Kooperativer Bibliotheksverbund

UID:

Umfang: 1 online resource (0 p.)

ISBN: 9780081000441 , 0081000448

Serie: Woodhead Publishing series in biomedicine ; Number 80

Anmerkung: Description based upon print version of record. , Front Cover -- Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control -- Copyright -- Dedication -- Contents -- Introduction -- References -- Chapter 1: Introduction to pharmaceutical microbiology -- 1.1 Introduction -- 1.2 Overview of pharmaceutical microbiology -- 1.3 Microbiological test methods -- 1.3.1 Product-related testing regimes -- 1.3.2 Starting materials -- 1.3.3 In-process samples/intermediate product -- 1.3.4 Final product formulations -- 1.3.5 Finished product -- 1.3.6 Testing of utilities -- 1.3.7 Environmental monitoring -- 1.3.8 Other microbiology laboratory tests -- 1.4 The application of pharmaceutical microbiology -- 1.4.1 Counting -- 1.4.2 Sampling -- 1.4.3 Microorganisms detected from pharmaceutical manufacturing environments -- 1.4.4 Contamination control strategy -- 1.4.5 Advances in pharmaceutical microbiology -- 1.5 Conclusion -- References -- Chapter 2: Microbiology and pharmaceuticals -- 2.1 Introduction -- 2.2 The basics of the pharmaceutical sector -- 2.2.1 Pharmaceuticals -- 2.2.2 Product evolution -- 2.2.3 Importance of R& -- D -- 2.2.4 Development -- 2.2.5 Cost -- 2.2.6 Generic drug products -- 2.2.7 Other sectors -- 2.3 Role of the microbiologist -- 2.4 Conclusion -- References -- Chapter 3: GMP and regulations -- 3.1 Introduction -- 3.2 Good manufacturing practice -- 3.2.1 EU good manufacturing practice -- 3.2.2 FDA and CFRs -- 3.2.3 Key aspects of GMP compliance -- 3.2.4 Ten rules of GMP -- 3.2.5 Risk management -- 3.3 Importance of medicines in public health -- 3.4 The role and development of pharmacopoeias -- 3.5 Importance of inspections in the lifecycle of medicines -- 3.5.1 Inspection process -- 3.6 Role of the company regulatory affairs department -- 3.6.1 Pharmacovigilance -- 3.7 Documentation -- 3.7.1 Types of documents. , 3.7.1.1 Specifications -- 3.7.1.2 Instructions -- 3.8 Conclusion -- References -- Chapter 4: Laboratory management and design -- 4.1 Introduction -- 4.2 Pharmaceutical microbiology laboratories -- 4.3 Laboratory management -- 4.3.1 Training -- 4.3.2 Quality -- 4.3.3 Test methods -- 4.3.3.1 Safety -- 4.3.3.2 Laboratory information management system -- 4.3.4 Lean labs -- 4.4 Laboratory design -- 4.4.1 General design -- 4.4.2 Sample collection and testing areas -- 4.4.3 Equipment -- 4.4.4 Utilities and services -- 4.4.5 Air supply -- 4.4.6 Clean air devices and containment -- 4.5 Conclusion -- References -- Chapter 5: Microbiological culture media -- 5.1 Introduction -- 5.2 Cultivation -- 5.3 A short history of culture media -- 5.4 Types of culture media -- 5.5 Quality control of culture media -- 5.5.1 Physical characteristics -- 5.5.2 Microbiological characteristics -- 5.5.3 Test methods and acceptance criteria -- 5.5.4 Solid media -- 5.5.5 Broth media -- 5.5.6 Test regime -- 5.5.7 Testing of selective media -- 5.5.8 Expiry time assessment of culture media -- 5.6 Manufacture of culture media -- 5.6.1 Initial preparation -- 5.6.2 Rehydration -- 5.6.3 Sterilization -- 5.6.4 Addition of supplements -- 5.6.5 Filling -- 5.6.6 Labeling -- 5.6.7 Secondary sterilization -- 5.7 Media release and quarantine -- 5.8 Summary -- References -- Chapter 6: Microbiology laboratory techniques -- 6.1 Introduction -- 6.2 Good laboratory practice and laboratory safety -- 6.3 Aseptic technique -- 6.4 Cultures and identifications -- 6.5 Microscopy -- 6.6 Pharmacopeia and microbiological tests -- 6.7 Microbiological examination of nonsterile products -- 6.7.1 Total viable aerobic count (Ph. Eur. 2.6.12, USP < -- 61> -- ) -- 6.7.1.1 Bioburden determination -- 6.7.1.2 Method validation -- 6.7.1.3 Media growth promotion. , 6.7.1.4 Sample preparation -- Water-soluble products -- Nonfatty products insoluble in water -- Fatty products -- 6.7.1.5 Test method -- 6.7.2 Tests for specified organisms (Ph. Eur. 2.6.13, USP < -- 62 > -- ) -- 6.7.3 Specification limits (harmonized method) -- 6.8 Measurement of cell concentration in suspension by optical density -- 6.9 Sterility testing -- 6.9.1 Validating the sterility test -- 6.10 In vitro and in vivo testing for pyrogens and endotoxins -- 6.10.1 Rabbit ( in vivo) pyrogen test -- 6.10.2 LAL testing for bacterial endotoxin -- 6.11 Microbiological assay of antibiotics -- 6.12 Environmental monitoring -- 6.13 Water analysis -- 6.14 Conclusion -- References -- Chapter 7: Bioburden determination -- 7.1 Introduction -- 7.2 Total microbial count -- 7.3 Units of measurement -- 7.4 Nonsterile products and microbial limits testing -- 7.4.1 Membrane filtration -- 7.4.2 Direct plating methods -- 7.4.2.1 Pour plate method -- 7.4.2.2 Spread plate method -- 7.4.3 Most probable number method -- 7.4.4 Method verification -- 7.5 In-process material bioburden assessment -- 7.6 Presterilization bioburden assessment -- 7.6.1 Terminally sterilized products -- 7.6.2 Aseptically filled products -- 7.6.3 Medical devices -- 7.7 Alternative methods of bioburden assessment -- 7.8 Conclusion -- References -- Chapter 8: Specified and objectionable microorganisms -- 8.1 Introduction -- 8.2 Indicator microorganisms -- 8.2.1 Pharmacopeia methods -- 8.2.2 Method qualification -- 8.3 Determining which microorganisms are objectionable and assessing risk -- 8.4 Human microbiome project -- 8.5 Conclusion -- References -- Chapter 9: Microbial identification -- 9.1 Introduction -- 9.2 Microbial taxonomy -- 9.3 Identification methods -- 9.4 Phenotypic methods -- 9.4.1 Colony and cell morphology. , 9.4.2 Staining techniques -- 9.4.2.1 Gram-stain -- 9.4.2.2 Bacterial spore stain -- 9.4.2.3 Fungal staining -- 9.4.2.4 Ziehl-Neelsen stain -- 9.4.3 Growth based and metabolic tests -- 9.5 Genotypic methods -- 9.6 Method validation -- 9.7 Conclusion -- References -- Chapter 10: Assessment of pharmaceutical water systems -- 10.1 Introduction -- 10.2 Pharmaceutical facility water -- 10.3 The microbial ecology of water -- 10.4 Design and control of water systems -- 10.5 Qualifying water systems -- 10.6 Microbial contamination -- 10.6.1 Biofilms -- 10.7 Microbiological sampling and testing -- 10.8 Action and alert limits -- 10.9 Undesirable (objectionable) microorganisms -- 10.10 Rapid microbiological methods -- 10.11 Microbiological assessment -- 10.12 Summary -- References -- Chapter 11: Endotoxin and pyrogen testing -- 11.1 Introduction -- 11.2 Pyrogenicity -- 11.3 Bacterial endotoxin -- 11.4 Quantifying endotoxin -- 11.5 The limulus amebocyte lysate test -- 11.6 Limulus amebocyte lysate test methods -- 11.6.1 Gel-clot -- 11.6.2 Turbidimetric -- 11.6.3 Chromogenic -- 11.7 Limulus amebocyte lysate test applications -- 11.8 Limulus amebocyte lysate test interference -- 11.9 Alternative test methods -- 11.10 Conclusion -- References -- Chapter 12: Sterilization and sterility assurance -- 12.1 Introduction -- 12.2 Sterility -- 12.3 Sterility assurance and the sterility assurance level -- 12.4 Sterility testing -- 12.5 Parametric release -- 12.6 Sterile products -- 12.6.1 Terminal sterilization -- 12.6.2 Aseptic filling -- 12.6.3 Blow-fill-seal technology -- 12.7 Sterilization -- 12.8 Factors affecting sterilization effectiveness -- 12.8.1 Number and location of microorganisms -- 12.8.2 Innate resistance of microorganisms -- 12.8.3 Physical and chemical factors -- 12.8.4 Organic and inorganic matter. , 12.8.5 Duration of exposure -- 12.8.6 Storage -- 12.9 Good manufacturing practice -- 12.10 Risk assessment -- 12.11 Conclusion -- References -- Chapter 13: Biological indicators: Measuring sterilization -- 13.1 Introduction -- 13.2 Origins -- 13.3 Types of biological indicators -- 13.4 Characteristics of biological indicators -- 13.4.1 Purity -- 13.4.2 Population -- 13.4.3 D value -- 13.4.4 Z value -- 13.4.5 Assessing results -- 13.5 Testing issues -- 13.6 Areas of concern and testing errors -- 13.7 Summary -- References -- Chapter 14: Antibiotics and preservatives -- 14.1 Introduction -- 14.2 Antibiotic susceptibility testing -- 14.2.1 Antimicrobials -- 14.2.2 Antimicrobial susceptibility test concepts -- 14.2.3 Broth dilution method -- 14.2.4 Disc diffusion method -- 14.2.5 Test variability -- 14.2.5.1 pH -- 14.2.5.2 Moisture -- 14.2.5.3 Effects of medium components -- 14.2.5.4 Microbial inoculum -- 14.2.6 Automated methods -- 14.2.7 Results interpretation -- 14.3 Antimicrobial efficacy testing (preservative efficacy testing) -- 14.3.1 Antimicrobial efficacy test -- 14.3.2 Antimicrobial effectiveness test validation -- 14.4 Conclusion -- References -- Chapter 15: Cleaning and disinfection -- 15.1 Introduction -- 15.2 Cleaning -- 15.3 Disinfection -- 15.3.1 Disinfectant efficacy -- 15.3.2 Types of disinfectants -- 15.3.3 Selecting disinfectants -- 15.4 Good manufacturing practice requirements -- 15.5 Measuring disinfection effectiveness: Environmental monitoring -- 15.6 Disinfectant efficacy -- 15.7 Conclusion -- References -- Chapter 16: Cleanrooms and environmental monitoring -- 16.1 Introduction -- 16.2 Cleanroom contamination -- 16.3 Cleanroom classification -- 16.4 Isolators -- 16.5 Cleanroom certification -- 16.6 Cleanroom testing -- 16.6.1 Physical parameters. , 16.6.1.1 Air patterns and air movement. , English

Weitere Ausg.: ISBN 9780081000229

Weitere Ausg.: ISBN 0081000227

Sprache: Englisch