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Questions and Answers

What are the different types of contamination commonly found in pharmaceutical products?

  • Biological, Bacterial, Fungal, Viral (correct)
  • Chemical, Biological, Bacterial, Physical
  • Biological, Bacterial, Fungal, Physical
  • Chemical, Fungal, Physical, Viral

    • Which of the following is NOT a source of biological contamination in pharmaceuticals?

  • Materials
  • Facilities
  • Utilities
  • Chemicals (correct)

    • How can the risk of contamination be reduced in pharmaceutical manufacturing processes?

  • Using more contaminated materials
  • Increasing the temperature in the clean room
  • Regular hand hygiene practices (correct)
  • Using PPE

    • Which of the following is NOT a control measure used to reduce microbial contamination in pharmaceutical production?

    <p>Reuse of disposable gloves</p> Signup and view all the answers

    What is one way to reduce the risk of long-term contamination and spoilage in pharmaceutical products?

    <p>Sterilisation of contaminated products before release</p> Signup and view all the answers

    What is a common method used to reduce the risk of personnel contamination in pharmaceutical manufacturing?

    <p>Wearing Personal Protective Equipment (PPE)</p> Signup and view all the answers

    What is the purpose of using High efficiency particulate air (HEPA) filtration in pharmaceutical manufacturing?

    <p>To remove at least 99.97% of 0.3 µm diameter airborne particles</p> Signup and view all the answers

    Which of the following environmental controls is specifically designed to provide a local zone for high-risk operations in pharmaceutical manufacturing?

    <p>Micro.Glovebox/isolator</p> Signup and view all the answers

    What distinguishes Grade A areas in aseptic production from other grades when manufacturing sterile medicinal products?

    <p>They are the local zones for high-risk operations</p> Signup and view all the answers

    Which of the following statements about water used in pharmaceutical manufacturing is true?

    <p>Purified water has stricter quality guidelines than water for injection</p> Signup and view all the answers

    Why is controlling microbial contamination from personnel important in pharmaceutical manufacturing?

    <p>To maintain sterility and prevent contamination of medicinal products</p> Signup and view all the answers

    What common source of biological contamination is highlighted in the text as being present on people's hands and worksurfaces?

    <p>~100 million microbes/cm3 from facial skin</p> Signup and view all the answers

    What is a common method to reduce the risk of transmission of contaminants between hands and products?

    <p>Using alcohol hand gels</p> Signup and view all the answers

    Which equipment is typically used for non-sterile manufacturing to reduce contamination?

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

    What does flow cytometry utilize to count microbes?

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

    Which method can show only viable cells and colony forming units (CFU)?

    <p>Direct inoculation</p> Signup and view all the answers

    What is the purpose of calculating the Total Viable Count in microbiology?

    <p>Calculating CFU/mL of the original inoculum</p> Signup and view all the answers

    Which method is believed to be suitable for getting organisms that are difficult to grow?

    <p>Total viable count</p> Signup and view all the answers

    What is the most serious health hazard associated with contamination of injectable products?

    <p>General bacteraemic shock</p> Signup and view all the answers

    In the context of pharmaceutical contamination, what can lead to death in patients?

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

    Which type of patients are most vulnerable to serious infections from contaminated products?

    <p>Immunocompromised patients</p> Signup and view all the answers

    What is the most significant effect of contamination with toxic microbial metabolites in pharmaceuticals?

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

    Which measure is particularly important to reduce the risk of contamination in pharmaceuticals?

    <p>Implementing aseptic techniques</p> Signup and view all the answers

    Which regulatory aspect is aimed at controlling microbial contamination in pharmaceutical products?

    <p>Microbial limit testing requirements</p> Signup and view all the answers

    What is the acceptable limit for E.coli in oral non-aqueous pharmaceutical products according to the British Pharmacopoeia standards?

    <p>100 CFU/mL</p> Signup and view all the answers

    Sterile pharmaceutical products must meet which criteria in terms of microbial contamination?

    <p>Contain no microbial contaminants and adhere to additional criteria</p> Signup and view all the answers

    What is one of the factors that can influence the rate of breakdown of a pharmaceutical product by microbial contamination?

    <p>Type and number of microbial contaminant</p> Signup and view all the answers

    What is an example of inactivation of a pharmaceutical product due to microbial contamination mentioned in the text?

    <p>Breakdown of thickening agents by amylases</p> Signup and view all the answers

    Which type of packing material is mentioned as being more resistant to microbial contamination in the text?

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

    Why is it important to understand where and how a pharmaceutical product will be used?

    <p>To manipulate the formulation for resistance to spoilage</p> Signup and view all the answers

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