2: Sterilization Flashcards
define sterility
absence of viable microorganisms
define aseptic processing
operations performed between sterilization of an object or preparation and final sealing of package
Carried out in complete absence of microorganisms
number of viable microorganisms in or on an object or preparation entering a sterilization step
bioburden
act of verifying that a procedure is capable of producing the intended result under all expected circumstances
validation
kills vegetative bacteria and some spores
bactericide
substances which stops growth but not kills
Usually start growing again after removed
bacteriostatic
bacterial cell capable of multiplication (as opposed to spore form which cannot multiply) less resistant than spore form
vegetative cell
body which some species of bacteria form within their cells which is more resistant than vegetative cell
spore
An agent that inhibits or destroys microorganisms on living tissue including skin, oral cavities, and open wounds.
aseptic
A chemical agent used on surfaces and objects to destroy infectious fungi, viruses, and bacteria, but not necessarily their spores.
chemical disinfectant
Sporicidal and antiviral agents may be considered a special class of _______
disinfectants.
Disinfectants are often categorized as __________________________ by medically oriented groups based upon their efficacy against various microorganisms.
high- level, intermediate-level, and low-level
An agent for the removal from facility and equipment surfaces of product residues that may inactivate sanitizing agents or harbor microorganisms.
cleaning agent
The removal of microorganisms by disinfection or sterilization.
decontamination
An agent for reducing, on surfaces, the number of all forms of microbial life including fungi, viruses, and bacteria
sanitizing agent
An agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative microorganisms.
sporicidal agent
: An agent that destroys all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. Sterilants are liquid or vapor-phase agents
sterilant
common antiseptic for hand sanitizer
70%b isopropyl alcohol
how to select disinfectant in pharmaceutical manufacturing environments
- type and number of microorganisms to be controlled
- nature of surface material + compatibility with disinfectant
- corrosiveness of disinfectant with repeated use
2 tests to see efficacy of disinfectant
dilution test
surface challenge test
describe the surface dilution test
screening disinfectants for their efficacy at various concentrations and contact times against a wide range of standard test organisms and environmental isolates
describe the surface challenge test
using standard test microorganisms and microorganisms that are typical environmental isolates, applying disinfectants to surfaces at the selected use concentration with a specified contact time, and determining the log reduction of the challenge microorganisms
T or F: disinfectants have DIN numbers
T
Sterility Assurance Level (SAL) equal to probability of finding a non-sterile unit ____
< 10-6
describe steam under pressure
moist heat in the from of saturated steam under pressure (autoclaving)
what is the most reliable method for destruction of all organisms
autoclaving
how does steam under pressure kill cells
coagulation of cell proteins
typical autoclave conditions
121C for 15 min, 1bar = 15 psi