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Questions and Answers
True or false: Sterile preparations are completely free from microorganisms & contaminants?
True or false: Sterile preparations are completely free from microorganisms & contaminants?
True (A)
True or false: Presence of pathogen in parenteral preparations is very serious (fatal in IV)?
True or false: Presence of pathogen in parenteral preparations is very serious (fatal in IV)?
True (A)
True or false: Preservatives are added to multi-dose vials to protect the injection from contamination during production, use, and storage?
True or false: Preservatives are added to multi-dose vials to protect the injection from contamination during production, use, and storage?
True (A)
True or false: Filtration can be used for suspensions in sterilization?
True or false: Filtration can be used for suspensions in sterilization?
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True or false: Antimicrobial agents are added to LVP (Large Volume Parenteral) preparations?
True or false: Antimicrobial agents are added to LVP (Large Volume Parenteral) preparations?
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Study Notes
Parenteral Dosage Forms
- Key specifications for parenteral preparations include:
- Sterility
- Clarity (limits for particulate matter)
- Absence of pyrogens
- Tonicity
- pH
Sterility
- Sterile preparations must be free from microorganisms and contaminants.
- Contamination by pathogens can lead to severe consequences, particularly fatal outcomes in intravenous (IV) applications.
- To maintain sterility in products, antimicrobial agents (preservatives) are employed.
Methods of Sterilization
- Moist Heat Sterilization: Involves steam under pressure to eliminate microorganisms.
- Dry Heat Sterilization: Utilizes higher temperatures without moisture to achieve sterility.
- Ionizing Radiation Sterilization: Employs gamma rays or electron beams to eliminate pathogens.
- Gaseous Sterilization: Ethylene oxide is used as a chemical agent for sterilization.
- Filtration: Utilizes bacterial filters; unsuitable for suspensions as it can alter the formulation.
Preservation in Multi-Dose Vials
- Antimicrobial agents are incorporated into multi-dose vials to safeguard against contamination during production and storage.
- Preservatives are typically not included in large volume parenterals (LVP).
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