Author : William V. Collentro
Publisher : CRC Press
Page : 490 pages
File Size : 30,3 MB
Release : 2016-04-19
Category : Medical
ISBN : 142007783X
A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries-used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.Drawing on the author's extensive field experience with more than 400 pharmaceutical and related wat
Author : Gongchen Zhang
Publisher : Academic Press
Page : 500 pages
File Size : 17,77 MB
Release : 2019-12-15
Category : Medical
ISBN : 9780128154397
Pharmaceutical water systems are an important part of good manufacturing practice. With development in design, installation and validation, pharmaceutical water systems are becoming key to new projects in the contemporary pharmaceutical industry. Pharmaceutical companies realize that pharmaceutical water systems can provide competitive advantage, consistent quality assurance, and cost saving. Pharmaceutical Water Systems offers comprehensive and in-depth coverage of the topic, presenting successful system operation examples selected from thousands of real-life systems. The title offers those working in pharma a deeper and more visual understanding of pharmaceutical water systems, promoting the popularization of design, manufacturing and validation through pharmaceutical water systems. The book introduces new and innovative technological concepts, including WFI generation with the purification method, online microorganism detecting technology, design and practice of WFI systems at normal temperature, residual chlorine removal technology with UV radiation, and rouge remediation and prevention, among others. The book consists in 13 chapters, covering pharmacopeia and regulations; design concepts; unit operation and components; generation of purified water; generation of water for injection; storage and distribution systems; pharmaceutical steam systems; sanitation and sterilization technology; rouge formation; derouging stainless steel systems; quality management; automatic control technology; and validation Presents successful system examples selected from real-life systems Introduces novel technological innovations Details how pharmaceutical companies can gain competitive advantage through pharmaceutical water systems Offers access to many combined years of practical experience and real-world examples applied to pharmaceutical water systems Promotes the popularization of design, manufacturing and validation through pharmaceutical water systems
Author : Theodore H. Meltzer
Publisher : Tall Oaks Pub
Page : 871 pages
File Size : 14,15 MB
Release : 1996-01-01
Category : Medical
ISBN : 9780927188067
Author : James P. Agalloco
Publisher : CRC Press
Page : 762 pages
File Size : 37,75 MB
Release : 2007-09-25
Category : Medical
ISBN : 1420019791
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Author : Organisation for Economic Co-Operation and Development (OECD)
Publisher : IWA Publishing
Page : 138 pages
File Size : 18,35 MB
Release : 2020-07-15
Category : Science
ISBN : 1789061814
This report calls for a better understanding of the effects of pharmaceutical residues in the environment, greater international collaboration and accountability distribution, and policy actions to prevent and remedy emerging concerns. Laboratory and field tests show traces of oral contraceptives causing the feminisation of fish and amphibians, and residues of psychiatric drugs altering fish behaviour. Antimicrobial resistance, linked to the overuse of antibiotics, has rapidly escalated into a global health crisis. Unless adequate measures are taken to manage the risks, pharmaceutical residues will increasingly be released into the environment as ageing populations, advances in healthcare, and intensification of meat and fish production spur the demand for pharmaceuticals worldwide. The report outlines a collective, life‑cycle approach to managing pharmaceuticals in the environment. A policy mix of source‑directed, use‑orientated and end‑of‑pipe measures, involving several policy sectors, can help to improve health and protect the environment.
Author : William V. Collentro
Publisher :
Page : 682 pages
File Size : 17,31 MB
Release : 1998
Category : MEDICAL
ISBN : 9781003027089
From chemical and biological purity requirements, to system design and its impact on water purity, to the requirements and restrictions imposed by the regulators, this book comprehensively covers the unique water requirements of the pharmaceutical and biotechnology industries. Beginning with a brief overview of the theory and application of the technology, William Collentro clarifies the seemingly overwhelming engineering aspects as he discusses design considerations, operation, maintenance, validation, and regulatory-related topics bases upon personal experience with more than 400 pharmaceutical and related water purification systems. His extensive field experience and the numerous case studies recounted in this book ensure that all relevant aspects of pharmaceutical water technology are thoroughly explained in a clear, concise style.Features
Author : Majeti Narasimha Vara Prasad
Publisher : Butterworth-Heinemann
Page : 506 pages
File Size : 16,45 MB
Release : 2019-04-04
Category : Science
ISBN : 0128165901
Pharmaceuticals and Personal Care Products Waste Management and Treatment Technology: Emerging Contaminants and Micro Pollutants provides the tools and techniques for identifying these contaminates and applying the most effective technology for their remediation, recovery and treatment. The consumption of pharmaceuticals and personal care products (PPCPs) has grown significantly over the last 35 years, thus increasing their potential risk to the environment. As PPCPs are very difficult to detect and remove using conventional wastewater treatment methods, this book provides solutions to a growing problem. Includes sampling, analytical and characterization methods and technology for detecting PPCPs in the environment Provides advanced treatment and disposal technologies for the removal of PPCPs from wastewater, surface water, landfills and septic systems Examines the pathways of PPCPs into the environment
Author : Diana S. Aga
Publisher : CRC Press
Page : 408 pages
File Size : 34,16 MB
Release : 2007-12-26
Category : Medical
ISBN : 1420052330
The detection of pharmaceutical residues remained elusive until instruments such as liquid chromatography and mass spectrometry became commonplace in environmental laboratories. The documentation of the occurrence of pharmaceutical residues and endocrine disrupting chemicals in water resources has raused questions about their long-term effects
Author : World Health Organization
Publisher : World Health Organization
Page : 414 pages
File Size : 27,45 MB
Release : 2007
Category : Business & Economics
ISBN : 9241547081
Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.
Author : James Agalloco
Publisher : CRC Press
Page : 1062 pages
File Size : 29,79 MB
Release : 2021-10-28
Category : Medical
ISBN : 1000436012
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
