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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 (D)</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 (A)</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) (C)</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 (B)</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 (D)</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 (A)</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 (C)</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 (D)</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 (C)</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 (B)</p> Signup and view all the answers

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

<p>Hairnets (A)</p> Signup and view all the answers

What does flow cytometry utilize to count microbes?

<p>Fluorescence (A)</p> Signup and view all the answers

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

<p>Direct inoculation (C)</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 (B)</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 (B)</p> Signup and view all the answers

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

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

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

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

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

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

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

<p>Death (B)</p> Signup and view all the answers

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

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

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

<p>Microbial limit testing requirements (A)</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 (B)</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 (D)</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 (D)</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 (A)</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 (D)</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 (D)</p> Signup and view all the answers
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