CONDUCTED BY AN INDEPENDENT FDA CERTIFIED
LABORATORY
- MICROBIOLOGICAL
REPORT
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Deutrel Industries / Nu Science
Corporation 155 West Avenue J-5 Lancaster, CA 93534 |
- REPORT DATE:
DATE-INITIATED: DATE-COMPLETED:
- PROJECT #:
REFERENCE
#:
- PO. #:
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- 08/04/99
- 06/25/99
- 08/04/99
- 83454
- 738-135
- N/A
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- SAMPLE DESCRIPTION:
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- ACCESSION #:
- 83454
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- SAMPLE:
- CELLFOOD
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- LOT. NO.
- ROM 508 EXP. 02/2009
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- TEST-PERFORMED:
- Preservative Effectiveness Test
Category 1C
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- BTS METHOD
- M101.R2
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- REFERENCE
- USP 23, 8th Supplement
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- SAMPLE PREPARATION:
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- The following organisms: Aspergillus niger, Candida albicans,
Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, were
used to challenge the specimen for twenty-eight (28) days. Microorganism
survival is monitored at fourteen (14) and twenty-eight (28) day
intervals.
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- RESULTS:
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- TABLE SUMMARY
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- MICROORGANISM
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- INITIAL INOCULUM/gm
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- Colony Forming Units/ml
14
Days
28 Days
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- A. niger
C. albicans E.
coli P. aeruginosa S. aureus |
- 4.8 x 105
- 3.2 x 105
- 1.2 x 105
- 6.7 x 105
- 7.3 x 105
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- <10
- <10
- <10
- <10
- <10
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- <10
- <10
- <10
- <10
- <10
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- LOG REDUCTION
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- A. niger
C. albicans E. coli P.
aeruginosa S. aureus |
14 DAYS 28
DAYS 4.7
4.7 4.5
4.5 5.1
0.0 4.8
0.0 4.9
0.0 |
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- INTERPRETATION:
For Category 1C
Products, the preservative is effective in the product examined if;
a) Not less than or equal to 1.0 log reduction from the initial
count at 14 days, and no increase* from the 14 day count at 28 days is
observed in the bacterial samples.
b) no increase* from the initial calculated count at 14 and 28
days is observed in the yeast and mold samples. *No increase is
defined as not more than 0.5 log10 unit higher than
the previous value measured.
CONCLUSION: The above test results meet the current
USP criteria for Antimicrobial Preservative Effectiveness Test.
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