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Quality Control Tests for Parenteral Product Packaging
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Quality Control Tests for Parenteral Product Packaging

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Questions and Answers

What is the science, art, and technology of enclosing or protecting products for distribution, storage, sale, and use called?

  • Product protection technology
  • Packaging (correct)
  • Enclosure science
  • Distribution science
  • Which type of glass is known as neutral or borosilicate glass?

  • Type IV
  • Type III
  • Type II
  • Type I (correct)
  • What is the purpose of the powdered glass test for glass containers?

  • To assess the color consistency of powdered glass
  • To measure the density of powdered glass
  • To determine the hardness of powdered glass
  • To estimate the amount of alkali leached from the powdered glass (correct)
  • What is the test conducted to evaluate water vapor permeability for plastic containers?

    <p>Water vapour permeability test</p> Signup and view all the answers

    What is the primary purpose of packaging material for parenteral products?

    <p>Enclosing and protecting products</p> Signup and view all the answers

    What is the type of glass known as general purpose soda lime glass?

    <p>Type IV</p> Signup and view all the answers

    What should be done to the components before filling the vials with the sterile product?

    <p>Washed and sterilized through a validated procedure</p> Signup and view all the answers

    What should be done to monitor component performance during compatibility trials?

    <p>Monitor for deterioration</p> Signup and view all the answers

    What should be examined before the experiment to ensure seal quality?

    <p>The seals of each vial</p> Signup and view all the answers

    What determines the effect of light passing through the bottle wall on product stability and appearance?

    <p>Light transmission test</p> Signup and view all the answers

    What should be done if terminally sterilizing the vials is part of the intended product operation?

    <p>Fill the vials with sterile product under sterile conditions</p> Signup and view all the answers

    What should be done to determine seal quality after cycling vials through temperature and pressure changes?

    <p>Careful cleaning of the vials and examination of contents for sterility</p> Signup and view all the answers

    What is the purpose of the Water Attack Test (USP)?

    <p>To determine the amount of alkali leached from the surface of treated soda lime glass containers</p> Signup and view all the answers

    What does the Hydrolytic Resistance Test measure?

    <p>The volume of hydrochloric acid required to neutralize alkali leached from glass containers</p> Signup and view all the answers

    What is the purpose of the Arsenic Test for glass containers?

    <p>To test for arsenic contamination in glass containers for aqueous parenteral use</p> Signup and view all the answers

    What does the Thermal Shock Test check?

    <p>The ability of glass containers to withstand rapid temperature changes</p> Signup and view all the answers

    What is tested in the Leakage Test for containers?

    <p>The container's integrity under high pressure by checking for any leakage</p> Signup and view all the answers

    What Quality Control Tests are performed for closures?

    <p>Testing for residue, sterilization, pH, and self-stability after preparing a sample with anionic surface active agents</p> Signup and view all the answers

    Study Notes

    • The sample is washed with acetone and then undergoes several tests.
    • Water Attack Test (USP) is performed on intact containers, specifically for treated soda lime glass. It determines the amount of alkali leached from the surface and estimates the leaching by heating the container.
    • Hydrolytic Resistance Test rinses containers with water, heats them in an autoclave, and measures the volume of hydrochloric acid required to neutralize the alkali leached.
    • Arsenic Test is for glass containers for aqueous parenteral use. It tests for arsenic contamination by heating the container with hydrochloric and hydroiodic acids and measuring the absorbance of the resulting solution.
    • Thermal Shock Test checks the container's ability to withstand rapid temperature changes by moving the container between hot and cold water baths.
    • The Leakage Test checks the container's integrity by filling it with a coloured solution under high pressure and checking for any leakage.
    • Quality Control Tests for closures include preparing a sample by washing with anionic surface active agents, cooling and separating the solution, and testing for residue, sterilization, pH, and self-stability.
    • Plastic containers undergo Quality Control Tests, which include a Leakage Test for plastic containers (filling with water, allowing to stand for 14 days at specific conditions, and checking for weight loss) and a Clarity of Aqueous Extract Test (checking for colourlessness and freedom from turbidity).

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    Description

    Test your knowledge of quality control tests for packaging materials of parenteral products with this quiz. Learn about the types of packaging materials, including glass and plastic containers, and the quality control tests required for ensuring the integrity of parenteral product packaging.

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