Handbook Of Microbiological Quality Control In Pharmaceuticals And Medical Devices (pharmaceutical Science Series)
by Stephen P. Denyer /
2000 / English / PDF
2.4 MB Download
Microbiologists working in both the pharmaceutical and medical
device industries, face considerable challenges in keeping abreast
of the myriad microbiological references available to them, and the
continuously evolving regulatory requirements. The Handbook of
Microbiological Quality Control 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 microbiological
quality assurance. All the chapters have been written by leading
experts in this field. The Handbook of Microbiological Quality
Control provides guidance on safe microbiological practices,
including laboratory design and sampling techniques. The design
storage, use and quality control of microbiological culture is
considered in depth. Principles of enumeration and identification
of micro-organisms, 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 disinfection 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 microbiologist.
Microbiologists working in both the pharmaceutical and medical
device industries, face considerable challenges in keeping abreast
of the myriad microbiological references available to them, and the
continuously evolving regulatory requirements. The Handbook of
Microbiological Quality Control 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 microbiological
quality assurance. All the chapters have been written by leading
experts in this field. The Handbook of Microbiological Quality
Control provides guidance on safe microbiological practices,
including laboratory design and sampling techniques. The design
storage, use and quality control of microbiological culture is
considered in depth. Principles of enumeration and identification
of micro-organisms, 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 disinfection 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 microbiologist.