Microbiology: Methods Of Sterilization Quiz Questions!

Cleanrooms are indeed measured for particulate counts at three different states: 'as-built', 'at rest', and 'in-operation'. These three states represent different conditions of the cleanroom and help in assessing its cleanliness and effectiveness in controlling particulate contamination. The 'as-built' state refers to the initial state of the cleanroom after construction or renovation. The 'at rest' state refers to the condition of the cleanroom when it is not in use but is operational, with all equipment and systems in place. The 'in-operation' state refers to the condition of the cleanroom during normal operations, with personnel and equipment in motion. By measuring particulate counts in these different states, the cleanliness and performance of the cleanroom can be evaluated.

Microbiological analysis is the use of biological, molecular, or chemical methods to detect and identify microorganisms in a material. It helps to control the proliferation of viruses, bacteria, and other microorganisms that can cause contamination and disease. This analysis is often applied to disease-causing and spoilage microorganisms. Factors such as contamination, cross-contamination, and contamination control processes can affect the microbiological analysis of pharmaceutical products.

Disinfection refers to the process of destroying microorganisms, excluding bacterial spores. While it may not completely eliminate organisms, it aims to reduce them to a level that is considered acceptable and not harmful to health or products. This process is different from sterilization, which aims to completely eradicate all forms of microorganisms, including bacterial spores. Disinfection is commonly achieved using biocides, which are chemical agents that have the ability to kill microorganisms. Antiseptics, on the other hand, are products with disinfectant properties that are specifically used on the skin and must be non-toxic and non-irritant. Preservatives are substances included in pharmaceutical products to prevent the growth and spoilage of microorganisms.

The primary source of contamination in cleanroom environments is humans, as they generate 80 - 90% of the normal microbial flora found in these environments. Therefore, it is crucial to use personal protective equipment (PPE) and follow proper cleanroom procedures to minimize microbial contamination. This includes using barriers such as sterile gloves and masks, preparing equipment properly, and implementing environmental controls.

All of the options listed (hand washing procedures, clean room clothing, working in appropriate isolators, hygienically designed clean room) are critical control points for an aseptically dispensed product. These control points are necessary to maintain the cleanliness and sterility of the product throughout the dispensing process, in accordance with HACCP principles.

Starting material labels should include at least the following information: the designated name of the product and the internal code reference where applicable, a batch number given at receipt, and where appropriate, the status of the contents (e.g. in quarantine, on test released, rejected).

The best way of controlling contamination in a clean room is by implementing a combination of hand washing, clean room clothing, clean room behavior, and good working practices. Hand washing helps to eliminate any potential contaminants on the hands, while clean room clothing helps to prevent the introduction of external contaminants into the clean room environment. Clean room behavior, such as avoiding unnecessary movements and minimizing the generation of particles, also helps to minimize contamination. Additionally, good working practices, such as following standard operating procedures and maintaining cleanliness, further contribute to contamination control in a clean room.

Low temperature gas plasma sterilization utilizes the fourth state of matter, plasma, as a sterilizing agent. This process generates free radicals from gases, which are effective in killing microorganisms. The plasma glow emitted during this sterilization process does not emit ultraviolet light. Additionally, low temperature gas plasma sterilization is commonly used to sterilize the surfaces of medical equipment. Therefore, the correct answer is "All the above."

Candida albicans is an eukaryotic micro-organism because it is a type of fungus. Eukaryotes are organisms that have cells with a nucleus and other membrane-bound organelles, and fungi are one of the main groups of eukaryotes. Burkholderia cepacia, Helicobacter pylori, Salmonella typhimurium, and Bacteriodes fragilis are all prokaryotic micro-organisms, meaning they lack a nucleus and other membrane-bound organelles.

Disinfection is the process of reducing the number of viable micro-organisms to a level that is considered safe and appropriate. This process does not usually eliminate bacterial endospores, which are highly resistant to disinfection methods. Therefore, the correct definition of disinfection is the reduction of viable micro-organisms to an appropriate level but not usually bacterial endospores.

A clean room is an enclosed space that maintains strict limits on airborne particulates, contaminants, and pollutants. It is commonly used in the pharmaceutical industry for manufacturing, industrial production, and scientific research of products. Clean rooms remove pollutants, particles, and contaminants from outside ambient air by circulating it through a filter system. The filters, either HEPA or ULPA, clean and decontaminate the outside air according to their specifications. The filtered air is then forced into the clean room, while contaminated air is either forced outside the room or recirculated back into the filter. This process continues in an ongoing cycle.

Steam is the most widely used, effective, economical, and reliable method of sterilization used in the healthcare setting. Steam sterilization, also known as autoclaving, uses high-pressure steam to kill microorganisms and spores on medical equipment and supplies. It is highly effective in eliminating a wide range of pathogens and is suitable for heat-resistant materials. Steam sterilization is cost-effective as it does not require the use of expensive chemicals or gases. Additionally, it is a reliable method as it can penetrate porous materials and has a shorter sterilization cycle compared to other methods.

Clostridium and Bacillus species produce endospores. Endospores are a dormant form of bacteria that are highly resistant to harsh environmental conditions. They are formed within the bacterial cell and can survive for extended periods of time until favorable conditions for growth are present. Clostridium and Bacillus species are well-known for their ability to produce endospores, which allows them to survive in various environments and makes them difficult to eradicate.

Resident skin bacteria are best described as being located deep in the epidermis, being part of the innate defense system, being effectively removed by antiseptic scrub, and potentially increasing in numbers due to washing.

Lipolysaccharide is the correct answer because it is a major component of the outer membrane of Gram-negative bacteria and is known to induce fever and inflammation in the body. It is a pyrogenic endotoxin, meaning it can cause fever when released into the bloodstream. Lipoprotein, phospholipid, and polysaccharide are not specifically known to have pyrogenic properties. Lipoteichoic acids are found in the cell walls of Gram-positive bacteria and do not have pyrogenic effects.

Candida albicans is a eukaryotic microorganism because it is a type of fungus. Eukaryotic organisms have cells that contain a nucleus and other membrane-bound organelles, and they can be single-celled or multicellular. Candida albicans is a single-celled fungus that is commonly found in the human body, particularly in the mouth and genital areas. It can cause infections, especially in individuals with weakened immune systems.

Bovine serum albumin is included in the bactericidal disinfectant test (BSEN 1276) to simulate the presence of interfering substances. This is because bovine serum albumin is a common protein found in blood and other bodily fluids, and its presence can affect the efficacy of disinfectants. By including bovine serum albumin in the test, it allows for a more realistic simulation of real-life conditions where interfering substances may be present.

The organisms S. typhimurium, E.coli, and P.aeruginosa are known to produce endotoxins/pyrogens. Endotoxins are a type of toxin that is released when the bacterial cell is damaged or destroyed, and they can cause fever and other inflammatory responses in the body. These organisms are commonly associated with infections and can cause various diseases in humans. Therefore, the correct answer is A, B, and C.

This statement is false because even if human error is identified as the cause of a deviation, it is still necessary to consider if the error was influenced by the lack of a procedure to control the activity. The absence of a procedure can increase the likelihood of human error and therefore should be taken into account when analyzing the cause of the deviation.

Micro-organisms discovered during monitoring should be identified in all cases because identification helps in determining the type of micro-organism present and its potential impact on the system being monitored. This information is crucial for taking appropriate actions to control or mitigate any potential risks associated with the presence of the micro-organisms. Identifying them consistently ensures that any changes or trends in the microbial population can be detected and addressed promptly, maintaining the safety and quality of the system.

Quality control (QC) is an essential step in ensuring sterility and meeting required standards for pharmaceutical products. It involves approving specifications for raw materials and products, which helps to identify and eliminate potential contaminants that can affect sterility. Particles, such as those derived from dust, human flora, rubber, glass, and clothing fibers, can easily contaminate a product. To address this, HEPA filters are used to remove 99.97% of particles at 0.3 microns or larger, further ensuring the sterility of the pharmaceutical products.

Alcohol hand rubs are effective in removing dirt from the hands, but they are not active against all bacteria and spores. While alcohol-based hand sanitizers can kill many types of bacteria, they may not be effective against certain strains or spores. Therefore, the statement "Removes dirt, not active against all bacteria and not active against all spores" accurately describes the properties of alcohol hand rubs.

Sterility refers to the complete absence of micro-organisms in a product. This means that the product has been thoroughly sterilized and is free from any potential contaminants. Achieving sterility requires a comprehensive contamination control program, which includes methods such as terminal sterilization and aseptic processing. These measures ensure that the product is safe for use and will not cause any harm or infection to the user.

Pseudomonas aeruginosa is an opportunistic pathogen that has been associated with contaminated eye drops and ointments. This bacterium is known for its ability to infect the eyes and cause severe eye infections, especially in individuals with compromised immune systems. It can contaminate eye care products during manufacturing or due to improper storage and handling, leading to infections when these products are used. Therefore, Pseudomonas aeruginosa is the correct answer in this case.

Clostridium and Bacillus species are known to produce endospores. Endospores are a dormant, tough, and non-reproductive structure formed by certain bacteria as a response to unfavorable environmental conditions. These endospores allow the bacteria to survive harsh conditions such as high temperatures, desiccation, and exposure to chemicals or radiation. Clostridium and Bacillus species are both Gram-positive bacteria that are capable of forming endospores, making them resistant to adverse conditions and allowing them to persist in the environment for extended periods.

The accepted Sterility Assurance Level (SAL) for pharmaceutical products is 1 x 10-6. SAL is a measure of the probability of a viable microorganism being present on a product after sterilization. A SAL of 1 x 10-6 means that there is a one in a million chance of a viable microorganism being present on the product. This level of sterility is considered acceptable for pharmaceutical products to ensure patient safety and prevent contamination.

The D value, also known as the decimal reduction time, is a measure of the time taken at a fixed temperature or radiation dose to achieve a 90% reduction in viable cells. It is used to assess the effectiveness of sterilization methods. The Z value, on the other hand, refers to the increase in temperature needed to reduce the D value by 90%. The inactivation factor (IF) is a standard used post-sterilization, and it is calculated as 10^t/d. The answer provided correctly explains the D value as the time required to achieve a 90% reduction in viable cells at a fixed temperature or radiation dose.

This answer is true because the statement implies that the drop of potassium chloride 0.9% does not support the survival or growth of E.coli, making it non-viable. However, E.coli is stated to be viable, meaning it can survive and grow in other conditions.

The correct answer is "Viable (e.g. bacteria, viruses) and non-viable (particulate or chemical)". This answer is the most correct because it includes both types of contamination that can be found in a clean room. Viable contamination refers to living organisms such as bacteria and viruses, while non-viable contamination refers to non-living particles such as dust or hair, as well as chemicals. This answer covers all the possible types of contamination that can be present in a clean room.

Viruses are incapable of growth in pharmaceutical products because they require a host cell to replicate. They are also sensitive to radiation and heat, which can be used to destroy or inactivate them.

To calculate the number of decimal reductions required to reach the accepted SAL (Sterility Assurance Level), we need to convert the given concentration of 1 x 10^12 cfu/mL to a decimal form. The decimal form of the concentration is 0.000000000001 cfu/mL. Since the accepted SAL is typically 10^-6, we can calculate the number of decimal reductions by dividing the initial concentration by the accepted SAL. In this case, 0.000000000001 / 0.000001 = 1,000,000. Therefore, 18 decimal reductions are required to reach the accepted SAL.

The correct answer is Lipid enveloped viruses, Gram positive bacteria, Fungi, Cysts, Endospores. This sequence is based on the susceptibility of organisms to disinfectants. Lipid enveloped viruses are the least susceptible as their outer lipid layer can be easily disrupted by disinfectants. Gram positive bacteria are next in line as they have a thick peptidoglycan layer that provides some resistance. Fungi are less susceptible than bacteria due to their unique cell wall composition. Cysts, which are dormant forms of certain parasites, are more resistant than fungi. Finally, endospores, which are highly resistant structures formed by some bacteria, are the most resistant to disinfectants.

The correct answer is "Installation is installed and operating, complete with production equipment, but with no operating personnel present." This means that the cleanroom is fully set up and functioning, including all production equipment, but there are no people present in the area. This condition is necessary to accurately measure the total particulate count in the cleanroom when it is in a state of rest.

Living/viable microorganisms can contaminate a product and affect its sterility. These microorganisms can cause dangerous diseases and can come from the normal flora present in the environment. It is important to control and prevent the presence of these microorganisms to ensure the safety and sterility of the product.

The correct answer defines fermentation as the process of altering or producing products with the assistance of microorganisms. This process typically involves the breakdown of sugars into alcohol or acids by yeast or bacteria. Fermentation is commonly used in the production of various food and beverages such as bread, beer, wine, and yogurt. It is an important process in the food industry as it helps to enhance flavors, preserve food, and produce certain desired products.

The intestinal tract is home to a diverse and abundant population of microorganisms, known as the gut microbiota. This is because the intestines provide an ideal environment for microbial growth, with a constant supply of nutrients and a warm temperature. The gut microbiota plays a crucial role in digestion, nutrient absorption, and immune function. It is estimated that the number of microbial cells in the intestinal tract is in the trillions, making it the area of the body with the highest numbers of microbial cells.

Chlorhexidine is a biguanide disinfectant that is used for clean instrument disinfection and preservation of eye drops and lens solutions. It is not a quaternary ammonium compound used as a preservative for eye drops, an aldehyde used for instrument disinfection, or an ester used for preservation of oral and topical products.

Acquired antimicrobial resistance refers to the development of resistance to antimicrobial drugs in microorganisms through genetic changes. This can occur through mutations in the organism's genes or through the transfer of resistance genes from other microorganisms. This process is not a natural property of the organism or due to inherent differences in cell permeability. Therefore, the correct answer is "Occurs due to a genetic change through mutation or genetic transfer."

If a microorganism has a D60 of 0.5 minutes, it means that it takes 0.5 minutes for the population of microorganisms to decrease by 1 log (or 90%). To achieve 8 decimal reductions, we need to decrease the population by 8 logs (or 99.999999%). Since each log reduction takes 0.5 minutes, it would take 4 minutes (8 x 0.5) to achieve 8 decimal reductions of the cell population.

Peracetic acid is an example of an oxidising disinfectant because it has strong oxidizing properties. It can break down organic matter and kill microorganisms by oxidizing their cell walls and proteins. This makes it an effective disinfectant for a wide range of applications, including medical and industrial settings.

The Gram positive cell envelope structure is characterized by a thick layer of peptidoglycan and lipoteichoic acids. This structure provides rigidity and protection to the cell. The peptidoglycan layer is responsible for the cell's shape and prevents osmotic lysis. Lipoteichoic acids are anchored in the cytoplasmic membrane and extend through the peptidoglycan layer, providing additional support and playing a role in cell adhesion and host-pathogen interactions. This structure is different from Gram negative cell envelopes, which have a thin layer of peptidoglycan and an outer membrane containing lipopolysaccharides.

Endospores are highly resistant structures that are produced by certain bacteria, such as Bacillus cereus and Clostridium difficile, in response to unfavorable conditions. They are not easily inactivated by disinfectants, including hypochlorite disinfectants. Therefore, the statement "Endospores can be inactivated by hypochlorite disinfectants" is false.

The correct answer is P. aeruginosa, E. coli, E. hirae, S. aureus. These organisms are considered obligatory test organisms in BSEN 1276, which is a standard for evaluating the antimicrobial activity of disinfectants and antiseptics. They are commonly used in testing because they represent different types of microorganisms, including Gram-negative bacteria (P. aeruginosa, E. coli), Gram-positive bacteria (E. hirae, S. aureus), and both environmental and pathogenic bacteria. By using these organisms in testing, it allows for a comprehensive evaluation of the effectiveness of disinfectants and antiseptics against a wide range of microorganisms.

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The correct answer is "Quality assurance protocols for pharmaceutical products do not always select for these microorganisms." This means that quality assurance protocols may not always specifically target or detect the microorganisms present in the human microbiome. This suggests that the presence of the human microbiome may not be considered a significant concern in contamination control for pharmaceutical products, as the protocols do not always account for these microorganisms.