F
OOD AND
D
RUG
A
DMINISTRATION
O
FFICE OF
R
EGULATORY
A
FFAIRS
Office of Regulatory Science
Document Number:
ORA.007
Revision #: 02
Revised:
25 Aug 2020
Title:
Pharmaceutical Microbiology Manual
Page 28 of 92
For the most current and official copy, check QMiS.
ii. Note if any growth is observed on aerobic plate and compare
to growth on anaerobic plates. Proceed with identification
when isolation is complete.
5. Subculturing from Soybean Casein Digest broth (SCD)
a. Sub culture SCD broth to general growth medium and incubate
aerobically. Streak one plate; incubate aerobically at 22.5 ± 2.5
ºC.
i. Note if any growth is observed on general growth medium
plate. Proceed with identification when isolation is complete.
ii. Each organism should be identified to genus and species, if
possible, using rapid identification kits or DNA sequencing.
I. Product-Induced Turbidity in Primary Test Media
When product-induced turbidity prevents the confirmation of visual
observation of growth, the following instructions apply
1. Record "T" for any subsample which is turbid due to product-medium
mixture.
2. On the daily observation page, indicate the meaning of "T" as: "T =
product induced turbidity”.
3. At the end of the initial 14 days of incubation, transfer portions of the
medium (not less than 1 ml) to a fresh container of the same
medium and then incubate the original and transferred containers for
not less than 4 days. Note: Follow the current edition of the USP for
any changes concerning subculturing and incubation of turbid
samples.
4. Examine original product inoculated media and the subcultured
media for growth daily when possible for not less than 4 days of
incubation and record the results on a new daily observation
continuation sheet.
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