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Author: Tim Sandle Publisher: Elsevier ISBN: 1908818638 Category : Medical Languages : en Pages : 370
Book Description
Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products
Author: Tim Sandle Publisher: Elsevier ISBN: 1908818638 Category : Medical Languages : en Pages : 370
Book Description
Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products
Author: Mohan L.H. Kaul Publisher: Springer Science & Business Media ISBN: 3642831397 Category : Science Languages : en Pages : 1016
Book Description
" . . . . . . Nature has something more in view than that its own proper males should fecundate each blossom. " Andrew Knight Philosophical Transactions, 1799 Sterility implicating the male sex solely presents a paradoxical situation in which universality and uniqueness are harmoniously blended. It maintains a built-in outbreeding system but is not an isolating mechanism, as male steriles, the "self-emasculated" plants, outcross with their male fertile sibs normally. Both genes (nuclear and cytoplasmic) and environment, individually as well as conjointly, induce male sterility, the former being genetic and the latter nongenetic. Genetic male sterility is controlled either exclusively by nuclear genes (ms) or by the complementary action of nuclear (lr) and cytoplasmic (c) genes. The former is termed genic and the latter gene-cytoplasmic male sterility. Whereas genic male sterility exhibits Mendelian inheritance, gene-cytoplasmic male sterility is non-Mendelian, with specific transmissibility of the maternal cytoplasm type. Genetic male sterility is documented in 617 species and species crosses com prising 320 species, 162 genera and 43 families. Of these, genic male sterility occurs in 216 species and 17 species crosses and gene-cytoplasmic male sterility in 16 species and 271 species crosses. The Predominance of species exhibiting genic male sterility and of species crosses exhibiting gene-cytoplasmic male sterility is due to the fact that for the male sterility expression in the former, mutation of nuclear genes is required, but in the latter, mutations of both nuclear and cytoplasmic genes are necessary.
Author: Byron J. Lambert Publisher: Academic Press ISBN: 0128050829 Category : Technology & Engineering Languages : en Pages : 266
Book Description
Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design.
Author: Abhishek Bohra Publisher: Springer Nature ISBN: 9811938083 Category : Technology & Engineering Languages : en Pages : 286
Book Description
This book covers all aspects of hybrid breeding technologies applied for crop improvement in major field crops. The different male sterility systems such as genetic male sterility (GMS), cytoplasmic male sterility (CMS), cytoplasmic and genetic male sterility (CGMS), and male sterility induced by the photoperiod (PGMS), temperature (TGMS), and chemicals are discussed in detail. The different chapters in this book provide a timeline of the key breakthroughs witnessed in the field of plant male sterility technologies, their application in hybrid breeding, and the relevance to the current need for food security. In-depth insights into the genetic and regulatory mechanisms of plant male sterility have been presented. This includes discussion on a variety of molecular players that induce male sterility and rescue male fertility in the hybrid plants. To enhance this book’s appeal, more emphasis has been given on the modern emerging approaches such as construction of heterotic pools that could boost hybrid breeding for enhanced crop performance amid climate change and growing population worldwide. This book is a guide for growers and industries related to field and horticultural crops. Further, it is a useful reference for plant breeders, researchers and extension workers, and students. The material can also be used for teaching undergraduate and postgraduate courses.
Author: S. K. Jain Publisher: Springer ISBN: 9401528292 Category : Science Languages : en Pages : 67
Book Description
or fruit production as a consequence of the lack of optimum pollination conditions (CLARK and FRYER, 1920; ARMSTRONG and WHITE, 1935; VALLEAU, 1918; KVAALE, 1927; and many others). In order to mini mize the influence of poor pollen producers, systematic planning of a field planting or an orchard might be necessary. Above all, the im portant reason for its wide popularity is its potential use in the com mercial production of hybrid seed. A male-sterile plant is an effective female for a crossing program and its employment renders the labori ous procedure of emasculation superfluous. ]ONES and EMSWELLER (1937) and STEPHENS (1937) were probably the first to outline a scheme of its application in onion and sorghum respectively. However certain specific problems have limited the practicability and hence some of them will be mentioned in a later seetion (Section VIII). Lately several attempts have been made to obtain some chemie al method for the artificial induction of male sterility. However, for a successful approach to the induction problem a thorough understan ding of various pathways that bring about pollen abortion in naturally occurring cases, would be of great value. It may be hoped that data from these induction experiments alongwith the available biochemi cal analyses would lead to the emergence and elucidation of useful information of both theoretical and practical interest.
Author: Byron J. Lambert Publisher: Academic Press ISBN: 0128131799 Category : Technology & Engineering Languages : en Pages : 268
Book Description
Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. - Introduces sterilization principles at the material selection and design stages - Addresses the industry need for new sterilization processes for new medical devices and biomaterials - Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products - Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies
Author: Tim Sandle
Author: Tim Sandle
Author: Mohan L.H. Kaul
Author: Peter Müller
Author: Byron J. Lambert
Author: Max Hühner
Author: Norman W. Earle
Author: Abhishek Bohra
Author: S. K. Jain
Author: Edwin Moses Hale
Author: Byron J. Lambert