Parenteral Medication Sterilization and Safety Quiz

Sterile products are unique because they are not only free from microorganisms (sterile), but also free from pyrogens which are substances that can cause fever when introduced into the body.

Sterility is defined as the absence of viable microorganisms, meaning no living microorganisms are present.

An autoclave is primarily used for sterilization using steam. It coagulates cellular protein at a lower temperature due to the use of pressure, making it ideal for items like solutions, glassware, surgical dressings, instruments, and tubing.

Dry heat sterilization works by dehydrating the cell and then oxidizing it with a slow burn, unlike the other methods mentioned.

Each incorrect answer describes a different method of sterilization, highlighting the key points of each process while the correct answer focuses specifically on the method of using gas for sterilization.

Radiation sterilization involves the use of gamma radiations or electron beam, not autoclaving, dry heat sterilization, or chemical sterilization.

Quality assurance in sterility testing is essential to ensure that products are free from contaminants, such as pyrogens, and meet the required potency. Turbidity in a product indicates potential contamination rather than quality assurance.

The correct answer includes products specifically designed for testing sterility, while the incorrect answers refer to other types of laboratory products not necessarily related to sterility testing.

Pyrogens are substances that can cause fever by inducing the release of cytokines and prostaglandins in the body. They are typically associated with microbial contamination and can have serious health implications if present in pharmaceutical products.

Contamination can occur from various sources such as air, insects, and raw materials, in addition to water or other aqueous vehicles, equipment, chemicals, containers and closures, as well as human touch and hair.

The correct methods for destroying pyrogens include high heat, oxidation with alkali or oxidizing agents, adsorption with charcoal or ion exchange resins, distillation, and filtration. Incorrect methods such as heating at low temperatures, mixing with organic solvents, or freezing are not effective in destroying pyrogens.

Particulate matter refers to extraneous undissolved substances that are unintentionally present, not microscopic organisms or dissolved substances. It can include a variety of contaminants such as chemicals, packaging components, insects, filter fibers, and even human skin and hair. Detection typically requires particles to be greater than or equal to 50 microns in size to be visible to the naked eye.

The answer includes commonly used plastics in medical devices, such as PVC, polyolefins, polyethylene, and acrylics. Nylon, polystyrene, and ABS are not typically used in medical devices.

Plastic's advantages over glass include being flexible, lightweight, and unbreakable, making it ideal for situations where durability and ease of handling are important. Additionally, plastic does not require air exchange for IV administration unlike glass, which makes it more convenient in medical settings.

Sterile single dose containers are specifically designed for single use and do not contain preservatives. They are intended for specific forms of administration and come in a range of sizes from 0.5mL to 1,000mL.

Pre filled syringes or cartridges are designed to contain specific medications for administration in healthcare settings. They are not typically filled with air, saline, or left empty for storage.

An ampule is a hermetically sealed glass container used for single doses of medications. It cannot be resealed and must be filtered before use.

Vials are commonly used as multiple dose containers due to their ability to hold up to 30mL with overfill. Aerosol cans, packets, and ampoules are typically not used for multiple dose medications.

When determining Compounded Sterile Product contamination risk levels, factors such as the probability of contamination, sources of contamination, and compliance with USP chapter 797 guidelines are key. Factors like vial color, moon phase, and number of windows do not have a direct impact on contamination risk levels.

The correct components of clean rooms and environmental controls in a sterile product admixing area include a remote location for product admixing, a work area with hand hygiene facilities and storage, and a clean area with laminar flow hoods and counter space.

The correct answer includes specific guidelines such as restricted access to the compounding area, decontamination of supplies in the anteroom, and restrictions on gum, food, and drink. The incorrect answers provided do not align with these established rules.