Pharmaceutical Microbiology
Pharmaceutical Microbiology
Pharmaceutical Microbiology
M icrobiology
Subtitle
Growth Promotion Test
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Growth Promotion Test
If testing agar, the number of colonies on the new batch of medium must be
within a factor of two of the number of colonies on the previously approved
medium. If testing broth, the new and previously approved medium must be
comparable in appearance.
For example, if the average number of colonies on the previously approved
agar is 40, then the acceptable number of colonies on the new agar should be
between 20 and 80.
In addition to growth promotion test, inhibition test is also performed.
Inhibition test is used for selective media which can support the growth of
particular microorganism and inhibit the growth of other type of
microorganisms.
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Microbial Enumeration Tests
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Bacterial Endotoxin Test
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Bacterial Endotoxin Test
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Bacterial Endotoxin Test
The
LAL test is generally limited to aqueous solutions or extracts of test
specimen.
The reaction requires a neutral pH (6.0-8.0) and is time and concentration
dependent. If the specimen, contains interfering substances, dilute or
modify the specimen to an extent that eliminates interference.
The maximum valid dilution is the maximum allowable dilution of a
specimen at which the endotoxin limit can be determined.
MVD
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Bacterial Endotoxins Test
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Bacterial Endotoxins Test
Reagents
Lyophilized LAL Reagent
LAL Reagent Water
Control Standard Endotoxin (CSE)
Test Procedure
Add 0.2 mL of test specimen to assay tubes.
Mix the contents gently until the contents are dissolved.
Immediately place the reaction tubes in a 37 C water bath for 60
minutes (2 minutes)
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Bacterial Endotoxins Test
Assay
Controls
Negative Control
LAL Reagent plus LRW
Verifies suitability of LAL reagent water
Positive Control
LAL Reagent plus 2 CSE
Product Positive Control
LAL Reagent plus 2 CSE & product
P
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Water For Pharmaceutical Purposes
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Water For Pharmaceutical Purposes
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Validation Of Aseptic Manufacturing Process
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Validation Of Aseptic Manufacturing Process
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Validation Of Aseptic Manufacturing Process
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