Drug products parenteral

Parenteral drug products are required to be sterile. There are principally five different ways to sterilize a product. These are steam, dry heat, radiation, gas. 

Manufacturing is performed in cleanroom conditions. Sterilization processes in the form of heat, steam, gas, or radiation are applied to ensure microorganisms are destroyed in the drug product. For protein-based drugs that can be damaged by the normal sterilization processes, the product is manufactured under aseptic conditions. Both sterility and pyrogen tests are performed to ensure parenteral drug products are safe to be injected. 

Inspect parenteral drug products visually for particulate matter and discoloration... 

Michael J. Groves, a pharmacist with a doctorate in chemical engineering, has spent much of his career working in industry and academe. Now retired, his scientific interests include dispersed drug delivery systems and quality control issues for parenteral drug products. Editor or joint editor of a number of books, he has published 400 research papers, patents, reviews, and book reviews. He is a Fellow of the Royal Pharmaceutical Society of Great Britain, the Institute of Biology, and the American Association of Pharmaceutical Scientists. 

Ingestion is the most common route of both accidental and intentional exposures to diethylstilbestrol. It is available in an oral dosage form. All oral and parenteral drug products contain 25 mg or more of diethylstilbestrol per unit dose. Occupational exposure to diethylstilbestrol may occur through inhalation and dermal contact with this compound at workplaces where diethylstilbestrol is produced or used. 

For parenteral drug products, the following tests are generally appropriate ... 

Parenteral drug products are required to be sterile. There are principally five different ways to sterilize a product. These are steam, dry heat, radiation, gas and filtration. Selection of which method to use is based on the product that requires sterilization. For example, protein-based drugs are heat-sensitive, so the normal means for sterilizing these products is filtration. The rationale for sterilization validation is to show the reduction in microbial load or destruction of biological indicators. 

Interaction of administration sets and dispensing devices with parenteral drug products, where warranted, should also be considered through appropriate-use test protocols to assure that absorption and adsorption during dwell time do not occur. 

Testing for extractables and leachables on stability studies may be appropriate in situations where other qualification tests have not provided sufficient information or assurance concerning the levels of extractables and leachables from plastics and elastomeric components. Interaction of administration sets and dispensing devices with parenteral drug products, where warranted, should also be considered through appropriate use test protocols to ensure that absorption and adsorption during dwell time do not occur. 

Where microbiological specifications have been established for the API (e.g., nonsterile APIs intended for incorporation into parenteral drug products), facilities should also be designed to limit objectionable microbiological contamination. 

Written procedures should be established and measures taken to control bioburden and endotoxin contamination of nonsterile APIs intended for use in the preparation of parenteral drug products. 

Microbiological testing should be conducted on each lot of API required to be free of objectionable microorganisms. Appropriate testing should also be conducted on each lot of API required to be pyrogen free or with a specified endotoxin limit (e.g., APIs intended for use in the preparation of parenteral drug products). 

Excipients are inactive ingredients in pharmaceuticals and vitamin and mineral preparations. These compounds, which often make up the majority of the mass or volume of oral and parenteral drug products, are considered to be inert and not affect the intended functioning of the active ingredients. Excipients, which frequently constitute the majority of the mass or volume of oral preparations, have a variety of purposes that include ... 

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