Pharmaceutical-Microbiology-unit-2

D) It is the process by which an article, surface or medium is made free of all microorganisms either in vegetative or spore form.

Explanation: Sterilization is defined as the process of absolute kill of microorganisms, ensuring that an article, surface, or medium is completely free of all microorganisms, whether in vegetative or spore form.

B) Rapid penetration of heat into equipment

Explanation: The autoclave's sterilization process is based on the higher pressure ensuring the rapid penetration of heat into the deeper parts of equipment, with the moisture present in the steam causing coagulation of proteins of microbes, leading to irreversible loss of their activity and functions.

D) They are very soft and brittle

Explanation: The main drawback of using sintered glass filters for sterilization is that they are very soft and brittle, making them prone to break easily during the filtration process, which can compromise the sterilization procedure.

C) Sterilizing powders and non-volatile compounds

Explanation: Dry heat sterilization is primarily used for sterilizing powders and other non-volatile compounds, making it an ideal method for certain pharmaceutical substances and equipment.

To carry out slow solidification of serum or egg, not for sterilization. However, if the process is repeated for days, some degree of sterilization is achieved, known as fractional sterilization.

D) All of the above

Explanation: The autoclave is made of various components including vessel or pressure chamber, lid or door, pressure gauge, pressure releasing unit (whistle), safety valve, and electrical heater, all of which are essential for its functioning in large scale sterilization processes.

B) Asbestos

Explanation: Seitz filters are made of asbestos material, which gives them a thick and strong structure, allowing them to effectively filter solutions and leave bacteria and residues on the top of the filter during the sterilization process.

C) It traps particles smaller than 93 microns

Explanation: A HEPA filter with 99.97 percent efficiency can trap particles smaller than 93 microns, making it effective in reducing air pollutants and improving air quality.

To sterilize media with sugar and gelatin, preserving sugar which might be decomposed at a higher temperature. It is not recommended for sterilization of instruments.

A) By killing the microorganism

Explanation: The growth of microorganisms can be controlled by killing the microorganism or by inhibiting their growth, achieved through the use of physical or chemical agents.

C) High penetrating power

Explanation: Gamma radiation is advantageous in sterilization due to its high penetrating power, allowing it to effectively sterilize materials of considerable thickness or volume, such as packaged food or medical devices.

B) To remove bacteria and microorganisms

Explanation: Irradiating cell cultures for research purposes primarily aims to remove bacteria and microorganisms from the cultures, ensuring a clean and sterile environment for research.

C) To confirm whether the products are either sterile or nonsterile.

Explanation: The sterility test is conducted to confirm whether the products are manufactured and processed under specified guidelines and are either sterile or nonsterile, as per cGMP standards.

D) Absorbing microbes in minute pores

Explanation: Candle filters have minute pores that have the tendency to absorb microbes during the sterilization process, making them effective in filtering out microorganisms from fluids and substances.

Boiling for 10 to 30 minutes kills mostly the vegetative forms of bacteria, fungi, and viruses at 50-70 degrees in a short time, but many spores withstand boiling for a considerable time, making it inadequate for sterilization purposes. It is not suitable for absolute sterility.

A) 'Cidal' agents

Explanation: The agents which kill the microorganisms are called 'cidal' agents, and they are used to eliminate bacteria, viruses, and fungi.

E) High production cost

Explanation: X-rays are rarely used in sterilization due to their expensive production and the difficulty in efficient utilization, as they are given off in all directions from the point of origin, making their application challenging and costly.

C) It results in the formation of pyrimidine dimer

Explanation: Ultraviolet radiation causes the bonding of two adjacent pyrimidines, leading to the formation of pyrimidine dimer, which in turn inhibits DNA replication, resulting in mutation and death of exposed organisms.

A) Through microbiological tests

Explanation: The efficiency of sterilization is evaluated through microbiological tests, which are essential for confirming the sterility of the products and ensuring compliance with cGMP standards.

The autoclave works on the principle of moist heat sterilization, where the high pressure inside the chamber increases the boiling point of water for the purpose of sterilization.

A) Static agents

Explanation: The agents which inhibit the growth of microorganisms without killing them are called static agents, and they are used to prevent the growth of bacteria, viruses, and fungi.

B) The time required to destroy microorganisms

Explanation: The D value indicates the time in minutes it takes to destroy 90% of viable microorganisms at a constant temperature, highlighting its significance in determining the efficiency of sterilization by measuring the time required to eliminate microorganisms.

E) Handling and disposal of radioactive material

Explanation: A disadvantage of ionizing radiation in sterilization is the requirement for handling and disposal of radioactive material, which adds complexity and safety concerns to the sterilization process.

B) It kills microorganisms by destructive oxidation of essential cell constituents

Explanation: Incineration as a sterilization method operates on the principle of killing microorganisms through the destructive oxidation of essential cell constituents, which is a key factor in its effectiveness in reducing the volume of waste and potentially destroying organic carbon-containing materials, including pathogens.

B) Membrane Filtration and Direct Inoculation Filtration

Explanation: Sterility tests can be carried out using methods such as Membrane Filtration and Direct Inoculation Filtration, which are crucial for evaluating the sterility of products and confirming their compliance with cGMP standards.

C) Oxidation of molecules as a result of heat generated

Explanation: Infra-red rays kill microorganisms by oxidizing molecules as a result of the heat generated, providing an effective method for the rapid mass sterilization of syringes and catheters.

A) Moist heat

Explanation: Autoclave sterilization is a method of sterilization using moist heat, which is achieved through the use of steam under pressure, making it effective in killing microorganisms.

A) The temperature change required to decrease one point in D value

Explanation: The Z value represents the amount of temperature change required to decrease one point in D value, indicating the impact of temperature on the efficiency of sterilization by influencing the D value and the killing of bacteria.

B) Sterilization of medical products

Explanation: An application of ionizing radiation is the sterilization of medical products such as insulin syringes and blood products, highlighting its crucial role in ensuring the safety and efficacy of healthcare-related materials.

B) 160°C for 2 hours

Explanation: The sterilization temperature and holding time for sterilization in a hot air oven is 160°C for two hours, which is essential information for understanding the process of sterilization using this method.

D) It potentially destroys any material containing organic carbon, including pathogens

Explanation: Incineration as a sterilization method offers the advantage of potentially destroying any material containing organic carbon, including pathogens, and typically reduces the volume and mass of material that must be disposed of in landfills by 80 to 95 percent, making it an effective waste management solution.

D) By showing that products are manufactured and processed under specified guidelines

Explanation: Sterility is confirmed by demonstrating that products are manufactured and processed under specified guidelines, as per cGMP standards, ensuring the quality and safety of the products.

A) Radiation

Explanation: Radiation sterilization using gamma rays is a method of sterilization that falls under the category of radiation sterilization, which is effective in killing microorganisms.

A) It kills microorganisms by destructive oxidation of essential cell constituents

Explanation: Flaming as a sterilization method operates on the principle of destructive oxidation of essential cell constituents, which is achieved by exposing metallic objects to flame for a specific duration, effectively eliminating microbes and other contaminants present on the instrument.

E) The probability of survivors remaining from a load

Explanation: The F value is used to calculate the probability of survivors remaining from a load, providing insight into the effectiveness of a sterilization method by determining the number of final residents volume of units and the initial population volume.

B) Non-corrosive for metal and sharp instruments

Explanation: A dry heat cabinet is advantageous as it is non-corrosive for metal and sharp instruments, highlighting its suitability for certain sterilization needs and the protection it offers to equipment.

B) It produces toxic compounds in the ash and waste water

Explanation: A disadvantage of incineration as a sterilization method is that it produces toxic compounds in the ash and waste water, which must be treated to avoid adverse effects on health, highlighting the environmental and health concerns associated with this process.

E) To confirm the efficiency of sterilization

Explanation: Sterility indicators are used to confirm the efficiency of sterilization processes, ensuring that the products meet the required sterility standards and are safe for use.

D) To sterilize metallic objects by holding them in a flame until they become red hot

Explanation: Red heat sterilization is utilized to sterilize metallic objects by holding them in a Bunsen flame until they become red hot, ensuring the destruction of any present pathogens and contaminants.

C) They are damaged by high temperatures

Explanation: High temperatures are not suitable for materials like rubber and plastic in sterilization because they are damaged by high temperatures, indicating the limitations of using certain materials in sterilization processes.

B) Clean the membrane filter unit and sterilize the unit and membrane filter separately by moist heat sterilization

Explanation: The first step in the membrane filtration method involves cleaning the membrane filter unit and sterilizing the unit and membrane filter separately by moist heat sterilization, ensuring the elimination of potential contaminants.

C) Double-walled chamber made of stainless steel

Explanation: Modern hot air ovens are constructed with a double-walled chamber made of aluminum or stainless steel, which is separated from the outer case by a thick layer of insulation made of fiberglass, ensuring efficient and controlled sterilization processes.

A) Measuring exposure time

Explanation: Witness tubes are utilized to calculate exposure time in sterilization processes by adjusting the volume of crystals and the diameter of the tube's constriction to match the required sterilization time at a specific temperature.

D) To ensure rapid penetration of heat

Explanation: The higher pressure in the sterilization process using an autoclave is intended to ensure the rapid penetration of heat into the deeper parts of the equipment, facilitating effective sterilization.

A) Sterilizing powders and non-volatile compounds

Explanation: Hot air oven sterilization is used to sterilize powders and other non-volatile compounds, demonstrating its specific application in the sterilization of certain materials and substances.

A) To observe the turbidity in the medium

Explanation: Placing one half part of the membrane filter in fluid thioglycollate medium and soyabean casein digest medium allows for the observation of turbidity in the medium by comparing with the standard tube, indicating the presence or absence of microorganisms.

B) 30 minutes

Explanation: The standard operating procedure for autoclaving at 115°C is 30 minutes, which ensures effective sterilization of components at this specific temperature.

D) Indicating temperature

Explanation: The Royce sachet serves as a chemical indicator for ethylene oxide sterilization, as it contains a color indicator that changes from yellow to purple upon exposure to ethylene oxide, indicating that a certain temperature has been reached.

D) Coagulation of proteins

Explanation: The presence of moisture in the steam causes coagulation of proteins of microbes, leading to the irreversible loss of their activity and functions during the sterilization process using an autoclave.

A) Using sterile forceps

Explanation: In the direct inoculation method, cotton or prefilled syringe is transferred directly to culture media using sterile forceps, ensuring the aseptic transfer of materials to prevent contamination.

B) 121°C for 15 minutes

Explanation: Autoclaving at 121°C for 15 minutes is recommended for rapid and effective sterilization, providing a quick and efficient method for ensuring sterility of items.

B) Interception

Explanation: Interception is the process by which air reroutes around fibers, but due to inertia, particles continue on their path and remain attached to the fibers, making it an important concept in filtration and sterilization processes.

C) Cold sterilization

Explanation: Sterilization by radiation is also known as cold sterilization due to the relatively little heat produced in the material being irradiated by ionizing radiations, allowing for the sterilization of heat-sensitive substances.

B) Determining sterilization parameters

Explanation: Biological indicators are used to measure sterilization processes directly and integrate all sterilization parameters, providing a comprehensive assessment of the effectiveness of the sterilization.

C) Asbestos gasket

Explanation: The lid of the autoclave is fastened by screw clamps and rendered airtight by an asbestos gasket, ensuring a secure and airtight seal for the sterilization process.

C) Gun metal or stainless steel

Explanation: The laboratory autoclave is typically constructed of gun metal or stainless steel, which ensures durability and resistance to the high pressure and heat involved in the sterilization process.

A) Rapid and effective components

Explanation: Autoclave sterilization is advantageous due to its rapid and effective components, making it a preferred method for sterilization in various settings.

C) It uses destructive oxidation of essential cell constituents to kill microorganisms

Explanation: The hot air oven functions by employing destructive oxidation of essential cell constituents to kill microorganisms, which is a key principle underlying its effectiveness in sterilization.

C) It is a costly technique

Explanation: One of the disadvantages of autoclaving is that it is a costly technique, which may impact its feasibility for certain applications and settings.

D) It is suitable for sterilizing blood plasma

Explanation: In addition to sterilizing thermolabile medications, such as blood products, insulin, and enzymes, the method is also suitable for sterilizing blood plasma, highlighting its versatility and applicability in pharmaceutical sterilization processes.

D) High energy and high penetration

Explanation: Radiation can be divided into two categories based on their wavelength and penetration power, with ionizing radiations having high energy and ionizing the target molecules, making it effective for sterilization.

D) High and reproducible resistance to the sterilizing agent

Explanation: The selected organism for biological indicators should possess high and reproducible resistance to the sterilizing agent, genetic stability, rapid characterizability, and non-pathogenicity, ensuring accurate assessment of sterilization effectiveness.

D) To release pressure

Explanation: The discharge tap on the autoclave's lid is used to release the entrapped pressure by opening the valve, allowing for the safe release of pressure during the sterilization process.

D) Asbestos gasket

Explanation: The lid of the autoclave is rendered airtight by an asbestos gasket, which helps to maintain the necessary pressure and prevent the escape of steam during the sterilization process.

B) By heating a concentrated solution of formaldehyde

Explanation: Formaldehyde gas used for room sterilization is generated by heating a concentrated solution of formaldehyde, which vaporizes the formaldehyde for sterilizing an enclosed area. This process is essential for the effective use of formaldehyde as a sterilizing agent.

E) It is effective for sterilizing cloth surgical packs and towel packs

Explanation: A disadvantage of autoclave sterilization is that it is time-consuming, taking 80 minutes for metal instruments and 15 minutes for applications, making it less time-efficient for certain items.

C) Double-walled chamber made of aluminum or stainless steel with insulation

Explanation: A modern hot air oven consists of a double-walled chamber made of aluminum or stainless steel separated from the outer case by a thick layer of insulation made of fiberglass, which is a crucial construction feature for its efficient functioning.

C) 15 lbs

Explanation: A pressure of 15 lbs is effective for sterilizing cloth surgical packs and towel packs, making it suitable for these specific types of items.

C) Gaseous and liquid

Explanation: Chemical sterilization methods are categorized into gaseous and liquid types, offering a range of options for effectively destroying microbes.

A) It is not reliable

Explanation: Sterility testing is necessary because the method is not reliable, emphasizing the importance of verifying the effectiveness of the sterilization process to ensure the safety and efficacy of pharmaceutical products.

C) Bacterial spores

Explanation: Bacterial spores are typically used as biological indicators due to their high resistance to sterilizing agents, making them suitable for accurately assessing the effectiveness of sterilization processes.

B) Breakage of DNA and degradation of enzymes

Explanation: The principle behind radiation sterilization involves the breakage of DNA and degradation of enzymes, leading to the death of the irradiated cells, which ensures the effectiveness of the sterilization process.

B) Rising temperature phase

Explanation: The temperature in the autoclave rises and reaches up to the set level of 121°C during the rising temperature phase, signifying a critical stage in the sterilization process.

B) Gas concentration and pressure

Explanation: Gaseous sterilization procedures involve monitoring gas concentration independently of pressure rise and routine leak tests to ensure gas-tight seals, as well as measuring pressure and humidity, making options B the correct choice.

C) To control the pressure

Explanation: The safety valve in the autoclave is designed to control the pressure and can be set to release excess pressure, ensuring the safe and effective operation of the sterilization process.

C) It is highly bactericidal and used in concentrations of 2 to 5 mg/litre

Explanation: B-Propiolactone is capable of killing all microorganisms and is highly bactericidal, making it very active against viruses. It is used in specific concentrations to ensure effective sterilization, highlighting its potency as a sterilizing agent.

A) 110 degrees Celsius

Explanation: Autoclave sterilization occurs at a temperature of 110 degrees Celsius, which is crucial for effectively sterilizing various items such as surgical dressings, fabrics, glass apparatus, and containers.

B) By using electrical heating elements and thermostat control

Explanation: Heating in a hot air oven is achieved by using electrical heating elements and thermostat control, which ensures the maintenance of the required temperature for effective sterilization.

C) Anything not injured by steam and high temperature

Explanation: Autoclaving can be used to sterilize anything that is not injured by steam and high temperature of sterilization, including various solutions and media, highlighting its broad applicability.

B) Permanently destroy microbes

Explanation: Liquid sterilization is designed to permanently destroy microbes, ensuring the complete elimination of harmful microorganisms.

C) Filters may allow medicaments to be absorbed from a solution

Explanation: Filters may allow medicaments to be absorbed from a solution, highlighting a potential drawback of the described sterilization process and the need for careful consideration of filtration methods in pharmaceutical manufacturing.

C) Immediate availability of media after sterilization

Explanation: One advantage of radiation sterilization is the immediate availability of the media after sterilization, providing a quick and efficient process for obtaining sterile materials.

C) Determining the pore size of filters

Explanation: The bubble point pressure test is employed to determine the pore size of filters by applying pressure and observing the pressure difference when the first bubble of air breaks away from the filter, making option C the correct choice.

D) To blow off at desired pressure

Explanation: The safety valve on the autoclave can be set to blow off at any desired pressure, serving as a crucial safety feature to maintain controlled pressure levels during the sterilization process.

A) It reacts with DNA and RNA

Explanation: The action of ethylene oxide as a sterilizing agent is due to its power of alkylating the amino, carboxyl, hydroxyl, and sulfhydryl groups in enzymes and protein molecules. It also reacts with DNA and RNA, making it a powerful sterilizing agent for various materials, including heat and moisture-sensitive items.

E) Items sensitive to heat cannot be sterilized

Explanation: Autoclave sterilization is not suitable for items sensitive to heat, as the high temperature involved can damage or alter the composition of certain materials, making them unsuitable for this method of sterilization.

D) To displace cooled air and ensure uniform heat distribution

Explanation: The fan in a hot air oven plays a crucial role in displacing cooled air and ensuring the uniform distribution of heat, which is essential for effective sterilization.

B) Killing microorganisms with hot water or steam

Explanation: Sterilization by moist heat involves the killing of microorganisms with hot water or steam, and this method is effective due to the denaturation and coagulation of proteins, making it a crucial principle in the field of sterilization.

A) Ethanol

Explanation: Usually, 70% of alcohols, including methyl alcohol, isopropyl alcohol, and ethyl alcohol, are used as chemicals to kill bacteria, making them important components of chemical sterilization processes.

A) Moist Heat Sterilization

Explanation: Parenteral solutions containing thermolabile medicines, such as insulin and heat-sensitive injections, can be sterilized without decomposition using moist heat sterilization. This method ensures the elimination of microorganisms while preserving the integrity of the thermolabile medicines.

C) Requires highly specialized equipment

Explanation: A disadvantage of radiation sterilization is the requirement for highly specialized equipment, making it a more costly alternative to heat sterilization.

B) 115°C, half an hour. 121°C, 15 minutes.

Explanation: The standard operating procedure for autoclaving is to maintain a temperature of 115°C for half an hour and 121°C for 15 minutes, ensuring effective sterilization within specified time and temperature parameters.

D) Heat, steam, sterilant gases and ionizing radiation

Explanation: Chemical monitoring of a sterilization process is based on the ability of heat, steam, sterilant gases, and ionizing radiation to alter the chemical or physical characteristics of a variety of chemical substances, making option D the correct choice.

B) 30-35°C

Explanation: The recommended temperature for incubating a sample containing fluid thioglycollate medium (FTM) is 30-35°C for not less than 7 days, which provides the optimal conditions for observing turbidity and evaluating the presence of microorganisms.

D) Sterilization of liquid substances or fluids

Explanation: Filtration is primarily used for the sterilization of liquid substances or fluids, such as sera and solutions of heat-labile substances like sugars and urea. This method is essential for ensuring the sterility of these specific types of materials.

D) 15 lbs

Explanation: Autoclave sterilization is typically conducted at a pressure of 15 lbs, which is essential for ensuring the effectiveness of the sterilization process, particularly for items such as aqueous parenteral solutions and liquid media.

C) Rapid heat transfer and high heat content

Explanation: Moist heat sterilization offers advantages such as rapid heat transfer and high heat content, making it more efficient in destroying micro-organisms compared to dry heat. It is also suitable for a wide range of medical products and materials.

C) They directly impact bacteria

Explanation: Chlorination, as well as the blend of iodine and chlorine compounds, directly impact bacteria, making halogens an effective component of chemical sterilization processes.

B) Absence of viable microorganisms

Explanation: Products labeled as 'sterile' must undergo strict controls to ensure the absence of viable microorganisms. This is a crucial criterion for maintaining the sterility of the products and ensuring their safety for medical use.

E) Observing color changes due to heat hydrolysis

Explanation: Browne tubes contain a red fluid that changes color on heating due to heat hydrolysis, making option E the correct choice.

C) To compare with the standard tube

Explanation: The observation of turbidity in the medium is conducted to compare with the standard tube, providing a visual indication of microbial growth or absence thereof, which is crucial for assessing the suitability of the sample for use.

C) Does not destroy pyrogens

Explanation: One of the disadvantages of moist heat sterilization is that it does not destroy pyrogens, which are fever-inducing substances. Additionally, it is not suitable for anhydrous materials such as powders and oils, and cannot be used for thermolabile substances.

E) Destroy microbes

Explanation: Heavy metals such as copper sulfate, mercuric salts, and silver nitrate are used in the sterilization method to effectively destroy microbes, ensuring the elimination of harmful microorganisms.

D) By using physical, chemical, or biological indicators

Explanation: The sterilization process can be monitored using physical, chemical, or biological indicators to assess the performance and effectiveness of the sterilization method. These indicators play a crucial role in ensuring the quality and safety of the sterilization process.

A) The tubes turn green

Explanation: When the temperature inside the autoclave reaches 121°C, the brown tubes placed inside turn green, providing a visual indication to determine whether the articles have been properly sterilized.

D) Sterilization by heat, used for milk

Explanation: Pasteurization is a method of sterilization by heat, specifically used for milk. It involves two different types of methods - the Holder method and flash method, which are effective against non-sporing pathogens found in milk.

C) Destruction of all living microorganisms with a gaseous or vapor state chemical

Explanation: Gaseous sterilization is defined as the destruction of all living microorganisms with a chemical in a gaseous or vapor state, offering an effective method for ensuring sterilization.

C) Master process record (MPR)

Explanation: In moist heat sterilization, a Master Process Record (MPR) is prepared as part of the validation procedure for a specific autoclave and each specified product and load configuration. The MPR serves as a critical document for ensuring the effectiveness and consistency of the sterilization process.

D) To ensure proper sterilization

Explanation: Exposing Bacillus Sterothermophilus spores to 121°C for 12 minutes is done to ensure proper sterilization, as the absence of spore growth in the culture media indicates that the sterilization process has been effectively performed.

B) 63°C for 30 minutes

Explanation: The Holder method of pasteurization involves heating milk at 63°C for 30 minutes, which is an effective process for sterilizing milk and eliminating non-sporing pathogens.

D) Temperature record chart

Explanation: In dry heat sterilization processes, a temperature record chart from each sterilization cycle is compared against a master temperature record. This comparison is essential for verifying the accuracy and consistency of the sterilization process using dry heat.

A) Plasma membrane; enzyme denaturation and Inactivation

Explanation: Phenol and Phenolics act through the mechanism of plasma membrane disruption and enzyme denaturation and inactivation, making them effective for various applications such as disinfecting instruments and sterilizing medical equipment's environmental surfaces.

D) To ensure proper sterilization

Explanation: The autoclave tane changing color when heated to 121°C serves the purpose of ensuring proper sterilization by indicating the ability to kill bacteria (microorganisms) and confirming the elimination of all microorganisms.

A) For instruments, mucous membranes, skin surfaces, and

Explanation: Chlorohexidine is applied for instruments, mucous membranes, and skin surfaces, making it a versatile antiseptic and disinfectant with broad applications.

E) Chlorine forms the strong oxidizing agent hypochlorous acid that changes cellular constituents

Explanation: Halogens act by forming the strong oxidizing agent hypochlorous acid, which changes cellular constituents, showcasing their powerful disinfecting properties and broad spectrum of applications.

B) Used to disinfect glass wares, utensils, water

Explanation: Alcohol is used to disinfect glass wares, utensils, and water, highlighting its effectiveness as a germicidal and antiseptic agent with diverse applications.

C) Denaturation of enzyme and other essential proteins

Explanation: Aldehydes act through the denaturation of enzyme and other essential proteins, showcasing their effectiveness in metabolic inhibition and largely affecting moulds, making them a valuable tool for sterilization and disinfection.