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| blow fill seal technology: Blow-Fill-Seal Technology Rainer Oschmann, Otto Ernst Schubert, 1999-03-29 Plastic containers are increasingly being used for the packaging of pharmaceutical products-solids, powders, liquids, creams and ointments-sterile and non-sterile. No only do plastic containers have proven compatibility with and impermeability to the product itself, but they also have the advantage over glass of being relatively cheap, lightweight, rigid or flexible in shape and shatter resistant. Blow-Fill Seal Technology discusses the advantages of genuine in house' packaging manufacture which includes the simultaneous filling and closing of the containers by one machine in one operation, the procedure called BFS, blow-fill-seal or, alternatively, FFS, form-fill-seal technology. This book explains the process in which the BFS machine carries out the complete cycle of blow molding, filling and sealing under conditions in which security can be validated using established aseptic test procedures, offering considerable advantages over conventional aseptic filling of preformed (plastic of other) containers. Offering 61 figures and 21 tables, this book helps people gain a better overview of the types of plastic materials, manufacturing in detail, machinery of BFS technology, validation aspects and quality assurance. Features · |
| blow fill seal technology: The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology K. Downey, M. Haerer, S. Marguillier, P. Åkerman, 2016 |
| blow fill seal technology: Sterilization of Medical Devices Anne Booth, 2018-12-12 This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies. |
| blow fill seal technology: Dosage Form Design Parameters , 2018-07-25 Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design |
| blow fill seal technology: Formulation, Characterization, and Stability of Protein Drugs Rodney Pearlman, Y. John Wang, 1996-10-31 Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot. |
| blow fill seal technology: Voigt's Pharmaceutical Technology Alfred Fahr, 2018-02-21 A textbook which is both comprehensive and comprehensible and that offers easy but scientifically sound reading to both students and professionals Now in its 12th edition in its native German, Voigt's Pharmaceutical Technology is an interdisciplinary textbook covering the fundamental principles of pharmaceutical technology. Available for the first time in English, this edition is produced in full colour throughout, with a concise, clear structure developed after consultation with students, instructors and researchers. This book: Features clear chapter layouts and easily digestible content Presents novel trends, devices and processes Discusses classical and modern manufacturing processes Covers all formulation principles including tablets, ointments, capsules, nanosystems and biopharmaceutics Takes account of legal requirements for both qualitative and quantitative composition Addresses quality assurance considerations Uniquely relates contrasting international pharmacopeia from EU, US and Japan to formulation principles Includes examples and text boxes for quicker data assimilation Written for both students studying pharmacy and industry professionals in the field as well as toxicologists, biochemists, medical lab technicians, Voigt’s Pharmaceutical Technology is the essential resource for understanding the various aspects of pharmaceutical technology. |
| blow fill seal technology: The Drugs and Cosmetics Act, 1940 , |
| blow fill seal technology: TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva, 2023-08-04 This book structured in TWO different parts. These parts are as follows: Part I emphasizes on GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), USFDA-NDA/ANDA (U S Food and Drug Administrations- New Drug Approval/Abbreviated New Drug Approval) and TQM (Total Quality Management). GCP (Good Clinical Practices) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates. GLP (Good Laboratory Practices) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. GMP (Good Manufacturing Practices) Manufacturing relies on the ability to reproduce exactly a single product hundreds, if not thousands, of times. To make this possible, guidelines have been drawn up in most countries that are similar to the FDA ones described here that define GMPs. Diagnostic companies, including those manufacturing and distributing biosensors, cannot sell their products for either public or professional use unless they have been approved on the basis of these guidelines. USFDA-NDA/ANDA (U S Food and Drug Ad |
| blow fill seal technology: Mucosal Delivery of Biopharmaceuticals José das Neves, Bruno Sarmento, 2014-02-03 Biopharmaceutical medicines, the newest class of therapeutics, are quite heterogeneous and include a range of molecules such as proteins, peptides, vaccines and nucleic acids, with use in virtually all therapeutic fields (e.g. cancer and infectious diseases, vaccination, metabolic dysfunctions) and diagnostics. This edited book gives a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals, the technological strategies that have been followed so far regarding the optimization of mucosal potentialities as well as the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. Following a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects toward beneficial or deleterious interaction with biopharmaceuticals and their delivery systems. The second part reviews the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications of drug delivery systems and products enclosing biopharmaceuticals for mucosal delivery, with a focus on the most successful case studies of recent years. The last section briefly centers on relevant aspects of the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals. Scientists and researchers in the fields of drug delivery, material science, biomedical science and bioengineering as well as professionals, regulators and policy makers in the pharmaceutical, biotechnology and healthcare industries will find in this book an important compendium of fundamental concepts and practical tools for their daily research and activities. |
| blow fill seal technology: Pharmaceutical Quality Assurance B.P. Nagori, Ajay Gaur, Renu Solanki, Vipin Mathur, 2018-01-01 he present state-of-art book has been written as per the new syllabus of B. Pharmacy, introduced by Pharmacy Council of India (PCI). This book has an inclusive content that covers the wider aspects of pharmaceutical quality assurance required by under- graduates, post graduates, industry personnels, researcher, and students preparing for various competitive exams. The distinguishing feature of this book is that the book is written in lucid, simple and easy to understand language. The book is accompanied with Multiple Choice, Fill in the Blank, True-False, Short Answer and Long Answer type of questions for the self- evluation of learning. The answers of the Multiple Choice, Fill in the Blank and True-False questions have also been given. Web links/further reading are included to help the readers for keeping themselves abreast with th latest developments in the held of pharmaceutical quality assurance. Academicians and instructors in universities/colleges may use the book as primary or additional teaching material for under-graduate and post-graduate pharmacy courses. |
| blow fill seal technology: Downstream Industrial Biotechnology Michael C. Flickinger, 2013-07-17 DOWNSTREAM INDUSTRIAL BIOTECHNOLOGY An affordable, easily accessible desk reference on biomanufacturing, focused on downstream recovery and purification Advances in the fundamental knowledge surrounding biotechnology, novel materials, and advanced engineering approaches continue to be translated into bioprocesses that bring new products to market at a significantly faster pace than most other industries. Industrial scale biotechnology and new manufacturing methods are revolutionizing medicine, environmental monitoring and remediation, consumer products, food production, agriculture, and forestry, and continue to be a major area of research. The downstream stage in industrial biotechnology refers to recovery, isolation, and purification of the microbial products from cell debris, processing medium and contaminating biomolecules from the upstream process into a finished product such as biopharmaceuticals and vaccines. Downstream process design has the greatest impact on overall biomanufacturing cost because not only does the biochemistry of different products ( e.g., peptides, proteins, hormones, antibiotics, and complex antigens) dictate different methods for the isolation and purification of these products, but contaminating byproducts can also reduce overall process yield, and may have serious consequences on clinical safety and efficacy. Therefore downstream separation scientists and engineers are continually seeking to eliminate, or combine, unit operations to minimize the number of process steps in order to maximize product recovery at a specified concentration and purity. Based on Wiley’s Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, this volume features fifty articles that provide information on down- stream recovery of cells and protein capture; process development and facility design; equipment; PAT in downstream processes; downstream cGMP operations; and regulatory compliance. It covers: Cell wall disruption and lysis Cell recovery by centrifugation and filtration Large-scale protein chromatography Scale down of biopharmaceutical purification operations Lipopolysaccharide removal Porous media in biotechnology Equipment used in industrial protein purification Affinity chromatography Antibody purification, monoclonal and polyclonal Protein aggregation, precipitation and crystallization Freeze-drying of biopharmaceuticals Biopharmaceutical facility design and validation Pharmaceutical bioburden testing Regulatory requirements Ideal for graduate and advanced undergraduate courses on biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology, Downstream Industrial Biotechnology is also a highly recommended resource for industry professionals and libraries. |
| blow fill seal technology: Handbook of Pharmaceutical Manufacturing Formulations, Third Edition Sarfaraz K. Niazi, 2019-12-09 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 |
| blow fill seal technology: Handbook of Pharmaceutical Manufacturing Formulations Safaraz K. Niazi, 2016-04-19 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 |
| blow fill seal technology: Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation Kenneth E. Avis, Vincent L. Wu, 2020-08-14 In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering. |
| blow fill seal technology: Advanced Aseptic Processing Technology James Agalloco, James Akers, 2016-04-19 The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies |
| blow fill seal technology: Handbook of Industrial Polyethylene and Technology Mark A. Spalding, Ananda Chatterjee, 2017-10-12 This handbook provides an exhaustive description of polyethylene. The 50+ chapters are written by some of the most experienced and prominent authors in the field, providing a truly unique view of polyethylene. The book starts with a historical discussion on how low density polyethylene was discovered and how it provided unique opportunities in the early days. New catalysts are presented and show how they created an expansion in available products including linear low density polyethylene, high density polyethylene, copolymers, and polyethylene produced from metallocene catalysts. With these different catalysts systems a wide range of structures are possible with an equally wide range of physical properties. Numerous types of additives are presented that include additives for the protection of the resin from the environment and processing, fillers, processing aids, anti-fogging agents, pigments, and flame retardants. Common processing methods including extrusion, blown film, cast film, injection molding, and thermoforming are presented along with some of the more specialized processing techniques such as rotational molding, fiber processing, pipe extrusion, reactive extrusion, wire and cable, and foaming processes. The business of polyethylene including markets, world capacity, and future prospects are detailed. This handbook provides the most current and complete technology assessments and business practices for polyethylene resins. |
| blow fill seal technology: Microbial Contamination Control in Parenteral Manufacturing Kevin Williams, 2004-05-20 This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, proce |
| blow fill seal technology: Microbiological Safety and Quality of Food Barbara M. Lund, Tony C. Baird-Parker, Grahame Warwick Gould, 2000 This authoritative two-volume reference provides valuable, necessary information on the principles underlying the production of microbiologically safe and stable foods. The work begins with an overview and then addresses four major areas: 'Principles and application of food preservation techniques' covers the specific techniques that defeat growth of harmful microorganisms, how those techniques work, how they are used, and how their effectiveness is measured. 'Microbial ecology of different types of food' provides a food-by-food accounting of food composition, naturally occurring microflora, effects of processing, how spoiling can occur, and preservation. 'Foodborne pathogens' profiles the most important and the most dangerous microorganisms that can be found in foods, including bacteria, viruses, parasites, mycotoxins, and 'mad cow disease.' The section also looks at the economic aspects and long-term consequences of foodborne disease. 'Assurance of the microbiological safety and quality of foods' scrutinizes all aspects of quality assurance, including HACCP, hygienic factory design, methods of detecting organisms, risk assessment, legislation, and the design and accreditation of food microbiology laboratories. Tables, photographs, illustrations, chapter-by-chapter references, and a thorough index complete each volume. This reference is of value to all academic, research, industrial and laboratory libraries supporting food programs; and all institutions involved in food safety, microbiology and food microbiology, quality assurance and assessment, food legislation, and generally food science and technology. |
| blow fill seal technology: Pharmaceutical Preformulation and Formulation Mark Gibson, 2016-04-19 Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne |
| blow fill seal technology: Medical Ethics And Legislations For Doctor's - Part 3 Dr. Shaikh Ahmad, Indian doctors, schooled in Western science, are ignorant of the medical ethics of their own culture. They make a conscious effort to distance themselves from Ayurvedic medicine, in which the ethical codes are enshrined.Teachers and students forget that values have universal applicability, regardless of the mode of practice - Western or traditional - and that the patient remains the same regardless of the system.Unethical practices in getting entry into medical colleges as students. |
| blow fill seal technology: Dosage Forms, Formulation Developments and Regulations Amit Kumar Nayak, Kalyan Kumar Sen, 2023-12-09 Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. - Examines trends and recent technologies in dosage, formulation and regulation - Contains contributions from leading experts in academia, research, industry and regulatory agencies - Includes high-quality illustrations, flow charts and tables for easy understanding of concepts - Discusses practical examples and research case studies |
| blow fill seal technology: Disinfection, Sterilization, and Preservation Seymour Stanton Block, 2001-01-01 This new edition is a comprehensive, practical reference on contemporary methods of disinfection, sterlization, and preservation and their medical, surgical, and public health applications. New topics covered include recently identified pathogens, microbial biofilms, use of antibiotics as antiseptics, synergism between chemical microbicides, pulsed-light sterilization of pharmaceuticals, and new methods for medical waste management. (Midwest). |
| blow fill seal technology: GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) Leonard Steinborn, 2004-12-30 This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa |
| blow fill seal technology: Aseptic Pharmaceutical Manufacturing II Michael J. Groves, Ram Murty, 2020-08-26 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. |
| blow fill seal technology: Plotkin's Vaccines,E-Book Walter A. Orenstein, Paul A. Offit, Kathryn M. Edwards, Stanley A. Plotkin, 2022-12-21 From the latest vaccination evidence, recommendations, and protocols . . . to new vaccine development and the use of vaccines in reducing disease, Plotkin's Vaccines, 8th Edition, covers every aspect of vaccination. Now completely revised and updated from cover to cover, this award-winning text continues to provide reliable information from global authorities, offering a complete understanding of each disease, as well as the latest knowledge of both existing vaccines and those currently in research and development. Described by Bill Gates as an indispensable guide to the enhancement of the well-being of our world, Plotkin's Vaccines is a must-have reference for current, authoritative information in this fast-moving field. - Contains all-new chapters on COVID-19, vaccine hesitancy, and non-specific effects of vaccines, as well as significantly revised content on new vaccine technologies such as mRNA vaccines, emerging vaccines, and technologies to improve immunization. - Presents exciting new data on evolution of adjuvants across the centuries, dengue vaccines, human papillomavirus vaccines, respiratory syncytial virus vaccines, tuberculosis vaccines, and zoster vaccines. - Provides up-to-date, authoritative information on vaccine production, available preparations, efficacy and safety, and recommendations for vaccine use, with rationales and data on the impact of vaccination programs on morbidity and mortality. - Provides complete coverage of each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, as well as epidemiology and public health and regulatory issues. - Keeps you up to date with information on each vaccine, including its stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease-control strategies. - Covers vaccine-preventable diseases, vaccine science, and licensed vaccine products, as well as product technologies and global regulatory and public health issues. - Analyzes the cost-benefit and cost-effectiveness of different vaccine options. - Helps you clearly visualize concepts and objective data through an abundance of tables and figures. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices. |
| blow fill seal technology: Pharmaceutical Microbiology Tim Sandle, 2015-10-09 Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. - Contains the applications of pharmaceutical microbiology in sterile and non-sterile products - Presents the practical aspects of pharmaceutical microbiology testing - Provides contamination control risks and remediation strategies, along with rapid microbiological methods - Includes bioburden, endotoxin, and specific microbial risks - Highlights relevant case studies and risk assessment scenarios |
| blow fill seal technology: Encyclopedia of Pharmaceutical Technology James Swarbrick, James C. Boylan, 2000-12-05 The Encyclopedia of Pharmaceutical Technology presents authoritative and contemporary articles on all aspects of drug development, dosage forms, manufacturing, and regulation-enabling the specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and a solid investment for years to come--maintaining currency through its supplements [Volume 18/Supplement 1: Published November, 1998] The Encyclopedia contains interdisciplinary contributions in a wide array of subjects, including Drugs decomposition metabolism pharmaceutical incompatibilities pharmacokinetics physicochemical properties preformulation stability Drug Delivery Systems and Devices-Development and Manufacture analysis and controls bioavailability use of computerization formulation and processing alternatives national and international registration packaging patents process validation scale-up safety and efficacy stability standards Post-Production and Practical Considerations governmental/industrial/professional organizations legal aspects national and international agencies patent life of drugs patient compliance ...and much, much more! |
| blow fill seal technology: Practical Aseptic Processing Jack Lysfjord, 2009 |
| blow fill seal technology: Modern Pharmaceutics, Two Volume Set Alexander T. Florence, Juergen Siepmann, 2016-04-19 This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current |
| blow fill seal technology: Parenteral Medications, Fourth Edition Sandeep Nema, John D. Ludwig, 2019-07-19 Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements |
| blow fill seal technology: Pharmaceutical Dosage Forms Sandeep Nema, John D. Ludwig, 2010-08-26 Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products |
| blow fill seal technology: Pharmaceutical Drug Product Development and Process Optimization Sarwar Beg, Majed Al Robaian, Mahfoozur Rahman, Syed Sarim Imam, Nabil Alruwaili, Sunil Kumar Panda, 2020-05-01 Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery. |
| blow fill seal technology: Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals Tim Sandle, 2013-10-31 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 |
| blow fill seal technology: Pharmaceutical Dosage Forms - Parenteral Medications Sandeep Nema, John D. Ludwig, 2016-04-19 This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the |
| blow fill seal technology: Biotechnology Kenneth E. Avis, Carmen M. Wagner, Vincent L. Wu, 2020-04-22 Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more. |
| blow fill seal technology: Hugo and Russell's Pharmaceutical Microbiology Stephen P. Denyer, Norman A. Hodges, Sean P. Gorman, 2008-04-15 Completely revised and updated Pharmaceutical Microbiologycontinues to provide the essential resource for the 21st centurypharmaceutical microbiologist ....a valuable resource for junior pharmacists graspingan appreciation of microbiology, microbiologists entering thepharmaceutical field, and undergraduate pharmacy students. Journal of Antimicrobial Chemotherapy .....highly readable. The content is comprehensive, withwell-produced tables, diagrams and photographs, and is accessiblethrough the extensive index. Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace ofchange in the teaching and practice of pharmaceuticalmicrobiology Expanded coverage of modern biotechnology, including genomicsand recombinant DNA technology Updated information on newer antimicrobial agents and theirmode of action Highly illustrated with structural formulas of organiccompounds and flow diagrams of biochemical processes |
| blow fill seal technology: Nanomaterials for Food Packaging Miguel Angelo Parente Ribei Cerqueira, Jose Maria Lagaron, Lorenzo Miguel Pastrana Castro, Antonio Augusto Martins de Oliveira Soares Vicente, 2018-05-10 Nanotechnology for Food Packaging: Materials, Processing Technologies, and Safety Issues showcases the latest research in the use of nanotechnology in food packaging, providing an in-depth and interdisciplinary overview of the field. Nanoscale advances in materials science, processing technology and analytical techniques have led to the introduction of new, cheaper and safer packaging techniques. Simultaneously, the increasing use of renewable nanomaterials has made food packaging more sustainable. Chapters provide a comprehensive review on materials used, their structure–function relationship, and new processing technologies for the application and production of nanotechnology-based packaging materials. In addition, the book discusses the use of functional materials for the development of active, smart and intelligent packaging, possible migration and toxicity of nanomaterials for foods and regulatory aspects, and commercial applications. - Provides detailed information on the use of nanomaterials and methodologies in food packaging, possible applications and regulatory barriers to commercialization - Presents an interdisciplinary approach that brings together materials science, bioscience, and the industrial and regulatory aspects of the creation and uses of food packaging - Helps those undertaking research and development in food packaging gain a cogent understanding on how nanotechnology is leading to the emergence of new packaging technologies |
| blow fill seal technology: Ophthalmic Product Development Seshadri Neervannan, Uday B. Kompella, 2022-03-11 This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use. Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product development. The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products. Critical elements such as pharmacokinetics, influence of formulation technologies and ingredients, as well as impact of disease conditions on products development are addressed. Products intended for both the front and the back of the eye are discussed with an eye towards future advances. @font-face {font-family:Cambria Math; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:3 0 0 0 1 0;}@font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-469750017 -1073732485 9 0 511 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:; margin:0cm; mso-pagination:widow-orphan; font-size:12.0pt; font-family:Times New Roman,serif; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:Calibri,sans-serif; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Times New Roman; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}div.WordSection1 {page:WordSection1;} |
| blow fill seal technology: Aseptic Pharmaceutical Manufacturing Wayne P. Olson, Michael J. Groves, 1987 |
| blow fill seal technology: Handbook of Validation in Pharmaceutical Processes, Fourth Edition James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, 2021-10-28 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 |
| blow-fill-seal technology: Blow-Fill-Seal Technology Rainer Oschmann, Otto Ernst Schubert, 1999-03-29 Plastic containers are increasingly being used for the packaging of pharmaceutical products-solids, powders, liquids, creams and ointments-sterile and non-sterile. No only do plastic containers have proven compatibility with and impermeability to the product itself, but they also have the advantage over glass of being relatively cheap, lightweight, rigid or flexible in shape and shatter resistant. Blow-Fill Seal Technology discusses the advantages of genuine in house' packaging manufacture which includes the simultaneous filling and closing of the containers by one machine in one operation, the procedure called BFS, blow-fill-seal or, alternatively, FFS, form-fill-seal technology. This book explains the process in which the BFS machine carries out the complete cycle of blow molding, filling and sealing under conditions in which security can be validated using established aseptic test procedures, offering considerable advantages over conventional aseptic filling of preformed (plastic of other) containers. Offering 61 figures and 21 tables, this book helps people gain a better overview of the types of plastic materials, manufacturing in detail, machinery of BFS technology, validation aspects and quality assurance. Features · |
| blow-fill-seal technology: The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology K. Downey, M. Haerer, S. Marguillier, P. Åkerman, 2016 |
| blow-fill-seal technology: Sterilization of Medical Devices Anne Booth, 2018-12-12 This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies. |
| blow-fill-seal technology: Dosage Form Design Parameters , 2018-07-25 Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design |
| blow-fill-seal technology: Formulation, Characterization, and Stability of Protein Drugs Rodney Pearlman, Y. John Wang, 1996-10-31 Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot. |
| blow-fill-seal technology: Voigt's Pharmaceutical Technology Alfred Fahr, 2018-02-21 A textbook which is both comprehensive and comprehensible and that offers easy but scientifically sound reading to both students and professionals Now in its 12th edition in its native German, Voigt's Pharmaceutical Technology is an interdisciplinary textbook covering the fundamental principles of pharmaceutical technology. Available for the first time in English, this edition is produced in full colour throughout, with a concise, clear structure developed after consultation with students, instructors and researchers. This book: Features clear chapter layouts and easily digestible content Presents novel trends, devices and processes Discusses classical and modern manufacturing processes Covers all formulation principles including tablets, ointments, capsules, nanosystems and biopharmaceutics Takes account of legal requirements for both qualitative and quantitative composition Addresses quality assurance considerations Uniquely relates contrasting international pharmacopeia from EU, US and Japan to formulation principles Includes examples and text boxes for quicker data assimilation Written for both students studying pharmacy and industry professionals in the field as well as toxicologists, biochemists, medical lab technicians, Voigt’s Pharmaceutical Technology is the essential resource for understanding the various aspects of pharmaceutical technology. |
| blow-fill-seal technology: The Drugs and Cosmetics Act, 1940 , |
| blow-fill-seal technology: TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva, 2023-08-04 This book structured in TWO different parts. These parts are as follows: Part I emphasizes on GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), USFDA-NDA/ANDA (U S Food and Drug Administrations- New Drug Approval/Abbreviated New Drug Approval) and TQM (Total Quality Management). GCP (Good Clinical Practices) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates. GLP (Good Laboratory Practices) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. GMP (Good Manufacturing Practices) Manufacturing relies on the ability to reproduce exactly a single product hundreds, if not thousands, of times. To make this possible, guidelines have been drawn up in most countries that are similar to the FDA ones described here that define GMPs. Diagnostic companies, including those manufacturing and distributing biosensors, cannot sell their products for either public or professional use unless they have been approved on the basis of these guidelines. USFDA-NDA/ANDA (U S Food and Drug Ad |
| blow-fill-seal technology: Mucosal Delivery of Biopharmaceuticals José das Neves, Bruno Sarmento, 2014-02-03 Biopharmaceutical medicines, the newest class of therapeutics, are quite heterogeneous and include a range of molecules such as proteins, peptides, vaccines and nucleic acids, with use in virtually all therapeutic fields (e.g. cancer and infectious diseases, vaccination, metabolic dysfunctions) and diagnostics. This edited book gives a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals, the technological strategies that have been followed so far regarding the optimization of mucosal potentialities as well as the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. Following a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects toward beneficial or deleterious interaction with biopharmaceuticals and their delivery systems. The second part reviews the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications of drug delivery systems and products enclosing biopharmaceuticals for mucosal delivery, with a focus on the most successful case studies of recent years. The last section briefly centers on relevant aspects of the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals. Scientists and researchers in the fields of drug delivery, material science, biomedical science and bioengineering as well as professionals, regulators and policy makers in the pharmaceutical, biotechnology and healthcare industries will find in this book an important compendium of fundamental concepts and practical tools for their daily research and activities. |
| blow-fill-seal technology: Pharmaceutical Quality Assurance B.P. Nagori, Ajay Gaur, Renu Solanki, Vipin Mathur, 2018-01-01 he present state-of-art book has been written as per the new syllabus of B. Pharmacy, introduced by Pharmacy Council of India (PCI). This book has an inclusive content that covers the wider aspects of pharmaceutical quality assurance required by under- graduates, post graduates, industry personnels, researcher, and students preparing for various competitive exams. The distinguishing feature of this book is that the book is written in lucid, simple and easy to understand language. The book is accompanied with Multiple Choice, Fill in the Blank, True-False, Short Answer and Long Answer type of questions for the self- evluation of learning. The answers of the Multiple Choice, Fill in the Blank and True-False questions have also been given. Web links/further reading are included to help the readers for keeping themselves abreast with th latest developments in the held of pharmaceutical quality assurance. Academicians and instructors in universities/colleges may use the book as primary or additional teaching material for under-graduate and post-graduate pharmacy courses. |
| blow-fill-seal technology: Downstream Industrial Biotechnology Michael C. Flickinger, 2013-07-17 DOWNSTREAM INDUSTRIAL BIOTECHNOLOGY An affordable, easily accessible desk reference on biomanufacturing, focused on downstream recovery and purification Advances in the fundamental knowledge surrounding biotechnology, novel materials, and advanced engineering approaches continue to be translated into bioprocesses that bring new products to market at a significantly faster pace than most other industries. Industrial scale biotechnology and new manufacturing methods are revolutionizing medicine, environmental monitoring and remediation, consumer products, food production, agriculture, and forestry, and continue to be a major area of research. The downstream stage in industrial biotechnology refers to recovery, isolation, and purification of the microbial products from cell debris, processing medium and contaminating biomolecules from the upstream process into a finished product such as biopharmaceuticals and vaccines. Downstream process design has the greatest impact on overall biomanufacturing cost because not only does the biochemistry of different products ( e.g., peptides, proteins, hormones, antibiotics, and complex antigens) dictate different methods for the isolation and purification of these products, but contaminating byproducts can also reduce overall process yield, and may have serious consequences on clinical safety and efficacy. Therefore downstream separation scientists and engineers are continually seeking to eliminate, or combine, unit operations to minimize the number of process steps in order to maximize product recovery at a specified concentration and purity. Based on Wiley’s Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, this volume features fifty articles that provide information on down- stream recovery of cells and protein capture; process development and facility design; equipment; PAT in downstream processes; downstream cGMP operations; and regulatory compliance. It covers: Cell wall disruption and lysis Cell recovery by centrifugation and filtration Large-scale protein chromatography Scale down of biopharmaceutical purification operations Lipopolysaccharide removal Porous media in biotechnology Equipment used in industrial protein purification Affinity chromatography Antibody purification, monoclonal and polyclonal Protein aggregation, precipitation and crystallization Freeze-drying of biopharmaceuticals Biopharmaceutical facility design and validation Pharmaceutical bioburden testing Regulatory requirements Ideal for graduate and advanced undergraduate courses on biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology, Downstream Industrial Biotechnology is also a highly recommended resource for industry professionals and libraries. |
| blow-fill-seal technology: Handbook of Pharmaceutical Manufacturing Formulations, Third Edition Sarfaraz K. Niazi, 2019-12-09 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 |
| blow-fill-seal technology: Handbook of Pharmaceutical Manufacturing Formulations Safaraz K. Niazi, 2016-04-19 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 |
| blow-fill-seal technology: Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation Kenneth E. Avis, Vincent L. Wu, 2020-08-14 In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering. |
| blow-fill-seal technology: Advanced Aseptic Processing Technology James Agalloco, James Akers, 2016-04-19 The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies |
| blow-fill-seal technology: Handbook of Industrial Polyethylene and Technology Mark A. Spalding, Ananda Chatterjee, 2017-10-12 This handbook provides an exhaustive description of polyethylene. The 50+ chapters are written by some of the most experienced and prominent authors in the field, providing a truly unique view of polyethylene. The book starts with a historical discussion on how low density polyethylene was discovered and how it provided unique opportunities in the early days. New catalysts are presented and show how they created an expansion in available products including linear low density polyethylene, high density polyethylene, copolymers, and polyethylene produced from metallocene catalysts. With these different catalysts systems a wide range of structures are possible with an equally wide range of physical properties. Numerous types of additives are presented that include additives for the protection of the resin from the environment and processing, fillers, processing aids, anti-fogging agents, pigments, and flame retardants. Common processing methods including extrusion, blown film, cast film, injection molding, and thermoforming are presented along with some of the more specialized processing techniques such as rotational molding, fiber processing, pipe extrusion, reactive extrusion, wire and cable, and foaming processes. The business of polyethylene including markets, world capacity, and future prospects are detailed. This handbook provides the most current and complete technology assessments and business practices for polyethylene resins. |
| blow-fill-seal technology: Microbial Contamination Control in Parenteral Manufacturing Kevin Williams, 2004-05-20 This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, proce |
| blow-fill-seal technology: Microbiological Safety and Quality of Food Barbara M. Lund, Tony C. Baird-Parker, Grahame Warwick Gould, 2000 This authoritative two-volume reference provides valuable, necessary information on the principles underlying the production of microbiologically safe and stable foods. The work begins with an overview and then addresses four major areas: 'Principles and application of food preservation techniques' covers the specific techniques that defeat growth of harmful microorganisms, how those techniques work, how they are used, and how their effectiveness is measured. 'Microbial ecology of different types of food' provides a food-by-food accounting of food composition, naturally occurring microflora, effects of processing, how spoiling can occur, and preservation. 'Foodborne pathogens' profiles the most important and the most dangerous microorganisms that can be found in foods, including bacteria, viruses, parasites, mycotoxins, and 'mad cow disease.' The section also looks at the economic aspects and long-term consequences of foodborne disease. 'Assurance of the microbiological safety and quality of foods' scrutinizes all aspects of quality assurance, including HACCP, hygienic factory design, methods of detecting organisms, risk assessment, legislation, and the design and accreditation of food microbiology laboratories. Tables, photographs, illustrations, chapter-by-chapter references, and a thorough index complete each volume. This reference is of value to all academic, research, industrial and laboratory libraries supporting food programs; and all institutions involved in food safety, microbiology and food microbiology, quality assurance and assessment, food legislation, and generally food science and technology. |
| blow-fill-seal technology: Pharmaceutical Preformulation and Formulation Mark Gibson, 2016-04-19 Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne |
| blow-fill-seal technology: Medical Ethics And Legislations For Doctor's - Part 3 Dr. Shaikh Ahmad, Indian doctors, schooled in Western science, are ignorant of the medical ethics of their own culture. They make a conscious effort to distance themselves from Ayurvedic medicine, in which the ethical codes are enshrined.Teachers and students forget that values have universal applicability, regardless of the mode of practice - Western or traditional - and that the patient remains the same regardless of the system.Unethical practices in getting entry into medical colleges as students. |
| blow-fill-seal technology: Dosage Forms, Formulation Developments and Regulations Amit Kumar Nayak, Kalyan Kumar Sen, 2023-12-09 Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. - Examines trends and recent technologies in dosage, formulation and regulation - Contains contributions from leading experts in academia, research, industry and regulatory agencies - Includes high-quality illustrations, flow charts and tables for easy understanding of concepts - Discusses practical examples and research case studies |
| blow-fill-seal technology: Disinfection, Sterilization, and Preservation Seymour Stanton Block, 2001-01-01 This new edition is a comprehensive, practical reference on contemporary methods of disinfection, sterlization, and preservation and their medical, surgical, and public health applications. New topics covered include recently identified pathogens, microbial biofilms, use of antibiotics as antiseptics, synergism between chemical microbicides, pulsed-light sterilization of pharmaceuticals, and new methods for medical waste management. (Midwest). |
| blow-fill-seal technology: GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) Leonard Steinborn, 2004-12-30 This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa |
| blow-fill-seal technology: Aseptic Pharmaceutical Manufacturing II Michael J. Groves, Ram Murty, 2020-08-26 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. |
| blow-fill-seal technology: Plotkin's Vaccines,E-Book Walter A. Orenstein, Paul A. Offit, Kathryn M. Edwards, Stanley A. Plotkin, 2022-12-21 From the latest vaccination evidence, recommendations, and protocols . . . to new vaccine development and the use of vaccines in reducing disease, Plotkin's Vaccines, 8th Edition, covers every aspect of vaccination. Now completely revised and updated from cover to cover, this award-winning text continues to provide reliable information from global authorities, offering a complete understanding of each disease, as well as the latest knowledge of both existing vaccines and those currently in research and development. Described by Bill Gates as an indispensable guide to the enhancement of the well-being of our world, Plotkin's Vaccines is a must-have reference for current, authoritative information in this fast-moving field. - Contains all-new chapters on COVID-19, vaccine hesitancy, and non-specific effects of vaccines, as well as significantly revised content on new vaccine technologies such as mRNA vaccines, emerging vaccines, and technologies to improve immunization. - Presents exciting new data on evolution of adjuvants across the centuries, dengue vaccines, human papillomavirus vaccines, respiratory syncytial virus vaccines, tuberculosis vaccines, and zoster vaccines. - Provides up-to-date, authoritative information on vaccine production, available preparations, efficacy and safety, and recommendations for vaccine use, with rationales and data on the impact of vaccination programs on morbidity and mortality. - Provides complete coverage of each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, as well as epidemiology and public health and regulatory issues. - Keeps you up to date with information on each vaccine, including its stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease-control strategies. - Covers vaccine-preventable diseases, vaccine science, and licensed vaccine products, as well as product technologies and global regulatory and public health issues. - Analyzes the cost-benefit and cost-effectiveness of different vaccine options. - Helps you clearly visualize concepts and objective data through an abundance of tables and figures. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices. |
| blow-fill-seal technology: Pharmaceutical Microbiology Tim Sandle, 2015-10-09 Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. - Contains the applications of pharmaceutical microbiology in sterile and non-sterile products - Presents the practical aspects of pharmaceutical microbiology testing - Provides contamination control risks and remediation strategies, along with rapid microbiological methods - Includes bioburden, endotoxin, and specific microbial risks - Highlights relevant case studies and risk assessment scenarios |
| blow-fill-seal technology: Encyclopedia of Pharmaceutical Technology James Swarbrick, James C. Boylan, 2000-12-05 The Encyclopedia of Pharmaceutical Technology presents authoritative and contemporary articles on all aspects of drug development, dosage forms, manufacturing, and regulation-enabling the specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and a solid investment for years to come--maintaining currency through its supplements [Volume 18/Supplement 1: Published November, 1998] The Encyclopedia contains interdisciplinary contributions in a wide array of subjects, including Drugs decomposition metabolism pharmaceutical incompatibilities pharmacokinetics physicochemical properties preformulation stability Drug Delivery Systems and Devices-Development and Manufacture analysis and controls bioavailability use of computerization formulation and processing alternatives national and international registration packaging patents process validation scale-up safety and efficacy stability standards Post-Production and Practical Considerations governmental/industrial/professional organizations legal aspects national and international agencies patent life of drugs patient compliance ...and much, much more! |
| blow-fill-seal technology: Practical Aseptic Processing Jack Lysfjord, 2009 |
| blow-fill-seal technology: Modern Pharmaceutics, Two Volume Set Alexander T. Florence, Juergen Siepmann, 2016-04-19 This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current |
| blow-fill-seal technology: Parenteral Medications, Fourth Edition Sandeep Nema, John D. Ludwig, 2019-07-19 Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements |
| blow-fill-seal technology: Pharmaceutical Dosage Forms Sandeep Nema, John D. Ludwig, 2010-08-26 Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products |
| blow-fill-seal technology: Pharmaceutical Drug Product Development and Process Optimization Sarwar Beg, Majed Al Robaian, Mahfoozur Rahman, Syed Sarim Imam, Nabil Alruwaili, Sunil Kumar Panda, 2020-05-01 Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery. |
| blow-fill-seal technology: Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals Tim Sandle, 2013-10-31 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 |
| blow-fill-seal technology: Pharmaceutical Dosage Forms - Parenteral Medications Sandeep Nema, John D. Ludwig, 2016-04-19 This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the |
| blow-fill-seal technology: Biotechnology Kenneth E. Avis, Carmen M. Wagner, Vincent L. Wu, 2020-04-22 Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more. |
| blow-fill-seal technology: Hugo and Russell's Pharmaceutical Microbiology Stephen P. Denyer, Norman A. Hodges, Sean P. Gorman, 2008-04-15 Completely revised and updated Pharmaceutical Microbiologycontinues to provide the essential resource for the 21st centurypharmaceutical microbiologist ....a valuable resource for junior pharmacists graspingan appreciation of microbiology, microbiologists entering thepharmaceutical field, and undergraduate pharmacy students. Journal of Antimicrobial Chemotherapy .....highly readable. The content is comprehensive, withwell-produced tables, diagrams and photographs, and is accessiblethrough the extensive index. Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace ofchange in the teaching and practice of pharmaceuticalmicrobiology Expanded coverage of modern biotechnology, including genomicsand recombinant DNA technology Updated information on newer antimicrobial agents and theirmode of action Highly illustrated with structural formulas of organiccompounds and flow diagrams of biochemical processes |
| blow-fill-seal technology: Nanomaterials for Food Packaging Miguel Angelo Parente Ribei Cerqueira, Jose Maria Lagaron, Lorenzo Miguel Pastrana Castro, Antonio Augusto Martins de Oliveira Soares Vicente, 2018-05-10 Nanotechnology for Food Packaging: Materials, Processing Technologies, and Safety Issues showcases the latest research in the use of nanotechnology in food packaging, providing an in-depth and interdisciplinary overview of the field. Nanoscale advances in materials science, processing technology and analytical techniques have led to the introduction of new, cheaper and safer packaging techniques. Simultaneously, the increasing use of renewable nanomaterials has made food packaging more sustainable. Chapters provide a comprehensive review on materials used, their structure–function relationship, and new processing technologies for the application and production of nanotechnology-based packaging materials. In addition, the book discusses the use of functional materials for the development of active, smart and intelligent packaging, possible migration and toxicity of nanomaterials for foods and regulatory aspects, and commercial applications. - Provides detailed information on the use of nanomaterials and methodologies in food packaging, possible applications and regulatory barriers to commercialization - Presents an interdisciplinary approach that brings together materials science, bioscience, and the industrial and regulatory aspects of the creation and uses of food packaging - Helps those undertaking research and development in food packaging gain a cogent understanding on how nanotechnology is leading to the emergence of new packaging technologies |
| blow-fill-seal technology: Ophthalmic Product Development Seshadri Neervannan, Uday B. Kompella, 2022-03-11 This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use. Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product development. The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products. Critical elements such as pharmacokinetics, influence of formulation technologies and ingredients, as well as impact of disease conditions on products development are addressed. Products intended for both the front and the back of the eye are discussed with an eye towards future advances. @font-face {font-family:Cambria Math; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:3 0 0 0 1 0;}@font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-469750017 -1073732485 9 0 511 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:; margin:0cm; mso-pagination:widow-orphan; font-size:12.0pt; font-family:Times New Roman,serif; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:Calibri,sans-serif; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Times New Roman; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}div.WordSection1 {page:WordSection1;} |
| blow-fill-seal technology: Aseptic Pharmaceutical Manufacturing Wayne P. Olson, Michael J. Groves, 1987 |
| blow-fill-seal technology: Handbook of Validation in Pharmaceutical Processes, Fourth Edition James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, 2021-10-28 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 |
Blow (film) - Wikipedia
Blow is a 2001 American biographical crime drama film produced and directed by Ted Demme, about an American cocaine kingpin and his international network. David McKenna and Nick Cassavetes adapted …
Blow (2001) - IMDb
Blow: Directed by Ted Demme. With Johnny Depp, Penélope Cruz, Franka Potente, Rachel Griffiths. The story of how George Jung, along with the Medellín Cartel headed by Pablo Escobar, established the American cocaine …
BLOW Definition & Meaning - Merriam-Webster
Verb (1) that horse was really blowing after the race each year he blows his holiday bonus on a trip to Las Vegas a huge crater …
BLOW | English meaning - Cambridge Dictionary
BLOW definition: 1. to move and make currents of air, or to be moved or make something move on a current of air: 2…. …
Blow (2001) - Movie - Moviefone
A boy named George Jung grows up in a struggling family in the 1950's. His mother nags at her husband as he is trying to make a living for the family. It is finally...
Blow (film) - Wikipedia
Blow is a 2001 American biographical crime drama film produced and directed by Ted Demme, about an American cocaine kingpin and his international network. David McKenna and Nick …
Blow (2001) - IMDb
Blow: Directed by Ted Demme. With Johnny Depp, Penélope Cruz, Franka Potente, Rachel Griffiths. The story of how George Jung, along with the Medellín Cartel headed by Pablo …
BLOW Definition & Meaning - Merriam-Webster
Verb (1) that horse was really blowing after the race each year he blows his holiday bonus on a trip to Las Vegas a huge crater was formed when the volcano last blew one false move and …
BLOW | English meaning - Cambridge Dictionary
BLOW definition: 1. to move and make currents of air, or to be moved or make something move on a current of air: 2…. Learn more.
Blow (2001) - Movie - Moviefone
A boy named George Jung grows up in a struggling family in the 1950's. His mother nags at her husband as he is trying to make a living for the family. It is finally...
Blow - Rotten Tomatoes
In the turbulence of the 1970s, the international drug trade underwent a fast, violent and lucrative revolution - and one ordinary American was at its center.
Blow - definition of blow by The Free Dictionary
To release air or gas suddenly; burst or explode: The tire blew when it hit the pothole. e. To spout moist air from the blowhole. Used of a whale. 3. a. To fail or break down, as from being …
Watch Blow - Netflix
Amid the violent, decadent drug trade of the 1970s, small-time smuggler George Jung rises to become one of Pablo Escobar's biggest traffickers. Watch trailers & learn more.
Blow movie review & film summary (2001) - Roger Ebert
Apr 6, 2001 · “Blow” stars Johnny Depp in a biopic about George Jung, a man who claims that in the late 1970s he imported about 85 percent of all the cocaine in America. That made him the …
BLOW definition and meaning | Collins English Dictionary
If you blow a chance or attempt to do something, you make a mistake which wastes the chance or causes the attempt to fail.
