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In
manufacture process the laboratory
uses the GMP standards for pharmaceutical laboratories. The GMP
standards are the rules of pharmaceutical products manufacture
designed in the USA. in 1963.
What does the technological process look like
- starting from the raw materials arrival and ending with the ready
packages going out of the doors? The raw materials are received and
undergo the ten days quarantine - for ten days they are kept in three
different zones with different temperature conditions - 4'C, 15'C
and normal temperature. During the quarantine the components of the
materials are analyzed, microbiological purity is tested and
toxicological safety is ensured. The reference samples are kept in
special containers and the samples taken for analysis are checked with them.
After quality check raw materials are
processed. At the first stage the materials undergo low temperature
refinement. This is the so-called cryogrinding process. Grinding under
low temperatures in nitrogen allow to minimize the loss of
active
components including flavonoides and
vitamins.
After cryogrinding the crude powder is
sifted to get rid of unnecessary fibers, and then the materials are
once again checked in the laboratory for microbiological purity and
toxicological safety. If the materials comply with all
requirements they undergo a second stage of processing. Initial parts are mixed in proportions in a
special mixer to get a homogeneous mass. The whole process is automated
and controlled by computers which allows each capsule to contain
exactly the same ingredients.
Next stage involves packaging of the powder
into capsules. In the processing facilities where this operation
takes place the purity regulations are especially strict. The automated
dosage dispensers guarantee the exact amount of powder to be placed into each capsule, at the same time
another device allows to get rid of broken or wrong capsules.
And the last stage is about packing the ready
capsules into plastic jars on an automated conveyor. Every 30 minutes
at the end of the conveyor a jar is checked as for number of capsules
contained and the packaging quality.
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