Pharmaceutical eHANDBOOK - Chemical Processing
Transcript of Pharmaceutical eHANDBOOK - Chemical Processing
Pharmaceutical eHANDBOOK
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TABLE OF CONTENTSDon’t Let Sterilization Bug You 5
Understand your options and the necessary calculations
Case Study: Supplement Company Combines Traditional with Modern 9
Pneumatic weighing moves blended products gently and quickly
Eliminate Static Electricity’s Effects on Analytical Weighing 13
Neutralization techniques keep sample and area around it free of charges
Consider LIW Feeders for Reactive Powders 19
Automated dispensing using loss-in-weight feeders improves the safety and efficiency of
powder handling
Additional Resources 24
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 3
www.ChemicalProcessing.com
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The dryer was down. The product
was contaminated. That’s what
the operator called at 11 pm to say.
When I got to the plant, the operator and
I realized the culprit was the long-ignored
steam sterilizer at the inlet to the spray
dryer. The temperature profile showed
the telltale sign of scaling; I reviewed
the trends and discovered we had for-
gotten to pull the exchanger to remove
the scale buildup on the steam side. I
reminded maintenance also to remove
the caramelized coating on the other side:
non-uniformity can burn the product.
Sterilization is an everyday practice at
facilities subject to regulations govern-
ing production of pharmaceuticals and
foods. Several metrics define performance.
The probability that a single bacterium
survived sterilization is expressed as the
sterility assurance level (SAL). An SAL of
10-6 — also known as a “6th log reduction”
— is the minimum acceptable probability
in pharmaceuticals and foods. The “biobur-
den” is the opposite probability. However,
there’s more to it: there must be enough
cells to form a colony; a colony forming
unit (CFU) could range from 70–1,200 cells.
All methods of sterilization suffer from
reliance on a method to determine bug
survivability: usually they use a bacterium
as this “biological indicator.”
Bugs just don’t roll over and die. A rela-
tionship between time and exposure
Don’t Let Sterilization Bug YouUnderstand your options and the necessary calculationsBy Dirk Willard, Contributing Editor,
Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 5
www.ChemicalProcessing.com
expresses their resistance. A “D-value”
defines the exposure time, in minutes, at
a given dwell temperature to kill 90% of
the organisms present. D-values intrinsi-
cally relate to conditions: temperature,
humidity and chemical concentration.
A “Z-value” is the temperature change
required to reduce the bug population
from 10 to one (log scale). It’s important
to define a bracket of bug population
versus time with divergent lines at maxi-
mum and minimum temperature. In simple
terms, if the bioburden is 100 CFU, with a
D-value of 0.7 min/log at 115°C, then the
dwell time for a 6th log reduction is: log
(100) + log (106)/0.7 = 11.4 min. There’s an
equation to find equivalent kill time, Fo, at
a different temperature: Fo = 10(T-T*)/Z-value
where T is the new temperature and T* is
the established temperature.
Pharmaceutical and food processors
generally rely on clean-in-place (CIP) pro-
cedures. These fall into three categories:
heat; chemical, e.g., ethylene oxide (EtO),
nitrogen oxide, hydrogen peroxide, chlo-
rine (Cl2) and ozone; and radiation. Plants
tend to favor the latter two categories
because they reduce contamination and
damage; with gas methods like EtO, it’s
easier to separate the product from the
agent. Unfortunately, those two categories
aren’t perfect. For instance, cardboard
absorbs EtO and Cl2 forms toxic chlo-
ramines with ammonia in water while
radiation hardens plastics and scrambles
electronics. In addition, some chemicals
pose a serious health and safety risk, as
exemplified by the 2006 EtO explosion at
Sterigenics. (For details on that incident,
see the video made by the U.S. Chemical
Safety Board: http://goo.gl/j5aJfD.)
Dry heat, which kills by oxidizing the bac-
teria, sometimes is an option. However, it
generally best suits wastes not production
materials. Dry heat lacks the penetration
capacity of wet heat.
You simply can’t beat the right kind of
steam for sterilization. What is the right
kind? A stream with 3–5% wet condensate
will penetrate more effectively than dry
steam, allowing a lower dwell temperature.
Besides, wet steam has a better heat trans-
fer coefficient.
What problems can you expect with
steam sterilization? Well, obviously, scale
buildup and caramelization; wet pack-
ing — allowing excess water to collect
— probably because of steam trap fail-
ure; trapped air — vent the steam and
air someplace; low temperature — often
Bugs just don’t roll over and die.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 6
chosen to preserve products that are
more difficult to maintain at temperature
for the time needed to achieve steriliza-
tion; and, saving the worst for last, poor
CIP practices — cleaning must remove the
bulk of the waste in the pipe for steriliza-
tion to be effective.
Some equipment is especially difficult to
clean and sterilize: filters, sample valves,
thermowells, heat exchangers, centrifuges
and pumps. So, it’s sensible to give special
consideration during design and construc-
tion to avoiding the need for cleaning that
involves disassembly, i.e., clean out of
place (COP).
Most regulations offer some general guide-
lines but lack practical recommendations.
May I suggest:
• “Succeed at Steam Sterilization,”
http://goo.gl/hYi6Gg
• “Guidance for Industry,”
http://goo.gl/oGqNNy
• “Aseptic Processing and Packaging…,”
http://goo.gl/1YT6pb
• “USP Activities Impacting Sterilization…,”
http://goo.gl/jeCSvm
• “Fo Value, D Value and Z Value Calcula-
tions,” http://goo.gl/fUdpcY.
DIRK WILLARD is a contributing editor for Chemical
Processing. Email him at [email protected]
Understand Key Challenges in Process Safety Education
Process safety (PS) academic education has evolved slowly
over the past four decades. University chemical engineering
departments began to establish and deliver process safety
courses in the 1980s. However, the majority of chemical
engineering curricula still do not offer a standalone
course, and fewer make it a requirement.
Chemical Processing, in collaboration with the
Mary Kay O’Connor Process Safety Center, has
developed this Journal to help you better understand
process safety management and solve your challenges.
Predict and Prevent Well-Control EventsRethink Safety and Control Systems Design
UNDERSTAND KEY CHALLE NG ES IN PROCESS SAFETY EDUCATION
FEBRUARY 2021
MKO PROCESS SAFETY JOURNAL
Download the journal at www.chemicalprocessing.com/journals
www.ChemicalProcessing.com
Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 7
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The new Coperion K-Tron pharma feeders are ideal for both batch and contin-uous applications. The overall concept is specifically designed for quick clean-ing and disassembly, requiring only a matter of seconds to disconnect the feeder bowl, agitator, feed screws and hopper assembly from the gearbox. www.coperion.com/pharma-feeders
CP_Powder-eHandbook_Mar21_Pharma-feeders-V200_200x266-7mm_en.indd 1CP_Powder-eHandbook_Mar21_Pharma-feeders-V200_200x266-7mm_en.indd 1 16.02.2021 10:34:4116.02.2021 10:34:41
With more than 34 years in the
herbal supplement arena,
Traditional Medicinals has
combined the ancient art of traditional for-
mulating with modern scientific methods
of quality assurance and production and
remains dedicated to preserving the earth’s
natural resources, both human and natural.
Operating 70% from solar power, the Sebas-
topol, Calif. company also continues its
commitment to preserving human resources
by continually improving the work environ-
ment for its employees, striving for the most
desirable and safe workplace.
The facility operates 20 hours a day, four
days per week, to produce 2 million teabags
per week. Raw materials are brought in from
around the world in already tea cut form,
reinspected and repackaged into barrel con-
tainers to feed into the blenders via a hopper
system. After the formulas have been
blended, they are transferred to the packag-
ing area and gravity-fed from a mezzanine
level to IMA machines that process between
135 and 185 teabags per minute.
While working on a major efficiency proj-
ect that culminated in the building of new
rooms for the blending area, Mary Goff,
plant manager, says that the company also
wanted “to cut down the amount of lifting
that the operators were doing manually in
our production department.”
Previously, the operators were weighing
individual 100-lb. batches into barrels, taking
Case Study: Supplement Company Combines Traditional with ModernPneumatic weighing moves blended products gently and quicklyBy Doan Pendleton, Vac-U-Max
Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 9
www.ChemicalProcessing.com
those barrels up to the top level and then
dumping them into hoppers by hand. In
search of a better method, the VP of quality
control and the site manager researched
open conveyor systems as an ergonomic
solution for transferring the raw materials.
Traditional Medicinals uses pharmaco-
peial-grade herbs, and one of its biggest
concerns was how to transfer the herbs and
blends from one area to another without
breaking down the product or losing any of it.
“We did a lot of studies up front,” says Goff,
of choosing the right systems to transfer
ingredients. “We spoke with some of our
raw materials vendors about the systems
they used to transfer materials, and a gen-
tleman from the consulting firm we were
working with on the efficiency project told
us about Vac-U-Max.”
Belleville, N.J.-based Vac-U-Max specializes
in the design and manufacture of pneumatic
systems and support equipment to convey,
weigh and batch dry materials in the phar-
maceutical, chemical and food industries.
Although the company’s herb suppliers
warned against conveying the herbs pneu-
matically, thinking that it would damage the
ingredients, Traditional Medicinals decided
to look into it anyway.
Pneumatic conveying systems have some
features open conveying systems such as
belt or bucket conveyors don’t have, includ-
ing ease of cleaning and a smaller footprint.
In addition, pneumatic conveying systems
are fully enclosed, protecting materials from
air, dirt and waste. Because product does
not escape from a pneumatic conveying
system, particulates that can endanger or
jam expensive equipment are prevented
from entering the environment.
Despite these advantages, Traditional Medic-
inals needed assurance that the vacuum
system (Figure 1) would perform reliably
without breaking down the product.
STAINLESS STEEL VACUUM RECEIVERFigure 1. Stainless steel vacuum receivers such as this one are ideal for sanitary pharmaceuti-cal and nutraceutical vacuum conveying appli-cations of powders and granular materials.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 10
TRY BEFORE YOU BUY“If the product is too fine, it creates prob-
lems with separation and blending and also
creates problems with packaging if it is
too dusty,” says Goff. “Before purchasing
the equipment, we wanted to be sure that
it could transfer the product correctly and
that it was holding its integrity from a qual-
ity standpoint.”
Vac-U-Max offers testing in its fully func-
tional 6,000-sq.-ft. test and demonstration
facility equipped to conduct a plethora of
vacuum conveying tests to simulate the
actual conditions at a customer’s site.
After consultation with the company to
arrive at system design and equipment
specifications, Goff traveled with the VP
of quality control and the site manager to
New Jersey to test the equipment with 15 of
the company’s raw materials. “They spent a
whole morning with us running through the
testing, making sure that we were happy
with their equipment,” she says.
“One of our biggest concerns was the
breakdown of the materials themselves, and
that’s one of the negatives that we kept
hearing from our herb suppliers, but Vac-U-
Max assured us that it wouldn’t. And they’ve
proven that it is a very gentle way to move
product,” says Goff.
During the testing, it was determined that
the three-filter system initially specified for
the application was capturing more product
than desired, so Vac-U-Max came up with a
single-filter system instead and adjusted the
flow rate.
Because Traditional Medicinals runs
between three and four blends per day
in the department, the conveyor man-
ufacturer set the company up with a
cloth-type cleanable filter that can be
cleaned, sanitized and reused. The com-
pany has several filters on hand for
each blend.
IMPLEMENTATIONWhen the new blending area was finished,
the Vac-U-Max system was implemented
into the new process where raw materials
are brought in and taken to a second level,
run through magnets and then scaled into
a barrel. The pneumatic conveyor system
transfers the product back up to another
room where the system performs as the
hopper feed for the blender itself.
Now rather than operators using forklifts
to bring barrels up to the mezzanine level
and manually scooping materials into the
hopper, operators insert a wand into the
barrels and product pneumatically is trans-
ferred from the wand to the blenders.
“The system has eliminated all the forklift
traffic, and from an ergonomic standpoint
it’s saving a lot of wear and tear on our
blenders’ backs,” says Goff.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 11
In addition to creating a better ergonomic
environment for the operators, Goff says
“their system is more efficient, too, and
we are really happy with that side of it.”
INCREASED EFFICIENCYAlthough Traditional Medicinals hasn’t been
working with the new system long, it has
performed a full protocol of validating the
equipment, process and cleaning proce-
dures. Goff says, “I am predicting that we’ll
be able to improve capacity by 20%.”
CLEANING AND MAINTENANCEWhen running three or four blends a day,
ease of cleaning quickly becomes an effi-
ciency point when sanitation between
runs is required. For this application,
the Vac-U-Max system has a food-grade
polished surface for effortless cleaning
and product flow, and all systems are
equipped with heavy-duty clamps that
enable quick take-apart without tools.
Goff says, “It is very easy to take it apart.
We’re taking it apart three to four times
a day, and we change the filter between
each blend.”
She’s happy with the system’s perfor-
mance, adding, “With the pneumatic
system, transferring the materials is a lot
quicker, and we expect that it will work
well when we bring in a higher capacity
machine later this year.”
DOAN PENDLETON is president of Vac-U-Max and can
be reached at [email protected].
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 12
Eliminate Static Electricity’s Effects on Analytical Weighing Neutralization techniques keep sample and area around it free of chargesBy Thomas Pertsch, Sartorius Lab Instruments
Static electricity is a physical phe-
nomenon that can have tremendous
significance in the chemical industry
in many quality control and research and
development laboratories. Electrostatic
charging of materials in industrial processes
and during production sequences or materi-
als analysis can have negative effects.
For example, dosing powders with a spat-
ula or dosing heads risks spreading the
substance so it cannot be brought into
the vessel without spilling. Electrostatic
discharges can damage electronic equip-
ment and components. Spark discharges
easily can ignite flammable substances in
the immediate vicinity, potentially lead-
ing to serious accidents. Millions of dollars
are spent around the world on efforts to
eliminate electrostatic charges and their
associated negative effects.
While simple, low-cost measures are avail-
able to eliminate static electricity during
analytical weighing, current metrological
and practical limitations render many of
them difficult and time-consuming to use,
and they are not universally applicable. Yet
methods exist that are both powerful and
space-saving, particularly when they are
integrated directly into the balance.
BASICS OF STATIC ELECTRICITYStatic electricity results from friction
between two objects (bodies). This fric-
tion process transfers electrons from
Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 13
www.ChemicalProcessing.com
objects with a lower work function (dona-
tor) to objects with a higher work function
(acceptor), which results in ion production
(Figures 1a and 1b). A body with excess
electrons takes on a negative charge, while
a body lacking electrons takes on a positive
charge. However, this is only a temporary
change in the charge because any excess
electrons flow off of the body once it has a
certain conductivity or is grounded.
Friction can occur within the sample itself
or between the sample and container or
tare vessel. For example, during convec-
tion in a drying oven, air friction creates a
charge on glass containers, and internal fric-
tion of powders and liquids when they are
transferred between containers creates a
charge on particles within that sample.
In practice, it is impossible to avoid fric-
tion during the processing or transport of
substances. Thus, electrostatic charging
occurs almost 100% of the time. Disruptive
electrostatic forces also can occur in the
area around the balance because of the
direct transfer of charge carriers by people
moving around the balance.
DIRECT IMPACT ON WEIGHING All balance manufacturers are called upon
to respond to the problems of weighing
substances with electrostatic charges with
appropriate technological solutions. Static
electricity can have a negative effect on
either the weighing process itself or on
the results, thus requiring time-consuming
material selection or material handling pro-
cedures to address these effects.
In some cases, weighing
a material may be close
to impossible due to the
build-up of electrostatic
charges during handling.
In addition, the electro-
static properties of some
materials may vary as
ambient humidity rises
and falls, making the
attempt to weigh it even
more difficult. Electro-
static phenomena may be
worse when the relative
humidity falls below 45%,
often the case in winter
ION CREATIONFigure 1a. When two neutral atoms collide or experience friction, the body with the lower work function loses an electron.
Figure 1b. The lost electron moves to the body with the higher work function, and an ion is created. The total charge of the atom on the left is positive (positive ion); the total charge of the atom on the right is negative (negative ion).
a
b
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 14
in European latitudes or in air-conditioned
rooms. Therefore, balance users will experi-
ence different conditions from one season
to the next or from one day to the next,
making it difficult to reproduce their results.
Electrostatic charging of materials can
occur in the following conditions:
• in solids, when the surface resistance
of the material Rs > 10 GΩ (according
to IEC93)
• in liquids, with a conductivity of < 10 nS/m
• in conductive materials that are
not grounded
During a weighing operation, the interaction
of electrical charges that have built up on
the material being weighed and the fixed
parts of the balance, which are not conduc-
tively connected to the weighing pan, cause
this electrostatic force.
An electric field builds between the material
being weighed and the fixed parts of the
balance. Some examples of fixed balance
parts include the draft shield or housing
parts, such as the balance base plate.
The resulting electrostatic forces can cause
load changes (displayed values) up to the
order of a gram. In practice, a false absolute
weight is not the only negative effect asso-
ciated with static electricity. Severe drift of
weight readouts and poor results repeat-
ability also are serious problems.
Built-up charges flow off slowly via the
weighing pan, so that the resulting forces
are not constant over time, causing drift
and poor repeatability. Depending on the
polarity the charge carries, the interaction
can be either repulsive or attractive, mean-
ing the weight results can deviate both
positively and negatively. A repulsive inter-
action occurs when both the charge on the
sample and the ambient charge have the
same polarity (both + or both –) (Figure 2).
The material being weighed seems heavier
than it actually is.
REPULSIVE INTERACTION DURING WEIGHINGFigure 2. When both the weighing container and the environment are negatively charged, the resulting force is directed downward (yellow arrow). This makes the sample appear heavier.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 15
An attractive interaction, on the other hand,
occurs when the charge on the sample and
the ambient charge have different polarities
(one + and one –). An attractive interaction
will make the material being weighed seem
lighter than it actually is (Figure 3).
NEUTRALIZING ELECTROSTATIC CHARGESTo eliminate the effects of static electric-
ity on weighing, keep both the sample and
the area around it free of any charges.
One method that has yielded excellent
results to shield the weighing chamber
and the weighing pan from electrostatic
fields is to use a fully transparent conduc-
tive coating on all glass elements of the
balance draft shield.
Another solution includes using ionizers
and antistatic pens near the balance. This
solution works on the principle of surface
neutralization via ion bombardment. In most
situations, surface neutralization is very
effective at reducing charge buildup when it
is helpful to eliminate electrostatic charges
on vessels and samples in the external envi-
ronment of the balance.
Below-balance weighing can be used for
weighing bulky materials, such as plas-
tic blocks. The sample is secured using a
hanger beneath the weighing pan to take
advantage of the proportional reduction
in electrostatic force that occurs with the
square of the distance between the charge
carriers.
This method of reduction of the influence
of electrostatic charges also can be used
while weighing on the weighing pan; any
influence of electrostatic forces on weigh-
ing results can be reduced if the distance
between the sample and the weighing pan
is significantly smaller than the distance
between the sample and the fixed parts of
the balance because the weighing pan pro-
vides an effective shield.
ATTRACTIVE INTERACTIONFigure 3. When the weighing container and the environment have opposite charges, the result-ing force is directed upward (yellow arrow). This makes the sample appear lighter.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 16
However, if the opposite is true, electro-
static charges still will affect the weighing
process. Sometimes it is sufficient to place
an object between the sample and the
weighing pan, reducing the forces to the
point that they have no noticeable effect
on the weighing result. For some appli-
cations, it also is enough to increase the
weighing pan’s shielding effect. For this
purpose, special pans with a greater diam-
eter than standard pans are offered.
A specific balance for weighing filters
that uses a Faraday cage (a grounded
metal shield) can solve the problem of
electrostatic charges. While weighing,
the weighing pan and an electrically con-
ductive cover attached to the pan shield
the filters completely. This filter weighing
balance often is used to determine partic-
ulate matter in emission measurements in
the automotive industry or environmen-
tal institutes.
EQUIPMENT TO AVOID ELECTROSTATIC CHARGE INFLUENCES Generally, the time needed to neutral-
ize electrostatic charges depends on the
sample’s material, surface and shape, as
well as the relative humidity in the bal-
ance’s vicinity.
CUBIS II MICRO BALANCEFigure 4. The Cubis II motorized automatic draft shield includes an ionizer with four jet nozzles for effective elimination of electrostatic charges.
www.ChemicalProcessing.com
Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 17
The Cubis II balance offers the Q-Stat
ionizer, which is integrated in the draft
shield I of the modular balance series and
eliminates electrostatic charges within a
few seconds. All glass draft shields use a
fully transparent conductive coating.
In the draft shield I of the Cubis II, four
nozzles jets are positioned in the rear
wall (Figure 4). The physical functional
principle of these nozzles is corona dis-
charge, a process by which a current
flows from an electrode with a high volt-
age into the air. Around the very thin
needle, the electric field strength is so
high that the air molecules are ionized
and create a region of plasma around the
electrode. The generated ions pass the
charge to areas of lower potential. After
recombination with free charges they
form neutral gas molecules again.
The use of four nozzles makes charge
elimination effective. By using opposite
polarity of the nozzles, a kind of focusing
effect in the area of the weighing pan
occurs. This makes the neutralization of
electrostatic charges from sample contain-
ers and substances, for instance, powders,
very effective without disturbing airflows.
This prevents errors from electrostatic
forces in the weight measurements.
Moreover, the fully transparent con-
ductive layer on the draft shield glass
panels provides additional protec-
tion from electrostatic fields in the
immediate proximity of the balance.
This, too, ensures stable and correct
weighing results independently of elec-
trostatic charges.
Cubis II supports different applications
in which an elimination of electrostatic
charges is essential to measure a very
small amount of particles on filters.
THOMAS PERTSCH is product manager at
Sartorius Lab Instruments GmbH & Co. KG,
The use of four nozzles makes charge elimination effective.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 18
Many chemical and pharmaceutical
process engineers face the chal-
lenge of metered dispensing of
reactive powders into reactors and large
tanks. The requirement to dispense diffi-
cult-to-handle ingredients in a contained
and accurate method is an application that
can be fulfilled and completely automated
using specifically designed loss-in-weight
(LIW) feeders.
The combination of advanced weighing
technology and a contained and sani-
tary feeder design provides for an ideal
automated method of powder delivery,
without the dangers and inefficiencies
of traditional manual powder loading
techniques.
APPLICATION AND PROCESS DETAILSLIW feeders can be designed to dispense
powders into a reactor, tank or large pro-
cess vessel. Figure 1 illustrates a single
feeder, complete with a vacuum receiver
mounted directly above the feeder, that
transfers the powders from the floor below.
Figure 2 illustrates the ability to also incor-
porate a bulk bag frame system above the
feeder to deliver the powder to the feed-
ing/dispensing system. It uses a second,
smaller LIW feeder on a portable weigh
scale to dispense even smaller amounts of a
second powder to the tank.
To provide maximum flexibility, feeders can
be equipped with a special caster system on
Consider LIW Feeders for Reactive PowdersAutomated dispensing using loss-in-weight feeders improves the safety and efficiency of powder handling By Sharon Nowak, Coperion K-Tron
Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 19
www.ChemicalProcessing.com
tracks. This enables the feeders to be rolled
in and out of place as required and also be
placed on pneumatic lifts. The feeder in
Figure 3 can be moved forward and back as
well as up and down, and the entire unit can
be moved in and out of position.
In all of these LIW batch designs, the effi-
cient batching program included in the
feeder controller is designed for a metered
flood flow of material out of the feeder until
the total weight of the material fed is within
90% of the batch weight setpoint.
At this point, the controller switches the
feeder automatically into a slower “trickle
SINGLE FEEDER Figure 1. This LIW feeder transfers the powders from the floor below.
LIW FEEDER WITH BULK BAGFigure 2. This feeder incorporates a bulk bag frame system above the feeder.
MOBILE SYSTEMFigure 3. This system can be moved vertically and horizontally as well as to a new location.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 20
feed” mode to reach the final setpoint
weight accurately. Based on the maxi-
mum achievable speeds determined with
calibration, the controller also calculates
the minimum batch time for the speci-
fied material.
WHY LOSS-IN-WEIGHT BATCHING?Batch size, number of materials, material
characteristics and accuracy requirements
all influence which type of batching — LIW
or gain-in-weight (GIW) — is best used.
Figure 4 illustrates the differences in
equipment setup for these two modes of
batching. Typical accuracies to be expected
with the Coperion K-Tron GIW method of
batch weighing are ±0.5% of the full scale
capacity. In other words, when batching
into a reactor or vessel mounted on a scale
or suspended from load cells, the full weight
of the vessel and its contents must be
reflected in the full scale capacity.
Most floor scales or high-capacity load cells
do not have sufficient speed and resolution
to detect small amounts of batched prod-
ucts relative to the larger overall weights
of the tanks, reactors or process vessels.
If accuracy requirements on powders are
in the range of 0.1–0.5%, individual LIW
feeders typically are used with the feeders
mounted on high-speed digital load cells
with 1 part in 8 million resolution in 20 ms.
An LIW batch controller monitors material
weight loss from the feeder hopper and
controls the speed and start/stop function
of the feeder to control the achievement of
the batch weight setpoint.
WEIGHING SYSTEM AND FEEDER PERFORMANCEAny LIW process controller requires accu-
rate high-speed measurement of material
weight changes to provide optimal feeder
control and performance. The weigh-
ing system also must be able to filter out
erroneous measurements that in-plant
vibrations or disturbances cause and be
stable over changes in process room or pro-
cess material temperatures.
The keys to accurate batching are high-
er-resolution weight measurement and
LIW AND GIW SETUPFigure 4. LIW and GIW setups differ; which to use depends on batch size, materials and accuracy requirements.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 21
controller speed. The faster those
weight measurements are taken, the
better the information provided to
the control algorithm, and the better
any vibration filtering algorithm
will work.
The advantages of weight control
through custom technologies can
be a factor in the product quality
and overall manufacturing costs. For
example, some load cells, as shown
in Figure 5, use a vibrating wire
technology based on the theory that
an oscillating wire’s resonance fre-
quency depends on the wire tension
produced when a load is applied.
An applied weight’s force is transferred
to the wire mechanically. The resonant
frequency is measured to determine the
weight. In Coperion K-Tron’s smart force
transducer (SFT) technology, a built-in
microprocessor converts the signal directly
into a digital weight signal. The signal then
is communicated noise-free via RS-485 to
the feeder controller. The KCM-III controller
includes a powerful and fast microproces-
sor, which is ideal for optimizing the batch
weight measurements and their control.
The most recent improvements to the
SFT technology result from a new custom
integrated circuit that allowed contin-
uous measurement and digital filtering
capability at even higher sample rates.
Previously, there were short gaps of time
between capturing the wire frequency,
processing the weight and restarting the
frequency capture.
The new system can capture an integer
number of periods of the weight frequency
using a 30 MHz reference frequency and
never miss a single pulse. The result is truly
continuous measurement. Every SFT pro-
vides a true 8,000,000:1 weight resolution
in 20 ms.
OPTIONS IN CLEANING, CONTAINMENT AND CONSTRUCTIONDepending on the powders to be batched
and frequency of batching, a variety of
VIBRATING WIRE TECHNOLOGYFigure 5. Some load cells use vibrating wire technology to determine batch weight.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 22
design executions can be provided for
the equipment to reduce overall cleaning
or changeover steps. In the case of phar-
maceutical applications, pharmaceutical
feeders provide optimal modularity and
cleanability (Figure 6). The use of stainless
steel for the contact components allows
for ease in cleaning and corrosion-resistant
operation, which also is an advantage in
chemical applications.
Feeders and conveying receivers can
be designed with in-place retractable
spray balls for wash-in-place cleaning
to ensure quick changeover and min-
imal contamination between material
runs. In addition, for toxic chemicals
or pharmaceuticals, incorporating split
butterfly valves at the product outlet
can serve to ensure full powder con-
tainment when the batch is complete
and the feeder moved away from the
vessel or reactor.
When designing for a batching
system, it is important to discuss all
aspects of the design requirements,
including the expected changeover
and cleaning times, optimal desired
batch times, containment requirements
and any issues with height limitations, as
the design requirements for these situa-
tions can greatly affect the overall system
cost.
SHARON NOWAK is business development
manager for Coperion K-Tron USA, Food &
Pharmaceutical Industries. She can be reached at
PHARMACEUTICAL FEEDERSFigure 6. Stainless steel contact components reduce corrosion and make cleaning easier.
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Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 23
Pharmaceutical eHANDBOOK: Fine-Tune Your Pharma Functions 24
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