PHAR5712 Week 3 - Sterilization Exam: Tested Questions and Answers, Exams of Nursing

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What is sterilisation - CORRECT ANSWERS Complete destruction or removal of all living micro-organisms and their spores from a product What is preservation - CORRECT ANSWERS Prevention of the growth of micro- organisms inside a product using anti-microbial chemical agents What is disinfection - CORRECT ANSWERS Reduction of the microbial population to some acceptable lower level for a defined purpose What products need to be sterile? - CORRECT ANSWERS - Parenteral products and their containers

• Parenteral drug delivery devices
• Ophthalmic preparations
• Non-injectable fluid
• Surgical tools/devices What are the two approaches to preparing sterile products? - CORRECT ANSWERS - Terminal sterilisation
• Aseptic production What are 3 physical methods of sterilisation? - CORRECT ANSWERS Thermal Radiation Filtration

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What are 2 chemical methods of sterilisation? - CORRECT ANSWERS Gaseous Bleach What 3 factors do we need to consider when choosing a method of sterilisation

• CORRECT ANSWERS - Ability of the product and container to withstand the sterilisation mathod
• Type of microorganism
• Bioburden What does a survivor curve tell you? - CORRECT ANSWERS The number of surviving micro-organism plotted versus the exposure time (or dose) of a killing process (e.g. sterilisation, disinfection) What does a D-value tell us - CORRECT ANSWERS The time required at a particular temperature (or radiation dose required) to achieve a 90% reduction in viable microbial population What does a Z value tell us? - CORRECT ANSWERS The increase in temperature needed to reduce the D value of a micro-organism by 90% (Can also look at it like what is the difference in time needed to reduce microbes by __% if we change the temp at which we're sterilising) What can a Z-value help determine? - CORRECT ANSWERS The resistance of micro-organisms against the influences of temperature (or radiation dose)

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What are the 2 different heat sterilisation methods? - CORRECT ANSWERS Moist Heat Dry Heat What 2 gases are used for gaseous sterilisation? - CORRECT ANSWERS Ethylene oxide Formaldehyde What are the 2 different methods of radiation sterilisation - CORRECT ANSWERS Ionising (Gamma, Electron) Non-ionising (UV) Filtration sterilisation methods - CORRECT ANSWERS Using a Depth Filter Membrane Filter How is moist/steam heat sterilisation conducted? - CORRECT ANSWERS In an autoclave Pressure is used to raise the temperature of steam in the steam-heated chamber to above 100 degrees C

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What type of steam is most effective in an autoclave and why? - CORRECT ANSWERS Dry saturated (steam that sits on the boundary between steam and liquid water) Causes water condensation and immediate release of latent heat when it comes into contact with a cooler surface (bacterial surface)--> fast heat transfer to bacteria --> proteins on surface of bacteria are denatured Why don't we use superheated steam for steam sterilisation? - CORRECT ANSWERS Steam does not condense into water --> acts like a hot gas --> slow to transfer heat Would need to be at even higher temps to destroy the bacteria What is the most commonly used standard temp/time cycle for steam sterilisation? - CORRECT ANSWERS 121.5 degrees C for 20mins What are the stages for operating an autoclave - CORRECT ANSWERS 1. Heating: heats up, removing air, steam input

2. Holding: load is exposed to steam (constant temp)
3. Cooling: drying and cool down If the autoclave is set at a higher temperature, should a shorter or longer cycle be chosen? - CORRECT ANSWERS Shorter

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When would you use Dry heat sterilisation - CORRECT ANSWERS When steam sterilisation isn't effective (like for oily products) Or when products are steam sensitive (powders) For glassware What is gaseous sterilisation used for? - CORRECT ANSWERS Used for sterilising vertain heat-sensitive articles (e.g. medical devices) How does gaseous sterilisation work? - CORRECT ANSWERS Alkylation of sulfhydryl, amino, hydroxyl and carboxyl groups of proteins and nucleic acid What is Ethylene Oxide usually diluted with for gaseous sterilisation and why? - CORRECT ANSWERS CO2 to reduce the explosive hazard What conditions are needed for ethylene oxide sterilisation? - CORRECT ANSWERS Temperature: 45 - 65 Time: 4-6 hours Concentration (mg/L): 800 - 1200 Humidity (%): 33- What are the advantages of Ethylene Oxide sterilisation - CORRECT ANSWERS

• Broad spectrum of materials can be sterilised

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• Can sterilise at room or low temperatures
• High penetration ability into the materials What are the disadvantages of Ethylene oxide sterilisation - CORRECT ANSWERS - Expensive and long procedure (compared to heat sterilisation)
• Very hazardous gas and difficult to use
• Ethylene oxide absorbed on the treated articles - difficulty of gas removal Properties of Formaldehyde gas - CORRECT ANSWERS Colourless with unpleasant odour Not explosive or flammable Acute toxicity and carcinogenic Absorbed by fabrics and plastic High affinity to water Can be polymerized at temperature below 80 degree C

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• Dry stuff (e.g. surgical instrument, powder)
• Disposable items (plastic syringes): large scale sterilisation is possible in gamma radiation
• Some pharmaceutical products How does ionising radiation work - CORRECT ANSWERS Emission from radioactive isotope Cobalt- Cleaves bonds in microbial DNA Formation of free radicals (e.g hydroxyl radical) which damages DNA What increases the effectiveness of ionising radiation sterilisation? - CORRECT ANSWERS Increased effectiveness in presence of water, oxygen and elevated temperature Advantages of Gamma sterilisation - CORRECT ANSWERS - good for heat and moist sensitive materials
• large volumes can be sterilised in one load (bc it has good penetrating power)
• can be done at room temp Disadvantages of Gamma sterilisation - CORRECT ANSWERS - requires highly specialised personnel equipment
• requires extensive precautions and expensive equipment

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• suitable for large scales only bc it's such a long process
• can damage certain products and containers What are the advantages of electron accelerators sterilisation - CORRECT ANSWERS - Suitable for heat and moist sensitive materials
• Fast sterilisation process (minutes)
• can be done at room temp Disadvantages of electron accelerator sterilisation - CORRECT ANSWERS - Suitable for produces in small packages (low penetration power)
• Requires extensive precautions and expensive equipment
• Possible alteration and damage to certain products and containers
• At high energies risk of X-ray induction in the product What source of non-ionising radiation is used for sterilisation? - CORRECT ANSWERS UV light at 260nm How does non ionising radiation sterilisation with UV work? - CORRECT ANSWERS Causes bonds between adjacent thymines in DNA chain (messes up DNA bonding basically) What is non-ionising radiation (UV) used for? - CORRECT ANSWERS Mostly used to sterilise the surface in laminar flow hood or vessels for water treatment

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What is "break through"? - CORRECT ANSWERS Possibility of organisms passing through the filter Would a membrane or depth filter be more likely to experience break through and grow through of microorganisms? - CORRECT ANSWERS Depth filter Grow through - CORRECT ANSWERS If bacteria left in contact with filter medium for long enough, they will reproduce and grow through the filter Which sterilisation method would you use for a stable (at room temp) aqueous solution? - CORRECT ANSWERS Filtration (w/ depth filter) then Radiation (reduced dose) Which sterilisation method would you use for a very unstable oily solution? - CORRECT ANSWERS Filter (membrane) and produce the produce under aseptic processing Which sterilisation method would you use for a very stable powder? - CORRECT ANSWERS Oven (160 degrees for 120mins) Which sterilisation method would you use for a very stable aqueous solution? - CORRECT ANSWERS Autoclave at 121 degrees for 15mins

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Which sterilisation method would you use for a stable aqueous solution? - CORRECT ANSWERS Filter (depth) then autoclave (reduced heat and time) How can we verify the sterility assurance of products? - CORRECT ANSWERS 1. Product testing (random microbiological assessments)

2. Monitoring the sterilisation process
3. Process validation practices (predict using survivor curve) How is the probability of accepting a contaminated batch calculated? - CORRECT ANSWERS P = (1-X)^y X = proportion of contaminated units in a batch Y = sample size Greater Y, lower probability of accepting any contaminated item Why is direct product testing not recommended when we can do process monitoring instead? - CORRECT ANSWERS Time consuming, expensive and impractical (bc batches can get large) What are some ways the sterilising process can be monitored? - CORRECT ANSWERS Equipment function tests (testing heat distribution, temp, pressure, time etc.)

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• Bioburden should not change significantly
• Containers and packaging shouldn't change
• Protocols should be constant What does GMP involve - CORRECT ANSWERS - Validated, defined and reviewed manufacturing processes
• Appropriately qualified and trained personnel
• Adequate premises and spaces
• Suitable equipment
• Suitable storage and transport
• Appropriate recording and reporting procedures