Unit 2 - Sterile manufacturing Flashcards
Give examples of viable contamination matter
Bacteria
Fungi
Yeasts
Viruses
What can viable contamination cause?
Infection
Sepsis
Death
Give examples of non-viable contamination matter
Particles
Dust
What can non-viable contamination cause?
Pathological effects
Spoilage of products
- quality control issues
Give examples of human sources of contamination
Hands
Hair
Skin
Nose
Mouth
Clothing
Give examples of non-human sources of contamination
Environment
Equipment
Surfaces
Components
How can viable contamination be removed or prevented?
Sterilisation
Disinfection
Preservation
What method of sterilisation should always be the method of choice?
Terminal sterilisation using heat or radiation methods on the final product should always be the method of choice
What should happen to products that can’t be terminally sterilised?
Not all products can be terminally by heat or radiation. In this instance only aseptic manufacturing is available for producing a safe product
Where can non-viable particles from personnel come from?
Skin cells
Normal clothing
Containment clothing itself
How does human skin lead to contamination?
The outer skin layer sheds every 24 hours
- 10^9 skin cells/day
Median size of 20 um
- 7-10% less than 10 um
Cells carry natural bacterial flora of the body
- males worse than females
How can contamination caused by shedding of human skin be reduced?
Impervious clothing prevents dispersion of these cells
- a ten fold reduction in viable particulate counts
- halving of the sepsis rate in implant operations
Where does the majority of non-viable contamination come from?
Skin cells
Normal clothing
Give another example of a source of contamination
Respiratory tract of the operator
- sneezing
- talking
