Pharmaceutical Microbiology

Author: Tim Sandle
Publisher: Woodhead Publishing
ISBN: 0081000448
Format: PDF, Kindle
Download Now
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

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Author: Rosamund M. Baird
Publisher: CRC Press
ISBN: 9780203305195
Format: PDF, ePub, Mobi
Download Now
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.

Biotechnology Operations

Author: John M. Centanni
Publisher: CRC Press
ISBN: 149875886X
Format: PDF, ePub
Download Now
This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.

Mikrobiologische Analysen Richtlinien zur Qualit tssicherung

Author: N.F. Lightfoot
Publisher: Springer
ISBN: 9783642629150
Format: PDF, ePub, Mobi
Download Now
Täglich werden in Europa tausende mikrobiologische Analysen durchgeführt, besonders zur Überwachung der Qualität von Lebensmitteln, Trinkwasser oder Badegewässern. Um Proben und Messergebnisse im gesamten europäischen Raum vergleichen und austauschen zu können, sind einheitliche Qualitätsstandards Voraussetzung. Diese wurden in verschiedenen EU-Projekten erarbeitet und unterstützt von der Europäischen Kommision in entsprechenden Richtlinien formuliert. Dabei wurde die EN 45001 zugrunde gelegt (nun ersetzt durch die Norm ISO/IEC 17025 "Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien"). Insbesonders gehören dazu: zuverlässige Referenzmaterialien, anerkannte Mess- und Auswertmethoden sowie validierte Abläufe von der Probennahme bis zur Dokumentation der Ergebnisse. Mit den nun auch in Deutsch vorliegenden Anleitungen kann jedes Untersuchungslabor ein Qualitätssicherungssystem implementieren.

Biocontamination Control for Pharmaceuticals and Healthcare

Author: Tim Sandle
Publisher: Academic Press
ISBN: 0128149124
Format: PDF, Mobi
Download Now
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy. Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

Predictive Modeling of Pharmaceutical Unit Operations

Author: Preetanshu Pandey
Publisher: Woodhead Publishing
ISBN: 0081001800
Format: PDF, ePub, Docs
Download Now
The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Medizinische Mykologie

Author: Siegfried Nolting
Publisher: Springer-Verlag
ISBN: 366208631X
Format: PDF, Kindle
Download Now
Erkrankungen durch Pilze beanspruchen in der täglichen Praxis ei nen breiten und ständig wachsenden Raum. Man hört und liest von einem unaufbaItsamen Vormarsch der Pilze und ihrer zunehmenden Gefährdung für den Menschen. Diese Behauptung gilt sicher nicht so allgemein für alle Erkrankungen durch Pilze. Jedoch müssen wir langsam lernen, die Gefahr, die von diesen Erregern ausgeht, richtig einzuschätzen. Wenn man heute von einer wachsenden Bedeutung der Pilzerkrankungen spricht, so sind in erster Linie Mykosen als Er krankungen durch parasitäre Pilze gemeint. Die Kenntnis der Mykosen ist für den praktisch tätigen Arzt ebenso wichtig wie die Kenntnis von Erkrankungen durch Bakterien oder Viren. Auf den ersten Blick erscheint dieses Gebiet der Mikrobiolo gie sicher außerordentlich verwirrend. Unser Anliegen ist es daher, den mykologisch Interessierten nicht durch eine Vielfalt unüber schaubarer Begriffe zu verunsichern und ihm die Unzulänglichkeit seines Tuns immer wieder zu beweisen, sondern es geht uns darum, Hilfen zu geben bei der Diagnostik, der Therapie und den prophy laktischen Maßnahmen in der Mykologie. Am Beginn der Mikrobiologie stand ohne Zweifel die Mykologie. Vor der Entdeckung der Bakterien wurden bereits 1836 von Remark in den Krusten des Favus verzweigte Fäden gesehen, die er zu die sem Zeitpunkt jedoch wohl nicht als Ursache für die Erkrankung an sah. 1839 erkannte dann Schönlein den Zusammenhang zwischen Pilzfäden und der Entstehung des Favus. Virchow führte schon den Begriff der Dermatomykosen in die Humanpathologie ein. Die My kologie erhielt jedoch ihre entscheidenden Impulse und Bedeutung durch die Arbeiten von Sabouraud.

Allgemeine Mikrobiologie

Author: Georg Fuchs
Publisher: Georg Thieme Verlag
ISBN: 3132418870
Format: PDF, ePub, Docs
Download Now
Das Standardwerk der Mikrobiologie – aktuell und umfassend Hier erfährst du alles, was du im Biologiestudium über Mikrobiologie wissen musst: - die verschiedenen Mikroorganismen im Überblick - allgemeiner Zellstoffwechsel mit Biosynthesen und Abbau organischer Verbindungen - unterschiedliche Stoffwechselleistungen der verschiedenen Mikroorganismen - Genetik und Molekularbiologie - Ökologie, Symbiose, Antagonismus - Systematik der Mikroorganismen, mit Vernetzung zum Stoffwechselkapitel - Biogeochemie und marine Mikrobiologie - Einführung in die medizinische Mikrobiologie und Infektionskrankheiten - Biotechnologie, inkl. Informationen zu Fermentationstechnik und Lebensmittelbiologie - Anhang mit den wichtigsten thermodynamischen Grundlagen des Stoffwechsels - Vokabularium mit den wichtigsten ins Deutsche übersetzten Fachausdrücken Großes Format, übersichtliches Layout, bewährtes didaktisches Konzept: - viele Bilder und Grafiken, komplett farbig - klar formulierter Haupttext - spannend und verständlich geschrieben - verschiedenfarbige Boxen mit vertiefendem Wissen und Methoden Jederzeit zugreifen: Der Inhalt des Buches steht Ihnen ohne weitere Kosten digital in der Wissensplattform eRef zur Verfügung (Zugangscode im Buch). Mit der kostenlosen eRef App haben Sie zahlreiche Inhalte auch offline immer griffbereit.

Quality Assurance of Pharmaceuticals

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241546195
Format: PDF, ePub, Docs
Download Now
The quality of pharmaceuticals is a continuing concern of the World Health Organization (WHO). The setting of global standards is requested in Article 2 of the WHO Constitution which cites as one of the Organization's functions that it should develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products. To respond to the global need for adequate quality assurnace of pharmaceuticals, WHO Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value.