Encapsulation Sticky Formulation Guide PDF

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A Complete Guide for

ENCAPSULATION ISSUES CAUSED BY

STICKY FORMULATIONS

636-926-8900 natoli.com
TABLE OF CONTENTS:

» Introduction

» Solutions to Try First

» Solutions to Try Next

» If All Else Fails


Introduction
This guide provides a best-practices approach
to troubleshooting capsule-filling problems
when handling a sticky product formulation.
A sticky formulation is one of the most
common causes of issues during capsule
filling. A capsule filler requires tight tolerances
between the machine’s tooling components,
including the dosing disks, tamping pins,
and sealing plate, as well as between the
capsules and the segments’ bores, which
hold the capsules during filling. Friction
between the formulation and these tooling
components during high-speed operation
can cause a sticky formulation to cake and
glaze onto the tooling surfaces, restricting
the components’ movement and leading to
inconsistent capsule weights, capsule splits,
non-separation, and even machine crashes.
Manufacturers often hope for a silver-bullet
approach—one single solution that will
fix every sticky formulation issue—but the
solution is rarely that simple. Several factors
often combine to cause a material to stick,
and the problem is best solved using a
systematic approach.

A Complete Guide for Encapsulation Issues Caused by Sticky Formulation


Solutions to Try First
The following items are a good place to begin troubleshooting when facing a
sticky formulation for a capsule product. These are common contributors to
sticking and can be fixed with minimal disruption to operations.

Control the Humidity


Many formulations have hygroscopic properties, meaning they will absorb moisture from their
immediate environment. As the moisture level in a formulation increases, it becomes stickier.
Operating in a lower humidity environment will reduce moisture in the formulation and the
likelihood of material buildup on the tooling. A good range for many products is between 35
and 45 percent relative humidity. Also, keeping holding containers closed as much as possi-
ble will minimize the formulation’s exposure to humidity in the environment.

Control the Temperature


You may be able to minimize stickiness by controlling the temperature in all production and
storage areas. One manufacturer even found success by positioning a cold-air duct directly
at the capsule filler’s dosing station. The optimal temperature to minimize stickiness for most
formulations is between 60° and 75°F, although some formulations may have especially low
melting points and require a cooler temperature.

Dry the Compressed Air


Even if the compressed air supply has a dryer positioned after the compressor, the air can
pick up condensation traveling to the capsule filler from its source. This condensation can
then find its way into segment bores at the machine’s cleaning station and cause the formu-
lation to stick. Installing an air dryer/water separator on the incoming pressurized air supply
directly at the capsule filler can eliminate this problem.

Slow the Machine


Decreasing the capsule filler’s operating speed can sometimes reduce the negative effects of
a sticky formulation, as the machine will often do a better job of containing the powder in the
appropriate areas.

A Complete Guide for Encapsulation Issues Caused by Sticky Formulation


Solutions to Try First (cont.)
Verify Slug Formation & Transfer
Proper slug formation is a key attribute of good capsule filling because it promotes weight
control, reduces waste, and keeps the formulation within the correct areas of the tooling. If
the machine doesn’t form a proper slug, loose powder can migrate into undesired areas of
the machine and coat the parts. A quality slug should hold its cylindrical form during transfer
from the dosing disk into the capsule body, and once again maintain its form as the machine
pushes the capsule body into the cap.

Ensure Proper Transfer Station Alignment


During dosing, the transfer station is where the formulation moves from the bowl into the
lower segment. The lower segment bores should align perfectly with the dosing disk bores
before the slug is transferred. If they are misaligned, material can shave off the side of the
slug during transfer, and the loose powder will find its way into the segment bores. You can
prevent this by using transfer alignment pins to qualify proper alignment.

Establish the Proper Gap at Dosing


The optimal gap between the bottom of the dosing disk and the top of the tamping ring can
be dependent on the formulation. For non-sticky formulations, a gap at or near .005 inch will
prevent excessive powder from escaping and building up on machine components. However,
with some formulations, that same gap can cause the dosing bowl to seize because of stick-
ing. In such cases, increasing the gap significantly—as large as .015 inch—may help. If a larger
gap is necessary to successfully run the formulation, be sure excess powder is removed via
the machine’s tamping ring support base vacuum ports. If the machine isn’t equipped with
this feature, be sure to periodically clean out excess powder.

A Complete Guide for Encapsulation Issues Caused by Sticky Formulation


Solutions to Try Next
If sticking is still an issue after troubleshooting the first-tier solutions, try the fol-
lowing. These solutions require a larger investment in operations but may help
solve a persistent sticking issue.

Add a Cleaning Station


You can minimize buildup of a sticky formulation by upgrading your capsule filler with a clean-
ing station. The cleaning station will be located directly after the machine’s ejection station
and uses pressurized air to intermittently blow residual powder from the segment bores into
a vacuum hood located above the segments.

Upgrade the Cleaning Station


If your filling machine already has a cleaning station but you are still experiencing powder
buildup, you may need to upgrade the cleaning station to include brushes on the cleaning
pins. The brushes will help scrub material out of the segment bores in conjunction with the
blasts of compressed air, resulting in a more thorough cleaning.

Reduce the Tamping Pin Diameter


Friction from the tamping pins entering and exiting the dosing disk can generate heat and
cause sticking problems. To reduce the friction generated, you can try reducing the tamping
pin diameter by one size. For example, if you are running size 00 tooling, try using size 0 tam-
pers at the five tamping stations and the transfer station.

Use Plastic Parts


Parts made of a lubricious, food-grade plastic, such as polyethylene terephthalate polyester
(PET-TX) can also reduce friction and minimize sticking problems. This plastic is internally
lubricated with Teflon and is FDA approved. Many manufacturers have used dosing disks,
transfer pins, tamping rings, and even bushed guide rings made of this plastic to successfully
encapsulate the stickiest formulations.

A Complete Guide for Encapsulation Issues Caused by Sticky Formulation


If All Else Fails
If sticking problems persist after you’ve tried all the previous solutions, you may
need to consider the following options.

Coat Problematic Parts


Using coated parts has proven effective in many cases, but it is relatively expensive and
doesn’t always resolve sticking issues. Typical parts that require coating include tamping
pins, dosing disks, and segments. Common coatings include chromium nitride (CrN), zirconi-
um nitride (ZrN), boron, and diamond-like carbon (DLC).

Polish Problematic Parts


Another option to alleviate sticking is to polish problematic parts using micro/chemical pol-
ishing. This method uses a polish consisting of a fine, abrasive chemical to remove small
peaks on critical surfaces, making the surface finish much smoother. It’s recommended to
have a professional complete this task or to receive proper training beforehand. While this
polishing method has proven effective, it can be expensive.

Test New Coatings & Processes


Testing unproven methods can also be expensive, but manufacturers facing a dire-enough
sticking problem may be willing to try anything. Technology is advancing quickly, and coat-
ing and material options will surely be available in the not-too-distant future that may prove
effective.

Change the Formulation


Adding a lubricant or a flow aid to the
formulation may also help reduce sticking.
However, developing a drug product
formulation is costly and time consuming,
so even small changes can seem daunting.
As a result, manufacturers are typically
reluctant to consider changing their
formulation to reduce sticking until they’ve
exhausted all other solutions.

A Complete Guide for Encapsulation Issues Caused by Sticky Formulation


KNOWLEDGE IS
POWER

Conclusion
Sticking problems are common in
encapsulation processes, and there is no
one-size-fits-all solution. Often a combination
of solutions is required. Following the
suggestions discussed in this article will
help to eliminate many of the common
root causes of sticking and increase your
odds of successfully encapsulating sticky
formulations.

Jon Carlisle is the founder of


Carlisle Precision Encapsu-
lation Parts, a subsidiary of
Natoli Engineering. The com-
pany is a leading manufactur-
er of aftermarket change part
kits and spare replacement parts
for encapsulation machines.

A Complete Guide for Encapsulation Issues Caused by Sticky Formulation

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