Quiz

True or false: Sterile preparations are completely free from microorganisms & contaminants?

True or false: Presence of pathogen in parenteral preparations is very serious (fatal in IV)?

True or false: Preservatives are added to multi-dose vials to protect the injection from contamination during production, use, and storage?

True or false: Filtration can be used for suspensions in sterilization?

True or false: Antimicrobial agents are added to LVP (Large Volume Parenteral) preparations?

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).

Test your knowledge on the specifications of sterile pharmaceutical preparations in this quiz. Topics covered include sterility, clarity, absence of pyrogens, tonicity, and pH. See how well you understand the requirements for parenteral dosage forms.