Sterile Manufacturing 1 Flashcards
What are the types of contamination?
Viable matter e.g. bacteria, fungi, yeast, viruses
- leads to infection or death
Non-viable matter e.g. particles, dust etc
- leads to pathological effects and spoilage (quality issues)
What are the sources of contamination?
Humans e.g. hands, hair, nose, mouth, clothing
Non-human e.g. environment, equipment, surfaces, components
How to remove or prevent contamination?
Sterilisation
Disinfection
Perseveration (adding substance to ensure product remains contamination free in between doses)
What is terminal sterilisation?
Using heat or radiation methods to seal the container
What is aseptic manufacturing?
Because not all products can be terminally sterilised.
Environment and steps must be of extremely high quality otherwise there may be a risk that contamination can take place after filtering
Where do particles come from?
Skin cells
Normal clothing
Contaminant clothing itself
Why does skin cause issues?
Carries particles which carry microorganisms
Natural bacteria may be on the skin
How to reduce viable contamination?
Wear protective clothing (cover up) so you trap the particles from getting out e.g gowns and masks and gloves
The clothing must benefit the manufacturing process
How to reduce non-viable contamination?
Protective clothing that is worn must benefit the manufacturing process
Masks
Environmental control
Actively reduce contamination levels caused by the environment, equipment and personnel
CLEANROOM
What is a cleanroom?
Reduces level of contamination both viable and non-viable.
Manufactures all types of products e.g medicinal, food or phones
Must be up to standard
Classification - based on particle count in room
Factors of a cleanroom?
Air circulation
Control of lighting
Filters
Painted walls and floors
Air conditioning and heating = attempt to recirculated air
- air is brought through ceilings down flow and exit through gated floor
