Verfügbarkeit: Handbook of pharmaceutical manufacturing formulations

Handbook of pharmaceutical manufacturing formulations: 6 Sterile products

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Bibliographische Detailangaben
1. Verfasser:	Niazi, Sarfaraz K. (VerfasserIn)
Format:	Buch
Sprache:	English
Veröffentlicht:	Boca Raton [u.a.] CRC Press 2004
Online-Zugang:	Inhaltsverzeichnis
Beschreibung:	354 S. 29 cm
ISBN:	0849317517

Internformat

MARC


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245	1	0	\|a Handbook of pharmaceutical manufacturing formulations \|n 6 \|p Sterile products \|c Sarfaraz K. Niazi
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Datensatz im Suchindex

_version_	1804135012362092544
adam_text	H A N D B O O K OF PHARMACEUTICAL MANUFACTURING FORMULATIONS STERILE PRODUCTS VOLUME 6 SARFARAZ K. NIAZI CRC PRESS BOCA RATON LONDON NEW YORK WASHINGTON, D.C TABLE OF CONTENTS PARTI STERILE MANUFACTURING PRACTICE. CHAPTER 1 INSPECTION OF STERILE PRODUCT MANUFACTURING FACILITIES 3 I. INTRODUCTION 3 II. CGMP COMPLIANCE BASICS 3 A. PERSONNEL 3 B. BUILDINGS 3 C. AIR 3 D. ENVIRONMENTAL CONTROLS 4 E. EQUIPMENT 4 F. WATER FOR INJECTION 4 G. CONTAINERS AND CLOSURES 4 H. STERILIZATION 4 1. METHODS 4 2. INDICATORS 4 3. FILLED CONTAINERS 5 I. PERSONNEL PRACTICES 5 J. LABORATORY CONTROLS 5 1. RETESTING FOR STERILITY 5 2. RETESTING FOR PYROGENS 5 3. PARTICULATE MATTER TESTING 6 4. PRODUCTION RECORDS 6 III. ASEPTIC PROCESSING 6 A. INTRODUCTION 6 B. BUILDINGS AND FACILITIES 6 1. CRITICAL AREA (CLASS 100) 7 2. SUPPORTING CLEAN AREAS 8 3. CLEAN AREA SEPARATION S 4. AIR FILTRATION S 5. DESIGN L C. PERSONNEL TRAINING. QUALIFICATION, AND MONITORING 10 1. MANUFACTURING PERSONNEL I 1 2. LABORATORY PERSONNEL 12 3. MONITORING PROGRAM 12 D. COMPONENTS AND CONTAINERS/CLOSURES 12 1. COMPONENTS 12 2. CONTAINERS/CLOSURES 13 E. ENDOTOXIN CONTROL 14 F. TIME LIMITATIONS 14 G. PROCESS VALIDATION AND EQUIPMENT QUALIFICATION 14 1. PROCESS SIMULATIONS 14 2. FILTRATION EFFICACY 17 3. STERILIZATION OF EQUIPMENT AND CONTAINERS/CLOSURES 1 X H. LABORATORY CONTROLS 19 1. ENVIRONMENTAL MONITORING 20 2. MICROBIOLOGICAL MEDIA AND IDENTIFICATION 21 I. STERILITY TESTING 22 1. CHOICE OF METHODS 22 2. MEDIA 22 3. PERSONNEL 23 4. SAMPLING AND INCUBATION 23 5. INVESTIGATION OF STERILITY POSITIVES 23 J. BATCH RECORD REVIEW: PROCESS CONTROL DOCUMENTATION 24 IV. PROCESSING PRIOR TO FILLING AND SEALING OPERATIONS 25 A. ASEPTIC PROCESSING FROM EARLY MANUFACTURING STEPS 25 B. ASEPTIC PROCESSING OF CELL-BASED THERAPY PRODUCTS (OR OF PRODUCTS INTENDED FOR USE AS CELL-BASED THERAPIES) 25 V. ASEPTIC PROCESSING ISOLATORS 25 A. MAINTENANCE 26 1. GENERAL 26 2. GLOVE INTEGRITY 26 B. DESIGN 26 1. AIRFLOW 26 2. MATERIALS OF CONSTRUCTION 26 3. PRESSURE DIFFERENTIAL 26 4. CLEAN-AREA CLASSIFICATIONS 26 C. TRANSFER OF MATERIALS AND SUPPLIES 26 1. INTRODUCTION 26 2. DISCHARGE 27 D. DECONTAMINATION 27 1. SURFACE EXPOSURE 27 2. EFFICACY 27 3. FREQUENCY 27 E. FILLING LINE STERILIZATION 27 F. ENVIRONMENTAL MONITORING 27 G. PERSONNEL 27 VI. BLOW-FILL-SEAL TECHNOLOGY 28 A. EQUIPMENT DESIGN AND AIR QUALITY 28 B. VALIDATION AND QUALIFICATION 28 C. BATCH MONITORING AND CONTROL 28 VII. LYOPHILIZATION OF PARENTERALS 29 A. INTRODUCTION 29 B. PRODUCT TYPE AND FORMULATION 29 C. FILLING 30 D. LYOPHILIZATION CYCLE AND CONTROLS 31 E. CYCLE VALIDATION 32 F. LYOPHILIZER STERILIZATION AND DESIGN 32 G. FINISHED PRODUCT TESTING .34 1. DOSE UNIFORMITY 34 2. STABILITY TESTING ....34 3. STERILITY TESTING 34 H. FINISHED PRODUCT INSPECTION * MELTBACK 34 VIII. HIGH-PURITY WATER SYSTEMS 35 A. SYSTEM DESIGN 35 B. SYSTEM VALIDATION 35 C. MICROBIAL LIMITS 35 1. WFI SYSTEMS 35 2. PURIFIED WATER SYSTEMS 35 D. WF1 SYSTEMS 37 E. STILL 37 F. HEAT EXCHANGERS 37 G. HOLDING TANK 3X H. PUMPS ^8 I. PIPING 38 J. REVERSE OSMOSIS 38 K. PURIFIED WATER SYSTEMS 3 ) L. PROCESS WATER 39 M. EVALUATION STRATEGY 39 REFERENCES 40 CHAPTER 2 NEW DRUG APPLICATION FOR STERILIZED PRODUCTS 45 I. INTRODUCTION 45 II. TERMINAL HEAT STERILIZATION 45 A. DESCRIPTION OF THE PROCESS AND PRODUCT 45 B. THERMAL QUALIFICATION OF THE CYCLE 45 C. MICROBIOLOGICAL EFFICACY OF THE CYCLE 46 D. MICROBIOLOGICAL MONITORING OF THE ENVIRONMENT 46 E. CONTAINER/CLOSURE AND PACKAGE INTEGRITY 47 F. BACTERIAL ENDOTOXINS TEST AND METHOD 47 G. STERILITY TESTING METHODS AND RELEASE CRITERIA 47 H. EVIDENCE OF FORMAL WRITTEN PROCEDURES 47 III. OTHER TERMINAL STERILIZATION PROCESSES 47 A. ETHYLENE OXIDE 47 B. RADIATION 48 IV. ASEPTIC FILL MANUFACTURING PROCESSES 48 A. BUILDINGS AND FACILITIES 48 B. OVERALL MANUFACTURING OPERATION 48 C. CONTAINERS AND CLOSURES 49 D. PROCEDURES AND SPECIFICATIONS FOR MEDIA FILLS 49 E. ACTIONS CONCERNING PRODUCT WHEN MEDIA FILLS FAIL 49 F. MICROBIOLOGICAL MONITORING OF THE ENVIRONMENT 49 G. CONTAINER/CLOSURE AND PACKAGE INTEGRITY 50 H. STERILITY TESTING METHODS AND RELEASE CRITERIA 50 I. BACTERIAL ENDOTOXINS TEST AND METHOD 50 J. EVIDENCE OF FORMAL WRITTEN PROCEDURES 50 V MAINTENANCE OF MICROBIOLOGICAL CONTROL AND QUALIN: STABILITY CONSIDERATIONS 5(1 A. CONTAINER/CLOSURE INTEGRITY 50 B. PRESERVATIVE EFFECTIVENESS 50 C. PYROGEN OR ENDOTOXIN TESTING 50 CHAPTER 3 MANUFACTURING FORMULATIONS TEMPLATE 5 1 AUTOCLAVES 54 ASEPTIC CONTRACT MANUFACTURERS 54 CLEAN ROOM DESIGN AND CONSTRUCTION 55 CLEAN-IN-PLACE ; STEAM-IN-PLACE (CIPISIPI 5^ CLOSURE WASHING AND STERILIZATION 56 CONSULTANTS 56 DISINFECTANTS AND PRESERVATIVES S6 DISTILLATION EQUIPMENT 5~ ENDNEERINE AND CONSTRUCTION 5 FILLING MACHINES 57 FILTER AIDS 58 FLOWMETERS (SANITARY) 58 FREEZE-DRYERS (STERILIZABLE) 58 MICROFILTRATION EQUIPMENT AND FILTERS 58 PUMPS (SANITARY) 59 STERILE TANKS AND RELATED STAINLESS EQUIPMENT 60 STERILITY TEST EQUIPMENT 60 STERILIZING AND DRYING TUNNELS (HOT AIR) 60 STOPPERING MACHINES 60 VIAL AND BOTTLE WASHERS 61 PART II STERILE PHARMACEUTICAL FORMULATIONS 63 ABCIXIMAB INJECTION 65 ACETAZOLAMIDE INJECTION 65 ACETYLCHOLINE CHLORIDE INTRAOCULAR SOLUTION 66 ACYCLOVIR SODIUM INJECTION 66 ADENOSINE INJECTION 67 ADRENAL CORTEX INJECTION 67 ADRENALINE TARTARATE INJECTION 67 ALATROFLOXACIN MESYLATE INJECTION 68 ALBUMIN (HUMAN) 70 ALBUTEROL SULFATE INHALATION SOLUTION 71 ALDESLEUKIN FOR INJECTION 71 ALEMTUZUMAB INJECTION 71 ALPHA TOCOPHEROL (VITAMIN E) INJECTION 72 ALPROSTADIL FOR INJECTION 72 ALTEPLASE RECOMBINANT INJECTION 72 AMIKACIN SULFATE INJECTION 73 AMINO ACID PARCNTERAL NUTRITION SOLUTION 75 AMINOHIPPURATE SODIUM FOR INJECTION 77 AMINOPHYLLINE INJECTION 78 AMIODARONE INJECTION 79 AMOXICILIIN-CLAVULANIC ACID INJECTION 80 AMOXICILLIN POWDER FOR INJECTION 80 AMPHOTERICIN B CHOLESTERYL SULFATE COMPLEX FOR INJECTION 81 AMPHOTERICIN B INJECTION 82 AMPHOTERICIN B LIPID COMPLEX INJECTION 83 AMPHOTERICIN B LIPOSOME FOR INJECTION 83 ANTAZOLINE SULFATE AND XYLOMETAZOLINE HYDROCHLORIDE OPHTHALMIC DROPS 84 ANTIPYRINE. PHENYLEPHRINE. AND PYRILAMINE MALEATE OPHTHALMIC DROPS 85 ANTIPYRINE. PHENYLEPHRINE. AND SODIUM THIOSULFATC OPHTHALMIC SOLUTION 86 ANTITHYMOCYTE GLOBULIN (RABBIT) FOR INJECTION 87 APROTININ INJECTION 87 ARGATROBAN (THROMBIN INHIBITOR) INJECTION 88 ARSENIC TRIOXIDE INJECTION 88 ASCORBIC F CID AND B-COMPLEX VITAMINS 89 ASCORBIC ACID. B-COMPLEX VITAMIN, WITH BETA CAROTENE INJECTION 93 ASCORBIC ACID INJECTION 94 ASCORBIC ACID. USP. INJECTION 94 ASCORBIC ACID. USP. 250 MG/ML INJECTION 95 ASPARAGINASE FOR INJECTION 95 ATROPINE. CHLORPHENIRAMINE MALEATE. AND PHENY LPROPANOLAMINE INJECT INN 9 ATROPINE SULFATE INJECTION 9D AZTREONAM FOR INJECTION 97 BASILIXIMAB TOR INJECTION 97 B-COMPLEX INJECTION 9S B-COMPLEX. VITAMIN D. VITAMIN L LYOPHILI/ED INJECTION 103 B-COMPLEX VITAMIN VETERINARY 106 B-COMPLEX WITH MINERALS INJECTION (VETERINARY ) 107 B-COMPLEX VITAMINS WITH HORMONES 107 B-COMPLEX VITAMINS WITH LIVER EXTRACT INJECTION 108 BENZODIAZEPINE INJECTION 108 BENZTROPINE MESYLATE INJECTION 10S BETA-CAROTENE INJECTION 109 BETAMETHASONE SUSPENSION INJECTION 109 BETHANECHOL CHLORIDE INJECTION 109 BIOTIN INJECTION 110 BIPERIDEN LACTATE INJECTION 110 BISANTRENC EMULSION INJECTION I I I BORAX SODIUM LUBRICATING OPHTHALMIC DROPS 1 12 BOTULINUM TOXIN 1 13 BRETYLIUM TOSYLATE IN DEXTROSE INJECTION I I 3 BUFLOMEDIL INJECTION 114 BUPIVACAINE HYDROCHLORIDE INJECTION 115 BUPRENORPHINE HYDROCHLORIDE INJECTABLE 1 16 CAFFEINE CITRATE INJECTION 116 CALCITONIN INJECTION 117 CALCITRIOL INJECTION 1 18 CALCIUM GLYCEROPHOSPHATE INJECTION 1 20 CALCIUM INJECTION 121 CAMPHOR INJECTION 121 CAMPTOTHECIN INJECTION I 22 CARBOPLATIN FOR INFUSION 122 CARBOPLATIN INJECTION 1 22 CARPROFEN INJECTION I 23 CEFAMANDOLE NAFATE FOR INJECTION 123 CEFAZOLIN INJECTION 1 23 CEFEPIME HYDROCHLORIDE FOR INJECTION I 24 CEFOTAXIME INJECTION I 24 CEFOTETAN INJECTION 121 CEFOXITIN INJECTION PREMIXED INTRAVENOUS SOLUTION 1 24 CEFTA/IDIME FOR INJECTION * L-ARGININE FORMULATION 125 CETTAZIDIME INJECTION 1 25 CEFTRIAXONE INJECTION 1 26 CEF UROX I ME FOR I NJECT ION I 2 ~ CETROREIIX ACETATE FOR INJEETION 1 2 ~ CHLORAMPLIENICOL AIUL PHENY HNERCURIC NITRATE OPHTHALMIC DROPS 1 2S CHLORAMPHENICOL FOR INJECTION 1 29 CHLORAMPHENICOL INJECTION I 3D CHLORAMPHENICOL SODIUM SUCCINATE FOR INJECTION 131 CHLORDIAZEPOXIDE HYDROCHLORIDE INIECTION 131 CHLOROPROCAINE HYDROCHLORIDE INJECTION I 2 CHLOROQUINE PHOSPHATE INJECTION 132 CHLOROTHIA/IDE SODIUM FOR INJECTION 1 ; 2 CHLORPHENIRAMINE MALEATE INJECTION 1 33 CHLORPROMAZINE HYDROCHLORIDE INJECTION 134 CHORIOGONADOTROPIN ALFA (RECOMBINANT) FOR INJECTION 134 CHORIONIC GONADOTROPIN FOR INJECTION 135 CHROMIUM CHLORIDE ADDITIVE INJECTION 136 CIDOFOVIR INJECTION 136 CIMETIDINE INJECTION 137 CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION 137 CIPROFLOXACIN INJECTION 138 CISPLATIN DIAMINEDICHLORIDE INJECTION 138 CISPLATIN WITH 2,2-DITHIO-BIS-ETHANE SULFONATE INJECTION 139 CLADRIBINE INJECTION INFUSION 139 CLARITHROMYCIN INJECTION 140 CLINDAMYCIN INJECTION IN 5% DEXTROSE 141 CLINDAMYCIN PHOSPHATE INJECTION 142 CLONIDINE HYDROCHLORIDE INJECTION 143 COAGULATION FACTOR VILA (RECOMBINANT) FOR INJECTION 143 COAGULATION FACTOR IX (RECOMBINANT) FOR INJECTION 143 COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE, AND HYDROCORTISONE ACETATE OTIC SUSPENSION 144 CONJUGATED ESTROGENS FOR INJECTION 144 COPPER SULFATE ADDITIVE INJECTION 145 CORTICORELIN OVINE TRIFLUTATE FOR INJECTION 145 CORTISONE ACETATE INJECTABLE SUSPENSION 146 COSYNTROPIN FOR INJECTION 146 CROMOLYN SODIUM OPHTHALMIC SOLUTION 146 CRUDE LIVER EXTRACT INJECTION 147 CYANOCOBALAMIN AND THIAMINE INJECTION 147 CYANOCOBALAMIN, CHOLINE, AND NIACINAMIDE INJECTION 147 CYANOCOBALAMIN INJECTION 148 CYANOCOBALAMIN INJECTION FOR VETERINARY USE 149 CYANOCOBALAMIN REPOSITORY INJECTION 1000 MG/ML 149 CYANOCOBALAMIN, PYRIDOXINE, AND THIAMINE INJECTION 150 CYCLOSPORINE AMPOULES FOR INFUSION 152 CYTARABINE LIPOSOME INJECTION FOR INTRATHECAL USE, 50 MG/5 ML VIAL 153 CYTOMEGALOVIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 153 DACARBAZINE INJECTION 154 DACLIZUMAB FOR INJECTION 154 DACTINOMYCIN FOR INJECTION 155 DALTEPARIN SODIUM INJECTION 155 DANAPAROID SODIUM INJECTION 156 DANTROLENE SODIUM FOR INJECTION 156 DAPIPRAZOLE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.57C 156 DAUNORUBICIN 157 DESMOPRESSIN ACETATE INJECTION-INTRANASAL 158 DEXAMETHASONE ACETATE SUSPENSION INJECTION 159 DEXPANTHENOL. NIACINAMIDE. PYRIDOXINE, RIBOFLAVIN, AND THIAMINE INJECTION 162 DEXRAZOXANE FOR INJECTION 163 DEXTROSE 25 C /C INJECTION (FLEXIBLE CONTAINER) 163 DEXTROSE INJECTION 5 7R AND 107R LVP 164 DEXTROSE WITH SODIUM CHLORIDE INJECTION LVP 164 DIAZEPAM EMULSION INJECTION 165 DIAZEPAM INJECTION 166 DIAZEPAM RECTAL SOLUTION 167 DIBENZAZEPINE CARBOXAMIDE INJECTION 167 DICLOFENAC INJECTION 168 DICYCLORNINE HYDROCHLORIDE INJECTION 170 DIGOXIN INJECTION 171 DIHYDROERGOTAMINE MESYLATE DROPS 172 DIHYDROERGOTAMINE MESYLATE INJECTION 173 DIHYDROERGOTAMINE MESYLATE NASAL SPRAY 173 DIISOPROPYLPHENOL INJECTION 1 74 DILTIAZEM HYDROCHLORIDE INJECTION 174 DIMENHYDRINATE INJECTION 175 DIMETHYL SULFOXIDE INJECTION 175 DINOPROSTONE CERVICAL GEL 175 DIPHENHYDRAMINE HYDROCHLORIDE INJECTION 176 DIPHENYLMETHYL PIPERAZINE INJECTION 176 DIPYRONE INJECTION 1 77 DIPYRONE, PAPAVERINE HC1, AND ATROPINE SULFATE INJECTION 177 DISODIUM EDETATE INJECTION 178 DISULFONIC ACIDS INJECTION 178 DOBUTAMINE INJECTION 179 DOPAMINE HYDROCHLORIDE INJECTION 180 DOXAPRAM HYDROCHLORIDE INJECTION, USP 181 DOXERCALCIFEROL INJECTION 181 DOXORUBICIN FOR INJECTION 182 DOXYCYCLINE HYCLATE INJECTION 183 DOXYCYCLINE HYDROCHLORIDE INJECTION 184 EBSELEN LIPOSOMAL INJECTION 184 EDETATE SODIUM, POLYVINYL ALCOHOL, SODIUM SULFACETAMIDE. SODIUM THIOSULFATE OPHTHALMIC DROPS 185 EDROPHONIUM INJECTABLE 188 ELECTROLYTE MAINTENANCE FLUID 189 ELECTROLYTES, TPN INJECTION 191 EMETINE HYDROCHLORIDE INJECTION 192 ENALAPRILAT INJECTION 192 EPHEDRINE AND PYRILAMINE MALEATE INJECTION VETERINARY 192 EPHEDRINE SULFATE INJECTION 193 EPINEPHRINE AUTO INJECTOR INJECTION 193 EPINEPHRINE INJECTION 193 EPOETIN ALFA FOR INJECTION 194 EPOPROSTENOL SODIUM FOR INJECTION 194 ERGOCALCIFEROL INJECTION (VITAMIN D) 194 ERGONOVINE MALEATE INJECTION 195 ERGONOVINE MALEATE INJECTION VETERINARY 195 ERYTHROMYCIN INJECTION 196 ESMOLOL HYDROCHLORIDE INJECTION 19 ESTRADIOL CYPIONATE INJECTION 19S ESTRADIOL SUSPENSION INJECTION 198 ESTRADIOL VALERATE INJECTION 19N ESTROGENIC SUBSTANCES IN OIL INJECTION 19N ESTRONE. ESTRADIOL. AND CYANOCOBALAMIN INJECTION 199 ESTRONE STERILE SUSPENSION VETERINARY INJECTION 199 FTANERCEPT INJECTION 199 FTORPHINE HYDROCHLORIDE VETERINARY 2OO EXEMESTANE AQUEOUS SUSPENSION INJECTION 200 LAMOTIDINE INJECTION 20 1 FENOLDOPAM MESY LATE INJECTION 2O 1 FENTANYL CITRATE INJECTION 201 FILGRASTIM INJECTION 202 FLOSULIDE INJECTION 202 FLUCONAZOLE INJECTION 202 FLUMAZENIL INJECTION 203 FOLIC ACID AND NIACINAMIDE INJECTION 203 FOLLITROPIN BETA FOR INJECTION 204 FUROSEMIDE INJECTION 204 GENTAMICIN AND PREDNISOLONE OPHTHALMIC DROPS 205 GENTAMICIN INJECTION 207 GENTAMICIN OPHTHALMIC DROPS 209 GLYCINE ANTAGONIST INJECTION 210 GLYCOPYRROLATE INJECTION 210 GRANISETRON HYDROCHLORIDE INJECTION 211 GUAIACOL-IODIDE SOLUTION VETERINARY 211 HALOPERIDOL INJECTION 211 HEMIN FOR INJECTION 212 HEPARIN INJECTION 213 HEPATITIS B IMMUNE GLOBULIN (HUMAN) 214 HEXAMETHYLMELAMINE INJECTION 214 HYDROCHLORIC ACID 215 HYDROCORTISONE SODIUM PHOSPHATE INJECTION 215 HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION 216 HYDROMORPHONE HYDROCHLORIDE INJECTION 219 HYDROXYCOBALAMIN INJECTION 220 HYDROXYPROGESTERONE CAPROATE INJECTION 220 HYDROXYPROPYLMETHYLCELLULOSE OPHTHALMIC SOLUTION 221 HYOSCINE BUTYLBROMIDE INJECTION 222 IBUPROFEN LYSINATE INJECTION 223 IBUTILIDE FUMARATE INJECTION 223 IDARUBICIN HYDROCHLORIDE INJECTION 223 IMIGLUCERASE FOR INJECTION 224 IMMUNE GLOBULIN (HUMAN) FOR INJECTION 224 INFIIXIMAB RECOMBINANT FOR INJECTION 224 INSULIN ASPART INJECTION 225 INSULIN GLARGINE INJECTION 225 INSULIN HUMAN 70/30 226 INSULIN HUMAN ISOPHANE SUSPENSION (NPH) 228 INSULIN LISPRO INJECTION 229 INSULIN REGULAR 230 INTERFERON INJECTION 231 INTERLEUKIN FOR INJECTION (IL-2) 232 IODINE INTRAVENOUS ADDITIVE 233 IRON COPPER SOLUTION VETERINARY 233 IRON DEXTRAN INJECTION 233 IRON SUCROSE INJECTION 233 ISOMETHEPTENE HYDROCHLORIDE VETERINARY INJECTION 234 ITRACONAZOLE INJECTION 234 KETOPROFEN LYSINE INJECTION 234 KETOROLAC TROMETHAMINE INJECTION 235 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 235 LABETALOL HYDROCHLORIDE INJECTION 235 LACTOBIONIC ACID INJECTION 236 LAMOTRIGINE INJECTION 236 LA/AMID INJECTION 237 LEPIRUDIN FOR INJECTION 237 LEUCOVORIN CALCIUM INJECTION 238 LEUPROLIDE ACETATE INJECTION 239 LEVORPHANOL TARTARATE INJECTION 241 LEVOTHYROXINE SODIUM FOR INJECTION 241 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION 242 LIDOCAINE HYDROCHLORIDE INJECTION 243 LINCOMYCIN HYDROCHLORIDE INJECTION 244 LIOTHYRONINE SODIUM INJECTION (T3 ) 244 LIPID EMULSION 207R FOR PARENTERAL NUTRITION 245 LIVER, IRON, AND CYANOCOBALAMIN WITH PROCAINE INJECTION 245 LIVER, IRON, AND VITAMIN B12 INJECTION VETERINARY 246 LORAZEPAM INJECTION 246 MAGNESIUM SULFATE 50% INJECTION 247 MANGANESE SULFATE INJECTION 247 MECHLORETHAMINE HYDROCHLORIDE FOR INJECTION TRITURATION 247 MEDROXYPROGESTERONE ACETATE STERILE AQUEOUS SUSPENSION 248 MEDROXYPROGESTERONE AND ESTRADIOL STERILE SUSPENSION 249 MELPHALAN HYDROCHLORIDE FOR INJECTION 250 MENADIONE INJECTION 250 MENADIONE SODIUM BISULFITE INJECTION VETERINARY 251 MENOTROPINS FOR INJECTION 251 MEPERIDINE HYDROCHLORIDE INJECTION 252 MEPERIDINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE INJECTION 252 MEPIVACAINE HYDROCHLORIDE INJECTION 253 MEROPENEM FOR INJECTION 253 MESORIDAZINE BESYLATE INJECTION 254 METARAMINOL BITARTRATE INJECTION 254 METHANDRIOL DIPROPIONATE INJECTION 254 METHOCARBAMOL INJECTION 254 METHOHEXITAL SODIUM FOR INJECTION 255 METHYLPREDNISOLONE ACETATE SUSPENSION INJECTION 255 METOCLOPRAMIDE INJECTION 256 METOLAZONE INJECTION 257 METRONIDAZOLE INFUSION 257 METRONIDAZOLE INJECTION 258 METRONIDAZOLE AND DEXTROSE INFUSION 259 MIDAZOLAM HYDROCHLORIDE INJECTION 259 MILRINONE LACTATE INJECTION 259 MINERAL COMPLEX INJECTION 260 MITOXANTRONE FOR INJECTION 260 MORPHINE SULFATE INFUSION 260 MORPHINE SULFATE INJECTION 26 1 MOXIDECTIN INJECTION 261 MULTIPLE ELECTROLYTES AND DEXTROSE INJECTION (ELLIOTT S B SOLUTION! 262 MUROMONAB-CD3 INJECTION 262 NALBUPHINE HYDROCHLORIDE 263 NALOXONE HYDROCHLORIDE INJECTION 263 NANDROLONE DECANOATE INJECTION 264 NANDROLONE PHENYIPROPIONATE INJECTION 264 NAPHA/OLINE OPHTHALMIC DROPS 265 NATAMYEIN OPHTHALMIC SUSPENSION 2MI NATURAL ESTROGENIC SUBSTANCES SUSPENSION 2W- NEDOCROMIL SODIUM OPHTHALMIC SOLUTION 2F 6 NEOMYCIN AND PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION YR NEOMYCIN SULFATE-POLYMYXIN B SULFATE TOR IRRIGATION 26 NEOSTIGMINE METHY ISULLATE INJECTION 2 O NESIRITIDE FOR INJECTION 2~0 NETILMICIN INJECTION 2~L NIACINAMIDE INJECTION 2~L NICARDIPINE HYDROCHLORIDE FOR INFUSION 272 NICARDIPINE HYDROCHLORIDE INJECTION 272 NIKETHAMIDE INJECTION 272 NIMESULIDE INJECTION 273 NIMODIPINE INJECTION 273 NYSTATIN FOR INJECTION 273 OCTREOTIDE ACETATE INJECTION 274 OFLOXACIN OTIC SOLUTION 275 ONDANSETRON HYDROCHLORIDE INJECTION 275 OPRELVEKIN FOR INJECTION 276 ORPHENADRINE CITRATE INJECTION 276 OXACARBAZEPINE-10 INJECTION 276 OXAZEPINE INJECTION 277 OXENDOLONE INJECTION 278 OXYMORPHONE HYDROCHLORIDE INJECTION 279 OXYTETRACYCLINE INJECTION 279 OXYTOCIN INJECTION 280 OXYTOCIN INJECTION, USP, 20 U/ML 280 PACLITAXEL INJECTION 281 PALIVIZUMAB FOR INJECTION 281 PANCURONIUM BROMIDE INJECTION 282 PARENTERAL NUTRITION FAT EMULSION 283 PARICALCITOL INJECTION 283 PEGADEMASE BOVINE INJECTION 284 PEGASPARGASE INJECTION 284 PEGINTERFERON ALFA-2B FOR INJECTION 284 PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTION 285 PENICILLIN G BENZATHINE INJECTABLE SUSPENSION 285 PENTOBARBITAL SODIUM SOLUTION INJECTION 285 PENTOSTATIN FOR INJECTION 286 PENTYIENETETRAZOLE INJECTION 286 PHENIRAMINE MALEATE INJECTION 286 PHENOL SALINE DILUENT 286 PHENYLBUTAZONE AND DIPYRONE INJECTION 287 PHENYLBUTAZONE INJECTION VETERINARY 287 PHENYLEPHRINE AND ZINC SULFATE OPHTHALMIC DROPS 288 PHENYLPROPANOLAMINE HYDROCHLORIDE INJECTION 289 PHENYTOIN SODIUM INJECTION 289 PHYTONADIONE (VITAMIN KL) INJECTION 290 PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM INJECTION 291 PLICAMYCIN FOR INJECTION 291 POLY VINYL ALCOHOL OPHTHALMIC SOLUTION 292 POTASSIUM ESTRONE SULFATE INJECTION VETERINARY 293 POTASSIUM ESTRONE SULFATE SUSPENSION INJECTION 293 POTASSIUM PHOSPHATE INJECTION 294 PREDNISOLONE AND NEOMYCIN OPHTHALMIC SUSPENSION 295 PREDNISOLONE INJECTION 298 PREDNISOLONE OPHTHALMIC DROPS 300 PROCAINE HYDROCHLORIDE INJECTION 302 PROCHLORPERAZINE INJECTION 302 PROGESTERONE AND TOCOPHERYL ACETATE INJECTION 302 PROGESTERONE INJECTION REPOSITORY VETERINARY 303 PROMAZINE HYDROCHLORIDE INJECTION 303 PROMETHAZINE HYDROCHLORIDE INJECTION 304 PROPOFOL EMULSION INJECTION 305 PYRIDOXINE AND THIAMINE INJECTION 05 PYRIDOXINE HYDROCHLORIDE INJECTION 06 PYRILAMINE MALEATE AND EPHEDRINE INJECTION VETERINARY 07 QUINIDINE SULFATE INJECTION 07 QUINOLONE LYOPHILIZED INJECTIONS QUINOLONE-CALCIUM LACTATE COMPLEX FOR INJECTION 08 RANITIDINE INJECTION 09 RETEPLASE RECOMBINANT FOR INJECTION 10 RETINOL (VITAMIN A) INJECTION RHO (D) IMMUNE GLOBULIN (HUMAN) INJECTION RINGER LACTATE SOLUTION INJECTION RITUXIMAB INJECTION RUBELLA VIRUS VACCINE LIVE 12 SALBUTAMOL AEROSOL FOR INHALATION SISOMICIN INJECTION SODIUM BICARBONATE AND DISODIUM EDETATE INJECTION 315 SODIUM BICARBONATE INJECTION 316 SODIUM CHLORIDE BACTERIOSTATIC INJECTION SODIUM CHLORIDE INJECTION 317 SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION 17 SODIUM HYALURONATE INJECTION IS SODIUM LACTATE COMPOUND (HARTMANN S) INJECTION MS SODIUM THIOSULFATE INJECTION 1 8 SOMATROPIN (RDNA ORIGIN) INJECTION 319 STERILE WATER FOR INJECTION 20 STREPTOMYCIN SULFATE INJECTION 320 SUCCINYLCHOLINE CHLORIDE INJECTION 321 SUMATRIPTAN SUCCINATE INJECTION TENECTEPLASE FOR INJECTION TESTOSTERONE INJECTION TETRAHYDROZOLINE OPHTHALMIC DROPS THEOPHYLLINE AND DEXTROSE INJECTION THIAMINE HYDROCHLORIDE INJECTION THIOPENTAL SODIUM FOR INJECTION 28 THIOTEPA FOR INJECTION 29 THIOTHIXENE HYDROCHLORIDE INJECTION 29 THYROTROPIN ALFA FOR INJECTION TIMOLOL OPHTHALMIC SOLUTION TINZAPARIN SODIUM INJECTION TIROFIBAN HYDROCHLORIDE INJECTION 3O TOBRAMYCIN SOLUTION FOR INHALATION 30 TOBRAMYCIN SULFATE INJECTION TOPOTECAN HYDROCHLORIDE FOR INJECTION TRACE ELEMENT CONCENTRATE INJECTION TRANCXAMIC ACID INJECTION IRASTU/UMAH FOR INJECTION TRIAMCINOLONE ACETONIDE SUSPENSION INJECTION TRITLUPROMAZINE HYDROCHLORIDE INJECTION TRIPELENNAMINE HYDROCHLORIDE INJECTION ETERINARY TUBOCURARINE CHLORIDE INJECTION TYPHOID VI POLYSACCHARIDC VACCINE UNDINE TRIPHOSPHATE INJECTION L ROKINASE FOR INJECTION VALPROATE SODIUM INJECTION VALRUBIEIN FOR INTRAVESICAL INSTILLATION VANCOMYEIN FOR INJECTION 339 VARICELLA VIRUS VACCINE LIVE 340 VASOPRESSIN (8-ARGININE VASOPRESSIN) INJECTION 340 VECURONIUM BROMIDE FOR INJECTION 341 VERAPAMIL HYDROCHLORIDE INJECTION 341 VINBLASTINE SULFATE FOR INJECTION . 342 VINCRISTINE SULFATE INJECTION 343 WATER FOR INJECTION 344 WATER FOR INJECTION. BACTERIOSTATIC 344 ZINC SULFATE ADDITIVE INJECTION 345 ZOLEDRONIC ACID FOR INJECTION 345 INDEX 347
adam_txt	H A N D B O O K OF PHARMACEUTICAL MANUFACTURING FORMULATIONS STERILE PRODUCTS VOLUME 6 SARFARAZ K. NIAZI CRC PRESS BOCA RATON LONDON NEW YORK WASHINGTON, D.C TABLE OF CONTENTS PARTI STERILE MANUFACTURING PRACTICE. CHAPTER 1 INSPECTION OF STERILE PRODUCT MANUFACTURING FACILITIES 3 I. INTRODUCTION 3 II. CGMP COMPLIANCE BASICS 3 A. PERSONNEL 3 B. BUILDINGS 3 C. AIR 3 D. ENVIRONMENTAL CONTROLS 4 E. EQUIPMENT 4 F. WATER FOR INJECTION 4 G. CONTAINERS AND CLOSURES 4 H. STERILIZATION 4 1. METHODS 4 2. INDICATORS 4 3. FILLED CONTAINERS 5 I. PERSONNEL PRACTICES 5 J. LABORATORY CONTROLS 5 1. RETESTING FOR STERILITY 5 2. RETESTING FOR PYROGENS 5 3. PARTICULATE MATTER TESTING 6 4. PRODUCTION RECORDS 6 III. ASEPTIC PROCESSING 6 A. INTRODUCTION 6 B. BUILDINGS AND FACILITIES 6 1. CRITICAL AREA (CLASS 100) 7 2. SUPPORTING CLEAN AREAS 8 3. CLEAN AREA SEPARATION S 4. AIR FILTRATION S 5. DESIGN L C. PERSONNEL TRAINING. QUALIFICATION, AND MONITORING 10 1. MANUFACTURING PERSONNEL I 1 2. LABORATORY PERSONNEL 12 3. MONITORING PROGRAM 12 D. COMPONENTS AND CONTAINERS/CLOSURES 12 1. COMPONENTS 12 2. CONTAINERS/CLOSURES 13 E. ENDOTOXIN CONTROL 14 F. TIME LIMITATIONS 14 G. PROCESS VALIDATION AND EQUIPMENT QUALIFICATION 14 1. PROCESS SIMULATIONS 14 2. FILTRATION EFFICACY 17 3. STERILIZATION OF EQUIPMENT AND CONTAINERS/CLOSURES 1 X H. LABORATORY CONTROLS 19 1. ENVIRONMENTAL MONITORING 20 2. MICROBIOLOGICAL MEDIA AND IDENTIFICATION 21 I. STERILITY TESTING 22 1. CHOICE OF METHODS 22 2. MEDIA 22 3. PERSONNEL 23 4. SAMPLING AND INCUBATION 23 5. INVESTIGATION OF STERILITY POSITIVES 23 J. BATCH RECORD REVIEW: PROCESS CONTROL DOCUMENTATION 24 IV. PROCESSING PRIOR TO FILLING AND SEALING OPERATIONS 25 A. ASEPTIC PROCESSING FROM EARLY MANUFACTURING STEPS 25 B. ASEPTIC PROCESSING OF CELL-BASED THERAPY PRODUCTS (OR OF PRODUCTS INTENDED FOR USE AS CELL-BASED THERAPIES) 25 V. ASEPTIC PROCESSING ISOLATORS 25 A. MAINTENANCE 26 1. GENERAL 26 2. GLOVE INTEGRITY 26 B. DESIGN 26 1. AIRFLOW 26 2. MATERIALS OF CONSTRUCTION 26 3. PRESSURE DIFFERENTIAL 26 4. CLEAN-AREA CLASSIFICATIONS 26 C. TRANSFER OF MATERIALS AND SUPPLIES 26 1. INTRODUCTION 26 2. DISCHARGE 27 D. DECONTAMINATION 27 1. SURFACE EXPOSURE 27 2. EFFICACY 27 3. FREQUENCY 27 E. FILLING LINE STERILIZATION 27 F. ENVIRONMENTAL MONITORING 27 G. PERSONNEL 27 VI. BLOW-FILL-SEAL TECHNOLOGY 28 A. EQUIPMENT DESIGN AND AIR QUALITY 28 B. VALIDATION AND QUALIFICATION 28 C. BATCH MONITORING AND CONTROL 28 VII. LYOPHILIZATION OF PARENTERALS 29 A. INTRODUCTION 29 B. PRODUCT TYPE AND FORMULATION 29 C. FILLING 30 D. LYOPHILIZATION CYCLE AND CONTROLS 31 E. CYCLE VALIDATION 32 F. LYOPHILIZER STERILIZATION AND DESIGN 32 G. FINISHED PRODUCT TESTING .34 1. DOSE UNIFORMITY 34 2. STABILITY TESTING .34 3. STERILITY TESTING 34 H. FINISHED PRODUCT INSPECTION * MELTBACK 34 VIII. HIGH-PURITY WATER SYSTEMS 35 A. SYSTEM DESIGN 35 B. SYSTEM VALIDATION 35 C. MICROBIAL LIMITS 35 1. WFI SYSTEMS 35 2. PURIFIED WATER SYSTEMS 35 D. WF1 SYSTEMS 37 E. STILL 37 F. HEAT EXCHANGERS 37 G. HOLDING TANK 3X H. PUMPS ^8 I. PIPING 38 J. REVERSE OSMOSIS 38 K. PURIFIED WATER SYSTEMS 3') L. PROCESS WATER 39 M. EVALUATION STRATEGY 39 REFERENCES 40 CHAPTER 2 NEW DRUG APPLICATION FOR STERILIZED PRODUCTS 45 I. INTRODUCTION 45 II. TERMINAL HEAT STERILIZATION 45 A. DESCRIPTION OF THE PROCESS AND PRODUCT 45 B. THERMAL QUALIFICATION OF THE CYCLE 45 C. MICROBIOLOGICAL EFFICACY OF THE CYCLE 46 D. MICROBIOLOGICAL MONITORING OF THE ENVIRONMENT 46 E. CONTAINER/CLOSURE AND PACKAGE INTEGRITY 47 F. BACTERIAL ENDOTOXINS TEST AND METHOD 47 G. STERILITY TESTING METHODS AND RELEASE CRITERIA 47 H. EVIDENCE OF FORMAL WRITTEN PROCEDURES 47 III. OTHER TERMINAL STERILIZATION PROCESSES 47 A. ETHYLENE OXIDE 47 B. RADIATION 48 IV. ASEPTIC FILL MANUFACTURING PROCESSES 48 A. BUILDINGS AND FACILITIES 48 B. OVERALL MANUFACTURING OPERATION 48 C. CONTAINERS AND CLOSURES 49 D. PROCEDURES AND SPECIFICATIONS FOR MEDIA FILLS 49 E. ACTIONS CONCERNING PRODUCT WHEN MEDIA FILLS FAIL 49 F. MICROBIOLOGICAL MONITORING OF THE ENVIRONMENT 49 G. CONTAINER/CLOSURE AND PACKAGE INTEGRITY 50 H. STERILITY TESTING METHODS AND RELEASE CRITERIA 50 I. BACTERIAL ENDOTOXINS TEST AND METHOD 50 J. EVIDENCE OF FORMAL WRITTEN PROCEDURES 50 V MAINTENANCE OF MICROBIOLOGICAL CONTROL AND QUALIN: STABILITY CONSIDERATIONS 5(1 A. CONTAINER/CLOSURE INTEGRITY 50 B. PRESERVATIVE EFFECTIVENESS 50 C. PYROGEN OR ENDOTOXIN TESTING 50 CHAPTER 3 MANUFACTURING FORMULATIONS TEMPLATE 5 1 AUTOCLAVES 54 ASEPTIC CONTRACT MANUFACTURERS 54 CLEAN ROOM DESIGN AND CONSTRUCTION 55 CLEAN-IN-PLACE ; STEAM-IN-PLACE (CIPISIPI 5^ CLOSURE WASHING AND STERILIZATION 56 CONSULTANTS 56 DISINFECTANTS AND PRESERVATIVES S6 DISTILLATION EQUIPMENT 5~ ENDNEERINE AND CONSTRUCTION 5" FILLING MACHINES 57 FILTER AIDS 58 FLOWMETERS (SANITARY) 58 FREEZE-DRYERS (STERILIZABLE) 58 MICROFILTRATION EQUIPMENT AND FILTERS 58 PUMPS (SANITARY) 59 STERILE TANKS AND RELATED STAINLESS EQUIPMENT 60 STERILITY TEST EQUIPMENT 60 STERILIZING AND DRYING TUNNELS (HOT AIR) 60 STOPPERING MACHINES 60 VIAL AND BOTTLE WASHERS 61 PART II STERILE PHARMACEUTICAL FORMULATIONS 63 ABCIXIMAB INJECTION 65 ACETAZOLAMIDE INJECTION 65 ACETYLCHOLINE CHLORIDE INTRAOCULAR SOLUTION 66 ACYCLOVIR SODIUM INJECTION 66 ADENOSINE INJECTION 67 ADRENAL CORTEX INJECTION 67 ADRENALINE TARTARATE INJECTION 67 ALATROFLOXACIN MESYLATE INJECTION 68 ALBUMIN (HUMAN) 70 ALBUTEROL SULFATE INHALATION SOLUTION 71 ALDESLEUKIN FOR INJECTION 71 ALEMTUZUMAB INJECTION 71 ALPHA TOCOPHEROL (VITAMIN E) INJECTION 72 ALPROSTADIL FOR INJECTION 72 ALTEPLASE RECOMBINANT INJECTION 72 AMIKACIN SULFATE INJECTION 73 AMINO ACID PARCNTERAL NUTRITION SOLUTION 75 AMINOHIPPURATE SODIUM FOR INJECTION 77 AMINOPHYLLINE INJECTION 78 AMIODARONE INJECTION 79 AMOXICILIIN-CLAVULANIC ACID INJECTION 80 AMOXICILLIN POWDER FOR INJECTION 80 AMPHOTERICIN B CHOLESTERYL SULFATE COMPLEX FOR INJECTION 81 AMPHOTERICIN B INJECTION 82 AMPHOTERICIN B LIPID COMPLEX INJECTION 83 AMPHOTERICIN B LIPOSOME FOR INJECTION 83 ANTAZOLINE SULFATE AND XYLOMETAZOLINE HYDROCHLORIDE OPHTHALMIC DROPS 84 ANTIPYRINE. PHENYLEPHRINE. AND PYRILAMINE MALEATE OPHTHALMIC DROPS 85 ANTIPYRINE. PHENYLEPHRINE. AND SODIUM THIOSULFATC OPHTHALMIC SOLUTION 86 ANTITHYMOCYTE GLOBULIN (RABBIT) FOR INJECTION 87 APROTININ INJECTION 87 ARGATROBAN (THROMBIN INHIBITOR) INJECTION 88 ARSENIC TRIOXIDE INJECTION 88 ASCORBIC F\CID AND B-COMPLEX VITAMINS 89 ASCORBIC ACID. B-COMPLEX VITAMIN, WITH BETA CAROTENE INJECTION 93 ASCORBIC ACID INJECTION 94 ASCORBIC ACID. USP. INJECTION 94 ASCORBIC ACID. USP. 250 MG/ML INJECTION 95 ASPARAGINASE FOR INJECTION 95 ATROPINE. CHLORPHENIRAMINE MALEATE. AND PHENY LPROPANOLAMINE INJECT INN 9 ATROPINE SULFATE INJECTION 9D AZTREONAM FOR INJECTION 97 BASILIXIMAB TOR INJECTION 97 B-COMPLEX INJECTION 9S B-COMPLEX. VITAMIN D. VITAMIN L LYOPHILI/ED INJECTION 103 B-COMPLEX VITAMIN VETERINARY 106 B-COMPLEX WITH MINERALS INJECTION (VETERINARY ) 107 B-COMPLEX VITAMINS WITH HORMONES 107 B-COMPLEX VITAMINS WITH LIVER EXTRACT INJECTION 108 BENZODIAZEPINE INJECTION 108 BENZTROPINE MESYLATE INJECTION 10S BETA-CAROTENE INJECTION 109 BETAMETHASONE SUSPENSION INJECTION 109 BETHANECHOL CHLORIDE INJECTION 109 BIOTIN INJECTION 110 BIPERIDEN LACTATE INJECTION 110 BISANTRENC EMULSION INJECTION I I I BORAX SODIUM LUBRICATING OPHTHALMIC DROPS 1 12 BOTULINUM TOXIN 1 13 BRETYLIUM TOSYLATE IN DEXTROSE INJECTION I I 3 BUFLOMEDIL INJECTION 114 BUPIVACAINE HYDROCHLORIDE INJECTION 115 BUPRENORPHINE HYDROCHLORIDE INJECTABLE 1 16 CAFFEINE CITRATE INJECTION 116 CALCITONIN INJECTION 117 CALCITRIOL INJECTION 1 18 CALCIUM GLYCEROPHOSPHATE INJECTION 1 20 CALCIUM INJECTION 121 CAMPHOR INJECTION 121 CAMPTOTHECIN INJECTION I 22 CARBOPLATIN FOR INFUSION 122 CARBOPLATIN INJECTION 1 22 CARPROFEN INJECTION I 23 CEFAMANDOLE NAFATE FOR INJECTION 123 CEFAZOLIN INJECTION 1 23 CEFEPIME HYDROCHLORIDE FOR INJECTION I 24 CEFOTAXIME INJECTION I 24 CEFOTETAN INJECTION 121 CEFOXITIN INJECTION PREMIXED INTRAVENOUS SOLUTION 1 24 CEFTA/IDIME FOR INJECTION * L-ARGININE FORMULATION 125 CETTAZIDIME INJECTION 1 25 CEFTRIAXONE INJECTION 1 26 CEF UROX I ME FOR I NJECT ION I 2 ~ CETROREIIX ACETATE FOR INJEETION 1 2 ~ CHLORAMPLIENICOL AIUL PHENY HNERCURIC NITRATE OPHTHALMIC DROPS 1 2S CHLORAMPHENICOL FOR INJECTION 1 29 CHLORAMPHENICOL INJECTION I 3D CHLORAMPHENICOL SODIUM SUCCINATE FOR INJECTION 131 CHLORDIAZEPOXIDE HYDROCHLORIDE INIECTION 131 CHLOROPROCAINE HYDROCHLORIDE INJECTION I 2 CHLOROQUINE PHOSPHATE INJECTION 132 CHLOROTHIA/IDE SODIUM FOR INJECTION 1 ; 2 CHLORPHENIRAMINE MALEATE INJECTION 1 33 CHLORPROMAZINE HYDROCHLORIDE INJECTION 134 CHORIOGONADOTROPIN ALFA (RECOMBINANT) FOR INJECTION 134 CHORIONIC GONADOTROPIN FOR INJECTION 135 CHROMIUM CHLORIDE ADDITIVE INJECTION 136 CIDOFOVIR INJECTION 136 CIMETIDINE INJECTION 137 CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION 137 CIPROFLOXACIN INJECTION 138 CISPLATIN DIAMINEDICHLORIDE INJECTION 138 CISPLATIN WITH 2,2-DITHIO-BIS-ETHANE SULFONATE INJECTION 139 CLADRIBINE INJECTION INFUSION 139 CLARITHROMYCIN INJECTION 140 CLINDAMYCIN INJECTION IN 5% DEXTROSE 141 CLINDAMYCIN PHOSPHATE INJECTION 142 CLONIDINE HYDROCHLORIDE INJECTION 143 COAGULATION FACTOR VILA (RECOMBINANT) FOR INJECTION 143 COAGULATION FACTOR IX (RECOMBINANT) FOR INJECTION 143 COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE, AND HYDROCORTISONE ACETATE OTIC SUSPENSION 144 CONJUGATED ESTROGENS FOR INJECTION 144 COPPER SULFATE ADDITIVE INJECTION 145 CORTICORELIN OVINE TRIFLUTATE FOR INJECTION 145 CORTISONE ACETATE INJECTABLE SUSPENSION 146 COSYNTROPIN FOR INJECTION 146 CROMOLYN SODIUM OPHTHALMIC SOLUTION 146 CRUDE LIVER EXTRACT INJECTION 147 CYANOCOBALAMIN AND THIAMINE INJECTION 147 CYANOCOBALAMIN, CHOLINE, AND NIACINAMIDE INJECTION 147 CYANOCOBALAMIN INJECTION 148 CYANOCOBALAMIN INJECTION FOR VETERINARY USE 149 CYANOCOBALAMIN REPOSITORY INJECTION 1000 MG/ML 149 CYANOCOBALAMIN, PYRIDOXINE, AND THIAMINE INJECTION 150 CYCLOSPORINE AMPOULES FOR INFUSION 152 CYTARABINE LIPOSOME INJECTION FOR INTRATHECAL USE, 50 MG/5 ML VIAL 153 CYTOMEGALOVIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 153 DACARBAZINE INJECTION 154 DACLIZUMAB FOR INJECTION 154 DACTINOMYCIN FOR INJECTION 155 DALTEPARIN SODIUM INJECTION 155 DANAPAROID SODIUM INJECTION 156 DANTROLENE SODIUM FOR INJECTION 156 DAPIPRAZOLE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.57C 156 DAUNORUBICIN 157 DESMOPRESSIN ACETATE INJECTION-INTRANASAL 158 DEXAMETHASONE ACETATE SUSPENSION INJECTION 159 DEXPANTHENOL. NIACINAMIDE. PYRIDOXINE, RIBOFLAVIN, AND THIAMINE INJECTION 162 DEXRAZOXANE FOR INJECTION 163 DEXTROSE 25 C /C INJECTION (FLEXIBLE CONTAINER) 163 DEXTROSE INJECTION 5 7R AND 107R LVP 164 DEXTROSE WITH SODIUM CHLORIDE INJECTION LVP 164 DIAZEPAM EMULSION INJECTION 165 DIAZEPAM INJECTION 166 DIAZEPAM RECTAL SOLUTION 167 DIBENZAZEPINE CARBOXAMIDE INJECTION 167 DICLOFENAC INJECTION 168 DICYCLORNINE HYDROCHLORIDE INJECTION 170 DIGOXIN INJECTION 171 DIHYDROERGOTAMINE MESYLATE DROPS 172 DIHYDROERGOTAMINE MESYLATE INJECTION 173 DIHYDROERGOTAMINE MESYLATE NASAL SPRAY 173 DIISOPROPYLPHENOL INJECTION 1 74 DILTIAZEM HYDROCHLORIDE INJECTION 174 DIMENHYDRINATE INJECTION 175 DIMETHYL SULFOXIDE INJECTION 175 DINOPROSTONE CERVICAL GEL 175 DIPHENHYDRAMINE HYDROCHLORIDE INJECTION 176 DIPHENYLMETHYL PIPERAZINE INJECTION 176 DIPYRONE INJECTION 1 77 DIPYRONE, PAPAVERINE HC1, AND ATROPINE SULFATE INJECTION 177 DISODIUM EDETATE INJECTION 178 DISULFONIC ACIDS INJECTION 178 DOBUTAMINE INJECTION 179 DOPAMINE HYDROCHLORIDE INJECTION 180 DOXAPRAM HYDROCHLORIDE INJECTION, USP 181 DOXERCALCIFEROL INJECTION 181 DOXORUBICIN FOR INJECTION 182 DOXYCYCLINE HYCLATE INJECTION 183 DOXYCYCLINE HYDROCHLORIDE INJECTION 184 EBSELEN LIPOSOMAL INJECTION 184 EDETATE SODIUM, POLYVINYL ALCOHOL, SODIUM SULFACETAMIDE. SODIUM THIOSULFATE OPHTHALMIC DROPS 185 EDROPHONIUM INJECTABLE 188 ELECTROLYTE MAINTENANCE FLUID 189 ELECTROLYTES, TPN INJECTION 191 EMETINE HYDROCHLORIDE INJECTION 192 ENALAPRILAT INJECTION 192 EPHEDRINE AND PYRILAMINE MALEATE INJECTION VETERINARY 192 EPHEDRINE SULFATE INJECTION 193 EPINEPHRINE AUTO INJECTOR INJECTION 193 EPINEPHRINE INJECTION 193 EPOETIN ALFA FOR INJECTION 194 EPOPROSTENOL SODIUM FOR INJECTION 194 ERGOCALCIFEROL INJECTION (VITAMIN D) 194 ERGONOVINE MALEATE INJECTION 195 ERGONOVINE MALEATE INJECTION VETERINARY 195 ERYTHROMYCIN INJECTION 196 ESMOLOL HYDROCHLORIDE INJECTION 19" ESTRADIOL CYPIONATE INJECTION 19S ESTRADIOL SUSPENSION INJECTION 198 ESTRADIOL VALERATE INJECTION 19N ESTROGENIC SUBSTANCES IN OIL INJECTION 19N ESTRONE. ESTRADIOL. AND CYANOCOBALAMIN INJECTION 199 ESTRONE STERILE SUSPENSION VETERINARY INJECTION 199 FTANERCEPT INJECTION 199 FTORPHINE HYDROCHLORIDE VETERINARY 2OO EXEMESTANE AQUEOUS SUSPENSION INJECTION 200 LAMOTIDINE INJECTION 20 1 FENOLDOPAM MESY LATE INJECTION 2O 1 FENTANYL CITRATE INJECTION 201 FILGRASTIM INJECTION 202 FLOSULIDE INJECTION 202 FLUCONAZOLE INJECTION 202 FLUMAZENIL INJECTION 203 FOLIC ACID AND NIACINAMIDE INJECTION 203 FOLLITROPIN BETA FOR INJECTION 204 FUROSEMIDE INJECTION 204 GENTAMICIN AND PREDNISOLONE OPHTHALMIC DROPS 205 GENTAMICIN INJECTION 207 GENTAMICIN OPHTHALMIC DROPS 209 GLYCINE ANTAGONIST INJECTION 210 GLYCOPYRROLATE INJECTION 210 GRANISETRON HYDROCHLORIDE INJECTION 211 GUAIACOL-IODIDE SOLUTION VETERINARY 211 HALOPERIDOL INJECTION 211 HEMIN FOR INJECTION 212 HEPARIN INJECTION 213 HEPATITIS B IMMUNE GLOBULIN (HUMAN) 214 HEXAMETHYLMELAMINE INJECTION 214 HYDROCHLORIC ACID 215 HYDROCORTISONE SODIUM PHOSPHATE INJECTION 215 HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION 216 HYDROMORPHONE HYDROCHLORIDE INJECTION 219 HYDROXYCOBALAMIN INJECTION 220 HYDROXYPROGESTERONE CAPROATE INJECTION 220 HYDROXYPROPYLMETHYLCELLULOSE OPHTHALMIC SOLUTION 221 HYOSCINE BUTYLBROMIDE INJECTION 222 IBUPROFEN LYSINATE INJECTION 223 IBUTILIDE FUMARATE INJECTION 223 IDARUBICIN HYDROCHLORIDE INJECTION 223 IMIGLUCERASE FOR INJECTION 224 IMMUNE GLOBULIN (HUMAN) FOR INJECTION 224 INFIIXIMAB RECOMBINANT FOR INJECTION 224 INSULIN ASPART INJECTION 225 INSULIN GLARGINE INJECTION 225 INSULIN HUMAN 70/30 226 INSULIN HUMAN ISOPHANE SUSPENSION (NPH) 228 INSULIN LISPRO INJECTION 229 INSULIN REGULAR 230 INTERFERON INJECTION 231 INTERLEUKIN FOR INJECTION (IL-2) 232 IODINE INTRAVENOUS ADDITIVE 233 IRON COPPER SOLUTION VETERINARY 233 IRON DEXTRAN INJECTION 233 IRON SUCROSE INJECTION 233 ISOMETHEPTENE HYDROCHLORIDE VETERINARY INJECTION 234 ITRACONAZOLE INJECTION 234 KETOPROFEN LYSINE INJECTION 234 KETOROLAC TROMETHAMINE INJECTION 235 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 235 LABETALOL HYDROCHLORIDE INJECTION 235 LACTOBIONIC ACID INJECTION 236 LAMOTRIGINE INJECTION 236 LA/AMID INJECTION 237 LEPIRUDIN FOR INJECTION 237 LEUCOVORIN CALCIUM INJECTION 238 LEUPROLIDE ACETATE INJECTION 239 LEVORPHANOL TARTARATE INJECTION 241 LEVOTHYROXINE SODIUM FOR INJECTION 241 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION 242 LIDOCAINE HYDROCHLORIDE INJECTION 243 LINCOMYCIN HYDROCHLORIDE INJECTION 244 LIOTHYRONINE SODIUM INJECTION (T3 ) 244 LIPID EMULSION 207R FOR PARENTERAL NUTRITION 245 LIVER, IRON, AND CYANOCOBALAMIN WITH PROCAINE INJECTION 245 LIVER, IRON, AND VITAMIN B12 INJECTION VETERINARY 246 LORAZEPAM INJECTION 246 MAGNESIUM SULFATE 50% INJECTION 247 MANGANESE SULFATE INJECTION 247 MECHLORETHAMINE HYDROCHLORIDE FOR INJECTION TRITURATION 247 MEDROXYPROGESTERONE ACETATE STERILE AQUEOUS SUSPENSION 248 MEDROXYPROGESTERONE AND ESTRADIOL STERILE SUSPENSION 249 MELPHALAN HYDROCHLORIDE FOR INJECTION 250 MENADIONE INJECTION 250 MENADIONE SODIUM BISULFITE INJECTION VETERINARY 251 MENOTROPINS FOR INJECTION 251 MEPERIDINE HYDROCHLORIDE INJECTION 252 MEPERIDINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE INJECTION 252 MEPIVACAINE HYDROCHLORIDE INJECTION 253 MEROPENEM FOR INJECTION 253 MESORIDAZINE BESYLATE INJECTION 254 METARAMINOL BITARTRATE INJECTION 254 METHANDRIOL DIPROPIONATE INJECTION 254 METHOCARBAMOL INJECTION 254 METHOHEXITAL SODIUM FOR INJECTION 255 METHYLPREDNISOLONE ACETATE SUSPENSION INJECTION 255 METOCLOPRAMIDE INJECTION 256 METOLAZONE INJECTION 257 METRONIDAZOLE INFUSION 257 METRONIDAZOLE INJECTION 258 METRONIDAZOLE AND DEXTROSE INFUSION 259 MIDAZOLAM HYDROCHLORIDE INJECTION 259 MILRINONE LACTATE INJECTION 259 MINERAL COMPLEX INJECTION 260 MITOXANTRONE FOR INJECTION 260 MORPHINE SULFATE INFUSION 260 MORPHINE SULFATE INJECTION 26 1 MOXIDECTIN INJECTION 261 MULTIPLE ELECTROLYTES AND DEXTROSE INJECTION (ELLIOTT'S B SOLUTION! 262 MUROMONAB-CD3 INJECTION 262 NALBUPHINE HYDROCHLORIDE 263 NALOXONE HYDROCHLORIDE INJECTION 263 NANDROLONE DECANOATE INJECTION 264 NANDROLONE PHENYIPROPIONATE INJECTION 264 NAPHA/OLINE OPHTHALMIC DROPS 265 NATAMYEIN OPHTHALMIC SUSPENSION 2MI NATURAL ESTROGENIC SUBSTANCES SUSPENSION 2W- NEDOCROMIL SODIUM OPHTHALMIC SOLUTION 2F 6 NEOMYCIN AND PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION YR NEOMYCIN SULFATE-POLYMYXIN B SULFATE TOR IRRIGATION 26 NEOSTIGMINE METHY ISULLATE INJECTION 2 "O NESIRITIDE FOR INJECTION 2~0 NETILMICIN INJECTION 2~L NIACINAMIDE INJECTION 2~L NICARDIPINE HYDROCHLORIDE FOR INFUSION 272 NICARDIPINE HYDROCHLORIDE INJECTION 272 NIKETHAMIDE INJECTION 272 NIMESULIDE INJECTION 273 NIMODIPINE INJECTION 273 NYSTATIN FOR INJECTION 273 OCTREOTIDE ACETATE INJECTION 274 OFLOXACIN OTIC SOLUTION 275 ONDANSETRON HYDROCHLORIDE INJECTION 275 OPRELVEKIN FOR INJECTION 276 ORPHENADRINE CITRATE INJECTION 276 OXACARBAZEPINE-10 INJECTION 276 OXAZEPINE INJECTION 277 OXENDOLONE INJECTION 278 OXYMORPHONE HYDROCHLORIDE INJECTION 279 OXYTETRACYCLINE INJECTION 279 OXYTOCIN INJECTION 280 OXYTOCIN INJECTION, USP, 20 U/ML 280 PACLITAXEL INJECTION 281 PALIVIZUMAB FOR INJECTION 281 PANCURONIUM BROMIDE INJECTION 282 PARENTERAL NUTRITION FAT EMULSION 283 PARICALCITOL INJECTION 283 PEGADEMASE BOVINE INJECTION 284 PEGASPARGASE INJECTION 284 PEGINTERFERON ALFA-2B FOR INJECTION 284 PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTION 285 PENICILLIN G BENZATHINE INJECTABLE SUSPENSION 285 PENTOBARBITAL SODIUM SOLUTION INJECTION 285 PENTOSTATIN FOR INJECTION 286 PENTYIENETETRAZOLE INJECTION 286 PHENIRAMINE MALEATE INJECTION 286 PHENOL SALINE DILUENT 286 PHENYLBUTAZONE AND DIPYRONE INJECTION 287 PHENYLBUTAZONE INJECTION VETERINARY 287 PHENYLEPHRINE AND ZINC SULFATE OPHTHALMIC DROPS 288 PHENYLPROPANOLAMINE HYDROCHLORIDE INJECTION 289 PHENYTOIN SODIUM INJECTION 289 PHYTONADIONE (VITAMIN KL) INJECTION 290 PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM INJECTION 291 PLICAMYCIN FOR INJECTION 291 POLY VINYL ALCOHOL OPHTHALMIC SOLUTION 292 POTASSIUM ESTRONE SULFATE INJECTION VETERINARY 293 POTASSIUM ESTRONE SULFATE SUSPENSION INJECTION 293 POTASSIUM PHOSPHATE INJECTION 294 PREDNISOLONE AND NEOMYCIN OPHTHALMIC SUSPENSION 295 PREDNISOLONE INJECTION 298 PREDNISOLONE OPHTHALMIC DROPS 300 PROCAINE HYDROCHLORIDE INJECTION 302 PROCHLORPERAZINE INJECTION 302 PROGESTERONE AND TOCOPHERYL ACETATE INJECTION 302 PROGESTERONE INJECTION REPOSITORY VETERINARY 303 PROMAZINE HYDROCHLORIDE INJECTION 303 PROMETHAZINE HYDROCHLORIDE INJECTION 304 PROPOFOL EMULSION INJECTION 305 PYRIDOXINE AND THIAMINE INJECTION '05 PYRIDOXINE HYDROCHLORIDE INJECTION '06 PYRILAMINE MALEATE AND EPHEDRINE INJECTION VETERINARY '07 QUINIDINE SULFATE INJECTION '07 QUINOLONE LYOPHILIZED INJECTIONS QUINOLONE-CALCIUM LACTATE COMPLEX FOR INJECTION ' '08 RANITIDINE INJECTION '09 RETEPLASE RECOMBINANT FOR INJECTION '10 RETINOL (VITAMIN A) INJECTION RHO (D) IMMUNE GLOBULIN (HUMAN) INJECTION RINGER LACTATE SOLUTION INJECTION RITUXIMAB INJECTION RUBELLA VIRUS VACCINE LIVE '12 SALBUTAMOL AEROSOL FOR INHALATION SISOMICIN INJECTION SODIUM BICARBONATE AND DISODIUM EDETATE INJECTION 315 SODIUM BICARBONATE INJECTION 316 SODIUM CHLORIDE BACTERIOSTATIC INJECTION SODIUM CHLORIDE INJECTION 317 SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION '17 SODIUM HYALURONATE INJECTION 'IS SODIUM LACTATE COMPOUND (HARTMANN'S) INJECTION MS SODIUM THIOSULFATE INJECTION ' 1 8 SOMATROPIN (RDNA ORIGIN) INJECTION 319 STERILE WATER FOR INJECTION '20 STREPTOMYCIN SULFATE INJECTION 320 SUCCINYLCHOLINE CHLORIDE INJECTION 321 SUMATRIPTAN SUCCINATE INJECTION TENECTEPLASE FOR INJECTION TESTOSTERONE INJECTION TETRAHYDROZOLINE OPHTHALMIC DROPS THEOPHYLLINE AND DEXTROSE INJECTION THIAMINE HYDROCHLORIDE INJECTION THIOPENTAL SODIUM FOR INJECTION '28 THIOTEPA FOR INJECTION '29 THIOTHIXENE HYDROCHLORIDE INJECTION '29 THYROTROPIN ALFA FOR INJECTION TIMOLOL OPHTHALMIC SOLUTION TINZAPARIN SODIUM INJECTION TIROFIBAN HYDROCHLORIDE INJECTION '3O TOBRAMYCIN SOLUTION FOR INHALATION '30 TOBRAMYCIN SULFATE INJECTION TOPOTECAN HYDROCHLORIDE FOR INJECTION TRACE ELEMENT CONCENTRATE INJECTION TRANCXAMIC ACID INJECTION IRASTU/UMAH FOR INJECTION TRIAMCINOLONE ACETONIDE SUSPENSION INJECTION TRITLUPROMAZINE HYDROCHLORIDE INJECTION TRIPELENNAMINE HYDROCHLORIDE INJECTION \ETERINARY TUBOCURARINE CHLORIDE INJECTION TYPHOID VI POLYSACCHARIDC VACCINE UNDINE TRIPHOSPHATE INJECTION L'ROKINASE FOR INJECTION VALPROATE SODIUM INJECTION VALRUBIEIN FOR INTRAVESICAL INSTILLATION VANCOMYEIN FOR INJECTION 339 VARICELLA VIRUS VACCINE LIVE 340 VASOPRESSIN (8-ARGININE VASOPRESSIN) INJECTION 340 VECURONIUM BROMIDE FOR INJECTION 341 VERAPAMIL HYDROCHLORIDE INJECTION 341 VINBLASTINE SULFATE FOR INJECTION '. 342 VINCRISTINE SULFATE INJECTION 343 WATER FOR INJECTION 344 WATER FOR INJECTION. BACTERIOSTATIC 344 ZINC SULFATE ADDITIVE INJECTION 345 ZOLEDRONIC ACID FOR INJECTION 345 INDEX 347
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spelling	Niazi, Sarfaraz K. Verfasser aut Handbook of pharmaceutical manufacturing formulations 6 Sterile products Sarfaraz K. Niazi Boca Raton [u.a.] CRC Press 2004 354 S. 29 cm txt rdacontent n rdamedia nc rdacarrier (DE-604)BV021244478 6 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014567164&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis
spellingShingle	Niazi, Sarfaraz K. Handbook of pharmaceutical manufacturing formulations
title	Handbook of pharmaceutical manufacturing formulations
title_auth	Handbook of pharmaceutical manufacturing formulations
title_exact_search	Handbook of pharmaceutical manufacturing formulations
title_exact_search_txtP	Handbook of pharmaceutical manufacturing formulations
title_full	Handbook of pharmaceutical manufacturing formulations 6 Sterile products Sarfaraz K. Niazi
title_fullStr	Handbook of pharmaceutical manufacturing formulations 6 Sterile products Sarfaraz K. Niazi
title_full_unstemmed	Handbook of pharmaceutical manufacturing formulations 6 Sterile products Sarfaraz K. Niazi
title_short	Handbook of pharmaceutical manufacturing formulations
title_sort	handbook of pharmaceutical manufacturing formulations sterile products
url	http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014567164&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA
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