[PHA6114 lab] Experiment 10 Flashcards
Antimicrobial Effectiveness Testing is a test for what?
Test for efficacy of preservatives present in products
When is AET used?
During product development - determine the effectiveness of the product
During stability - demonstrate the preservative system is stable over time
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
Antimicrobial preservatives
T or F: Antimicrobial Effectiveness Test is for non-sterile products only
False, both sterile and non-sterile
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
True
These are used to minimize the risk to the consumer for acquiring an infection when the preparation is administered
Preservatives
Give characteristics of an ideal preservative
- 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
T or F: Preservatives are “necessary” additives
True
A preservative will only provide protection from microbial growth for a ______ period of time
Short
How many days is typically stated as the maximum shelf life after the preservative-containing product has been opened?
28 days
T or F: Antimicrobial preservatives can be an alternative for good manufacturing processes
False, GMP»_space;> preservatives
All useful antimicrobial agents are ________ substances
Toxic
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
False, lower concentration than a level toxic to humans
The concentration of an added antimicrobial preservative can be kept at minimum if the active ingredients possess an ___________
Intrinsic antimicrobial activity
Give examples of preservatives
- phenol
- benzyl alcohol
- phenoxy ethanol
- m cresol
- chlorobutanol
- methyl and propyl paraben
- sodium benzoate
- benzoic acid
What cultures of microorganisms are used in AET?
Candida albicans - yeast
Aspergillus niger - molds
Escherichia coli - bacteria
Pseudomonas aeruginosa - bacteria
Staphylococcus aureus - bacteria
[Table 10.1 Compendial Product Categories]
Category 1
Injections and other parenteral
Emulsions, otic products, sterile nasal products, and ophthalmic products
*sterile
[Table 10.1 Compendial Product Categories]
Category 2
Topically used products
Nonsterile nasal products, emulsions, including those applied in mucous membrane
*nonsterile
[Table 10.1 Compendial Product Categories]
Category 3
Oral products, other than antacids
[Table 10.1 Compendial Product Categories]
Category 4
Antacids made with an aq. base or vehicle
[Table 10.2 Criteria for Tested Microorganisms]
For Category 1 Products
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
[Table 10.2 Criteria for Tested Microorganisms]
For Category 2 Products
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
[Table 10.2 Criteria for Tested Microorganisms]
For Category 3 Products
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
[Table 10.2 Criteria for Tested Microorganisms]
For Category 4 Products
Bacteria, Yeasts, and Molds
- No increase from the initial calculated count at 14 and 28 days
