IV Infusions and Sterility

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Questions and Answers

What is a requirement for IV infusions?

  • They must be sterile and isotonic (correct)
  • They must be sterile and pyrogenic
  • They must be stable chemically and physically
  • They must be isotonic and contaminated with visible particles

What kind of stability must be maintained in IV products throughout their shelf life?

  • Neither physical and chemical, nor microbiological stability
  • Only microbiological stability
  • Only physical and chemical stability
  • Both physical and chemical, as well as microbiological stability (correct)

What is meant by 'microbiologically stable' in the context of IV products?

  • The product is free from pyrogenic contamination only
  • The product is not sterile and contains visible particulate contamination
  • The product is sterile and free from pyrogenic and visible particulate contamination (correct)
  • The product is free from visible particulate contamination only

What would happen if IV infusions were not isotonic?

<p>Cellular destruction or creation would occur (B)</p>
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Why must IV products be sterile?

<p>To prevent microbiological contamination (A)</p>
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What are the two common sources of heat for ovens?

<p>Gas and electricity (A)</p>
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How are the ovens controlled?

<p>Thermostatically (C)</p>
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Why are higher temperatures and longer periods of exposure required in dry heat?

<p>Because dry heat is less effective (D)</p>
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What type of heat is less effective in killing microorganisms?

<p>Dry heat (A)</p>
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What is the advantage of using moist heat?

<p>It is more effective in killing microorganisms (A)</p>
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What is a key characteristic of the selected vehicle?

<p>It should be nonirritating (D)</p>
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What is the primary concern when selecting a vehicle?

<p>Its nontoxic properties (B)</p>
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What should be avoided when selecting a vehicle?

<p>A vehicle that is sensitizing (D)</p>
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What is the main consideration when administering a vehicle?

<p>The amount of the vehicle administered (C)</p>
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What should the selected vehicle not be?

<p>Sensitizing (D)</p>
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What is the primary focus of topic 4 in the context of parenteral preparations?

<p>Formulation of small and large volume preparations (B)</p>
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What is the primary focus of topic 8 in the context of ophthalmic preparations?

<p>Eye anatomy and pathogenesis (B)</p>
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What is the primary focus of topic 5 in the context of parenteral preparations?

<p>Additives used in parenteral preparations (C)</p>
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What is the primary focus of topic 6 in the context of parenteral preparations?

<p>Quality control tests for parenteral preparations (A)</p>
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What is the primary focus of topic 10 in the context of ophthalmic preparations?

<p>Different dosage forms that can be applied into the eye (C)</p>
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What is the primary purpose of parenteral products?

<p>For administration via hypodermic injection (D)</p>
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What type of sterile product is used for instillation in the eye?

<p>Ophthalmic (A)</p>
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What is an example of a topical product for exposed tissues?

<p>Ointment (C)</p>
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What is the purpose of implants in parenteral therapy?

<p>To act as a matrix for insertion into a defect site (B)</p>
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What is an example of a pulmonary dosage form?

<p>Inhalation delivery system (D)</p>
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Study Notes

Sterile Products

  • IV infusions must be isotonic to ensure safe administration.
  • Sterile products must be stable, not only chemically and physically, but also microbiologically, maintaining sterility, freedom from pyrogenic and visible particulate contamination throughout their shelf life.

Characteristics of Vehicles

  • Vehicles must be nonirritating, nontoxic in the amounts administered, and not sensitizing.

Sterilization

  • Dry heat is less effective in killing microorganisms than moist heat, requiring higher temperatures and longer periods of exposure.
  • Different methods of sterilization are used in the preparation of sterile dosage forms.

Routes of Administration

  • Sterile dosage forms can be administered through different routes, including parenteral, ophthalmic, topical, and pulmonary routes.

Types of Sterile Products

  • Parenterals: packed in a manner for administration via hypodermic injection, either in the form prepared or after addition of a suitable solvent or suspending agent.
  • Ophthalmic: intended for instillation in the eye.
  • Irrigating solutions: for contact with blood vessels of wounds or abraded mucous membranes.
  • Topicas for exposed tissues: ointments, creams, gels, for burns, wound healing, and other skin damage.
  • IV systems: administration devices.
  • Implants: a matrix for insertion into a defect site.
  • Pulmonary dosage forms: inhalation delivery system.

Parenteral Therapy

  • Parenteral therapy is used to produce a localized effect.

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