■ 22 MARCH 2014 | PHARMACEUTICAL PROCESSING
■ PHARMPRO. COM
ments to the closing setup. The gap between
the capsule and the upperclosing mechanism
was too large. Once adjusted to the improved
setting, the machine could run at full speed
without the presence of poorly joined capsules.
Result: The company realized a $972,488
impact annually. This impact comprised the
effect of producing 10,000 more capsules per
hour with the same equipment and people.
The savings were also helped by a significant
reduction in the waste associated with the
poorly joined capsules.
Case Study B: The $305K Impact of
Problem: A new pharmaceutical product
was being filled at three different strengths.
But the company was experiencing low yield
due to weight variation for all three strengths
on a machine it had been using for years. It
also experienced a financial hit from waste
from filling failures of the expensive product.
Solution: Capsugel re-trained veteran employees and new employees on the production
line as to how to handle the capsules and
set the machine to successfully achieve the
proper fill weight.
Results: The yield increased by 1% for
two different strengths and 2% for the third
strength, for a cumulative impact of $240,817.
The dollar amount is substantial despite the
relatively minor yield increase because of the
costly nature of the product. By eliminating
the waste from filling failures, the company
also could realize additional potential product
sales of a cumulative $64,259.
Case Study C: The $487K Annual Impact
from Cutting Downtime and Reducing
Losses of Yield
Problem: Capsules were not separating at
the proper location during runs so they could
be filled with powder. Yields were suffering
and the capsule-filling machine kicked out
non-separated capsules that accounted for
more than 7% of wasted empty rotations.
Solution: Capsugel discovered that the
capsule bore – the hole in which the capsule
sits throughout the filling process – was dirty.
The dirty bore prevented the capsule body
from separating. Production time was also
lost because runs had to be stopped so that
the machine table could be cleaned of the
powder fills that slipped around the un-sepa-
rated capsules and through the bore. The cap-
sules could separate properly if the bore was
cleaned once per hour, but that would mean
the machine would have to be stopped and
production time would still be lost. Capsugel
recommended that the ingredients be refor-
mulated with different excipients so the bores
would not become dirty. The company is
working on the reformulation solution.
Results: Upon immediate, thorough cleaning
of the capsule bore, capsules now separated
99.5% of the time, but downtime for bore
cleaning was still experienced. By reformulating the ingredients as a long-term solution,
however, the company is projected to realize
a $399,924 annual savings due to cut in yield
losses and $87,456 annual savings by reducing
down time one hour per eight-hour shift for
cleaning of the bore and machine table.
MEASUREMENT OF SAVINGS:
CAPSULE-FILLING EFFICIENCY REPORT
To unlock pathways for greater efficiency,
Capsugel Technical Support Service Engineers
have consulted on equipment purchase for fill
products, process flow evaluations, training on
equipment adjustments – and more – from the
beginning of the process to the end.
As we’ve shown, improvements are important. Equally critical are measuring the
financial gains of the improvements. Existing
metrics of filling-room performance tend to
measure the negative impacts when established standards such as yield and downtime
are not met, but those metrics fall short of
quantifying the business impact. Capsugel
Technical Service Engineers have developed
a “savings calculator” that aggregates all cost
drivers, including labor and overhead, to
more accurately compute financial savings.
Measurement of the drivers of a business is a
powerful tool for maximizing profits and critical to success.
These savings reports can help to substanti-
ate key maintenance and to sidestep pointless
costs as well. They allow manufacturers to
better justify and obtain resources to make
the changes that would improve productivity
of their capsule-fill-
Case Study D: ROI
Problem: One company experienced various defects after encapsulation. A Capsugel
inspection determined that excessively worn
segments on the machine needed to be replaced.
Solution: Capsugel’s Capsule-Filling
Efficiency Report revealed that the financial
impact of the losses far exceeded the cost of
replacing the segments.
Result: Armed with the business case, the
company’s production team justified the cost
of replacing the parts with their internal stakeholders.
There isn’t one type of equipment for every
situation. The entire filling process needs to
be designed from formulation to production
to ensure a quality product that is produced
efficiently. Understand the different types of
capsule-filling systems and the type of fill that
works best in each. Determine the optimal
setup and combination during early development – a move to QbD – to reduce future costs
by increasing the potential production speed
and yield while avoiding downtime. Improving
in these categories after development can also
help to deliver continued financial savings. ■
ABOUT THE AUTHOR
John Davidson, Six Sigma Black Belt, is the
Manager of Quality Engineering Services
with Capsugel. Mr. Davidson is an engineering graduate from the Georgia Institute of
Technology. Today, he manages a team of
Quality and Technical Service Engineers who
work with hundreds of pharmaceutical companies across North and Central America to
improve operational efficiencies.
Determine the optimal setup and combination during early development –
a move to Quality by Design – to reduce future costs by increasing the
potential production speed and yield while avoiding downtime.