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

" . . . . . . 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.

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.

Over 98% of sprayed insecticides and 95% of herbicides reach a destination other than their target species, including non-target species, air, water and soil. The extensive reliance on insecticide use reduces biodiversity, contributes to pollinator decline, destroys habitat, and threatens endangered species. This book offers a more effective application of the Integrated Pest Management (IPM) approach, on an area-wide (AW) or population-wide (AW-IPM) basis, which aims at the management of the total population of a pest, involving a coordinated effort over often larger areas. For major livestock pests, vectors of human diseases and pests of high-value crops with low pest tolerance, there are compelling economic reasons for participating in AW-IPM. This new textbook attempts to address various fundamental components of AW-IPM, e.g. the importance of relevant problem-solving research, the need for planning and essential baseline data collection, the significance of integrating adequate tools for appropriate control strategies, and the value of pilot trials, etc. With chapters authored by 184 experts from more than 31 countries, the book includes many technical advances in the areas of genetics, molecular biology, microbiology, resistance management, and social sciences that facilitate the planning and implementing of area-wide strategies. The book is essential reading for the academic and applied research community as well as national and regional government plant and human/animal health authorities with responsibility for protecting plant and human/animal health.

The sterile insect technique (SIT) is an environment-friendly pest control method that fits into area-wide integrated pest management (AW-IPM) programmes. This book describes the principles and practice of SIT, frankly evaluating its strengths and weaknesses, successes and failures. SIT is useful against pests that have considerable impact on plant, animal and human health, and criteria are provided to guide in the selection of pests appropriate for SIT.