Nancy: Sterilisation Flashcards
Why do we sterilise pathogen contamination (salmonella contamination)
- Microbes harm patient and can cause infectious disease
2. Provides opportunistic infection
Why do we sterilise microbial spoilage (like milk)?
- Microbes damage product
- Degrade API
- Make dose unpalatable
What sort of order of growth is microbe growth?
First order (doubling time)
What is the order of sterilisation of microbial growth?
- Death of microbes follow 1st order kinetics
- 1000 microbes (0 minutes)
- 100 microbes (1 minute)
- 10 microes (2 minute)
What is the order of sterility in different forms of pharmaceutical products?
- Parenteral injection is a major infection hazard
- Application to sensitive sites like ocular, ears and creams
- Tablets (not so sterile)
What is the sterility assurance level?
- A level of sterility the pharmacopoeia requires for terminally sterilised products of 10-6 or better
- Only 1 microbe should be surviving in 1 million products
What is absolute sterilisation?
Absolutely no microbes
How do you do sterilisation testing?
- One sample is taken
- Either liquid, swab or filtrate
- Add to culture medium
- Wait for 14 days any growth at all? if not it’s sterile
What are the 5 sterilisation methods?
- Heat
- Filtration
- Chemical
- Irradiation
- Gas
Describe how steam sterilisation works, the equipment and what it’s applied on?
- Steam under pressure
- Autoclaves widely used: low cost, certified sterilisation
(121 degrees, high pressure for 15 to 30 minutes) - Has high latent heat of vapourisation: transfer heat really well to the surface it condenses to
- Hydrolysis of proteins in particular, enzymes
- Application: Equipment and liquids
Describe how dry sterilisation works, the advantages and disadvantages?
- Dry oven: 170 degrees for 2 hours
- Dry heat kills by oxidation
- Not suitable for liquids (dries them out), mainly used for lab glass ware, dental tools and surgical knives
Describe how filtration sterilisation works, what its mainly for and the equipment?
- Used to sterilise heat sensitive materials such as ophthalmic solutions
antibiotics
head sensitive injectables - Membrane filters:
uniform pore size is VITAL
0.22 micrometers: Removes most bacteria- NOT VIRUSES
0.01- 0.1 micrometers: Retains all viruses and some large proteins - Industrial filters: Large cartridges, controlled pressure, continuous use
Describe how some examples of chemical sterilisation work?
Examples:
1. Strong acids and bases (HCl and NaOH)
- Phenols interupt bio membranes and denature proteins that are low to mid disinfectants
- Alcohols denature proteins and dissolve membranes: Mid level disinfectants
- Aldehydes: effect the cross link between biomolecules
Describe how the irradiation method of sterilisation works for UV and gamma rays?
UV:
1. Rapid surface sterilisation
- Surface only absorbed by most material this weak penetration
Gamma rays:
1. Passes many materials deep penetration
- Used to sterilise pre packaged products (in-situ)
Describe how the gas method of sterilisation works?
Mist and spray:
1. Rapid surface sterilisation
Ethylene Oxide:
1. Sterilisation of heat sensitive products
- Highly flammable, toxic and carcinogenic