Exam 4- Parenterals III

Question 1

What is a pyrogen?

Answer 1

A fever-reducing substance

Question 2

What is a disinfectant?

Answer 2

A substance used on in-animate objects to render them non-infectious (cidal vs. static)

Question 3

What is sterilization?

Answer 3

complete destruction of all viable organisms

Question 4

What is sterility?

Answer 4

Absence of life

Question 5

What are some methods of sterilization?

Answer 5

• steam
• dry heat
• filtration
• gas
• ionizing radiation

Question 6

What is steam sterilization?

Answer 6

• moist heat in the form of saturated steam under pressure (autoclaving)
• the most reliable method for the destruction of all forms of microorganisms
• Kills by the result of coagulation of some protein in the cell (bacteria easier than spores)
• good for bulk solutions, glassware, surgical dressings and instruments, solutions in sealed container (ampoules), sealed empty vials only with a little bit of water

Question 7

What preparations are steam sterilization not suitable for?

Answer 7

Oils/fats
oleaginous preparations
powders

Question 8

What is dry heat sterilization?

Answer 8

• microorganism death by oxidation process

- good for dry glassware, petroleum jelly, mineral oils, talcum powder, and some dry powders

Question 9

What is sterilization by filtration?

Answer 9

• for solutions that cannot be heated at high temperatures
• filtration through a membrane filter
• filters work by interlacing bacteria or particles entrapped in the pores
• complete removal of live and dead microorganisms along with other particulate microorganisms
• inexpensive equipment

Question 10

Which type of sterilization is good for small volumes?

Answer 10

sterilization by filtration

Question 11

What are the two factors of sterilization by filtration?

Answer 11

• Primary factor: pore size

- Secondary factor: electrical charge, pH, temperature, pressure

Question 12

What is gas sterilization?

Answer 12

Destruction of all living microorganisms with a chemical in a gaseous or vapor state

ex) ethylene oxide, propylene oxide

Question 13

What are advantages and disadvantages of gas sterilization?

Answer 13

• Advantage: not having to expose to high pressure or temperature
• Disadvantage: gas can alter the solubility of the drug which would reduce the compliance

Question 14

What is sterilization by ionizing radiation?

Answer 14

• UV light

- Gamma radiation

Question 15

What are some disadvantages of ionizing radiation?

Answer 15

Disadvantages:

• Need a specialized room to do this (gamma)
• rays can go into the substance and contaminate it

Question 16

Spore to use for autoclave sterility validation

Answer 16

bacillus stearothermophilus

Question 17

Spore to use for dry heat and gas sterility validation

Answer 17

bacillus subtilis

Question 18

Spore to use for ionizing radiation

Answer 18

bacillus pumilus

Question 19

What are pyrogens?

Answer 19

fever-producing organic substances arising from microbial contamination and responsible for many of the febrile reactions in patients following injection

Question 20

What are some characteristics of pyrogens?

Answer 20

• Endotoxins: gram-negative bacteria
• Lipopolysaccharide
• Thermostable
• Water soluble

Question 21

Where do pyrogens come from?

Answer 21

• Water used as the solvent
• The Container
• Chemicals

Question 22

How can pyrogens be removed?

Answer 22

• heating at excessively high temperature

- using a potassium permanganate/barium hydroxide filter

Question 23

What is the USP Rabbit test?

Answer 23

To test for pyrogens

• use healthy rabbits
• inject the product in their marginal ear vein
• temperature check

Question 24

What is the Limulus Amebocyte Lysate (LAL) test?

Answer 24

To test for pyrogens

• extract from the blood cells of Horse-crab contains an enzyme and protein that coagulates in the presence of lipopolysaccharides (pyrogen)
• substitution for USP rabbit test
• for the end product testing of human injectible drugs

Question 25

What is an advantage of the Limulus Amebocyte Lysate test?

Answer 25

• can detect the pyrogens at a very low concentration

- very sensitive

Question 26

Small volume parenterals

Answer 26

• packaged in small volumes (less than 100 mL)
• available in ready-to-use systems
• extended stability
• reduced wastage
• some products require thawing

Question 27

Large volume parenterals

Answer 27

• packaged in large volumes
• administered by IV infusion
• no bacteriostatic agent

Question 28

What are the uses of large volume parenterals?

Answer 28

- maintenance therapy
       Total parenteral nutrition (TPN)
-Replacement therapy
     Water requirement
     Electrolyte requirement
     Caloric requirement
     Parenteral nutrition
     Enteral nutrition