Pharmaceutical Sterilization Methods

The process of ensuring that products are free from living microorganisms.

The process of eliminating all living microorganisms from a product or material.

The use of heat to eliminate microorganisms from a product.

The use of ionizing radiation to eliminate microorganisms from a product.

The use of gases to eliminate microorganisms from a product.

The use of filters to remove microorganisms from a product.

The study of how microorganisms die over time when exposed to a sterilization method.

A measure of the probability that a product will be sterile after sterilization.

A process of testing a product to determine if it is sterile.

The process of proving that a sterilization process consistently delivers sterile products.

Products administered directly into the bloodstream, bypassing the body's natural defenses.

Products that are applied to the eyes, which are very sensitive to infection.

A process where the product is sterilized in its final container, ensuring that it is sterile throughout its lifetime.

A method of producing sterile products where all components and environments are kept sterile throughout the manufacturing process, minimizing the risk of contamination.

The absence of viable microorganisms, meaning that any organism present is incapable of reproducing.

The European Pharmacopoeia provides guidelines and standards for pharmaceutical products, including sterility requirements.

A microorganism capable of reproducing and forming progeny.

A non-growing, dormant form of a microorganism that can survive harsh conditions.

A process where a sample is cultured to determine if any microorganisms are present.

A method used to sterilize products by using heat and steam.

A method used to sterilize products by using heat in a dry environment.

A method that uses high energy radiation to destroy microorganisms.

The time required to reduce the number of viable microorganisms by 90% (one log cycle) at a specific temperature.

The rate at which microorganisms are killed during a sterilization process. It can be determined from the slope of a graph of natural log of survivors vs. time.

A measure of the temperature change needed to achieve a tenfold change in the D-value. It indicates how resistant a microorganism is to heat.

A graph that depicts the number of surviving microorganisms over time during a sterilization process.

Sterilization parameters that can be determined from microbial survival curves. These include D-value, Z-value, and F-value.

The designated filter that ensures sterility of the product after filtration, marking the point beyond which the product is considered sterile.

Microorganisms do not die at the same time during sterilization. There is a gradual reduction in the number of survivors, and the rate of reduction depends on the sterilization method and conditions.

Sterilization kinetics also apply to gas sterilization, but the exposure time is influenced by other factors like concentration, humidity, and temperature.

In radiation sterilization, the total absorbed dose, not just the exposure time, is crucial for achieving sterility.

Filtration sterilization kinetics are different from other methods because it depends on the filtration process itself, not a time-dependent kill rate of microorganisms.

A completely sealed, enclosed area where operators work with products through gloves or gauntlets.

A specialized chamber designed to maintain a sterile environment with filtered air continuously moving across the workspace.

A transfer system that allows products to move in and out of clean areas while maintaining sterility.

Pressure differences between clean areas, ensuring air flow from cleaner zones to less clean zones.

A high-efficiency particulate air filter that removes contaminants from air entering a clean room.

Airflow directed in a single, controlled direction, minimizing turbulence and contamination.

Airflow that moves in multiple directions, less controlled than uni-directional airflow.

Personnel are a significant source of contamination in clean rooms, so proper training and gowning protocols are crucial.