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Questions and Answers
What is the minimum temperature and time required to effectively sterilize under dry heat conditions?
What is the minimum temperature and time required to effectively sterilize under dry heat conditions?
What must be validated before applying a sterilization procedure in practice?
What must be validated before applying a sterilization procedure in practice?
Which of the following sterilization methods is considered the most reliable?
Which of the following sterilization methods is considered the most reliable?
Which type of filter is known to trap particles through a maze of channels?
Which type of filter is known to trap particles through a maze of channels?
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What is the main reason why boiling at 100°C for 10 minutes is not considered a sterilization technique?
What is the main reason why boiling at 100°C for 10 minutes is not considered a sterilization technique?
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Which sterilization monitoring method changes color to indicate the appropriate conditions have been met?
Which sterilization monitoring method changes color to indicate the appropriate conditions have been met?
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In autoclaving, what conditions must be achieved to effectively kill spores?
In autoclaving, what conditions must be achieved to effectively kill spores?
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Why does the presence of water enhance sterilization efficacy?
Why does the presence of water enhance sterilization efficacy?
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Which statement about sterilization monitoring indicators is correct?
Which statement about sterilization monitoring indicators is correct?
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What is the primary purpose of performance qualification data in the validation process?
What is the primary purpose of performance qualification data in the validation process?
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Which of the following materials can be effectively autoclaved?
Which of the following materials can be effectively autoclaved?
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What does a sterilizing filter need to accomplish when challenged with Pseudomonas diminuta?
What does a sterilizing filter need to accomplish when challenged with Pseudomonas diminuta?
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What is a primary limitation of boiling as a disinfection method?
What is a primary limitation of boiling as a disinfection method?
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Which of the following is NOT a common application for non-terminal sterilization?
Which of the following is NOT a common application for non-terminal sterilization?
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At what pressure is steam maintained in an autoclave to achieve sterilization at 121°C?
At what pressure is steam maintained in an autoclave to achieve sterilization at 121°C?
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Which sterilisation technique utilizes heat as its primary principle?
Which sterilisation technique utilizes heat as its primary principle?
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Which process is NOT categorized as sterilization?
Which process is NOT categorized as sterilization?
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What happens to proteins during moist sterilization that assists in killing microorganisms?
What happens to proteins during moist sterilization that assists in killing microorganisms?
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Which of the following is a liquid chemical sterilant?
Which of the following is a liquid chemical sterilant?
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What is the main role of biological indicators in sterilisation assurance?
What is the main role of biological indicators in sterilisation assurance?
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Which statement accurately describes dry heat sterilisation?
Which statement accurately describes dry heat sterilisation?
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What would be an inappropriate application for dry heat sterilisation?
What would be an inappropriate application for dry heat sterilisation?
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Which of the following is a primary characteristic of nonterminal sterilisation?
Which of the following is a primary characteristic of nonterminal sterilisation?
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What is the primary advantage of using gaseous sterilisation methods?
What is the primary advantage of using gaseous sterilisation methods?
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Which type of radiation is commonly associated with physical sterilisation?
Which type of radiation is commonly associated with physical sterilisation?
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What is the maximum temperature at which bacterial spores have little or no activation?
What is the maximum temperature at which bacterial spores have little or no activation?
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Which spores are usually irradicated above 80 °C?
Which spores are usually irradicated above 80 °C?
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How long can yeast typically survive at 60 °C?
How long can yeast typically survive at 60 °C?
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At which temperature range are viruses unlikely to survive for more than 20 minutes?
At which temperature range are viruses unlikely to survive for more than 20 minutes?
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Which type of radiation is characterized by deep penetration and negligible heating of sterilized products?
Which type of radiation is characterized by deep penetration and negligible heating of sterilized products?
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Which particle is known for its low penetration power despite being heavy and slow traveling?
Which particle is known for its low penetration power despite being heavy and slow traveling?
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What is the primary application of beta particles in sterilization processes?
What is the primary application of beta particles in sterilization processes?
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What happens to energy during the emission of gamma radiation?
What happens to energy during the emission of gamma radiation?
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Which radiation type is negatively charged and has similar mass to an electron?
Which radiation type is negatively charged and has similar mass to an electron?
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Which of the following statements is true regarding algal survival at lower temperatures?
Which of the following statements is true regarding algal survival at lower temperatures?
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What effect does dehydration have on resistance to radiation sterilisation?
What effect does dehydration have on resistance to radiation sterilisation?
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Which range of UV wavelengths is most effective for bactericidal activity?
Which range of UV wavelengths is most effective for bactericidal activity?
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How does the presence of oxygen influence radiation sensitivity?
How does the presence of oxygen influence radiation sensitivity?
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What property of ethylene oxide contributes to its hazardous nature?
What property of ethylene oxide contributes to its hazardous nature?
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What is a limitation of UV sterilisation regarding moisture?
What is a limitation of UV sterilisation regarding moisture?
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Which groups on proteins are impacted by the mechanism of alkylating gases during sterilisation?
Which groups on proteins are impacted by the mechanism of alkylating gases during sterilisation?
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What impact does freezing have on an organism's resistance to radiation?
What impact does freezing have on an organism's resistance to radiation?
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In the context of gaseous sterilisation, what are the immediate risks associated with acute toxicity?
In the context of gaseous sterilisation, what are the immediate risks associated with acute toxicity?
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What characteristic of membrane filters is crucial for effective filtration sterilisation?
What characteristic of membrane filters is crucial for effective filtration sterilisation?
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Study Notes
Sterilisation Techniques
- Sterilisation is an essential process for creating sterile dosage forms, and for reprocessing medical devices.
- There are several types of sterilisation processes, each with its own advantages and disadvantages, but steam sterilisation is the most common method.
- Users must understand the technology, its activity, and limitations, and follow appropriate guidelines.
- Validation of the sterilisation process is very important.
Learning Objectives
- Understanding commonly employed sterilisation techniques and their applications.
- Critical evaluation of different sterilisation techniques.
- Describing the role of sterilisation assurance and the application of biological indicators.
Sterilization Technologies
-
Terminal Sterilization:
- Heat: Steam, Dry heat
- Radiation: Accelerated electrons, gamma rays
- Chemical: Ethylene oxide, Low-temperature steam formaldehyde, Gas plasma, Glutaraldehyde, o-phthalaldehyde, formaldehyde, peracetic acid, hydrogen peroxide
-
Nonterminal Sterilization (Filtration):
- Aseptic procedure, membrane filters
Physical Sterilisation - Heat Sterilisation
-
Moist Heat:
- Steam sterilisation:
- Boiling (100°C for 10 minutes): Kills vegetative bacteria, fungi, and viruses, but not endospores.
- Autoclaving (121 °C for 15 minutes): Most reliable sterilisation method, steam at high pressure.
- Tyndallization: Series of treatments with moist heat, to kill vegetative and spore-forming bacteria.
- Pasteurization: Mild heat treatment to kill pathogenic bacteria, but not sterilise completely.
- Steam sterilisation:
-
Dry Heat:
- Dry heat sterilisation:
- High temperatures (160-180°C): Used for materials not damaged by high heat, such as glassware, metal instruments and powders.
- Dry heat sterilisation:
Physical Sterilisation - Radiation
-
Electromagnetic Radiation:
- gamma rays, X-rays, UV.
- High penetration power, wave length of radiation
-
Particulate Radiation:
- α-particles, β-particles, Neutrons.
- Low penetration power, radioactive elements, nuclei disintegration
Physical Sterilisation - UV
- Bactericidal activity; 220-280 nm
- Excites electrons non ionising radiation.
- Used for destruction of microorganisms on surfaces and in the air
- Formation of crosslinks between adjacent pyrimidine bases in DNA
- UV wavelengths have limited penetration power. Cell aggregates, wet vs dry state, proteins limit penetration.
Chemical Sterilisation - Gaseous Sterilisation
-
Alkylating Gases: E.g., Ethylene oxide (EO)
- Low-temperature steam formaldehyde (LTSF)
- Gas plasmas: Used for the sterilisation process
- Applications: Re-usable surgical instruments, medical, diagnostic and electrical equipments, surface sterilisation of powder.
Chemical Sterilisation - Gaseous Sterilisation - Limitations
- Potentially mutagenic and carcinogenic.
- Acute toxicity, including skin, conjunctiva and nasal mucosa irritation.
- Strict control of atmosphere needed to protect personnel.
- Highly explosive above 3.6% in air.
- Resistance in dried state because of protection by inclusion in crystalline or dried organic deposits.
Non-terminal Sterilisation - Filtration
- Membrane filters (0.2-0.22 µm nominal pore diameters): Used for sterilising products sensitive to heat & radiation.
- Filter medium are sterilised by steam treatment.
Validation of Sterilisation Process
- Sterility of a product cannot be guaranteed by testing, so a validated process is needed.
- Documentation of the process is very important (e.g. commissioning data, performance qualifications data).
- Physical, chemical and biological indicators are used to validate the process (e.g., autoclave tape, temptubes, spore tests).
Validation of Sterilisation Process - Process Indicators
- Spores added to a carrier (e.g., disk, strip).
- Spore suspension inoculated on/into the product to be sterilized.
- Self-contained indicators (e.g. 3M™ Attest™ indicators)
Selection of Sterilisation Process
- Considerations:
- Type of product/preparation (volume, composition).
- Possible damage to the preparation/product (heat, radiation, corrosiveness).
- Possible damage to the product/container (water ballasting, moisture, glass breaking, change in composition, corrosiveness).
- Other considerations (toxicity, safety, level of bioburden, sterilisation regimen, cost).
Process Summary
- Sterilisation is essential for sterile dosage forms & medical devices/products.
- Different processes have advantages and disadvantages, steam sterilisation is a reference standard.
- Users need to understand sterilisation technology, its activities and limitations; follow guidelines & validate processes.
- Failure in process validation can result in potentially fatal consequences.
References
- Pharmaceutics (Aulton, 2007)
- Hugo and Russell's pharmaceutical microbiology (Denyer et al., 2004)
- EMA guideline (2017)
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Description
Explore the essential sterilisation techniques used in healthcare and pharmaceuticals. This quiz covers various methods, including steam and chemical sterilisation, as well as the importance of validation and assurance. Test your knowledge on the applications and critical evaluation of these processes.
