Download or read book Microbial Limit and Bioburden Tests written by Lucia Clontz and published by CRC Press. This book was released on 2008-10-14 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c

Download or read book The Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-23 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

Download or read book Introduction to Contamination Control and Cleanroom Technology written by Matts Ramstorp and published by John Wiley & Sons. This book was released on 2008-07-11 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control is being used by more and more industries where the highest level of cleanliness and hygiene is of vital importance. This book covers the basic principles of contamination control and cleanroom technology from a holistic point of view. It deals with cleanliness and hygiene and their effects on the outcome of a process, reflecting the latest results from both scientific and practical points of view. The following topics are covered: contaminants and how they are measured cleanrooms and clean zones cleaning and decontamination cleanroom clothing the impact of people on cleanliness. Intended as an introduction to the area of contamination control, the text is also an excellent source of knowledge for people with both theoretical and practical experience. The Swedish version has been used for a long time within the Nordic countries as a basic training textbook within the pharmaceutical, microelectronics, food and beverage, optics and many other industries.

Download or read book Healthcare Sterilisation written by Wayne J Rogers and published by Smithers Rapra. This book was released on 2013-12-30 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ways of sterilisation begin as far back as biblical and roman times, from early beginnings to standardization. Sterilisation evolution has gone through a series of trials and wizardry before it achieved the status of science. And even with a scientific approach, some of its modalities frequently has been referred to as an art (an imaginary focus), while most have achieved a certain scientific standardization. This book provides a drawbridge between history, terminology, environmental and fundamentals of sterilisation that beginners to sterilisation should recognize, but continues with advancements, which supervisors and managers should know and apply. So while providing historical and current sterilisation information, the book also provides interfacial areas with design practices, development, environmental control, material compatibility, microbiology, packaging, process selection, statistics, technical information and validation. This book consists of two volumes (Healthcare Sterilisation, Introduction and Standard Practices: Volume 1, and Healthcare Sterilisation, Challenging Practices: Volume 2). Volume 1 provides an introduction, and an overview of sterilisation on early and classical sterilisation principles such as absolutism and overkill, and steadfast and standard methods. It will help answer some healthcare sterilisation queries such as: what are the origins and evolution of sterilisation? How does environmental control and microbiology affect sterilisation? What are some of the classical as well as standard sterilisation methods? What are the most consistent and reliable sterilisation methods? Is sterilisation in your future? An ounce of prevention is worth a pound of cure. Without sterilisation, infectious disease and contamination would run rampant. Consequently, sterilisation has tremendous value and disease control, and this book provides a three dimensional view of it.

Download or read book Contamination Control in Practice written by Matts Ramstorp and published by John Wiley & Sons. This book was released on 2008-06-25 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control has received great interest and found increasing use within several industrial branches including microelectronics, pharmaceuticals, food and beverages using various concepts of contamination control in their production, purification or packaging process. The book supplies a holistic view of contamination control, presenting the different types of contaminants in a summarized form. The focus is on how to protect products and processes from external contamination and also on different ways to take care of and control contaminants generated in the process. The aim is to eliminate them from a product or a process flow (e.g. through filtration), or to render them harmless (e.g. through sterilisation by moist heat). Product purity or the cleanliness of process flows are often complex matters and hard to define in easily understood terms. This book covers a variety of different techniques used in order to achieve and maintain certain overall cleanliness levels for both microbiological or inanimate particle contaminants. It supplies basic knowledge including validation aspects for industrial branches working with increased demands of cleanliness, for instance water purification, steam, pressurized gases and different flows in a process together with finished products.

Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy

Download or read book The ASQ Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2024-09-30 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.

Download or read book Compounding Sterile Preparations written by E. Clyde Buchanan and published by ASHP. This book was released on 2009-02-01 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.

Download or read book Compounding Sterile Preparations written by Ryan Forrey and published by ASHP. This book was released on 2023-11-13 with total page 1069 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest edition of Compounding Sterile Preparations by Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv reflects the latest advancements in the field, providing you with an indispensable resource to navigate the complex landscape of sterile compounding. New in this Edition: Updated Standards: All chapters have undergone extensive revisions to align with the most recent literature and the revised USP standards. USP Chapter : Now includes information on radiopharmaceutical compounding in USP Chapter . Expanded Knowledge Base: Two brand-new chapters covering Allergenic Extracts and Corrective and Preventative Action (CAPA) Plans.

Download or read book Materials for Medical Application written by Robert B. Heimann and published by Walter de Gruyter GmbH & Co KG. This book was released on 2020-08-24 with total page 637 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives an introduction to the highly interdisciplinary field of biomaterials. It concisely summarizes properties, synthesis and modification of materials such as metals, ceramics, polymers or composites. Characterization, in vitro and in vivo testing as well as a selection of various applications are also part of this inevitable guide.

Download or read book Aerosol Measurement written by Pramod Kulkarni and published by John Wiley & Sons. This book was released on 2011-09-09 with total page 1497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aerosol Measurement: Principles, Techniques, and Applications Third Edition is the most detailed treatment available of the latest aerosol measurement methods. Drawing on the know-how of numerous expert contributors; it provides a solid grasp of measurement fundamentals and practices a wide variety of aerosol applications. This new edition is updated to address new and developing applications of aerosol measurement, including applications in environmental health, atmospheric science, climate change, air pollution, public health, nanotechnology, particle and powder technology, pharmaceutical research and development, clean room technology (integrated circuit manufacture), and nuclear waste management.

Download or read book Quality written by Kathleen E. McCormick and published by Butterworth-Heinemann. This book was released on 2022-07-14 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools. - Fully revised, updated, and expanded new edition - Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools - Includes end-of-chapter summaries and end-of-chapter question and/or problems - Provides detailed steps and examples for applying the guidelines and quality tools - Written in an accessible style making the content easy to understand and apply

Download or read book Handbook of Pharmaceutical Manufacturing Formulations Third Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-12-09 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Medical Device written by Rommel Garcia and published by Xlibris Corporation. This book was released on 2017-06-06 with total page 403 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.

Download or read book Sterilisation of Polymer Healthcare Products written by Wayne J. Rogers and published by iSmithers Rapra Publishing. This book was released on 2005 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterilisation has always been challenging but sterilisation of healthcare products and polymers, especially together is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This book discusses all the sterilisation methods used for polymeric healthcare products both traditional and new.

Download or read book GB T 2010 GB 2010 Chinese National Standard PDF English Catalog year 2010 written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2020-06-06 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2010.

Download or read book Chinese Standard GB GB T GBT JB JB T YY HJ NB HG QC SL SN SH JJF JJG CJ TB YD YS NY FZ JG QB SJ SY DL AQ CB GY JC JR JT written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 7263 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards and Industry Standards (Total 17,000 standards).