Monitoring particle contamination levels is required in various fields, e.g. the electronics and pharmaceutical industries, and in the manufacturing of precision machines and in medical operations. Particle counters are useful instruments for monitoring particle contamination in the air. The purpose of this part of ISO 21501 is to provide a calibration procedure and verification method for particle counters, so as to minimize the inaccuracy in the measurement result by a counter, as well as the differences in the results by different instruments.

Written by a team of experts, Nanotechnology Standards provides the first comprehensive, state-of-the-art reviews of nanotechnology standards development, both in the field of standards development and in specific areas of nanotechnology. It also describes global standards-developing processes for nanotechnology, which can be extended to other emerging technologies. For topics related to nanotechnology, the reviews summarize active areas of standards development, supporting knowledge and future directions in easy-to-understand language aimed at a broad technical audience. This unique book is also an excellent resource for up-to-date information on the growing base of knowledge supporting the introduction of nanotechnology standards and applications into the market. Praise for this volume: “This book provides a valuable and detailed overview of current activities and issues relevant to the area as well as a useful summary of the short history of standardization for nanotechnologies and the somewhat longer history of standardization in general. I have no hesitation in recommending this book to anyone with an interest in nanotechnologies whether it is from a technical or societal perspective.” --Dr. Peter Hatto, Director of Research, IonBond Limited, Durham, UK

A central resource of technology and methods for environments where the control of contamination is critical.

A central resource of technology and methods for environments where the control of contamination is critical.

A central resource of technology and methods for environments where the control of contamination is critical.

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines