IN VITRO TEST REQUIREMENTS......Page 385
B. SPECIAL TEST CRITERIA......Page 386
REFERENCES......Page 387
A. METHODS INVOLVING SKIN/ STRATUM CORNEUM REMOVAL......Page 389
A. BIOPSY/ SKIN SCRAPING......Page 390
B. ADHESIVE TAPE – STRIPPING TECHNIQUE......Page 391
A. SWABBING......Page 392
C. GLOVE/ BAG JUICE TECHNIQUES......Page 393
A. THE CUP SCRUB METHOD......Page 394
B. THE HANDWASHINGS COLLECTION METHOD......Page 395
B. FINGERNAIL REGION – SAMPLING TECHNIQUES......Page 396
REFERENCES......Page 397
I. INTRODUCTION......Page 405
II. VIRUSES AND THEIR SPREAD BY HANDS......Page 406
III. IMPORTANCE OF HAND ANTISEPSIS......Page 408
A. TEST VIRUS(ES)......Page 409
B. CULTURE AND INFECTIVITY ASSAY OF TEST VIRUS(ES)......Page 410
D. DILUENT FOR TEST GERMICIDE......Page 411
H. TIME FOR VIRUS-GERMICIDE CONTACT......Page 414
I. NEUTRALIZATION OF VIRUCIDAL ACTIVITY......Page 415
J. ELIMINATION OF CYTOTOXICITY......Page 416
M. OTHER ESSENTIAL CONTROLS......Page 417
N. PRODUCT PERFORMANCE CRITERIA......Page 418
A. SUSPENSION TESTS AND TESTING USING INANIMATE CARRIERS......Page 419
B. TESTS USING HUMAN SUBJECTS......Page 422
A. IS IN SITU INACTIVATION OF VIRUSES BY HANDWASH PRODUCTS NECESSARY?......Page 430
D. SHOULD THE TESTING DETERMINE VIRUS ELIMINATION BY THE PRODUCT ALONE OR BY THE PROCESS OF HAND DECONTAMINATION AS A WHOLE?......Page 431
VII. CONCLUDING REMARKS......Page 432
REFERENCES......Page 434
