NUTRACEUTICAL BLENDING CYCLES CUT
With increasing demand for its
health and wellness nutraceutical
supplements, A&Z Pharmaceutical
built a 2483m 2 wing and
production line here dedicated to
nutraceutical products that were
previously produced at another
site. The company cut blending
times on a new production line
over 90 percent by opting for
Rotary Batch Mixing over the
V-cone blending employed on
other lines.

“Chiefly, A&Z needed uniform
blends of dry ingredients without
compacting them,” says Marian Vija,
director research & development.

“We make claims of uniformity for
all the actives in our formulations
and have to meet those claims in
the final product - capsule, tablet,
and powder drink.” The company
also desired shorter mixing cycle
times with no product damage or
segregation of materials.

The V-cone blenders did the
job on the existing calcium and
vitamin D production lines but
typically were taking 45 to 60
minutes per batch to achieve the
desired uniformity, prompting
the purchase of a 1133L capacity
stainless steel model 700-TS-40-SS
Rotary Batch Mixer from Munson
Machinery. The unit contains internal mixing
flights that tumble, cut, turn and
fold the batch, causing particles to
recombine 288 times per minute,
achieving batch uniformity in
four minutes, or 11 to 15 times
faster than the company’s V-cone
blenders. The company also gained
production flexibility, as the mixer
is equally efficient from 100% down
to 15% of rated capacity.

On the production line, an
operator starts the empty mixer
and uses a drum lift to transfer
ingredients from fibre drums into
the mixer’s stationary inlet in a
prescribed order, following the
steps in the master batch record.

“Half of the time they are very
fluffy materials that would occupy
the whole volume of the machine.

So we load them in and add
another material to reduce the
volume,” explains Vija.

For products intended for tablets
or capsules, a dry lubricant such
as magnesium stearate powder is
added to the ingredients. This is
a critical parameter in the mixing
procedure, because one gram of
the additive can lubricate 7 to 9
m3 of material. Excessive lubricant
or overmixing will prevent product
particles from sticking together
in tableting. Adding lubricant
extends the mixing time in the
Rotary Batch Mixer by about half a
minute, versus five minutes in the
V-blenders. “The shorter mixing
time makes overmixing and/or
over-lubricating less likely,” says Vija.

The blended batch is unloaded
into the same fibre drums in which
the ingredients arrived. Lined with
GMP compliant plastic bags, the
drums are staged beneath the
mixer’s discharge gate and filled as
one operator at the control panel
adjusts the mixer to rotate slowly,
while a second operator positions
each fibre drum below the gate.

A&Z established a protocol
that complies with FDA Good
Manufacturing Practices for
sanitising and preventing cross-
contamination. Once the mixing
04 CHP PACKER INTERNATIONAL update
vessel is emptied, it is put under
vacuum to remove residual dust.

Large access doors on opposite
sides of the mixing vessel are then
opened and any remaining product
is vacuumed, after which the
interior is pressure washed with
hot water, and the vessel is rotated
for several minutes. After the water
is drained, a hot-water cleaning
solution is added, and themixer
is rotated for several additional
minutes. That solution is removed
and the interior is again hosed
down and drained and/or softly
brushed as necessary. For a final
rinse, hot water is added and the
blender is rotated for several
minutes,then drained. One litre
of 70% isopropyl alcohol is then
added, the mixer is rotated 10
times and drained. This step is then
repeated, after which the mixer is
dried under vacuum for two hours,
and ready for another cycle.

The large doors of the vessel allow
unobstructed access for cleaning
and visual inspection of all product
contact surfaces, which Vija says can
be accomplished without moving
the drum.

Actual A&Z nutraceutical
ingredients were tested at the
manufacturer’s facility using a
laboratory-sized Rotary Batch
Mini Mixer, with four minutes
established as the optimum mixing
time. A&Z also performed content
uniformity studies on commercial
batches made in the Rotary Batch
Mixer in production. “We obtained
excellent results: uniformity and a
good mixing procedure,” Vija says.

“The blends are suitably robust for
compressing and encapsulation.”
www.munsonmachinery.com