PhysioLogics
pharmaceutical grade fish oils are of premium quality and are
manufactured under an Hazard Analysis and Critical Control Point
(HACCP) and sanitary program in accordance with the U.S. FDA’s
Seafood HACCP regulation 2 CFR (Code of Federal Regulations)
123. All PhysioLogics products are manufactured following United
States Pharmacopeia (USP) standards for dietary supplements and
strict National Nutritional Foods Association (NNFA) Good
Manufacturing Practices (GMP) guidelines.
Fish families such as
Sardine, Anchovy, Sprat, Salmon and Herring are the sources of
the unrefined oil. Over 90% of the oils we use come from wild
fish sources. The unrefined oils are analyzed and controlled for
pesticides and heavy metals prior to acceptance for processing
and throughout the stages of manufacturing. All shipments of
fish oil must meet or exceed our stringent quality guidelines,
including strict upper limits for polychlorinated biphenyls
(PCBs) and heavy metals. All of our fish oils test well below
the 2.0 pg/kg maximum level set by the EU Regulation
(EC/2375/2001). Each lot meets California’s Proposition 65 for
PCBs, lead and other toxins or the product is not released for
manufacture.
Our fish oils are
manufactured using the latest technology to ensure highly
purified, premium quality oil. The processing begins with
deacidifcation during which free fatty acids from the unrefined
oil are mixed with aqueous sodium hydroxide solution to yield
sodium soaps. These soaps are subsequently removed in a
separator, washed with water and continuously dried in a vacuum
at a temperature not exceeding 100
In order to ensure
that the oil stays transparent during the entire shelf life, the
oil is then winterized under controlled conditions. During this
process, the oil is cooled to separate impurities that solidify
at higher temperatures than the oil.
The solid,
crystalline material (Stearine) which is formed is then removed
by a filtering process. The oil must remain clear after 3 hours
at
0oC
or it is rejected.
Next, the oil is
molecularly distilled to remove contaminants. Analysis conducted
on the oils show that during molecular distillation and other
processes any contents of pesticides and heavy metals are
reduced to levels below the limitsof detection.
Natural clay is then
used as a non-chemical bleaching agent, added to the oil to
absorb color components and oxidation products. The natural
clay, along with color components and oxidation products, are
removed by filtering. This step reduces the Peroxid and Anisidin
values, resulting in a clear, light yellow oil.
Volatile components
responsible for unpleasant taste and smell are subsequently
stripped away by steam heating at low pressure, resulting in oil
with almost no flavor or odor. Additives, commonly used to
disguise rancidity, are never used to cover up odor.
Finally, antioxidants
in the form of Vitamin E are added to prevent oxidation of the
oils. The purified cholesterol-free oil is poured into new steel
drums and nitrogen blanketed to prevent oxidation of the oils.
Nitrogen gas creates a barrier between the purified fish oil in
the drum and the outside air. The shelf life for our fish oils
is two years in an unopened drum stored below 25oC
