Sterilization in Practice Quiz

Two limitations of steam sterilization that can damage the container are wetting the product, leading to potential contamination after sterilization, and the risk of damage from the pressure buildup during the process.

Two hazards associated with ethylene oxide sterilization directly related to the operator are its high toxicity, posing a risk of exposure, and its explosive nature, making it a safety concern.

Two limitations of ethylene oxide sterilization are the slow pace of the process, requiring significant time, and the need to control multiple factors for proper sterilization.

<p>Both steam and dry heat sterilization have the potential to cause damage to the preparation due to the high temperatures involved.</p> Signup and view all the answers

<p>Formaldehyde sterilization can be damaging to materials like plastics.</p> Signup and view all the answers

<p>Dry heat sterilization may not require as long an exposure time as steam sterilization for achieving sterilization.</p> Signup and view all the answers

<p>Air ballasting in steam sterilization can damage the container because the introduction of air can create pressure changes within the container, potentially causing damage.</p> Signup and view all the answers

<p>Decontamination is required after ethylene oxide sterilization.</p> Signup and view all the answers

<p>Filtration sterilization is not efficient for small particles such as viruses and prions.</p> Signup and view all the answers

<p>Strict aseptic techniques are necessary to prevent contamination during the filtration process.</p> Signup and view all the answers

<p>The integrity of a membrane filter can be compromised by physical damage, improper handling, or excessive pressure.</p> Signup and view all the answers

<p>Microbial contaminants can grow within depth filters, leading to compromised sterilization.</p> Signup and view all the answers

<p>Shedding refers to the release of particles or contaminants from depth filters, which can introduce impurities into the final product.</p> Signup and view all the answers

<p>The purpose is to test for viable microorganisms in the product.</p> Signup and view all the answers

<p>Sterility testing is destructive because it requires the destruction of the item to confirm the absence of microorganisms.</p> Signup and view all the answers

<p>An inactivation factor of 10^10 is required.</p> Signup and view all the answers

<p>A D value of 1.5 indicates the time in minutes needed at a specific temperature to reduce the population of bacteria by 90%.</p> Signup and view all the answers

<p>The sterility assurance level achieved is 10^-6.</p> Signup and view all the answers

<p>Because it only tests a portion of the batch, it can only suggest that no microorganisms were found in that sample.</p> Signup and view all the answers

<p>It limits the ability to test each item without compromising it, necessitating sampling protocols.</p> Signup and view all the answers

<p>A positive sterility test indicates the presence of microorganisms, compromising the product's safety.</p> Signup and view all the answers

<p>Sterility cannot be guaranteed by testing; it must be assured by applying a suitably validated production process.</p> Signup and view all the answers

<p>MPED refers to the dose that is most likely to effectively reduce a certain number of microorganisms, independent of the survivor curve's slope.</p> Signup and view all the answers

<p>Sterility testing is essential to confirm that a sterilized product is free from microorganisms that may compromise patient safety.</p> Signup and view all the answers

<p>Establishing an MPED requires complex calculations that take various factors into account, making it challenging.</p> Signup and view all the answers

<p>A validated production process ensures that all parameters are consistently controlled to maintain sterility throughout manufacturing.</p> Signup and view all the answers

<p>The final container or packaging must also be validated to ensure it does not introduce contaminants that compromise sterility.</p> Signup and view all the answers

<p>MPED calculations do not rely on the specific slope of the survivor curve, allowing for a more straightforward evaluation of effective dosage.</p> Signup and view all the answers

<p>Failure to apply a validated sterilization process increases the risk of contaminated products, posing significant safety concerns.</p> Signup and view all the answers

<p>The absence of growth indicates that the sterilization process has had sufficient lethality.</p> Signup and view all the answers

<p>Diffusion rate tests measure the rate of gas flow through a wetted filter, which is important for assessing large-area filters.</p> Signup and view all the answers

<p>A higher potential risk of failure suggests that additional precautionary measures, like using a prefiltration stage, may be necessary.</p> Signup and view all the answers

<p>Confidence is established by testing each batch of filters to ensure they meet specifications for performance and safety.</p> Signup and view all the answers

<p>Filters are tested for particulate release, mechanical strength, and chemical characteristics.</p> Signup and view all the answers

<p>The increased possibility of transmission of Creutzfeldt–Jakob disease (CJD) has heightened the importance of monitoring proteins.</p> Signup and view all the answers

<p>The holes in the filter must be perfect uniform capillaries to ensure effective sterilization.</p> Signup and view all the answers

<p>The required pressure can be compared with specifications provided by the filter’s manufacturer.</p> Signup and view all the answers

<p>The bubble point refers to the pressure required to produce a steady stream of gas bubbles through a wetted filter.</p> Signup and view all the answers

<p>Spores are used because they provide a way to assess the efficiency of the sterilization method based on their survival after exposure.</p> Signup and view all the answers

<p>Surface tension causes liquid to be retained in the capillaries if they become wet, affecting gas flow.</p> Signup and view all the answers

<p>Indicators are removed aseptically and incubated to detect the presence of any surviving microorganisms.</p> Signup and view all the answers

<p>The force needed to expel the liquid is proportional to the diameter of the capillaries (pore diameter).</p> Signup and view all the answers

<p>A significant limitation is that if the capillaries become wet, they can trap liquid and compromise the gas flow.</p> Signup and view all the answers

<p>The method being assessed refers to any predetermined means of sterilizing items to ensure the elimination of microorganisms.</p> Signup and view all the answers

<p>Uniform capillaries allow for consistent testing of gas flow and liquid retention across the filter.</p> Signup and view all the answers

Signup and view all the answers

<p>Qualified personnel are crucial because they are trained in microbiology, aseptic techniques, and gowning practices, reducing the risk of contamination in sensitive areas.</p> Signup and view all the answers

<p>A CCS aims to identify critical control points, monitor contamination risks, and implement measures to prevent contamination throughout the manufacturing process.</p> Signup and view all the answers

<p>Environmental monitoring helps assess the effectiveness of air filtration systems and detect potential microbial contamination, ensuring the cleanroom meets established standards.</p> Signup and view all the answers

<p>Airlocks act as transition zones between areas of differing cleanliness levels, minimizing the risk of contaminants being carried from less clean areas into the cleanroom.</p> Signup and view all the answers

<p>Regular gowning qualifications ensure that personnel are properly attired and minimize the risk of shedding contaminants from their bodies into the controlled environment.</p> Signup and view all the answers

<p>Microbial growth in water systems can contaminate products and compromise their sterility, leading to potential safety risks for patients.</p> Signup and view all the answers

<p>Depyrogenation methods aim to remove endotoxins, which are potent pyrogens, from pharmaceutical products, reducing the risk of adverse reactions in patients.</p> Signup and view all the answers

<p>Risk assessments evaluate the potential for contamination during aseptic connections and interventions, allowing for the development of specific protocols to mitigate those risks.</p> Signup and view all the answers

<p>An SAL of 10⁻⁶ indicates a probability of only one non-sterile unit in one million sterilized units, which signifies a very low risk of microbial contamination, making it a high level of sterility assurance.</p> Signup and view all the answers

<p>Two critical parameters are steam penetration and load temperature. Steam must effectively penetrate the entire load to ensure all microorganisms are exposed to the sterilization conditions, and the internal temperature of the load must reach and maintain the required temperature for a sufficient duration.</p> Signup and view all the answers

<p>Biological indicators (BIs) are used to validate the effectiveness of sterilization processes by challenging the process with resistant microbial spores. Two common examples are <em>Geobacillus stearothermophilus</em> for moist heat sterilization and <em>Bacillus atrophaeus</em> for dry heat and ethylene oxide sterilization.</p> Signup and view all the answers

<p>F₀ Value represents the equivalent time at 121°C (for moist heat) to achieve a specific level of sterilization, while Fₕ Value represents the equivalent time at 160°C (for dry heat) to achieve the same level of microbial lethality. Distinguishing between them is important because each value represents a different thermal death time for microorganisms under different sterilization conditions.</p> Signup and view all the answers

<p>Aseptic assembly is necessary when terminal sterilization (sterilization after packaging) is not feasible due to product sensitivity to heat or other sterilization methods. Aseptic assembly involves assembling the product using a validated aseptic process, which ensures sterility throughout the manufacturing process without relying on terminal sterilization.</p> Signup and view all the answers

<p>Membrane filtration sterilizes by removing microorganisms using filters with pore sizes ≤ 0.22 μm. Advantages include its ability to sterilize heat-sensitive solutions, its compatibility with small volumes, and its effectiveness against a wide range of microorganisms. However, limitations include its potential for clogging by particulate matter, its inability to remove viruses or endotoxins, and the need for sterile handling and equipment.</p> Signup and view all the answers

<p>A bubble point test involves applying pressure to a wetted filter until a gas bubble is observed passing through the filter. This indicates the point at which the filter membrane is breached. The higher the bubble point pressure, the tighter the filter pores and less likely microbial contamination.</p> Signup and view all the answers

<p>Surface tension plays a crucial role in filtration sterilization because it affects the flow of liquid through the filter capillaries. High surface tension can create resistance to liquid flow, potentially trapping microorganisms within the capillaries and hindering their removal. Therefore, filter materials with lower surface tensions are preferred for effective sterilization.</p> Signup and view all the answers

<p>Proper personnel hygiene reduces the risk of contaminating sterile products with viable microorganisms.</p> Signup and view all the answers

<p>The Inactivation Factor is calculated using the formula: $IF = 10^{\frac{t}{D}}$, where $t$ is the exposure time and $D$ is the decimal reduction value.</p> Signup and view all the answers

<p>Chemical indicators, such as autoclave tape that changes color at specific temperatures, are used to assess the effectiveness of sterilization conditions.</p> Signup and view all the answers

<p>Biological indicators contain bacterial spores that are resistant to specific sterilization processes; an example for moist heat sterilization is <em>Geobacillus stearothermophilus</em>.</p> Signup and view all the answers

<p>Routine monitoring is essential to ensure that the sterilization processes remain effective and consistently meet sterility assurance requirements.</p> Signup and view all the answers

<p>An SAL of 10⁻⁶ means that there is no more than one viable microorganism per million items processed.</p> Signup and view all the answers

<p>Commissioning data ensures that sterilization equipment is properly installed and functioning as intended.</p> Signup and view all the answers

<p>The destructive nature of sterility testing means that it can only assess a small sample of a batch, impacting how product safety is evaluated across the entire production lot.</p> Signup and view all the answers