Handbook of Microbiological Quality Control

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1 Handbook of Microbiological Quality Control Pharmaceuticals and Medical Devices Edited by ROSAMUND M. BAIRD Department of Pharmacy and Pharmacology, University of Bath, UK NORMAN A. HODGES School of Pharmacy and Biomolecular Sciences, University of Brighton, UK STEPHEN P. DENVER School of Pharmacy and Biomolecular Sciences, University of Brighton, UK

2 Contents Contributors Preface xiv xv 1 Safe Microbiological Practices 1 Anthony W. Smith 1.1 Scope and aims Overview of current legislation The Advisory Committee on Dangerous Pathogens (ACDP) Background Classification Containment Level Containment Level Risk assessment and Control of Substances Hazardous to Health Regulations Assessment of risk Eight steps to risk assessment Risk ranking Genetically Modified Organisms (Contained Use) (Amendment) Regulations Laboratory facility design Workflow Size and shape of rooms Benches Floors, walls and ceilings Heating, lighting and ventilation Microbiological safety cabinets Siting and maintenance Other laboratory equipment 13

3 VI Contents 1.8 Sterilization, disinfection and decontamination Autoclaving Disinfection 1.9 Personnel and training Hygiene Handling techniques 1.10 Documentation Standard Operating Procedures Quality Systems 1.11 Putting theory and legislation into good laboratory practice 1.12 Summary References Culture Media Used in Pharmaceutical Microbiology 22 Rosamund M. Baird Introduction Design of media Specialized media for neutralizing antimicrobial agents Specialized media for recovering injured cells Good laboratory practice in culture media preparation Media preparation Storage of incoming raw materials Water Preparation of culture media Measurement of ph Sterilization Plate pouring Prepared media storage Plate drying Use of media Records Quality control of culture media Manufacturer's responsibility User's responsibility Ecometric streaking technique Maintenance of test cultures Control of ready-to-use agar plates External quality control schemes Trouble-shooting guide The future of culture media References Sampling: Principles and Practice 38 Rosamund M. Baird 3.1 General principles Sampling guidance 39

4 Contents vii Single sampling Attribute sampling Resampling Reference samples HACCP approach to management of quality Specialized sampling Sterile products Bioburden sampling Water sampling Environmental sampling Cleaning materials Equipment Operator sampling Medical devices 50 References 52 4 Enumeration of Micro-organisms 54 Ronnie Millar 4.1 Introduction Sample preparation Aqueous materials Soluble materials Insoluble materials Medical devices Pressurized products Gases Antimicrobial materials Counting methods Pour plating Membrane filtration Spread plating Miles and Misra plating Most probable number Turbidimetric methods Culture media Method validation 66 References 68 5 Identification of Micro-organisms 69 Norman Hodges 5.1 Circumstances in which microbial identification is undertaken Classes of organisms and identification strategies Bacteria Cultural (macroscopic) characteristics Microscopic characteristics Biochemical tests 76

5 viii Contents 5.4 Fungi Yeasts Moulds 80 References 84 6 Pharmacopoeial Methods for the Detection of Specified Micro-organisms 86 Norman Hodges 6.1 Introduction and scope Significance and applicability of microbial limit tests General principles of the conduct of tests for specified micro-organisms Sample preparation Liquid enrichment media Selective agar media Confirmatory biochemical or immunological tests The detection of Staphylococcus aureus Baird-Parker medium Mannitol salt agar Vogel-Johnson agar Coagulase test Deoxyribonuclease test The detection of Pseudomonas aeruginosa Cetrimide agar Pseudomonas media for the detection of fluorescein and pyocyanin Oxidase test for Pseudomonas aeruginosa The detection of E. coli and Enterobacteriaceae Introduction MacConkey agar Crystal violet, neutral red bile agar with glucose and lactose Levine eosin-methylene blue agar Indole test for confirmation of E. coli The detection of Salmonella species Introduction Brilliant green agar Xylose, lysine, deoxycholate (XLD) agar Bismuth sulphite agar Deoxycholate citrate agar Triple sugar iron agar Confirmation of salmonellae The detection of clostridia Summary 105 References 105

6 Contents ix 7 Rapid Methods for Enumeration and Identification in Microbiology 107 Paul Newby 7.1 The need for change Enumeration Current methods New technologies Identification Current methods Automated identification systems Future trends in identification Conclusions 117 References 117 Microbiology Laboratory Methods in Support of the Sterility Assurance System 120 Andrew Bill Introduction Sterility' testing Preliminary considerations Application Sampling Facility and equipment People Methods Preparation and materials Workstation Aseptic manoeuvres Labelling Filter holders and filtration Media Incubation Examination Interpretation Documentation Summary Bioburden testing Scope Methods and principles Sampling Limits Interpretation of results Characterization of flora Recording and reporting data Biological indicators Introduction Applications

7 Sampling Handling Culture evaluation and interpretation of survivors Miscellaneous considerations Environmental monitoring References General Sampling Selection of media and incubation conditions Settle plates Surface testing Air testing - specific notes Contents Endotoxin Testing Alan Baines 9.1 Introduction Endotoxins and pyrogens Regulatory development Introduction to the LAL test 9.2 The gel-clot method Test principle and procedure Gel-clot lysate sensitivity Product interference 9.3 The chromogenic end-point method Test principle and procedure Performance characteristics 9.4 The kinetic turbidimetric assay Reagent preparation Test procedures Performance characteristics 9.5 The kinetic chromogenic assay Test procedure Performance characteristics 9.6 Method selection Water samples Samples other than water 9.7 Depyrogenation 9.8 Summary References 10 Antimicrobial Preservative Efficacy Testing Norman Hodges and Geoffrey Hanlon 10.1 Introduction The requirement for a biological assessment of preservative activity Limitations of preservative efficacy tests 10.2 Test procedure and factors influencing reproducibility

8 Contents xi Selection of viable counting method and demonstration of operator competence Selection and maintenance of test organisms Growth, standardization and storage of test inocula Test container, product inoculation, mixing and storage Product sampling and preservative neutralization Incubation conditions for organisms recovered from inoculated product Validation Interpretation of test results Adaptations and alternatives to pharmacopoeial tests The use of additional test organisms and more precisely defined cultural conditions Mixed cultures, repeated challenges and variable inoculum concentrations Rapid methods Future developments 187 References Microbiological Assay of Antibiotics in Pharmaceutical Preparations 190 Colin Thompson 11.1 Introduction Principles of antibiotic assay Practical aspects of antibiotic assays Preparation of diffusion plates Test organisms Media and diluents Reference standards Test preparations Conduct of diffusion assays Conduct of turbidimetric assays Calculations Summary Addresses 203 Reference standards 203 Culture supply 203 Equipment 204 References 204 Further reading Disinfection and Cleansing 205 Norman Hodges and Rosamund M. Baird 12.1 General considerations and terminology Implementation of a cleaning and contamination control programme 206

9 xii Contents Protective clothing and equipment Selection of cleaning agents and disinfectants Cleaning practices and application methods Cleaning, disinfection and sterilization of isolators Standard operating procedures Clean-in-place (CIP) and sterilization-in-place (SIP) facilities Application to isolators Validation Data and document collection Analytical methods Sampling methods Acceptance criteria Disinfectant monographs 217 Alcohols 217 Aldehydes 217 Amphoterics 217 Biguanides 218 Chlorine dioxide 218 Hypochlorites 218 Peracetic acid 218 Phenolics 218 Quaternary ammonium compounds 219 Acknowledgements 219 References Microbiological Hazard Analysis and Audit: The Practice 221 Martin Lush 13.1 Objectives Planning and management of audits: the key to success Why audit? Who should audit? Audit leader: responsibilities Planning the audit Key elements of the planning process Information gathering Administration The opening meeting During the audit Key personal skills Review meetings Classification of deficiencies Audit report Follow-up Auditing the microbiology laboratory Overview information Product range and manufacturing First impressions Organization and management 226

10 Contents Training and expertise The laboratory Method validation Equipment validation Equipment maintenance and calibration Culture media Good laboratory practice (GLP) Areas of specific interest to the auditor Hazard analysis of critical control points (HACCP) Auditing the manufacturing process Why audit? Product information Process information General areas of interest in the building Raw materials Water Packaging materials Effective ventilation Cleaning and disinfection Clothing disciplines and personal hygiene Summary xiii Case Studies and Worked Examples Calculation of viable count and preservative efficacy test data Viable counts Preservative efficacy test data Calculation of air change rates Calculation of airborne contamination levels Environmental monitoring in non-sterile manufacturing areas: a case study Introduction Background Inspection findings at the contractor's site Assessment Summary Questions relevant to an audit of a culture medium manufacturer Calculation of linear regression equation Relationship between inactivation factor, sterility assurance level and F o value Biological indicator case study The problem The solution Conclusion Index 251

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