Sterile Drug Products
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Sterile Drug Products
Formulation, Packaging, Manufacturing and Quality
Akers, Michael J.
Taylor & Francis Ltd
10/2024
516
Mole
9781032919119
Pré-lançamento - envio 15 a 20 dias após a sua edição
Descrição não disponível.
Introduction, scope, and history of sterile productsCharacteristics of sterile dosage formsTypes of sterile dosage formsSterile product packaging systemsOverview of product developmentFormulation components (solvents and solutes)Sterile products packaging chemistryFormulation and stability of solutionsDispersed systemsFormulation of freeze-dried powdersOvercoming formulation problems and some case studiesOverview of sterile product manufacturingContamination controlSterile manufacturing facilitiesWater and air quality in sterile manufacturing facilitiesPersonnel requirements for sterile manufacturingSterilization methods in sterile product manufacturingSterile filtrationSterile product filling, stoppering, and sealingFreeze-dry (lyophilization) processingAseptic processingInspection, labeling, and secondary packagingBarrier and other advanced technologies in aseptic processingStability, storage, and distribution of sterile drug productsGood manufacturing practiceQuality assurance and controlMicroorganisms and sterility testingPyrogens and pyrogen/endotoxin testingParticles and particulate matter testingSterile product-package integrity testingAdministration of injectable drug productsClinical hazards of injectable drug administrationBiopharmaceutical considerations with injectable drug delivery
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
C32 July;LAL Reagent;dosage;Rubber Closures;form;Sterile Product;rubber;Dosage Forms;closure;LAL Test;aseptic;Aseptic Processing;processes;Sterile Dosage Forms;united;Drug Products;states;HEPA Filter;pharmacopeia;Baxter Healthcare Corporation;forms;Dry Heat;Visible Particulate Matter;Aseptic Area;Terminally Sterilized;Sterility Assurance;SVI;Antimicrobial Preservative Agent;Sodium Chloride Injection;Sterile Manufacturing Facilities;Clean Room;Sterile Product Manufacturing;Sterility Test;Batch Record;Delivery Systems
Introduction, scope, and history of sterile productsCharacteristics of sterile dosage formsTypes of sterile dosage formsSterile product packaging systemsOverview of product developmentFormulation components (solvents and solutes)Sterile products packaging chemistryFormulation and stability of solutionsDispersed systemsFormulation of freeze-dried powdersOvercoming formulation problems and some case studiesOverview of sterile product manufacturingContamination controlSterile manufacturing facilitiesWater and air quality in sterile manufacturing facilitiesPersonnel requirements for sterile manufacturingSterilization methods in sterile product manufacturingSterile filtrationSterile product filling, stoppering, and sealingFreeze-dry (lyophilization) processingAseptic processingInspection, labeling, and secondary packagingBarrier and other advanced technologies in aseptic processingStability, storage, and distribution of sterile drug productsGood manufacturing practiceQuality assurance and controlMicroorganisms and sterility testingPyrogens and pyrogen/endotoxin testingParticles and particulate matter testingSterile product-package integrity testingAdministration of injectable drug productsClinical hazards of injectable drug administrationBiopharmaceutical considerations with injectable drug delivery
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
C32 July;LAL Reagent;dosage;Rubber Closures;form;Sterile Product;rubber;Dosage Forms;closure;LAL Test;aseptic;Aseptic Processing;processes;Sterile Dosage Forms;united;Drug Products;states;HEPA Filter;pharmacopeia;Baxter Healthcare Corporation;forms;Dry Heat;Visible Particulate Matter;Aseptic Area;Terminally Sterilized;Sterility Assurance;SVI;Antimicrobial Preservative Agent;Sodium Chloride Injection;Sterile Manufacturing Facilities;Clean Room;Sterile Product Manufacturing;Sterility Test;Batch Record;Delivery Systems
