Aseptic Services and Sterile Products
52 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What was the year of the Breckenbridge Report that led to changes in Aseptic Services?

  • 1974 (correct)
  • 1972
  • 1994
  • 1984

    • What is one of the benefits of making products aseptically in a pharmacy aseptics unit?

  • Reducing the cost of production
  • Improving product shelf life
  • Reducing or eliminating medication dosing errors (correct)
  • Increasing the production capacity

    • What is the purpose of risk assessment tools developed by NPSA?

  • To control medication dosing errors
  • To monitor microbiological contamination
  • To improve patient care
  • To identify risks in aseptic production (correct)

    • What is the main reason for making unlicensed products in an aseptics unit?

    <p>When licensed products are not commercially available</p> Signup and view all the answers

    What is one of the complexities around stability in Parenteral Nutrition?

    <p>Unstable pH levels</p> Signup and view all the answers

    What is the benefit of ready-to-use injectables in clinical areas?

    <p>Saves nurses time for better patient care</p> Signup and view all the answers

    What is the primary importance of taking finger dabs before sanitizing the gloves?

    <p>To prevent glove contamination</p> Signup and view all the answers

    What type of agar medium is used in the finger dab plates?

    <p>Tryptic Soy Agar (TSA)</p> Signup and view all the answers

    How should the plates be incubated to reduce the risk of condensation?

    <p>In an inverted position</p> Signup and view all the answers

    What is the purpose of operator broth validation?

    <p>To validate the operator's aseptic technique</p> Signup and view all the answers

    How many consecutive validation tests must an operator pass?

    <p>3</p> Signup and view all the answers

    What is the purpose of process simulation in validation?

    <p>To simulate the product preparation process</p> Signup and view all the answers

    What is the focus of product validation?

    <p>Product consistency and shelf life</p> Signup and view all the answers

    What is the purpose of validation of training?

    <p>To ensure staff have the required knowledge and competency</p> Signup and view all the answers

    How often must operators repeat the validation process?

    <p>Every 6 months</p> Signup and view all the answers

    What is the definition of validation?

    <p>The accumulation of documented evidence to show that a system will consistently perform as expected</p> Signup and view all the answers

    What is the primary purpose of producing high risk drug lists by Aseptic Organisations PASG and UKMI?

    <p>To categorize injectable medicines according to their risk level</p> Signup and view all the answers

    What is the significance of finding Streptococcus in environmental monitoring samples?

    <p>It may have clinically significant consequences if introduced into the bloodstream</p> Signup and view all the answers

    Where should additions to Parenteral nutrition (PN) be made?

    <p>In the aseptics unit</p> Signup and view all the answers

    What is the consequence of contamination in injectables given to patients?

    <p>Serious and possibly fatal infections</p> Signup and view all the answers

    What property of Bacillus cereus makes it resistant to physical removal?

    <p>Adhesive-like substances</p> Signup and view all the answers

    Why are Staphylococcus species often found in environmental monitoring samples?

    <p>Because they are commensals found on human skin and in sputum</p> Signup and view all the answers

    What is the primary purpose of an isolator's hatch?

    <p>To allow access of materials into and out of the isolator</p> Signup and view all the answers

    Why are Pseudomonas aeruginosa found in warm wet conditions?

    <p>Because they are saprophytes in warm wet conditions</p> Signup and view all the answers

    What is the primary method of controlling Staphylococcus contamination?

    <p>Using 70% alcohol solution</p> Signup and view all the answers

    What is the purpose of finger dabs in environmental monitoring?

    <p>To check for contamination of the gloved hand</p> Signup and view all the answers

    What is the consequence of finding glove holes during manufacture?

    <p>Manufacturing is stopped and a deviation is raised</p> Signup and view all the answers

    What is the primary goal of a Contamination Control Strategy (CCS)?

    <p>To protect the product from contamination</p> Signup and view all the answers

    What is the purpose of reviewing errors or incidents in relation to injectables across the organisation?

    <p>To learn from errors and put risk reduction and control measures in place</p> Signup and view all the answers

    What is the significance of finding Micrococcus in environmental monitoring samples?

    <p>It indicates poor cleaning or transfer technique</p> Signup and view all the answers

    What is the benefit of automation in aseptic manufacturing?

    <p>Improving efficiency and meeting the increasing demand for injectables</p> Signup and view all the answers

    Why are biofilms formed by Pseudomonas species?

    <p>To survive attack by disinfectants</p> Signup and view all the answers

    What is the consequence of system failures in aseptics units?

    <p>Serious harm or catastrophic harm to patients</p> Signup and view all the answers

    Who should prepare intrathecal chemotherapy and Parenteral nutrition (PN)?

    <p>Pharmacy aseptics unit</p> Signup and view all the answers

    What is the purpose of microbial monitoring in aseptic units?

    <p>To ensure robust processes and safe product manufacturing</p> Signup and view all the answers

    What is the purpose of a pressure decay test in isolator operation?

    <p>To verify the integrity of the isolator</p> Signup and view all the answers

    What is the expected outcome of implementing a Contamination Control Strategy (CCS)?

    <p>Layers of protection for the product</p> Signup and view all the answers

    What is the significance of Bacillus species in environmental monitoring samples?

    <p>It may indicate inadequate cleaning or disinfection</p> Signup and view all the answers

    Why is effective communication necessary in relation to injectables prepared in clinical areas?

    <p>To cover contingency plans and define responsibilities</p> Signup and view all the answers

    Why are Pseudomonas species opportunistic pathogens?

    <p>Because they can cause disease in immunocompromised patients</p> Signup and view all the answers

    What is the purpose of the risk register in relation to injectable medicines?

    <p>To record and review risks that have not been appropriately controlled</p> Signup and view all the answers

    What is used to remove Bacillus species from surfaces?

    <p>Sporicidal agents such as hypochlorite</p> Signup and view all the answers

    What is the primary purpose of validating cleaning processes in parenteral nutrition manufacturing?

    <p>To ensure the removal of chemical contaminants</p> Signup and view all the answers

    Why is it essential to maintain physical stability in parenteral nutrition formulations?

    <p>To prevent precipitation of ingredients</p> Signup and view all the answers

    What happens when lipid globules come into contact with cationic electrolytes in large quantities?

    <p>The lipid globules separate out</p> Signup and view all the answers

    Why is it essential to protect parenteral nutrition formulations from light?

    <p>To prevent lipid peroxidation</p> Signup and view all the answers

    What is the purpose of a multilayer bag in parenteral nutrition manufacturing?

    <p>To prevent the introduction of air bubbles</p> Signup and view all the answers

    What is the maximum number of particles (0.5 μm) permitted per cubic meter of air in a Grade B cleanroom at rest?

    <p>3,520</p> Signup and view all the answers

    What is the primary purpose of using a laminar airflow cabinet in parenteral nutrition manufacturing?

    <p>To reduce the risk of contamination</p> Signup and view all the answers

    What is the primary purpose of wearing clean room clothing in parenteral nutrition manufacturing?

    <p>To reduce the risk of contamination</p> Signup and view all the answers

    What is the significance of maintaining staff hygiene in parenteral nutrition manufacturing?

    <p>To reduce the risk of contamination</p> Signup and view all the answers

    What is the primary purpose of using HEPA filters in parenteral nutrition manufacturing?

    <p>To reduce the risk of contamination</p> Signup and view all the answers

    More Like This

    Use Quizgecko on...
    Browser
    Open
    Browser
    Browser