HANDBOOK OF MICROBIOLOGICAL QUALITY CONTROL PHARMACEUTICALS AND MEDICAL DEVICES (SIE) (HB 2026)

Microbiologists Working In Both The Pharmaceutical And Medical Device Industries Face Considerable Challenges In Keeping Abreast Of The Myriad Of Microbiological References Available To Them And The Continuously Evolving Regulatory Requirements. This Book Provides A Unique Distillation Of Such Material, By Providing A Wealth Of Microbiological Information Not Only On The Practical Issues Facing The Company Microbiologist Today, But Also The Underlying Principles Of Micro Biological Quality Assurance. All The Chapters Have Been Written By The Leading Experts In This Field. The Book Provides Guidance On Safe Microbiological Practices, Including Laboratory Design And Sampling Techniques. The Design, Storage, Use And Quality Control Of Microbiological Culture Media Is Considered In Depth, And The Principles Of Enumeration And Identification Of MicroOrganisms, Using Both Traditional And Rapid Methods As Well As The Pharmacopoeial Methods For The Detection Of Specified Organisms, Are Elaborated In Detail. Guidance Is Given On Laboratory Methods Supporting The Sterility Assurance System: Sterility Testing, Bioburden Testing, The Use Of Biological Indicators And Environmental Monitoring Methods, As Well As Methods For Detecting And Quantifying Endotoxins. Pharmacopoeial Methods For Microbiological Assay And Preservative Efficacy Testing Are Reviewed. Problems For Those Involved In Dis Infection And Cleansing Techniques And Microbiological Audit Are Discussed From A Practical Viewpoint. Finally, A Number Of Pertinent Case Studies And Worked Examples Illustrate Problems Highlighted In The Text. The Handbook Of Microbiological Quality Control Is The Essential Reference Source For The Professional Microbic Gist. Rosamund M. Baird Is A Consultant Specialising Pharmaceutical Micro Biology. Norman A. Hodges Is Principal Lecturer In Pharmaceutical Microbiology At The University Of Brighton. Stephen P. Denyer Is Head Of The School Of Pharmacy And Biomolecular Sciences At The University Of Brighton.