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PHA6114 > [PHA6114 lab] Experiment 10 > Flashcards

[PHA6114 lab] Experiment 10 Flashcards

1
Q

Antimicrobial Effectiveness Testing is a test for what?

A

Test for efficacy of preservatives present in products

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2
Q

When is AET used?

A

During product development - determine the effectiveness of the product

During stability - demonstrate the preservative system is stable over time

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3
Q

These are substances added to non-sterile dosage forms to protect them from microbiological growth and subsequent spoilage/product deterioration or from microorganisms that are introduced inadvertently during or subsequent to the manufacturing process

A

Antimicrobial preservatives

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4
Q

T or F: Antimicrobial Effectiveness Test is for non-sterile products only

A

False, both sterile and non-sterile

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5
Q

T or F: For sterile articles packaged in multiple-dose containers, antimicrobial preservatives are added to inhibit the
growth of microorganisms that may be introduced from repeatedly withdrawing individual doses

A

True

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6
Q

These are used to minimize the risk to the consumer for acquiring an infection when the preparation is administered

A

Preservatives

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7
Q

Give characteristics of an ideal preservative

A
  • rapidly effective
  • topically nonirritating
  • wide spectrum of activity
  • inexpensive
  • stable and soluble
  • tasteless and odorless
  • nontoxic and non-sensitive
  • compatible with packaging materials
  • compatible with other ingredients
  • different modes of action
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8
Q

T or F: Preservatives are “necessary” additives

A

True

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9
Q

A preservative will only provide protection from microbial growth for a ______ period of time

A

Short

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10
Q

How many days is typically stated as the maximum shelf life after the preservative-containing product has been opened?

A

28 days

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11
Q

T or F: Antimicrobial preservatives can be an alternative for good manufacturing processes

A

False, GMP&raquo_space;> preservatives

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12
Q

All useful antimicrobial agents are ________ substances

A

Toxic

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13
Q

T or F: For maximum protection of patients, concentration of preservative shown to be effective in the final package should be higher than a level that may be toxic to human beings

A

False, lower concentration than a level toxic to humans

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14
Q

The concentration of an added antimicrobial preservative can be kept at minimum if the active ingredients possess an ___________

A

Intrinsic antimicrobial activity

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15
Q

Give examples of preservatives

A
  • phenol
  • benzyl alcohol
  • phenoxy ethanol
  • m cresol
  • chlorobutanol
  • methyl and propyl paraben
  • sodium benzoate
  • benzoic acid
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16
Q

What cultures of microorganisms are used in AET?

A

Candida albicans - yeast
Aspergillus niger - molds
Escherichia coli - bacteria
Pseudomonas aeruginosa - bacteria
Staphylococcus aureus - bacteria

17
Q

[Table 10.1 Compendial Product Categories]

Category 1

A

Injections and other parenteral

Emulsions, otic products, sterile nasal products, and ophthalmic products

*sterile

18
Q

[Table 10.1 Compendial Product Categories]
Category 2

A

Topically used products

Nonsterile nasal products, emulsions, including those applied in mucous membrane

*nonsterile

19
Q

[Table 10.1 Compendial Product Categories]

Category 3

A

Oral products, other than antacids

20
Q

[Table 10.1 Compendial Product Categories]

Category 4

A

Antacids made with an aq. base or vehicle

21
Q

[Table 10.2 Criteria for Tested Microorganisms]

For Category 1 Products

A

Bacteria
- Not less than 1.0 log reduction from the initial calculated count at 7 days, not less than 3.0 log reduction from the initial calculated count at 14 days, and no increase from the 14 days’ count at 28 days

Yeasts and Molds
- No increase from the initial calculated count at 7, 14, 28 days

22
Q

[Table 10.2 Criteria for Tested Microorganisms]

For Category 2 Products

A

Bacteria
- Not less than 2.0 log reduction from the initial calculated count at 14 days, no increase from the 14 days’ count at 28 days

Yeasts and Molds
- No increase from the initial calculated count at 14 and 28 days

23
Q

[Table 10.2 Criteria for Tested Microorganisms]

For Category 3 Products

A

Bacteria
- Not less than 1.0 log reduction from the initial count at 14 days, and no increase from the 14 days’ count at 28 days

Yeasts and Molds
- No increase from the initial calculated count at 14 and 28 days

24
Q

[Table 10.2 Criteria for Tested Microorganisms]

For Category 4 Products

A

Bacteria, Yeasts, and Molds
- No increase from the initial calculated count at 14 and 28 days

25
Q

Suitable Medium for Escherichia coli (bacteria)

A

Soybean-Casein Digest Broth
Soybean-Casein Digest Agar

26
Q

Suitable Medium for Pseudomonas aeruginosa (bacteria)

A

Soybean-Casein Digest Broth
Soybean-Casein Digest Agar

27
Q

Suitable Medium for Staphylococcus aureus (bacteria)

A

Soybean-Casein Digest Broth
Soybean-Casein Digest Agar

28
Q

Suitable Medium for Candida albicans (yeast)

A

Sabouraud Dextrose Agar
Sabouraud Dextrose Broth

29
Q

Suitable Medium for Aspergillus niger

A

Sabouraud Dextrose Agar
Sabouraud Dextrose Broth

30
Q

T or F: Media used for AET should be tested for growth promotion by inoculating the medium with appropriate microorganisms

A

True, it is preferable that the test microorganisms be chosen from growth promotion testing

31
Q

In testing, bacterial and yeast suspensions are to be used within _______?

A

24 hours of harvest

32
Q

T or F: In testing fungal preparations, it may be refrigerated and be used for up to 10 days

A

False, up to 7 days only

33
Q

Formula for Log Reduction

A

Log reduction = log of initial calculated - log of product challenge results

34
Q

Steps for Computing Log Reduction

A
  1. Get the log values for all initial calculated (initial, 7 days, 14 days, 28 days)
  2. Determine the category of the product
  3. Get log reduction by getting the difference of the log of initial calculated concentration and the log value of the challenge product (based on the category)
  4. Check whether it complies with the criteria
  5. Pass or Fail
35
Q

SAMPLE PROBLEM

A

PRACTICE IN YOUR MODULE RIGHT NOW !!!

PHA6114 (6 decks)

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