Deutrel Industries / Nu Science Corporation
155 West Avenue J-5
Lancaster, CA 93534
REPORT DATE: 08/04/99
DATE-INITIATED: 06/24/99
DATE-COMPLETED: 08/04/99
PROJECT #: 83454
REFERENCE #: 738-135
PO. #: N/A
SAMPLE DESCRIPTION:
ACCESSION #: 83454
SAMPLE: CELLFOOD
LOT. NO. ROM 508 EXP. 02/2009
TEST-PERFORMED:
Preservative
Effectiveness Test
Category 1C
BTS METHOD
M101.R2
REFERENCE:
USP 23, 8th Supplement
SAMPLE PREPARATION:
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.
| RESULTS: |
|
|
|
TABLE SUMMARY |
MICROORGANISM
|
|
INITIAL INOCULUM/gm |
|
Colony Forming Units/ml |
| |
|
|
|
14 Days |
|
28 Days |
| A. niger |
|
4.8 x 105 |
|
<10 |
|
<10 |
| C. albicans |
|
3.2 x 105 |
|
<10 |
|
<10 |
| E. coli |
|
1.2 x 105 |
|
<10 |
|
<10 |
| P. aeruginosa |
|
6.7 x 105 |
|
<10 |
|
<10 |
| S. aureus |
|
7.3 x 105 |
|
<10 |
|
<10 |
| LOG REDUCTION |
|
|
|
|
| |
|
14 Days |
|
28 Days |
| A. niger |
|
4.7 |
|
4.7 |
| C. albicans |
|
4.5 |
|
4.5 |
| E. coli |
|
5.1 |
|
0.0 |
| P. aeruginosa |
|
4.8 |
|
0.0 |
| S. aureus |
|
4.9 |
|
0.0 |
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. |