Alomac Technical Specifications

Aug 12th 2024

alomac-plant-square.jpeg

Alomac® is Aloe macroclada gel, manually extracted and dried using Refractance Window Drying then milled. Particle size distribution data available for each Lot. All Alomac Lots include a Certificate of Analysis.

Physical Test

Method

Release Limits

Test Results

Appearance

Visual

Light beige to brown chips

Pass

Odor

Olfactory

Characteristic

Pass


Analyses

Method

Release Limits

Test

Aloins (1X ppm)

Internal HPLC H075

<10.0 ppm

Complies

Polysaccharides (% w/w)

Internal HPLC H087

For Information

20%

Moisture (% w/w)

AOAC 926.08

< 5.0 %

Complies

Microbial

Method

Release Limits

Test

Total Microbial Count

USP/NF,61

<1000 cfu/g

Complies

Yeast and Mold

USP/NF,61

<1000 cfu/g

Complies

E.Coli

USP/NF,61

Negative

Complies

Salmonella

USP/NF,62

Negative

Complies

Staphylococcus Aureus

USP/NF,62

Negative

Complies

Heavy Metals

Method

Release Limits

Test

Lead

ICP/MS

Total of heavy metals

<0.001 ppm


Mercury

ICP/MS

not to exceed 10 ppm

<0.5 ppm

Cadmium

ICP/MS

and no single metal

<0.001 ppm

Arsenic

ICP/MS

to exceed 5 ppm

<0.01 ppm

Moisture analyses are performed at the production facility in Antananarivo, Madagascar. Extracted Aloe macroclada gel is ~98.5% water, containing ~1.5% solids. All other tests are performed at CEAMED. No affiliation with Mioty Voajanahary: 


Centre Atlantico del Medicamento, S.A                       Phone : 822 102 653
Avinida Trinidad 61                                                      Email: ceamedsa@gmail.com
7a Planta torre Augustin Arevalo.                                gmcsmith@ceamedsa.com

38204 La Laguna San Cristobal de la Terrife
Canary Island – SPAIN



Every Aloe macroclada leaf received is inspected prior to processing and unacceptable leaves rejected.
Following washing and sterilizing in a hypochlorite bath, the leaves are allowed to dry on open racks. Following
the hypochlorite wash step, the facility is designated as clean. All employees wear masks, hairnets, aprons and
gloves in the clean areas.

Manual extraction of the gel allows for skilled removal of the gel fillet while minimizing aloin inclusion into the
gel. This results in Alomac having a very low aloin content (<10ppm) without any treatment. Manual extraction
also allows for continual monitoring of leaf and gel quality.

Extracted Aloe macroclada gel is treated with 0.5% citric acid as a preservative during the initial blending
process. No enzymatic digestion of lignins is performed to preserve the polysaccharides, which average >25%.
After passing through an in-line, multi-step homogenizer the gel is dried using Refractance Window Drying. This
drying method minimizes drying times and minimizes degradation of Alomac, specifically the polysaccharides,
during drying.

Alomac is vacuum sealed in 1.5kg quantities in thick-walled polypropylene bags and labelled with the
production date, expiration date, production location, Lot number and bag number. Each Lot of material is
tested by a third party for microbials, yeast and mold (as described above) and other parameters. Five years of
stability (at a minimum) has been demonstrated. Heavy metals and pesticides/herbicides have always been
found to be well below acceptable limits.

Production is performed following written Standard Operating Procedures which includes recordkeeping from
leaves in the field to export of final product. Mioty Voajanahary's facility makes every attempt to operate as a
Good Manufacturing Facility, following FDA and EMA Guidelines. The facility has not been audited by either
agency. Mioty Voajanahary welcomes inspections.