Considerations in Powder Filling

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Considerations in Powder Filling
Dennis Martin
Regional Director
Cozzoli Machine Company
A Century of Innovation
Since 1919 Cozzoli Machine Company has provided
technologically advanced machinery for the packaging industry,
worldwide. Cozzoli’s expertise lies in aseptic and non-aseptic
pharmaceutical, cosmetic, health and beauty aids.
In pharmaceutical powder
filling, every effort is generally
made to eliminate waste, avoid
contamination, save product,
increase operating efficiency, as
well as comply with regulatory
requirements.
But what do you look for in
powder filling technology to avoid
these common issues?
1986
Cozzoli Machine Company has made great
strides in understanding the pharmaceutical
powder filling/cleaning processes.
2010
We want to share with you our
insights and the technology we
developed to counter obstacles
typical to powder filling.
This information can help simplify
your operation, increase productivity
and meet regulatory compliance.
Cozzoli’s first powder filling
patent was designed to
improve the existing powder
filling process for better
accuracy, reliability, easy
cleaning and less waste.
The goal was to create a powder
filling machine that was simple,
accurate, high-speed, and low cost
that was of rugged construction.
The resulting machine is capable of
running for long periods of time,
with low maintenance and quick
changeover to different types and
volumes of filling material.
This machine is easy to clean and
sterilize, with simple and troublefree operation.
With it’s accurate and consistent
fills, this powder filling technology
is especially useful for
pharmaceutical applications.
This filling method can be scaled from
tabletop application with two fill stations
to full production of up to twelve, using
the same type heads.
This filling method is useful for any
number of powder filling applications,
from 50 mg to 75 grams in a single
dose (and is capable of multiple
doses). This allows one machine to
perform many fill requirements.
But it's most interesting for pharmaceutical sterile fills.
Performing regulatory mandated media fills
test for pharmaceutical powder products
required a separate liquid filler and
additional personnel. And, it was not
possible to simulate production conditions.
Cozzoli’s powder filling technology can
handle liquid filling for media testing.
Therefore, testing can be conducted using
only production equipment and personnel,
resulting in better accuracy.
The feature that is unique to this filling
method is the capability to do media fills
with the same filler, simply by filling the
hopper with liquid growth media instead
of product powder.
This is unlike other methods that require
additional filling equipment.
The media is dispensed
into vials, just the same as
powder would be, and then
the vials need to be
incubated.
The negative incubation results, where media shows
no growth, will substantiate the sterile fill capability,
as required by the FDA or other regulatory body.
Other features include the
enclosed powder pathway,
preventing possible external
contamination.
Simultaneous dose and filter
purge, eliminating purging waste.
When the dosing process
finishes, a pulse cleans residue
powder from inside the dosing
chamber and filter and directs it
into the container.
This is an example of helping
customers meet their regulatory
requirements in a simple way.
In addition, this filling method allows
for fast and easy cleaning, as
opposed to other methods.
Primarily we focus on accurate filling,
aseptic/sterile methods, and easy
cleaning for eliminating contamination
or cross-contamination.
An additional constraint is the high cost
of space, so our equipment is designed
and optimized for small areas.
The accuracy of up to +\- 1% of
fill volume means less product
loss. No scraper blades or
particle-generating components
are used, minimizing the threat
of contamination further.
Dosing weight can be individually adjusted during operation.
Case Study: Pharmaceutical Powder Filling Line
Cozzoli Machine Company developed a powder filling line for filling antibiotic
powders into vials in a sterile pharmaceutical environment. This fully
ntegrated line handles multiple size vials and varying doses with ease.
Complete automated processing will reduce risk for contamination.
Case Study, Continued
Functions include:
• Washing vials,
Sterilizing/depyrogenating,
• Filling antibiotic powder,
• Closing with stoppers
• Crimp capping the vials
The line fills powder from 250 mg to 3.0 gm in single dose, with
batch sizes ranging from 1750 vials to a maximum 33,000 vials.
Output per hour is 9000 vials of ISO 10R with one shot dosing.
Case Study, Continued
The individual machines on the line, all supplied from Cozzoli, include:
AW160 washing machine
ST200 sterilizing tunnel
UT42 unscrambling table
PF8 powder filler
• CWS100 check weighing system
• RS400 stoppering machine
• Swing conveyor (for easy access to other
side of line)
• CM200 crimping machine
About Cozzoli Machine Company
Cozzoli Machine Company provides technologically advanced
machinery for the packaging industry. As a global supplier of
precision cleaning, sterilizing, filling, and closing systems,
Cozzoli is your single source provider for individual
components to fully integrated lines.
About Dennis Martin
Mr. Dennis Martin is the Regional Director for Cozzoli Machine
Company. A respected member of the Cozzoli team for almost
ten years, Dennis has over 40 years of technical and sales
experience in the packaging industry covering retail packaging,
chemical, food, pharmaceutical, cosmetic and personal care.
Contact Us
For more information about our powder filling technology or this
presentation, please contact Dennis Martin at [email protected].
Cozzoli Machine Company
50 Schoolhouse Road • Somerset, NJ 07856 USA
Tel: 732-564-0400 • Fax: 732-564-0444
Email: [email protected] • www.cozzoli.com
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