quiz 4 Pharmaceutical Contamination: Types and Control Measures 4,5,6
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Questions and Answers

Which element is the main constituent of a cell?

  • Oxygen
  • Carbon (correct)
  • Nitrogen
  • Hydrogen

    • From which source do heterotrophs obtain carbon?

  • Organic molecules (correct)
  • Light
  • Reduced inorganic compounds
  • CO2

    • What is the function of iron in a bacterium?

  • Nucleic acids and nucleotides
  • Main inorganic cations and enzymatic cofactor
  • Cytochrome component and enzymatic cofactor (correct)
  • Proteins and several coenzymes

    • Which element is the electron acceptor in aerobic respiration?

    <p>Oxygen</p> Signup and view all the answers

    From which source do lithotrophs obtain electrons?

    <p>Reduced inorganic compounds</p> Signup and view all the answers

    What is the primary source of potassium for a bacterium?

    <p>Potassium salts</p> Signup and view all the answers

    What is the primary purpose of using solid media (agar plates) for culturing microorganisms?

    <p>To form colonies with distinctive appearances for easier culture purification</p> Signup and view all the answers

    What is the main difference between undefined media and defined media for microorganism culture?

    <p>Undefined media contains chemically undefined components, while defined media has all components chemically defined</p> Signup and view all the answers

    Which method is used for anaerobic culture by producing CO2 and H2 from breakdown of citric acid, cobalt chloride, and sodium borohydride?

    <p>GasPak sachets</p> Signup and view all the answers

    Which type of microorganism can tolerate oxygen in the air but produces energy by fermentation?

    <p>Facultative aerobe</p> Signup and view all the answers

    What is the main characteristic of bacterial growth during the exponential (log) phase?

    <p>Growth and division occur at maximum possible rate given genetic potential and environmental conditions</p> Signup and view all the answers

    What is the primary purpose of secondary metabolism in microbial cells?

    <p>Synthesis of natural products e.g. antibiotics</p> Signup and view all the answers

    Which method aims to remove or kill all microorganisms and infectious proteins?

    <p>Gas sterilization</p> Signup and view all the answers

    What type of infection is characterized by minor infections that do not spread beyond the site of injection or contact?

    <p>Local infection</p> Signup and view all the answers

    Which process involves the series of operations to purify and sterilize medical products, reducing the risk of contamination and side effects?

    <p>Downstream processing</p> Signup and view all the answers

    What is the most serious effect that can come from contaminated injectable products?

    <p>Systemic/bloodstream infection</p> Signup and view all the answers

    Which method involves the process of separating products from production mixtures and removing unwanted components?

    <p>Purification</p> Signup and view all the answers

    What is the main purpose of downstream processing?

    <p>Purification</p> Signup and view all the answers

    Which method is important for minimizing microbial contamination while minimizing product damage?

    <p>Filtration</p> Signup and view all the answers

    What can result from contamination of injectable products with toxic microbial metabolites?

    <p>Systemic/bloodstream infection</p> Signup and view all the answers

    What is an example of a recognized sterilization method by European Pharmacopoeia(2002)?

    <p>Ionizing radiation</p> Signup and view all the answers

    What is the process of separating products from production mixtures and removing unwanted components using methods such as sedimentation, precipitation, centrifugation, adsorption, and filtration?

    <p>Purification</p> Signup and view all the answers

    What type of infection is often caused by ingestion of contaminated products?

    <p>GI infection</p> Signup and view all the answers

    Which method involves the use of methods such as heat, filtration, and radiation to remove or kill all microorganisms and infectious proteins?

    <p>Steam sterilization</p> Signup and view all the answers

    Which type of contamination is not mentioned in the text?

    <p>Radiological</p> Signup and view all the answers

    What is one of the sources of biological contamination mentioned in the text?

    <p>Raw materials</p> Signup and view all the answers

    Which type of area is used for clean or aseptic preparation in controlling microbial contamination?

    <p>Grade C</p> Signup and view all the answers

    What is used for environmental controls in aseptic production as mentioned in the text?

    <p>High Efficiency Particulate Air (HEPA) filtration</p> Signup and view all the answers

    What type of water has stricter quality guidelines than purified water as per the text?

    <p>Purified Water for injection</p> Signup and view all the answers

    What is a common source of microbial contamination from personnel mentioned in the text?

    <p>Facial skin microbes</p> Signup and view all the answers

    What method is used for product sampling and clinical samples as per the text?

    <p>Filtration and broth/agar methods</p> Signup and view all the answers

    Which standard is mentioned in the text for regulating contamination?

    <p>QC Standards</p> Signup and view all the answers

    What are the potential consequences of microbial contamination according to the text?

    <p>Spoilage and inactivation of products</p> Signup and view all the answers

    What method is used for liquid sampling according to the text?

    <p>Liquid chromatography</p> Signup and view all the answers

    In which area are environmental controls maintained for aseptic production?

    <p>Area with HEPA filtration and air drawn from outside aseptic area</p> Signup and view all the answers

    Which method of sterilization is generally reserved for temperature sensitive items such as reusable surgical instruments and medical diagnostic equipment?

    <p>Radiation sterilization</p> Signup and view all the answers

    What is the assumed mechanism of action for broad spectrum antimicrobials used in sterilization?

    <p>Alkylation of various protein functional groups</p> Signup and view all the answers

    Which type of radiation used for sterilization requires the facility to be heavily shielded and can damage some materials due to radiolysis of water?

    <p>γ-rays</p> Signup and view all the answers

    What is the primary target of both ionising and non-ionising radiation used for sterilization?

    <p>Microbial DNA</p> Signup and view all the answers

    How can sterilization be checked to ensure its success?

    <p>Using chemical indicators based on visible alteration of chemical characteristics</p> Signup and view all the answers

    What is the purpose of using biological indicators during sterilization?

    <p>To assess the sterilization process by placing non-pathogenic bacterial spore preparations around the sterilizer</p> Signup and view all the answers

    According to sterility assurance, what does 'sterile' mean?

    <p>No surviving organism after exposure to the sterilization process</p> Signup and view all the answers

    What is the microbial safety index aiming for in terms of probability?

    <p>1 in 1 million (10-6)</p> Signup and view all the answers

    What method is used as the primary choice for assessing whether a sterilized product is free from microbial contamination by incubating a sample in nutrient medium?

    <p>Membrane filtration</p> Signup and view all the answers

    What can happen when sterility testing indicates that a sterilized product is not free from microbial contamination?

    <p>Product recall and litigation</p> Signup and view all the answers

    What does achieving true sterility entail based on microbial safety index probability?

    <p>Achieving a probability no more than 1 in 1 million (10-6)</p> Signup and view all the answers

    What will have a direct impact on the success of sterilization, according to the text?

    <p>The nature of the contaminant involved</p> Signup and view all the answers

    Which type of culture allows for controlled growth with constant nutrient supply?

    <p>Continuous culture</p> Signup and view all the answers

    What are the three growth modes for bulk culturing?

    <p>Batch, fed batch, continuous</p> Signup and view all the answers

    What is an important criterion for scaling up production?

    <p>Maintaining adequate mixing</p> Signup and view all the answers

    What does viral replication rely on?

    <p>Host cell machinery</p> Signup and view all the answers

    What can bacterial evolution result from?

    <p>Mutation or DNA acquisition</p> Signup and view all the answers

    What results from bacterial evolution and selective pressure from antibiotics?

    <p>Antimicrobial resistance</p> Signup and view all the answers

    What is strain improvement aimed at achieving?

    <p>Improving product production</p> Signup and view all the answers

    What is the process of producing human-identical insulin through cloning and gene modification in E. coli called?

    <p>Heterologous gene expression</p> Signup and view all the answers

    What mechanism does bacterial evolution include?

    <p>Transformation, transduction, and conjugation</p> Signup and view all the answers

    What can contamination of pharmaceutical products lead to?

    <p>Increased resistance in bacteria</p> Signup and view all the answers

    What does lab-scale culture optimize steps for?

    <p>Product production only</p> Signup and view all the answers

    What can some viruses do during replication?

    <p>Destroy host cells</p> Signup and view all the answers

    Study Notes

    • Pyocyanin: produced in batch and continuous laboratory-scale cultures
    • Batch culture: limited nutrient availability and product production due to closed systems
    • Continuous culture: open systems, allows for controlled growth with constant nutrient supply
    • Scaling up production: bulk culturing, three growth modes: batch, fed batch, and continuous
    • Important criteria: maintain adequate mixing, high oxygen levels, control pH, temperature, and foam
    • Viral replication: relies on host cell machinery, can lead to cell destruction or budding
    • Bacterial evolution: changes in population over time due to mutation or DNA acquisition
    • Antimicrobial resistance: results from bacterial evolution, selective pressure from antibiotics
    • Strain improvement: increase production through spontaneous or targeted mutations, genetic modification
    • Heterologous gene expression: production of human-identical insulin through cloning and gene modification in E. coli

    Additional bullet points:

    • Lab-scale culture: optimizes steps for product production, limited in industrial applications
    • Viral replication: can lead to human disease, some viruses integrate into host genome
    • Bacterial evolution: mechanisms include transformation, transduction, and conjugation
    • Antimicrobial resistance: can lead to increased resistance in bacteria, decreased effectiveness of treatments
    • Contamination of pharmaceutical products: understanding origins, reducing risks, testing and results.

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    Description

    Test your knowledge of the types of contamination in pharmaceuticals, including chemical, biological, bacterial, fungal, viral, and physical contamination. Explore the sources of biological contamination and the control measures to reduce the risk of microbial contamination. Learn about environmental controls, clean room practices, personnel controls, and more.

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