Research & Peer Review Studies

FHSA Primary Skin Irritation (March 3rd, 2008)
Test article: Kenrico Sap Sheet
Test device: Gauze, zonas porous tape, dental dam/rubber sheeting, Micropore surgical tape, 25 gauge needle.


This study is designed to show the degree of skin irritation caused by the test article under evaluation.


RESULT
Non-irritant.




Microbial Test (March 3rd, 2008)
Test article: Kenrico Sap Sheet
Test device: Triptic Soy Agar (TSA), Sabouraud Dextrose Agar (SDA), Modified Tryptic Soy Broth (TSB-M), Modified Lactose Broth (LCB-M), Selenite Cystine Broth (SC), Tetrathionate Broth w/Brilliant Green (TTB with BG), Baird Parker Agar (BP), Cetrimide Agar (CA), MacConkey Agar (MAC), Xylose-Lysine-desoxycholate Agar (XLD), Brilliant Green Agar (BGA), Bismuth Sulfite Agar (BSA).


This procedure, which is performed on pharmaceuticals of all kinds, from raw materials to finished forms, provides an estimation of the number of viable aerobic microorganisms present in a given product, and ensures that the product is free from designated mircobial species.


RESULT
Free from germs and bacteria.







FHSA Primary Skin Irritation (May 7th, 2003)
Test article: Kenrico Sap Sheet
Test device: Gauze, zonas porous tape, dental dam/rubber sheeting, Micropore surgical tape, 25 gauge needle.


This study is designed to show the degree of skin irritation caused by the test article under evaluation.


Six New Zealand White rabbits were used in the test. Twenty four hours prior to dosing, the hair on each animal's back was removed with clippers. One inch square pieces of the test article were cut and applied to intact and abraded areas on the skin of each animal. The squares of test article were held in place with surgical tape. To protect the dosing sites and to promote occlusion, the trunks of each animal were wrapped with gauze, which was held in place with zonas tape. The gauze was then wrapped with an elastic bandage.


After 24 hours, the animals were unwrapped and the article removed. The test sites were observed and scored 24 and 72 hours after dosing. Based on the scores, a Primary Irritation Index was calculated in order to evaluate the material's potential to be a primary irritant.


RESULT
Primary Irritation Score was 0. The test article is NOT a primary irritant.



Microbial Limit (June 26th, 2003)
Test article: Kenrico Sap Sheet
Test device: Triptic Soy Agar (TSA), Sabouraud Dextrose Agar (SDA), Modified Tryptic Soy Broth (TSB-M), Modified Lactose Broth (LCB-M), Selenite Cystine Broth (SC), Tetrathionate Broth w/Brilliant Green (TTB with BG), Baird Parker Agar (BP), Cetrimide Agar (CA), MacConkey Agar (MAC), Xylose-Lysine-desoxycholate Agar (XLD), Brilliant Green Agar (BGA), Bismuth Sulfite Agar (BSA).


This procedure, which is performed on pharmaceuticals of all kinds, from raw materials to finished forms, provides an estimation of the number of viable aerobic microorganisms present in a given product, and ensures that the product is free from designated mircobial species.


RESULT
Acceptable recovery was obtained.



USP Microbial Limit Validation (June 9th, 2003)
Test article: Kenrico Sap Sheet
Test device: Scissors, Forcep, TSB, LCB, TSA, SDA, TTB, Selenite Cystine Broth, MacConkey Agar, Baird Parker Agar, Cetrimide Agar, BSA (Bismuth Sulfate Agar), Brilliant Green Agar, XLD Agar.


This procedure validates the test results obtained from the performance of the Microbial Limits Test. Recovery of the appropriate positive colonies on the selective agars is considered to validate Mircobial Limits test results for that product and any other product with the same active ingredient at a lower concentration. This validation should be conducted on any unique product, or any product that is significantly changed.


If the appropriate positive colonies on the selective agars are not recovered, the validation test may be repeated. In this case, the Microbial Limits Test procedure is modified to ensure maximum recovery of the challenge organism. If a procedure modification cannot eliminate the bactericidal activity of the product, then the product is not likely to be contaminated with the given species.


RESULT
Safe and free from micro organisms.


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