M1L5 - Quality control

Sterility

This is the absence of viable microbes, both pathogenic and non-pathogenic

Validation

This is the establishment of documented evidence that a system does what it should do, and tests all possible methods of contamination

Terminal sterilisation

This is the sterilisation of a product in its final container (autoclaving, dry heat sterilisation, IR irradiation, ethylene oxide treatment)

Sterility assurance level

This is the degree of assurance with which the process in question renders a population of items sterile, given as the probability of finding a non-sterile item in the sterile population

Indicator organism

This is a more resistant organism to the sterilisation method compared to pathogens, used as a control in sterilisation procedures

Bacillus stearothermophilus

This is an indicator bacteria present in hot springs, and isolated from soil

Bacillus subtilis

This is an indicator bacteria found in and isolated from soil

Bacillus pumilus

This is an indicator bacteria isolated from soil, has a high resistance to UV radiation

Category 1

This requires items to be sterile

Category 2

This requires a viable aerobe count <100, and the absence of pseud. aeruginosa and staph. aureus

Category 3

This requires a viable aerobe count <1000, and the absence of e. coli

Pseudomonas aeruginosa

This is a bacteria commonly found in the environment, causative of infections in burns patients

Staphylococcus aureus

This is a bacteria commonly found in the environment, causative of skin and more rarely, systemic, infections

Candida albicans

This is a fungus carried in the gut and urogenital tracts, causative of thrush infections

Aspergillus niger

This is a fungus found in soil, water, vegetation, and fecal matter. Causative of black mould growth

E. coli

This is the most studied bacteria, used in quality control testing in water treatment to detect fecal contamination