Pharmaceutical Sterilization Methods

A viable microorganism is one that can form progeny, meaning it can reproduce and create new organisms.

Sterilization is the process of removing or destroying all viable microorganisms. It ensures that a product is free from contamination.

It is difficult to definitively prove a product is sterile. Sampling and culturing can potentially introduce contamination during the process, making it challenging to guarantee complete sterility.

<p>The three primary sterilisation methods listed in the pharmacopoeia are thermal methods, ionising radiation sterilisation, and gas (vapour phase) sterilisation.</p> Signup and view all the answers

<p>This statement emphasises the importance of validation and product suitability when adapting or combining sterilisation methods.</p> Signup and view all the answers

<p>Aseptic processing is an approach used to produce a sterile product, but it is not considered a sterilisation method itself.</p> Signup and view all the answers

<p>Different products require different sterilisation methods depending on their sensitivity to heat, radiation, or chemical agents.</p> Signup and view all the answers

<p>The pharmacopoeia serves as a guide for pharmaceutical manufacturers, outlining accepted and validated sterilisation methods.</p> Signup and view all the answers

<p>The decimal reduction time (D) is the reciprocal of the death rate constant (k).</p> Signup and view all the answers

<p>The D-value is temperature-dependent. A change in temperature generally affects the time required to reduce the microbial population by one log cycle.</p> Signup and view all the answers

<p>The Z-value represents the temperature change required to produce a tenfold change in the D-value. It indicates the heat resistance of a microorganism.</p> Signup and view all the answers

<p>The Z-value and the D-value are inversely related. A higher Z-value implies a lower D-value at a given temperature, indicating a less heat-resistant microorganism.</p> Signup and view all the answers

<p>A plot of log natural % survivors vs. time illustrates the relationship between microbial survival and time during a sterilization process.</p> Signup and view all the answers

<p>The decimal reduction time (D) represents the time required for a one-log cycle reduction in the microbial population.</p> Signup and view all the answers

<p>Sterilization refers to the complete elimination of all microorganisms, while disinfection involves a reduction in the number of viable microorganisms to a safe level. The D-value is a critical parameter for both sterilization and disinfection, as it quantifies the time required to achieve a specific reduction in the microbial population.</p> Signup and view all the answers

<p>Studying sterilization kinetics provides valuable insights into the effectiveness of sterilization processes and allows for accurate prediction of microbial inactivation based on different parameters like temperature and time. It also helps determine the appropriate sterilization conditions to ensure product safety and efficacy.</p> Signup and view all the answers

<p>To eliminate all viable microorganisms from a product.</p> Signup and view all the answers

<p>Thermal, radiation, gas, and filtration.</p> Signup and view all the answers

<p>It is the time required to reduce the microbial population by 90%, or one log.</p> Signup and view all the answers

<p>The F-value represents the time at a given temperature required to achieve a specific level of sterility.</p> Signup and view all the answers

<p>SAL stands for Sterility Assurance Level, and it's the probability of a non-sterile unit after sterilization.</p> Signup and view all the answers

<p>The tests themselves can introduce contamination, and they are destructive, testing only a sample of the batch.</p> Signup and view all the answers

<p>Validation ensures that the sterilization process consistently achieves its intended outcome.</p> Signup and view all the answers

<p>To assess the effectiveness of the sterilization by containing microorganisms with a known resistance.</p> Signup and view all the answers

<p>To simulate the manufacturing process using a sterile growth medium to assess the risk of contamination.</p> Signup and view all the answers

<p>Airflow in cleanrooms should be unidirectional and filtered to remove particles and prevent contamination.</p> Signup and view all the answers

<p>Sterility is defined as the absence of viable microorganisms.</p> Signup and view all the answers

<p>Injectable products bypass the body's natural defenses, making sterility crucial to prevent infection.</p> Signup and view all the answers

<p>Ophthalmic products (e.g., eye drops) must be sterile.</p> Signup and view all the answers

<p>A terminally sterilized product is one that is sterilized in its final container.</p> Signup and view all the answers

<p>Products made by aseptic processing are considered high-risk because they are not terminally sterilized.</p> Signup and view all the answers

<p>Sepsis and/or death are potential consequences.</p> Signup and view all the answers

<p>To prevent product spoilage.</p> Signup and view all the answers

<p>Medicated foams when used on large open wounds.</p> Signup and view all the answers

<p>A sterilising filter acts as a barrier that ensures the filtrate beyond it is considered sterile.</p> Signup and view all the answers

<p>Microbial death during thermal sterilisation follows an exponential decrease, with a constant proportion of organisms killed over time.</p> Signup and view all the answers

<p>Moist heat sterilisation typically results in a constant percentage of organisms killed over time, while gas sterilisation is affected by factors like concentration and humidity.</p> Signup and view all the answers

<p>It indicates an exponential decrease in microbial survival numbers over time during the sterilisation process.</p> Signup and view all the answers

<p>Factors such as concentration, humidity, and temperature also significantly affect the effectiveness of gas sterilisation.</p> Signup and view all the answers

<p>The total absorbed dose is the key consideration in radiation sterilisation, rather than merely the time of exposure.</p> Signup and view all the answers

<p>Aseptic conditions are crucial to prevent contamination and ensure the filtrate remains sterile.</p> Signup and view all the answers

<p>The death rate changes such that a consistent proportion of surviving organisms is killed in each time increment, leading to an exponential decrease.</p> Signup and view all the answers

<p>An isolator is designed to completely seal the operator from the environment, allowing for safe handling of products through gloves or gauntlets.</p> Signup and view all the answers

<p>Filtered air continuously sweeps the room, and pressure differentials ensure that air moves from cleaner to less clean areas.</p> Signup and view all the answers

<p>Both the isolator and the gloves must be tested for integrity to confirm that there are no breaches.</p> Signup and view all the answers

<p>Personnel introduce contaminants through their movements and actions, making them a primary concern in contamination control.</p> Signup and view all the answers

<p>HEPA filters deliver filtered air to the clean room, removing particulates and ensuring high air quality.</p> Signup and view all the answers

<p>Positive or negative pressure within an isolator helps maintain the desired environmental conditions and prevent contamination.</p> Signup and view all the answers

<p>Isolators can be placed in lower grades of clean rooms than laminar airflow cabinets due to their sealed environment.</p> Signup and view all the answers

<p>The pressure decreases as one moves from a higher grade clean room to a lower grade, facilitating airflow from cleaner to less clean areas.</p> Signup and view all the answers