Restore 2 New - Preservation Effectiveness Test

Restore 2 New » Preservation Effectiveness Test

CELLFOODŽ USP Test

CONDUCTED BY AN INDEPENDENT FDA CERTIFIED LABORATORY

MICROBIOLOGICAL REPORT


Deutrel Industries / Nu Science Corporation 155 West Avenue J-5 Lancaster, CA 93534	REPORT DATE: 08/06/99 DATE-INITIATED: 07/22/99 DATE-COMPLETED: 07/30/99 PROJECT #: 83454 REFERENCE #: UPS 23 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 aerugino, Staphylococcus aureus, were used to challenge the specimen for twenty-eight (28) days. Microorganism monitered at fourteen (14) and twenty-eight (28) day intervals.

RESULTS:

MICROORGANISM

A. niger
C. albicans
E. coli
P. aeruginosa
S. aureus

TABLE SUMMARY

INITIAL INOCULUM/gm

            4.8 x 105
            3.2 x 105
            1.2 x 105
            6.7 x 105
            7.3 x 105

Colony Forming Units/ml
14 Days                28 days

(10                         (10
(10                         (10
(10                         (10
(10                         (10
(10                         (10


LOG REDUCTION A. niger C. albicans E. coli P. aeruginosa S. aureus	Colony Forming Units/ml 14 Days 28 days 4.7 4.7 4.5 4.5 5.1 0.0 4.8 0.0 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 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 sam.

*No increase is defined as not more than 0.5 log unit higher than the previous value measured.

CONCLUSION:

The above test results meet the current USP criteria for Antimicrobial Preservative Effectiveness Test.

Copies of this report are on file and available by directly contacting Deutrel
Industries / Nu Science Corporation at: testing@deutrel.com