Topical Antimicrobials Industrial Applications in Consumer Products and Pharmaceuticals

HANDBOOK OF TOPICAL ANTIMICROBIALS INDUSTRIAL APPLICATIONS IN CONSUMER PRODUCTS AND PHARMACEUTICALS......Page 1
PREFACE......Page 3
CONTENTS......Page 5
CONTRIBUTORS......Page 8
A. SOCIETAL REQUIREMENTS......Page 10
CONTENTS......Page 0
C. PERSONAL OBJECTIVE ATTRIBUTES......Page 11
II. A CHRONIC PROBLEM: REDUCTIONISM......Page 12
IV. HEALTHCARE CONTINUUM MODEL......Page 13
B. SOCIETAL REQUIREMENTS......Page 14
C. CULTURAL REQUIREMENTS......Page 15
A. PERSONAL OBJECTIVE......Page 16
D. PERSONAL SUBJECTIVE......Page 17
B. SOCIETAL REQUIREMENTS......Page 18
A. PERSONAL OBJECTIVE......Page 19
C. CULTURAL REQUIREMENTS......Page 21
D. PERSONAL SUBJECTIVE......Page 22
C. CULTURAL REQUIREMENTS......Page 23
REFERENCES......Page 24
CHAPTER 2 FOOD AND DRUG ADMINISTRATION PERSPECTIVE ON TOPICAL ANTISEPTIC DRUG PRODUCT DEVELOPMENT......Page 26
II. FDA REGULATORY PROCESS......Page 27
A. DEVELOPMENT OF EFFICACY STANDARDS FOR OTC TOPICAL ANTISEPTIC DRUG PRODUCTS......Page 28
A. IN VITRO AND TIME KILL KINETIC STUDIES......Page 44
B. CLINICAL SIMULATION STUDIES......Page 47
C. NEUTRALIZATION......Page 48
D. RESISTANCE TO ANTISEPTICS......Page 50
IV. CONCLUSIONS......Page 52
REFERENCES......Page 53
I. INTRODUCTION......Page 56
II. BACKGROUND......Page 57
IV. GENERAL POPULATION PRODUCTS: ANTIMICROBIAL HANDWASH AND ANTIMICROBIAL BODYWASH......Page 59
B. PUBLIC HEALTH IMPORTANCE......Page 60
C. ANTIMICROBIAL HANDWASHES......Page 62
D. FOODHANDLER HANDWASH......Page 65
E. HEALTHCARE PERSONNEL HANDWASH......Page 67
F. SURGICAL PRODUCTS: PREOPERATIVE SKIN PREPARATIONS AND SURGICAL SCRUBS......Page 69
V. EFFECTIVENESS TEST METHODS......Page 70
C. REDUCTION OF TRANSMISSION DURING PRESURGICAL/ SURGICAL, PREINJECTION PROCEDURES (SURGICAL SCRUB, PREOP PREP)......Page 72
REFERENCES......Page 73
I. ANTISEPSIS AND THE DEVELOPMENT OF IODINE ANTIMICROBIALS......Page 78
II. THE BIOCHEMISTRY OF POVIDONE-IODINE......Page 80
III. MECHANISM OF ACTION OF PVP-I AS AN ANTIMICROBIAL......Page 81
VI. CLINICAL USES OF PVP-I, GENERAL CONSIDERATIONS......Page 82
VII. PVP-I FOR PROPHYLACTIC PREOPERATIVE SKIN DECONTAMINATION......Page 86
IX. PVP-I AS A PROPHYLACTIC DISINFECTANT OF SUPERFICIAL ABRASIONS AND LACERATIONS......Page 87
X. PVP-I FOR MICROBIAL CONTAMINATION CONTROL OF ULCERS AND BURNS......Page 88
XI. COMPARISON OF PVP-I TO OTHER GENERAL ANTISEPTICS......Page 89
XII. AVOIDING ANTIBIOTICS WITH PVP-I......Page 90
A. PVP-I FUNCTION IN THE PRESENCE OF ORGANIC SUBSTANCES......Page 91
B. PVP-I AND WOUND REPAIR......Page 92
C. LOCAL IRRITATION AND SYSTEMIC TOXICITY......Page 93
XIV. CONCLUSION......Page 94
REFERENCES......Page 95
I. INTRODUCTION......Page 100
II. CHEMICAL DIVERSITY OF QACS......Page 101
III. CHEMICAL PROPERTIES OF QACS......Page 103
V. BENZETHONIUM CHLORIDE......Page 104
VII. CHEMICAL STRUCTURE AND MECHANISM OF QAC ANTIMICROBIAL ACTIVITY......Page 105
VIII. EFFECTS OF FORMULA COMPOSITION AND QAC ACTIVITY......Page 108
IX. SPECTRUM OF QAC ACTIVITY......Page 109
X. EXAMPLE OF BROAD-SPECTRUM ANTIMICROBIAL ACTIVITY FOR A BEC TOPICAL PRODUCT......Page 110
REFERENCES......Page 115
I. CHLORHEXIDINE GLUCONATE......Page 118
A. ANTIMICROBIAL ACTION......Page 119
A. SURGICAL SCRUB FORMULATIONS......Page 120
B. PREOPERATIVE SKIN PREPARATION......Page 121
C. HEALTHCARE PERSONNEL HANDWASH......Page 122
REFERENCES......Page 123
I. ALCOHOLS......Page 124
IV. ALCOHOLS FOR SKIN DEGERMING......Page 125
V. TRANSIENT MICROORGANISMS......Page 126
VI. RESIDENT SKIN MICROORGANISMS......Page 127
VII. ALCOHOLS USED TO PREVENT INFECTIONS......Page 129
REFERENCES......Page 130
I. INTRODUCTION......Page 132
II. INFECTION......Page 133
IV. MULTIPLICATION......Page 134
V. IMMUNE SYSTEM......Page 135
VII. PHYSICAL FACTORS......Page 136
IX. ADHERENCE......Page 137
X. SPREAD......Page 138
REFERENCES......Page 139
CHAPTER 9 NOSOCOMIAL INFECTION......Page 140
I. PHYSIOLOGICAL SUSCEPTIBILITY OF A PATIENT TO AN INFECTIOUS OPPORTUNISTIC MICROORGANISM......Page 141
II. VIRULENCE OF AN INFECTION-CAUSING MICROORGANISM......Page 142
IV. COMMON NOSOCOMIAL INFECTIONS......Page 143
V. SURGICAL SITE INFECTIONS......Page 144
VII. ANTIBIOTIC-RESISTANT MICROORGANISMS......Page 145
IX. PREOPERATIVE SKIN PREP......Page 146
X. PRECATHETERIZATION PREPS......Page 148
XI. PERIPHERAL VENOUS CATHETERS......Page 149
XVI. PREINJECTION/ PHLEBOTOMY SKIN PREPS......Page 150
XVII. HEALTHCARE PERSONNEL HANDWASH......Page 151
REFERENCES......Page 152
CHAPTER 10 POSTSURGERY INFECTION......Page 155
I. INFECTION......Page 156
III. EXOGENOUS ETIOLOGY......Page 157
A. LENGTH OF HOSPITALIZATION......Page 158
C. LENGTH OF SURGICAL PROCEDURE......Page 159
E. PRESENCE OF OTHER INFECTION......Page 160
A. PATIENT PREOPERATIVE PREPS......Page 161
C. SURGICAL SCRUB WASH......Page 162
REFERENCES......Page 163
I. INTRODUCTION......Page 165
II. MICROBIOLOGY OF ANTISEPTIC BODY WASHES......Page 169
III. PERFORMANCE AND REGULATORY ASPECTS OF ANTIMICROBIAL BODY WASHES......Page 171
IV. CONCLUSIONS......Page 175
REFERENCES......Page 176
I. INTRODUCTION......Page 179
III. COLONIZATION......Page 182
IV. DRUG RESISTANCE......Page 184
REFERENCES......Page 185
CHAPTER 13 FULL-BODY SHOWER WASH: EFFICACY EVALUATION OF A 4% CHLORHEXIDINE GLUCONATE......Page 187
I. METHODS......Page 188
II. RESULTS......Page 190
III. DISCUSSION......Page 192
REFERENCES......Page 193
I. INTRODUCTION......Page 195
II. WHERE THE BACTERIA ARE......Page 196
REFERENCES......Page 214
I. INTRODUCTION......Page 219
II. MICROBIOLOGY OF HAND ASEPSIS-RELATED TO BRUSHLESS SCRUBBING......Page 226
III. CURRENT PROGRESS TOWARDS BRUSHLESS TECHNOLOGIES......Page 228
IV. CONCLUSIONS......Page 234
REFERENCES......Page 235
A. TYPES OF ORGANISMS......Page 238
B. ANTIMICROBIAL COMPOUNDS......Page 239
C. RELATIONSHIP BETWEEN INFECTION AND SOAPS......Page 240
B. HEALTH CARE PERSONNEL HANDWASH EVALUATIONS......Page 241
C. MODIFIED CADE HANDWASH PROCEDURE......Page 242
E. OPTIMAL EVALUATION DESIGN......Page 243
A. EXPERIMENTAL DESIGNS......Page 245
B. QUANTITATIVE RESEARCH DESIGNS......Page 246
REFERENCES......Page 248
A. MICROORGANISMS OF CONCERN......Page 249
B. ETIOLOGY OF INFECTIOUS DISEASE......Page 250
A. BARRIER GLOVES......Page 251
III. RECOMMENDATIONS AND COMMENTS......Page 252
IV. BEHAVIORAL ASPECTS......Page 253
A. SHARED VALUES......Page 254
C. INTEGRATION......Page 255
B. RECOMMENDATIONS AND COMMENTS......Page 256
C. CONTROL CHART METHODOLOGY......Page 257
E. USING THE CONTROL CHARTS......Page 259
G. MEAN CHART CONSTANT/ RANGE CHART SHIFTING......Page 261
REFERENCES......Page 262
II. METHODS......Page 264
A. MEDICAL LITERATURE......Page 265
B. MICROBIOLOGY LITERATURE......Page 268
C. FOOD INDUSTRY LITERATURE......Page 269
IV. DISCUSSION......Page 270
REFERENCES......Page 271
I. INTRODUCTION......Page 283
A. MATERIALS......Page 284
B. GLOVE JUICE SAMPLING METHOD......Page 285
A. PHASE 1......Page 289
REFERENCES......Page 293
I. INTRODUCTION......Page 294
II. MATERIALS AND METHODS......Page 295
C. PRETEST PERIOD......Page 296
D. PRACTICE WASH......Page 297
H. GLOVE JUICE SAMPLING PROCEDURE......Page 298
J. STATISTICAL ANALYSIS......Page 299
V. OPTIONAL SKIN IRRITATION......Page 300
A. SKIN IRRITATION EVALUATIONS......Page 301
REFERENCES......Page 302
II. THE HEALTHCARE PERSONNEL HANDWASH TEST......Page 304
A. INOCULATING HANDS TWICE WITH BACTERIA......Page 306
B. INOCULATING HANDS WITH A LARGE VOLUME......Page 307
C. EXTRACTION EFFICIENCY AND CROSS-CONTAMINATIONOF HANDS DURING THE WASH......Page 308
D. WASH AND RINSE TIMES......Page 309
F. SUBUNGUAL AREAS AS RESERVOIRS FOR BACTERIA......Page 311
A. SOURCE OF CONTAMINATION......Page 315
B. HANDWASHING HABITS......Page 318
REFERENCES......Page 319
II. CONSUMER DATA THAT SUPPORT DEVELOPMENT OF NEW METHODS......Page 321
B. SOURCES OF CONSUMER CONTAMINATION......Page 322
III. PROMISING METHODS FOR ASSESSING THE BENEFITS OF HANDWASHING IN CONSUMERS......Page 327
B. QUANTITATIVE MICROBIAL RISK ASSESSMENT......Page 328
C. SUMMARY......Page 329
A. USE OF AGAR PLATES TO ASSESS POTENTIAL FOR TRANSFER PRE- AND POST-WASH......Page 330
B. MEAL PREPARATION TEST......Page 332
C. POTENTIAL OF HANDS TO CAUSE CROSS-CONTAMINATION......Page 333
E. CONSUMER REALISTIC RESIDUAL EF.CACY TEST......Page 335
F. CONTINUED METHOD DEVELOPMENT......Page 337
V. SUMMARY......Page 338
REFERENCES......Page 339
CHAPTER 23 IMPORTANCE OF SKIN CARE ATTRIBUTES IN DEVELOPING TOPICAL ANTIMICROBIALS......Page 342
I. IMPORTANT FUNCTIONS......Page 343
II. SUCCESSFUL PRODUCT DEVELOPMENT......Page 344
REFERENCES......Page 348
I. INTRODUCTION......Page 350
III. PROPOSED NEUTRALIZER SYSTEM......Page 351
IV. STATISTICAL ANALYSIS......Page 352
B. TEST MICROORGANISM(S)......Page 356
C. PROCEDURES......Page 357
D. DATA COLLECTION......Page 358
VI. CONCLUSION......Page 359
REFERENCES......Page 360
I. INTRODUCTION......Page 362
A. GENERAL TEST CRITERIA......Page 363
B. SPECIFIC TEST CRITERIA......Page 364
A. GENERAL TEST CRITERIA: IN VITRO TEST REQUIREMENTS......Page 365
B. SPECIFIC TESTING CRITERIA......Page 368
IV. PROPOSITION OF A NEW REQUIREMENT FOR POSP TESTS—THE REQUIREMENT OF METHOD VALIDATION......Page 369
A. METHODOLOGY VALIDATION USING SPORE CHALLENGE......Page 370
B. EFFICACY ESTIMATE USING CHEMICAL ANALYSIS......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. SPECIAL TEST CRITERIA......Page 376
REFERENCES......Page 377
A. METHODS INVOLVING SKIN/ STRATUM CORNEUM REMOVAL......Page 379
A. BIOPSY/ SKIN SCRAPING......Page 380
B. ADHESIVE TAPE – STRIPPING TECHNIQUE......Page 381
A. SWABBING......Page 382
C. GLOVE/ BAG JUICE TECHNIQUES......Page 383
A. THE CUP SCRUB METHOD......Page 384
B. THE HANDWASHINGS COLLECTION METHOD......Page 385
B. FINGERNAIL REGION – SAMPLING TECHNIQUES......Page 386
REFERENCES......Page 387
I. INTRODUCTION......Page 395
II. VIRUSES AND THEIR SPREAD BY HANDS......Page 396
III. IMPORTANCE OF HAND ANTISEPSIS......Page 398
A. TEST VIRUS(ES)......Page 399
B. CULTURE AND INFECTIVITY ASSAY OF TEST VIRUS(ES)......Page 400
D. DILUENT FOR TEST GERMICIDE......Page 401
H. TIME FOR VIRUS-GERMICIDE CONTACT......Page 404
I. NEUTRALIZATION OF VIRUCIDAL ACTIVITY......Page 405
J. ELIMINATION OF CYTOTOXICITY......Page 406
M. OTHER ESSENTIAL CONTROLS......Page 407
N. PRODUCT PERFORMANCE CRITERIA......Page 408
A. SUSPENSION TESTS AND TESTING USING INANIMATE CARRIERS......Page 409
B. TESTS USING HUMAN SUBJECTS......Page 412
A. IS IN SITU INACTIVATION OF VIRUSES BY HANDWASH PRODUCTS NECESSARY?......Page 420
D. SHOULD THE TESTING DETERMINE VIRUS ELIMINATION BY THE PRODUCT ALONE OR BY THE PROCESS OF HAND DECONTAMINATION AS A WHOLE?......Page 421
VII. CONCLUDING REMARKS......Page 422
REFERENCES......Page 424
PART I OVERVIEW......Page 426
I. IODINE COMPLEXES......Page 427
III. PARACHLOROMETAXYLENOL......Page 428
IV. ALCOHOLS......Page 429
VI. QUATERNARY AMMONIUM COMPOUNDS......Page 430
PART III PRODUCT APPLICATIONS......Page 432
PART IV FOOD......Page 433
V CONSUMER PRODUCTS......Page 434