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Drug compounding pharmacies : risk and oversight issues / / Seth Sharpe, editor
| Drug compounding pharmacies : risk and oversight issues / / Seth Sharpe, editor |
| Pubbl/distr/stampa | [Hauppauge] New York : , : Nova Publishers, , [2013] |
| Descrizione fisica | 1 online resource (184 pages) |
| Disciplina | 338.4/76151 |
| Collana |
Pharmacology, research, safety testing and regulation
Public health in the 21st century |
| Soggetto topico |
Pharmaceutical technology - Standards
Pharmaceutical industry - United States - Quality control Products liability - Drugs - United States |
| ISBN | 1-62808-177-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910151722103321 |
| [Hauppauge] New York : , : Nova Publishers, , [2013] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Global approach in safety testing : ICH guidelines explained
| Global approach in safety testing : ICH guidelines explained |
| Edizione | [1st ed. 2013.] |
| Pubbl/distr/stampa | New York, : Springer, 2012 |
| Descrizione fisica | 1 online resource (320 p.) |
| Disciplina | 615.190218 |
| Altri autori (Persone) |
van der LaanJan Willem
DeGeorgeJoseph J |
| Collana | AAPS Advances in the Pharmaceutical Sciences Series |
| Soggetto topico |
Pharmaceutical industry - Quality control
Drugs - Law and legislation Drugs - Testing - Standards Pharmaceutical technology - Standards |
| ISBN |
1-299-33560-8
1-4614-5950-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | The International Conference on Harmonisation. History of Safety Guidelines -- EU Perspective on ICH -- The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities Advancing Harmonization for Better Public Health -- A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process -- Towards more Scientific Relevance in Carcinogenicity Testing -- The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals -- Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies , Where are we now; an S3A/S3B update (1995-2011) -- Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B) -- Why and how did Reproduction Toxicity Testing make its early entry into and Rapid Success in ICH? -- ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals -- Safety Pharmacology: Guidelines S7A and S7B -- ICH S8: History and Perspectives -- ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals a Perspective from Regulators on the Development of the Guideline -- Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals ICH M3 and M3(R2). |
| Record Nr. | UNINA-9910437852303321 |
| New York, : Springer, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
International IT regulations and compliance [[electronic resource] ] : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad
| International IT regulations and compliance [[electronic resource] ] : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad |
| Autore | Segalstad Siri H |
| Pubbl/distr/stampa | Chichester, West Sussex, United Kingdom, : Wiley, 2008 |
| Descrizione fisica | 1 online resource (340 p.) |
| Disciplina |
615
615.19 |
| Soggetto topico |
Pharmaceutical technology - Standards
Pharmaceutical industry - Standards Pharmaceutical industry - Quality control Drugs - Standards |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-282-34277-0
9786612342776 0-470-72182-0 0-470-72183-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
International IT Regulations and Compliance; Contents; Preface and Acknowledgements; 1 Quality Standards; 1.1 What Quality Is; 1.2 Mandatory and Voluntary Standards; 1.3 Pharmaceutical Industry Regulations; 1.4 US GxP Regulations; 1.5 European GxP Regulations; 1.6 Other GxP Regulations; 1.7 Good Manufacturing Practice; 1.8 Good Laboratory Practice; 1.9 Good Clinical Practice; 1.10 Medical Device Standards; 1.11 IT Systems in the GxP and Medical Device Regulations; 1.12 GAMP; 1.13 Mandatory Quality Standards in Other Industries; 1.14 Legal Issues; 1.15 The ISO; 1.16 The ASTM; 1.17 The IEEE
1.18 TasksReferences; 2 Regulatory Requirements for IT Systems; 2.1 Introduction; 2.2 US Requirements; 2.3 EU Requirements; 2.4 21 CFR Part 11; 2.5 The 'Part 11 Project'; 2.6 EU GMP Annex 11; 2.7 The PIC Document PI 011 Recommendation on Computerized Systems in Regulated 'GxP' Environments; 2.8 GAMP; 2.9 The ISO 9000 Series; 2.10 A Comparison between the Standards; 2.11 Conclusion; 2.12 Tasks; References; 3 IT Security; 3.1 Introduction; 3.2 Continuous Connections - Wireless Networks; 3.3 Threats; 3.4 The Security Policy; 3.5 Tasks; References; 4 Quality Management Systems 4.1 An Introduction to QMS4.2 Definitions; 4.3 Principles for Quality Management; 4.4 Quality Management System Levels; 4.5 Creating a QMS; 4.6 Roles and Responsibilities; 4.7 Work Processes; 4.8 Controlled Documents; 4.9 The Quality Policy; 4.10 The Quality Manual; 4.11 Standard Operating Procedures; 4.12 The Art of Writing an SOP; 4.13 Tasks; References; 5 IT Integrated in the QMS in the User Organization; 5.1 Introduction; 5.2 How to Integrate IT Systems in the QMS; 5.3 Generic Standard Operating Procedures; 5.4 Procedures for Each System; 5.5 Tasks; References 6 IT Integrated in the Supplier's QMS6.1 Introduction; 6.2 Which Standards Should Be Used?; 6.3 The Quality Management System; 6.4 System Development Models; 6.5 Documents for Software Development; 6.6 The Customer-Supplier Relationship; 6.7 Tasks; References; 7 Organization for an IT System; 7.1 Introduction; 7.2 Roles and Responsibilities for a Live System; 7.3 Groups in the IT System Organization; 7.4 Roles and Responsibilities for an IT Validation Project; 7.5 Outsourcing; 7.6 The Service Level Agreement for Outsourcing; 7.7 Consultants; References 8 The Legal Implications of an IT System8.1 Introduction; 8.2 Pharmaceutical Regulations; 8.3 Financial Systems; 8.4 Patent Systems; 8.5 Human Resources Systems; 8.6 Healthcare Systems; 8.7 Systems for Legal Information; Reference; 9 Advanced Quality Management Systems; 9.1 Introduction; 9.2 The Live QMS is a Good QMS; 9.3 Changes; 9.4 How to Keep the QMS Updated; 9.5 Training and Understanding; 9.6 How to use a QMS Effectively as a Tool in the Organization - Not as a Straightjacket; 9.7 Tasks; References; 10 Audits; 10.1 Introduction; 10.2 The ISO 9000 Series; 10.3 TickIT; 10.4 Why Audit? 10.5 Audit in a Risk-Based Environment |
| Record Nr. | UNINA-9910144386003321 |
Segalstad Siri H
|
||
| Chichester, West Sussex, United Kingdom, : Wiley, 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
International IT regulations and compliance [[electronic resource] ] : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad
| International IT regulations and compliance [[electronic resource] ] : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad |
| Autore | Segalstad Siri H |
| Pubbl/distr/stampa | Chichester, West Sussex, United Kingdom, : Wiley, 2008 |
| Descrizione fisica | 1 online resource (340 p.) |
| Disciplina |
615
615.19 |
| Soggetto topico |
Pharmaceutical technology - Standards
Pharmaceutical industry - Standards Pharmaceutical industry - Quality control Drugs - Standards |
| ISBN |
1-282-34277-0
9786612342776 0-470-72182-0 0-470-72183-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
International IT Regulations and Compliance; Contents; Preface and Acknowledgements; 1 Quality Standards; 1.1 What Quality Is; 1.2 Mandatory and Voluntary Standards; 1.3 Pharmaceutical Industry Regulations; 1.4 US GxP Regulations; 1.5 European GxP Regulations; 1.6 Other GxP Regulations; 1.7 Good Manufacturing Practice; 1.8 Good Laboratory Practice; 1.9 Good Clinical Practice; 1.10 Medical Device Standards; 1.11 IT Systems in the GxP and Medical Device Regulations; 1.12 GAMP; 1.13 Mandatory Quality Standards in Other Industries; 1.14 Legal Issues; 1.15 The ISO; 1.16 The ASTM; 1.17 The IEEE
1.18 TasksReferences; 2 Regulatory Requirements for IT Systems; 2.1 Introduction; 2.2 US Requirements; 2.3 EU Requirements; 2.4 21 CFR Part 11; 2.5 The 'Part 11 Project'; 2.6 EU GMP Annex 11; 2.7 The PIC Document PI 011 Recommendation on Computerized Systems in Regulated 'GxP' Environments; 2.8 GAMP; 2.9 The ISO 9000 Series; 2.10 A Comparison between the Standards; 2.11 Conclusion; 2.12 Tasks; References; 3 IT Security; 3.1 Introduction; 3.2 Continuous Connections - Wireless Networks; 3.3 Threats; 3.4 The Security Policy; 3.5 Tasks; References; 4 Quality Management Systems 4.1 An Introduction to QMS4.2 Definitions; 4.3 Principles for Quality Management; 4.4 Quality Management System Levels; 4.5 Creating a QMS; 4.6 Roles and Responsibilities; 4.7 Work Processes; 4.8 Controlled Documents; 4.9 The Quality Policy; 4.10 The Quality Manual; 4.11 Standard Operating Procedures; 4.12 The Art of Writing an SOP; 4.13 Tasks; References; 5 IT Integrated in the QMS in the User Organization; 5.1 Introduction; 5.2 How to Integrate IT Systems in the QMS; 5.3 Generic Standard Operating Procedures; 5.4 Procedures for Each System; 5.5 Tasks; References 6 IT Integrated in the Supplier's QMS6.1 Introduction; 6.2 Which Standards Should Be Used?; 6.3 The Quality Management System; 6.4 System Development Models; 6.5 Documents for Software Development; 6.6 The Customer-Supplier Relationship; 6.7 Tasks; References; 7 Organization for an IT System; 7.1 Introduction; 7.2 Roles and Responsibilities for a Live System; 7.3 Groups in the IT System Organization; 7.4 Roles and Responsibilities for an IT Validation Project; 7.5 Outsourcing; 7.6 The Service Level Agreement for Outsourcing; 7.7 Consultants; References 8 The Legal Implications of an IT System8.1 Introduction; 8.2 Pharmaceutical Regulations; 8.3 Financial Systems; 8.4 Patent Systems; 8.5 Human Resources Systems; 8.6 Healthcare Systems; 8.7 Systems for Legal Information; Reference; 9 Advanced Quality Management Systems; 9.1 Introduction; 9.2 The Live QMS is a Good QMS; 9.3 Changes; 9.4 How to Keep the QMS Updated; 9.5 Training and Understanding; 9.6 How to use a QMS Effectively as a Tool in the Organization - Not as a Straightjacket; 9.7 Tasks; References; 10 Audits; 10.1 Introduction; 10.2 The ISO 9000 Series; 10.3 TickIT; 10.4 Why Audit? 10.5 Audit in a Risk-Based Environment |
| Record Nr. | UNINA-9910830674403321 |
|
Segalstad Siri H
|
||
| Chichester, West Sussex, United Kingdom, : Wiley, 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
International IT regulations and compliance : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad
| International IT regulations and compliance : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad |
| Autore | Segalstad Siri H |
| Pubbl/distr/stampa | Chichester, West Sussex, United Kingdom, : Wiley, 2008 |
| Descrizione fisica | 1 online resource (340 p.) |
| Disciplina | 615/.19 |
| Soggetto topico |
Pharmaceutical technology - Standards
Pharmaceutical industry - Standards Pharmaceutical industry - Quality control Drugs - Standards |
| ISBN |
1-282-34277-0
9786612342776 0-470-72182-0 0-470-72183-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
International IT Regulations and Compliance; Contents; Preface and Acknowledgements; 1 Quality Standards; 1.1 What Quality Is; 1.2 Mandatory and Voluntary Standards; 1.3 Pharmaceutical Industry Regulations; 1.4 US GxP Regulations; 1.5 European GxP Regulations; 1.6 Other GxP Regulations; 1.7 Good Manufacturing Practice; 1.8 Good Laboratory Practice; 1.9 Good Clinical Practice; 1.10 Medical Device Standards; 1.11 IT Systems in the GxP and Medical Device Regulations; 1.12 GAMP; 1.13 Mandatory Quality Standards in Other Industries; 1.14 Legal Issues; 1.15 The ISO; 1.16 The ASTM; 1.17 The IEEE
1.18 TasksReferences; 2 Regulatory Requirements for IT Systems; 2.1 Introduction; 2.2 US Requirements; 2.3 EU Requirements; 2.4 21 CFR Part 11; 2.5 The 'Part 11 Project'; 2.6 EU GMP Annex 11; 2.7 The PIC Document PI 011 Recommendation on Computerized Systems in Regulated 'GxP' Environments; 2.8 GAMP; 2.9 The ISO 9000 Series; 2.10 A Comparison between the Standards; 2.11 Conclusion; 2.12 Tasks; References; 3 IT Security; 3.1 Introduction; 3.2 Continuous Connections - Wireless Networks; 3.3 Threats; 3.4 The Security Policy; 3.5 Tasks; References; 4 Quality Management Systems 4.1 An Introduction to QMS4.2 Definitions; 4.3 Principles for Quality Management; 4.4 Quality Management System Levels; 4.5 Creating a QMS; 4.6 Roles and Responsibilities; 4.7 Work Processes; 4.8 Controlled Documents; 4.9 The Quality Policy; 4.10 The Quality Manual; 4.11 Standard Operating Procedures; 4.12 The Art of Writing an SOP; 4.13 Tasks; References; 5 IT Integrated in the QMS in the User Organization; 5.1 Introduction; 5.2 How to Integrate IT Systems in the QMS; 5.3 Generic Standard Operating Procedures; 5.4 Procedures for Each System; 5.5 Tasks; References 6 IT Integrated in the Supplier's QMS6.1 Introduction; 6.2 Which Standards Should Be Used?; 6.3 The Quality Management System; 6.4 System Development Models; 6.5 Documents for Software Development; 6.6 The Customer-Supplier Relationship; 6.7 Tasks; References; 7 Organization for an IT System; 7.1 Introduction; 7.2 Roles and Responsibilities for a Live System; 7.3 Groups in the IT System Organization; 7.4 Roles and Responsibilities for an IT Validation Project; 7.5 Outsourcing; 7.6 The Service Level Agreement for Outsourcing; 7.7 Consultants; References 8 The Legal Implications of an IT System8.1 Introduction; 8.2 Pharmaceutical Regulations; 8.3 Financial Systems; 8.4 Patent Systems; 8.5 Human Resources Systems; 8.6 Healthcare Systems; 8.7 Systems for Legal Information; Reference; 9 Advanced Quality Management Systems; 9.1 Introduction; 9.2 The Live QMS is a Good QMS; 9.3 Changes; 9.4 How to Keep the QMS Updated; 9.5 Training and Understanding; 9.6 How to use a QMS Effectively as a Tool in the Organization - Not as a Straightjacket; 9.7 Tasks; References; 10 Audits; 10.1 Introduction; 10.2 The ISO 9000 Series; 10.3 TickIT; 10.4 Why Audit? 10.5 Audit in a Risk-Based Environment |
| Record Nr. | UNINA-9910877343903321 |
|
Segalstad Siri H
|
||
| Chichester, West Sussex, United Kingdom, : Wiley, 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland
| Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland |
| Pubbl/distr/stampa | Hoboken, NJ : , : Wiley, , 2020 |
| Descrizione fisica | 1 online resource (xxxv, 546 pages) : illustrations |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical technology - Standards
Microbiological Techniques - standards Microbiological Phenomena Drugs - Testing Pharmaceutical chemistry |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-119-35612-1
1-119-35619-9 1-119-35611-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Microbiological control strategy -- Microbial contamination risk assessment in non-sterile drug product manufacturing and risk mitigation -- Qualification of Microbiological laboratory personnel and equipment -- Introduction to culture media in pharmaceutical microbiology for non-sterile products -- Microbiological examination of non-sterile final dosage forms and raw material including acceptance criteria and testing frequency -- Microbial requirements and testing of primary packaging -- Utilities design and testing -- Microbiological Environmental Monitoring -- Identification of microorganisms -- Calculating alert levels and trending of microbiological data -- Exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products -- Data integrity and microbiological excursion handling -- Rapid microbiological methods -- Validation of a rapid microbiological method for the microbiological examination of non-sterile and non-filterable drug products, APIs and excipients -- An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries -- Practical guide for microbiological QA/QC of non-sterile pharmaceuticals manufacturing for EU -- Which microbiological tests can better be performed in-house and what can be easily outsourced. |
| Record Nr. | UNINA-9910555136903321 |
| Hoboken, NJ : , : Wiley, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland
| Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland |
| Pubbl/distr/stampa | Hoboken, NJ : , : Wiley, , 2020 |
| Descrizione fisica | 1 online resource (xxxv, 546 pages) : illustrations |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical technology - Standards
Microbiological Techniques - standards Microbiological Phenomena Drugs - Testing Pharmaceutical chemistry |
| ISBN |
1-119-35612-1
1-119-35619-9 1-119-35611-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Microbiological control strategy -- Microbial contamination risk assessment in non-sterile drug product manufacturing and risk mitigation -- Qualification of Microbiological laboratory personnel and equipment -- Introduction to culture media in pharmaceutical microbiology for non-sterile products -- Microbiological examination of non-sterile final dosage forms and raw material including acceptance criteria and testing frequency -- Microbial requirements and testing of primary packaging -- Utilities design and testing -- Microbiological Environmental Monitoring -- Identification of microorganisms -- Calculating alert levels and trending of microbiological data -- Exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products -- Data integrity and microbiological excursion handling -- Rapid microbiological methods -- Validation of a rapid microbiological method for the microbiological examination of non-sterile and non-filterable drug products, APIs and excipients -- An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries -- Practical guide for microbiological QA/QC of non-sterile pharmaceuticals manufacturing for EU -- Which microbiological tests can better be performed in-house and what can be easily outsourced. |
| Record Nr. | UNINA-9910830890003321 |
| Hoboken, NJ : , : Wiley, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
| Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer |
| Autore | Bohrer Denise |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, 2012 |
| Descrizione fisica | 1 online resource (593 p.) |
| Disciplina |
338.4/76151
338.476151 |
| Soggetto topico |
Microbial contamination
Pharmaceutical industry - Quality control Pharmaceutical technology - Standards |
| ISBN |
1-118-44905-3
1-283-64526-2 1-118-44906-1 1-118-44908-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Title page; Copyright page; Contents; Preface; Acknowledgments; 1: Introduction; Reference; 2: Directives for Contamination Control; PART I: Chemical Contamination; 3: Raw Materials; 3.1 Water; 3.2 Inorganic Impurities; 3.3 Organic Impurities; 3.3.1 By-products; 3.3.2 Genotoxic Impurities (GTIs); 3.3.3 Degradation Products; 3.4 Additives; 3.5 Residual Solvents; Concluding Remarks; References; 4: Medicinal Gases and Volatile Anesthetics; 4.1 Medicinal Gases; 4.2 Volatile Anesthetics; Concluding Remarks; References; 5: Diagnostic Imaging Agents; 5.1 Radiopharmaceuticals
5.1.1 Technetium-Based Products5.1.2 Iodine-Based Products; 5.1.3 Fluorine-Based Products; 5.2 Contrast Agents; 5.2.1 Gadolinium-Based Products; 5.2.2 Iodine-Based Products; 5.2.3 Barium Sulfate; Concluding Remarks; References; 6: Containers; 6.1 Glass Containers; 6.2 Plastic Containers; 6.2.1 Polymer Formation; 6.2.2 PVC Containers; 6.2.3 Other Plastic Containers; 6.3 Metal Containers; Concluding Remarks; References; 7: Closures; Concluding Remarks; References; 8: Delivery Systems and Filters; 8.1 Delivery Systems Made of PVC; 8.2 Delivery Systems Made of Other Plastic Materials; 8.3 Filters Concluding RemarksReferences; 9: Medical Devices; 9.1 General Use Devices; 9.1.1 Medical Gloves; 9.1.2 Syringes; 9.2 Extracorporeal Circuits; 9.3 Devices for Administration of Aerosolized Drugs; 9.4 Reprocessed Medical Devices; 9.5 Tissue Substitutes; 9.5.1 Skin Substitutes and Surgical Dressings; 9.5.2 Hard Tissue Substitutes; 9.5.3 Soft Tissue Substitutes; Concluding Remarks; References; PART II: Physical Contamination; 10: Particulate Matter; Concluding Remarks; References; PART III: Microbiological Contamination; 11: Microbiological and Endotoxin Contamination; 11.1 Water 11.2 Raw Materials11.3 Sterile Products; 11.3.1 Single- and Multiple-Dose Products; 11.3.2 Parenteral Nutrition (PN); 11.3.3 Propofol; 11.3.4 Ophthalmic Products; 11.4 Medicinal Gases; 11.5 Medical Devices; 11.5.1 Syringes; 11.5.2 Endoscopes; 11.5.3 Other Devices; 11.6 Biofilms; 11.7 Dialysis Circuits; 11.8 Nosocomial Infections; Concluding Remarks; References; PART IV: Miscellaneous; 12: Contamination from Sterilization Procedures; 12.1 Residuals from Radiation Sterilization; 12.1.1 Radiolysis of Water; 12.1.2 Effect of Ionizing Radiation on Drug Products; 12.1.3 Polymers in Drug Delivery 12.1.4 Radiolysis of Selected Nondrug Components12.1.5 Effect of Ionizing Radiation on Materials Used in Packaging and in Medical Devices; 12.2 Heat Sterilization; 12.3 Residuals from Chemical Disinfection and Sterilization Agents; 12.3.1 Ethylene Oxide (EtO); 12.3.2 Peracetic Acid and Hydrogen Peroxide; 12.3.3 Formaldehyde; Concluding Remarks; References; 13: Biotechnological Products; 13.1 DNA and HCP Residuals; 13.2 Viruses and Mycoplasma; 13.3 Endotoxin; 13.4 Protein Degradation; 13.5 Protein Aggregation; Concluding Remarks; References Appendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products |
| Record Nr. | UNINA-9910141378403321 |
|
Bohrer Denise
|
||
| Hoboken, N.J., : Wiley, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer
| Sources of contamination in medicinal products and medical devices [[electronic resource] /] / Denise Bohrer |
| Autore | Bohrer Denise |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, 2012 |
| Descrizione fisica | 1 online resource (593 p.) |
| Disciplina |
338.4/76151
338.476151 |
| Soggetto topico |
Microbial contamination
Pharmaceutical industry - Quality control Pharmaceutical technology - Standards |
| ISBN |
1-118-44905-3
1-283-64526-2 1-118-44906-1 1-118-44908-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Title page; Copyright page; Contents; Preface; Acknowledgments; 1: Introduction; Reference; 2: Directives for Contamination Control; PART I: Chemical Contamination; 3: Raw Materials; 3.1 Water; 3.2 Inorganic Impurities; 3.3 Organic Impurities; 3.3.1 By-products; 3.3.2 Genotoxic Impurities (GTIs); 3.3.3 Degradation Products; 3.4 Additives; 3.5 Residual Solvents; Concluding Remarks; References; 4: Medicinal Gases and Volatile Anesthetics; 4.1 Medicinal Gases; 4.2 Volatile Anesthetics; Concluding Remarks; References; 5: Diagnostic Imaging Agents; 5.1 Radiopharmaceuticals
5.1.1 Technetium-Based Products5.1.2 Iodine-Based Products; 5.1.3 Fluorine-Based Products; 5.2 Contrast Agents; 5.2.1 Gadolinium-Based Products; 5.2.2 Iodine-Based Products; 5.2.3 Barium Sulfate; Concluding Remarks; References; 6: Containers; 6.1 Glass Containers; 6.2 Plastic Containers; 6.2.1 Polymer Formation; 6.2.2 PVC Containers; 6.2.3 Other Plastic Containers; 6.3 Metal Containers; Concluding Remarks; References; 7: Closures; Concluding Remarks; References; 8: Delivery Systems and Filters; 8.1 Delivery Systems Made of PVC; 8.2 Delivery Systems Made of Other Plastic Materials; 8.3 Filters Concluding RemarksReferences; 9: Medical Devices; 9.1 General Use Devices; 9.1.1 Medical Gloves; 9.1.2 Syringes; 9.2 Extracorporeal Circuits; 9.3 Devices for Administration of Aerosolized Drugs; 9.4 Reprocessed Medical Devices; 9.5 Tissue Substitutes; 9.5.1 Skin Substitutes and Surgical Dressings; 9.5.2 Hard Tissue Substitutes; 9.5.3 Soft Tissue Substitutes; Concluding Remarks; References; PART II: Physical Contamination; 10: Particulate Matter; Concluding Remarks; References; PART III: Microbiological Contamination; 11: Microbiological and Endotoxin Contamination; 11.1 Water 11.2 Raw Materials11.3 Sterile Products; 11.3.1 Single- and Multiple-Dose Products; 11.3.2 Parenteral Nutrition (PN); 11.3.3 Propofol; 11.3.4 Ophthalmic Products; 11.4 Medicinal Gases; 11.5 Medical Devices; 11.5.1 Syringes; 11.5.2 Endoscopes; 11.5.3 Other Devices; 11.6 Biofilms; 11.7 Dialysis Circuits; 11.8 Nosocomial Infections; Concluding Remarks; References; PART IV: Miscellaneous; 12: Contamination from Sterilization Procedures; 12.1 Residuals from Radiation Sterilization; 12.1.1 Radiolysis of Water; 12.1.2 Effect of Ionizing Radiation on Drug Products; 12.1.3 Polymers in Drug Delivery 12.1.4 Radiolysis of Selected Nondrug Components12.1.5 Effect of Ionizing Radiation on Materials Used in Packaging and in Medical Devices; 12.2 Heat Sterilization; 12.3 Residuals from Chemical Disinfection and Sterilization Agents; 12.3.1 Ethylene Oxide (EtO); 12.3.2 Peracetic Acid and Hydrogen Peroxide; 12.3.3 Formaldehyde; Concluding Remarks; References; 13: Biotechnological Products; 13.1 DNA and HCP Residuals; 13.2 Viruses and Mycoplasma; 13.3 Endotoxin; 13.4 Protein Degradation; 13.5 Protein Aggregation; Concluding Remarks; References Appendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products |
| Record Nr. | UNINA-9910830989003321 |
|
Bohrer Denise
|
||
| Hoboken, N.J., : Wiley, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Sources of contamination in medicinal products and medical devices / / Denise Bohrer
| Sources of contamination in medicinal products and medical devices / / Denise Bohrer |
| Autore | Bohrer Denise |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, 2012 |
| Descrizione fisica | 1 online resource (593 p.) |
| Disciplina | 338.4/76151 |
| Soggetto topico |
Microbial contamination
Pharmaceutical industry - Quality control Pharmaceutical technology - Standards |
| ISBN |
1-118-44905-3
1-283-64526-2 1-118-44906-1 1-118-44908-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Title page; Copyright page; Contents; Preface; Acknowledgments; 1: Introduction; Reference; 2: Directives for Contamination Control; PART I: Chemical Contamination; 3: Raw Materials; 3.1 Water; 3.2 Inorganic Impurities; 3.3 Organic Impurities; 3.3.1 By-products; 3.3.2 Genotoxic Impurities (GTIs); 3.3.3 Degradation Products; 3.4 Additives; 3.5 Residual Solvents; Concluding Remarks; References; 4: Medicinal Gases and Volatile Anesthetics; 4.1 Medicinal Gases; 4.2 Volatile Anesthetics; Concluding Remarks; References; 5: Diagnostic Imaging Agents; 5.1 Radiopharmaceuticals
5.1.1 Technetium-Based Products5.1.2 Iodine-Based Products; 5.1.3 Fluorine-Based Products; 5.2 Contrast Agents; 5.2.1 Gadolinium-Based Products; 5.2.2 Iodine-Based Products; 5.2.3 Barium Sulfate; Concluding Remarks; References; 6: Containers; 6.1 Glass Containers; 6.2 Plastic Containers; 6.2.1 Polymer Formation; 6.2.2 PVC Containers; 6.2.3 Other Plastic Containers; 6.3 Metal Containers; Concluding Remarks; References; 7: Closures; Concluding Remarks; References; 8: Delivery Systems and Filters; 8.1 Delivery Systems Made of PVC; 8.2 Delivery Systems Made of Other Plastic Materials; 8.3 Filters Concluding RemarksReferences; 9: Medical Devices; 9.1 General Use Devices; 9.1.1 Medical Gloves; 9.1.2 Syringes; 9.2 Extracorporeal Circuits; 9.3 Devices for Administration of Aerosolized Drugs; 9.4 Reprocessed Medical Devices; 9.5 Tissue Substitutes; 9.5.1 Skin Substitutes and Surgical Dressings; 9.5.2 Hard Tissue Substitutes; 9.5.3 Soft Tissue Substitutes; Concluding Remarks; References; PART II: Physical Contamination; 10: Particulate Matter; Concluding Remarks; References; PART III: Microbiological Contamination; 11: Microbiological and Endotoxin Contamination; 11.1 Water 11.2 Raw Materials11.3 Sterile Products; 11.3.1 Single- and Multiple-Dose Products; 11.3.2 Parenteral Nutrition (PN); 11.3.3 Propofol; 11.3.4 Ophthalmic Products; 11.4 Medicinal Gases; 11.5 Medical Devices; 11.5.1 Syringes; 11.5.2 Endoscopes; 11.5.3 Other Devices; 11.6 Biofilms; 11.7 Dialysis Circuits; 11.8 Nosocomial Infections; Concluding Remarks; References; PART IV: Miscellaneous; 12: Contamination from Sterilization Procedures; 12.1 Residuals from Radiation Sterilization; 12.1.1 Radiolysis of Water; 12.1.2 Effect of Ionizing Radiation on Drug Products; 12.1.3 Polymers in Drug Delivery 12.1.4 Radiolysis of Selected Nondrug Components12.1.5 Effect of Ionizing Radiation on Materials Used in Packaging and in Medical Devices; 12.2 Heat Sterilization; 12.3 Residuals from Chemical Disinfection and Sterilization Agents; 12.3.1 Ethylene Oxide (EtO); 12.3.2 Peracetic Acid and Hydrogen Peroxide; 12.3.3 Formaldehyde; Concluding Remarks; References; 13: Biotechnological Products; 13.1 DNA and HCP Residuals; 13.2 Viruses and Mycoplasma; 13.3 Endotoxin; 13.4 Protein Degradation; 13.5 Protein Aggregation; Concluding Remarks; References Appendix Polymeric Materials: Components, Additives, Extractables, and Degradation Products |
| Record Nr. | UNINA-9910877607203321 |
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Bohrer Denise
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| Hoboken, N.J., : Wiley, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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