Handbook Of Topical Antimicrobials: Industrial Applications In Consumer Products And Pharmaceuticals (manufacturing Engineering & Materials Processing)

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 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. "This reference explores the properties, performance, and classification of topical antimicrobial compounds - examining the latest laboratory techniques and FDA and industry perspectives on medical, food service, and consumer product applications." --Book Jacket