Topic 21

What is sterilization?

The complete elimination or destruction of ALL microbial life forms, including resistant endospores in a product, typically using pressurized steam or sterile gases

What is disinfection?

the removal or killing of active pathogenic microorganisms on nonliving surfaces by physical or chemical techniques

What is antisepsis?

the elimination of active pathogens on living tissues using chemical antimicrobials

What is degerming?

the mechanical removal of microbes from a small, localized area, such as the skin near an injection site by wiping with an ethanol-soaked cotton swab

What is sanitization?

a process aimed at reducing microbial populations on things (such as eating/drinking utensils) to levels considered safe for health by washing or immersion in chemical disinfectants

What does aseptic mean?

free of pathogenic microorganisms

what does sterile mean?

characterized by complete absence of life or ability to reproduce

What is a sterility assurance level (SAL)?

the statistical probability of finding a nonsterile drug product in a produced set

What is the bioburden?

the load or count of microorganisms present

What is a CFU?

the colony forming units, is the units of measurement for the bioburden

What is the FT?

The terminal death time, or the time needed to kill a microorganism at a specified reference temperature

what is a pyrogen?

and endotoxin that induces fever upon injection

what is a clean room?

a highly controlled sterile environment

What is a media fill?

a simulation of filling drug product to prove that the operation is sterile

what did early civilizations in Egypt and Greece use to clean their tools?

Fire and sunlight

What did Nickolas Appert do?

In 1810 he wrote about conservation by boiling of juices/jellies/jams/syrups in his cookbook

What did Louis Pasteur do?

In 1857 he developed the germ theory of fermentation, then in 1862 he developed the patent for Pasteurization (primarily on wine)

What did Robert Koch do?

1876 he connected Bacillus anthracis to anthrax, in 1882 he connected mycobacterium tuberculosis to tuberculosis, and in 1883 he conntected vibrio cholerae to cholera

What happened in the late 1800s regarding sterilization?

Steam sterilization was adopted around the world

What happened regarding sterilization in the early 1900s?

chemical agents, auto claving, irradiation, and ethylene oxide were used for medical instruments

Why do parenterals have to be sterile?

Because they are administered behind body’s sterility barrier

What are examples of sterile parenteral products?

Injections, non-non-injectable sterile fluids, ophthalmic preparations, wound dressings, implants, absorbable hemostats, surgical ligatures, instruments and equipment

What are the main components of sterile product production?

the environment, the formulation, the manufacturing/processing equipment, the personnel, the packaging components.

How many ways are there to sterilize things?

two (aseptic processing and terminal sterilization

Explain the ways to sterilize things?

in aseptic processing you sterilize everything separately and then asseble the product; in terminal sterilization you asseble the product then you sterilize.