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Author : John Cluney
Publisher :
ISBN 13 :
Total Pages : 92 pages
Book Rating : 4.:/5 (811 download)
Download or read book Clean-ability Assessment of Process Piping and Equipment in Pharmaceutical Manufacturing written by John Cluney and published by . This book was released on 2003 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 1439826617
Total Pages : 608 pages
Book Rating : 4.4/5 (398 download)
Download or read book Cleaning Validation Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2010-05-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-
Author : Priscilla Browne
Publisher :
ISBN 13 : 9781974570263
Total Pages : 120 pages
Book Rating : 4.5/5 (72 download)
Download or read book Cleaning Validation written by Priscilla Browne and published by . This book was released on 2017-08-14 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: This paperback book (Reference Edition) provides an introduction to Cleaning Verification and Validation for pharmaceutical and biological equipment and facilities. It provides a practical framework for the design and execution of cleaning validation. Cleaning Validation is a regulatory requirement as per GMP. There are many organisations and bodies which provide guidance of implementing a Cleaning Program such as PIC/s ICH, PDA reports, EU GMP V4 to name a few. The key elements to achieving a successful cleaning validation include (1) understanding the sources of residues (soils, excipients, actives, microbes etc) (2) developing a cleaning procedure (3) developing a test method (4) validating the cleaning procedure in respect of the products and equipment to be used in manufacturing. Summary of title index Introduction,What is Cleaning, Why Clean,Verification and Validation Definitions, Regulatory Requirements FDA, EU GMP. ICH Q7, Validation Standards Stages of Validation, Stage 1 Process Design Stage 2 Process Qualification, Stage 3 Continued Process Verification, Validation General Principles and Practices Cleaning Validation Prerequisites to Cleaning Validation Execution Validation Report Clean In Place (CIP) Visibly Clean Soils and their behaviour Detergents Validation Strategies Summary How are Acceptance levels defined? Historical Context of Limits Uses of the term limit PDA Technical Report No. 29 Calculation of MACO MACO for each piece of equipment Cleaning Validation Protocol PIC/S Guidance on Limits Test Methods ICH Q7 Validation of Analytical Methods Definitions Cleaning Process Design Equipment Considerations Cleaning Agent Approval Critical Cleaning Parameters Cleaning Pipes Dead Legs Connections and Tie-ins Valves Materials of Construction Pressure Testing Sampling Direct Sampling Rinse Sampling Sources of Contaminants Utilities Introduction Key Definitions Compressed Air Water Systems Clean Steam Useful References Appendix Precision Cleaning (Medical Devices)Page Count 119, Reference Edition, 8" X 10" Paperback
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1351592238
Total Pages : 453 pages
Book Rating : 4.3/5 (515 download)
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 453 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
Author : Sam A. Hout
Publisher : John Wiley & Sons
ISBN 13 : 1119802326
Total Pages : 372 pages
Book Rating : 4.1/5 (198 download)
Download or read book Sterile Processing of Pharmaceutical Products written by Sam A. Hout and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes the methodologies and best practices of the sterile manufacture of drug products Thoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements. Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments provides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitary piping and equipment, cleaning and manufacturing process validation, computerized automated systems, personal protective equipment (PPE), clean-in-place (CIP) systems, barriers and isolators, and guidelines for statistical procedure. Offering authoritative guidance on the key aspects of sterile manufacturing engineering, this volume: Covers fundamentals of aseptic techniques, quality by design, risk assessment and management, and operational requirements Addresses various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH Provides techniques for systematic process optimization and good manufacturing practice Emphasizes the importance of attention to detail in process development and validation Features real-world examples highlighting different aspects of drug manufacturing Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments is an indispensable reference and guide for all chemists, chemical engineers, pharmaceutical professionals and engineers, and other professionals working in pharmaceutical sciences and manufacturing.
Author : Safaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420081314
Total Pages : 458 pages
Book Rating : 4.4/5 (2 download)
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster
Author : William M. (Bill) Huitt
Publisher : John Wiley & Sons
ISBN 13 : 1119284236
Total Pages : 543 pages
Book Rating : 4.1/5 (192 download)
Download or read book Bioprocessing Piping and Equipment Design written by William M. (Bill) Huitt and published by John Wiley & Sons. This book was released on 2016-10-24 with total page 543 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard’s content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.
Author : Barbara Kanegsberg
Publisher : CRC Press
ISBN 13 : 1439828296
Total Pages : 576 pages
Book Rating : 4.4/5 (398 download)
Download or read book Handbook for Critical Cleaning: Applications, processes, and controls written by Barbara Kanegsberg and published by CRC Press. This book was released on 2011 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Nearly all companies which manufacture or fabricate high-value physical objects (components, parts, assemblies) perform critical cleaning at one or more stages. These range from the giants of the semiconductor, aerospace, and biomedical world to a host of small to medium to large companies producing a dizzying array of components"--
Author : Michael J. Groves
Publisher : CRC Press
ISBN 13 : 9780935184778
Total Pages : 544 pages
Book Rating : 4.1/5 (847 download)
Download or read book Aseptic Pharmaceutical Manufacturing II written by Michael J. Groves and published by CRC Press. This book was released on 1995-05-31 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.
Author : Barbara Kanegsberg
Publisher : CRC Press
ISBN 13 : 1466515945
Total Pages : 1109 pages
Book Rating : 4.4/5 (665 download)
Download or read book Handbook for Critical Cleaning, Second Edition - 2 Volume Set written by Barbara Kanegsberg and published by CRC Press. This book was released on 2020-01-02 with total page 1109 pages. Available in PDF, EPUB and Kindle. Book excerpt: This set consists of two volumes: Cleaning Agents and Systems and Applications, Processes, and Controls. Updated, expanded, re-organized, and rewritten, this two-volume handbook covers cleaning processes, applications, management, safety, and environmental concerns. The editors rigorously examine technical issues, cleaning agent options and systems, chemical and equipment integration, and contamination control, as well as cleanliness standards, analytical testing, process selection, implementation and maintenance, specific application areas, and regulatory issues. A collection of international contributors gives the text a global viewpoint. Color illustrations, video clips, and animation are available online to help readers better understand presented material.
Author : James P. Agalloco
Publisher : CRC Press
ISBN 13 : 1420019791
Total Pages : 762 pages
Book Rating : 4.4/5 (2 download)
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : William M. (Bill) Huitt
Publisher : John Wiley & Sons
ISBN 13 : 1119284252
Total Pages : 610 pages
Book Rating : 4.1/5 (192 download)
Download or read book Bioprocessing Piping and Equipment Design written by William M. (Bill) Huitt and published by John Wiley & Sons. This book was released on 2016-09-23 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard’s content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.
Author : Destin A. LeBlanc
Publisher : CRC Press
ISBN 13 : 1000835596
Total Pages : 216 pages
Book Rating : 4.0/5 (8 download)
Download or read book Cleaning Validation written by Destin A. LeBlanc and published by CRC Press. This book was released on 2022-12-23 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
Author : Dale A. Seiberling
Publisher : CRC Press
ISBN 13 : 9780849340697
Total Pages : 0 pages
Book Rating : 4.3/5 (46 download)
Download or read book Clean-In-Place for Biopharmaceutical Processes written by Dale A. Seiberling and published by CRC Press. This book was released on 2007-10-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system.
Author : Stanley Nusim
Publisher : CRC Press
ISBN 13 : 1439803390
Total Pages : 452 pages
Book Rating : 4.4/5 (398 download)
Download or read book Active Pharmaceutical Ingredients written by Stanley Nusim and published by CRC Press. This book was released on 2016-04-19 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
Author : Joerg Gutzeit
Publisher : Materials Technology Ins S
ISBN 13 :
Total Pages : 360 pages
Book Rating : 4.3/5 (91 download)
Download or read book Cleaning of Process Equipment and Piping written by Joerg Gutzeit and published by Materials Technology Ins S. This book was released on 1997 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process equipment and piping in chemical and petrochemical plants and petroleum refineries have to be cleaned periodically as part of normal maintenance operations to remove fouling that interferes with process flow, heat transfer, or other operations. Cleaning is also necessary to allow safe personnel entry prior to equipment inspection, repairs, or modifications. Most cleaning operations are expensive and time-consuming and need to be planned, budgeted, and carried out in a timely fashion to ensure minimum interference with normal process or maintenance operations. Certain process equipment and piping may also have to be cleaned prior to being put into service for the first time. Such pre-commission cleaning removes rust, dirt, and other debris that formed or entered during fabrication, shipment, or erection, and that are likely to cause damage after start-up. process equipment and piping in chemical plants, petrochemical plants and petroleum refineries. Practical information and guidance is provided for plant engineers and operators who, from time to time, are charged with planning various cleaning operations that will be carried out either by in-house maintenance personnel or outside cleaning contractors. Sufficient information is given to enable the nonspecialist to either propose cleaning procedures or evaluate cleaning procedures proposed by others. The manual enumerates a multitude of factors that need to be considered before a cleaning operation is started, including timing, alternative methods, costs, manpower requirements, safety concerns, and waste disposal issues.
Author : Terry Jacobs
Publisher : CRC Press
ISBN 13 : 1482258919
Total Pages : 535 pages
Book Rating : 4.4/5 (822 download)
Download or read book Good Design Practices for GMP Pharmaceutical Facilities written by Terry Jacobs and published by CRC Press. This book was released on 2016-08-19 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
