As appeared in Tablets & Capsules January 2012. Copyright CSC Publishing www.tabletscapsules.

com

capsule filling
The role of tooling in finished capsule Stephen W. Lee
quality CapsCanada

This article describes how the tooling and capsules interact and if you asked a capsule filling professional to specify the
how worn tooling can degrade productivity and quality. diameter of a size 0 upper capsule bore, you’ll get either a

O
blank stare or a lengthy and confusing answer.
That’s why, even as a capsule specialist, I applaud the
ften overlooked, the design and condition of tooling people who pioneered the American Pharmacist Asso-
play critical roles in producing high-quality filled capsules. ciation’s Tableting Specification Manual (TSM). It outlines
The issue is often overlooked because there are few if any the dimensions and other specifications of tablet press
industry standards for manufacturing empty capsules or the tooling, including the bore size required to accommodate
equipment that fills them. That makes the job of consis- “B” size punches. To institute these specifications, industry
tently manufacturing good filled capsules more difficult. But professionals—many of whom are competitors—met and
with a firm grasp on the technical specifications that your agreed on the standards. The meetings continued over the
capsule supplier uses and a better understanding of capsule years, and the current TSM (seventh edition) includes
tooling, you can improve your capsule filling operation. many changes and improvements. Today, two similar stan-
If you asked a group of tabletting professionals to dards are also used: Eurostandard and ISO 18084:2005,
specify the diameter of a “B” size punch bore, every one and it’s possible that all the three standards will merge [1].
of them would answer 19 millimeters. The response Standard specifications promote the consistent manu-
would be uniform because manufacturers of tablet press facture of tablet presses and tools. Their greatest benefit,
tooling and tablet presses adhere to a standard. However, however, accrues to the companies that manufacture
tablets because they are provided equipment and tooling
whose dimensions are identical and consistent from one
tool and tablet press supplier to another.
In the capsule filling industry, standardization is lim-
ited to the identification of basic capsule sizes, and the
most common range from size 000 to size 5. However,
no published standard defines exactly what the sizes must
be, so equipment suppliers must try to engineer their
tooling to fit capsules of all the mainstream suppliers. Or,
alternatively, the capsule suppliers must make their prod-
ucts meet the specifications of various tooling suppliers.
Either way, with no exact standard, there is a risk of mis- The cap seat, near the bottom of the upper tool, is where the edge of the
matching the tools and the capsules. capsule rests once inserted.
Consider a manufacturer that has just purchased sev-
eral high-speed capsule fillers to handle demand for its facturing personnel to better care for the tooling.
new product. As the machines fill the capsules, it be- Identifying tool wear
comes apparent that a large percentage of empty capsules
Another common issue related to mismatched tooling
are not separating and instead go straight to waste,
and capsules stems from normal tooling wear. Many
thereby causing excessive losses of both capsules and
ingredients that go into capsules are abrasive and, over
powder. Eventually, someone finds that the bore of the
time, wear the tooling to a point where the tool no
upper capsule tool is slightly undersized, causing the cap
longer supports the capsules, which causes joining
to pinch the body and preventing it from releasing and
defects. The problem is often misdiagnosed as a capsule
separating properly. What to do? Given the investment,
quality issue, and I’ve fielded a few of those calls. Other
changing capsule fillers isn’t an option, and the manufac-
times, instead of discussing the issue with Capsule
turer also has a long-standing commitment to buy from
Supplier A—whose products have worked well for
its capsule supplier. The only options are to purchase cus-
years—the manufacturer suspects the supplier’s quality
tom tooling or to somehow alter the capsule design, a
has declined and begins to favor Capsule Supplier B. In
reality, it is more likely that the condition of the tooling
has changed, and the filler now runs better with a capsule

The cap and body segments as they appear when assembled. Inverted upper tool shows the body passage.

that has dimensions that accommodate worn tooling. But

complex undertaking. Either approach would be costly
that often goes unnoticed and the manufacturer will
and time consuming. Yet if there had been a standard in
instead pressure Capsule Supplier A to change its manu-
place for the capsules and/or the tooling, the entire prob-
facturing criteria to accommodate the tooling. That can
lem would likely have been avoided.
cause major problems for capsule suppliers, especially
As the number of suppliers of capsules, equipment,
when the manufacturer is a large-volume customer. When
and tooling increases, the risk of problems also grows.
in doubt, try this the next time your tooling begins to
Many manufacturers have on their shelves tooling that
deteriorate: Replace the tooling and keep the tighter-
will not work with capsules from certain suppliers. There
specification capsule that had been working well. You’ll
are also many boxes of capsules gathering dust in ware-
notice a big rebound in performance and productivity.
houses because the dimensions of the capsules are incom-
Also recognize that flip-flopping between capsule sup-
patible with the manufacturer’s filling equipment. The
pliers to accommodate tool wear can hurt your relation-
ensuing challenge then is to educate everyone who fills
ship with valuable suppliers. It’s better to learn how to
capsules to understand the interaction between the tool-
recognize worn tooling and budget for replacement.
ing and the capsules. Only then will they be able to
decide whether to change or add capsule suppliers, pur- Upper and lower tooling must stabilize without restricting
chase new capsule fillers, and/or specify non-OEM tools. To understand how tooling affects filled-capsule qual-
A good understanding of the issues will also help manu- ity, let’s examine two pieces of tooling in detail: the
 Use pin gauges to check for wear of the cap seat, body passage, and
body seat.

upper-capsule (cap) bore, and the lower-capsule (body)

The lower tool is easily damaged, especially at its top surface. tool, as shown in the photo on page 23 and below. (Note:
All the photos here show segments, which are the tooling
for Bosch machines. Machines from IMA would use bush-
ings, while other capsule fillers may use rings.)
Following the capsule rectification step, the empty cap-
sule is transferred to tooling that acts as a carrier, holding
the cap and the body of the capsule separately. Depending
on the machine type, the capsule is transferred to either
upper and lower segments, upper and lower rings, or upper
and lower bushings. Regardless of the carrier type, each
tool has independent bores to house the caps and bodies.
The upper tool. In the upper, or cap, tool, two areas
are critical to success: the cap seat and the body passage.
The cap seat is a visible ring located near the bottom of
the tool, and that is where the cut edge of the capsule
rests when inserted into the tool. See the photo top right.
The purpose of the cap seat and its sidewalls is to hold
the cap securely and level at the center of the bore, par-
ticularly during capsule closing. As the cap seat wears or
if it becomes damaged, the cap may shift during closing,
creating joining defects.
Deeper within the upper tool, beyond the cap seat,
the bore narrows significantly to form the body passage,
through which the capsule body passes during separation
and by which it re-enters when the capsule halves are
A damaged lower tool will often cause the capsule body to sit high.
joined. See the photo below. The body passage is a criti-
cal point and must be maintained in prime condition for
good joining. Unfortunately, this is another area subject
to wear as fill material is pushed up through the passage
during closing. Some very abrasive fills, such as a cal-
cium-magnesium combination, can wear out this area
within a few months as the granules gradually abrade the
metal. Once the body passage is worn, the bore widens
enough for the capsule to misalign during closing. To
protect the body passage from premature wear, ensure
that the fill material forms a slug that moves cleanly
through the passage before the capsule is closed.
The lower tool. The lower, or body, tool usually suffers
damage from operator handling. See the image at the top of
Because the capsule body cannot descend into the tool, its edge is the next page. Damage from handling often occurs at the
crushed over during filling. This critical defect is called a body fold. top surface of the tool, which is generally flat, with no
chamfer or lead-in to the bore. That makes it susceptible to
damage when operators allow it to contact other metal
parts during disassembly and cleaning. For this reason, it is
imperative that this tool not be stacked and it be handled
carefully during cleaning. If the tool is damaged, it is usually
visible because metal is pushed over the edge of the bore,
restricting the movement of the capsule into the tool. As a
result, during the filling operation, the capsule body is
restricted and sits high in the tool (photo on next page,
center). Its edge will then be crushed over, and the dose will
be deposited atop the cut edge, as shown on the next page,
bottom. This is called a body fold and is considered a criti-
cal defect.
To address the maladies described above, ask your
tooling suppliers to provide the criteria for damaged or
worn-out tools, and periodically measure them. For
example, Bosch sells a go/no-go kit for inspecting its
tools. For checking capsule bores, an instrument called a
pin gauge is used. If a kit is not available for your capsule
filler, ask the equipment supplier to inform you about the
acceptable range for wear. With that information, you
can buy pin gauges from an industrial supplier such as
McMaster-Carr or Grainger and make your own go/no-
go kit. To analyze your tooling, you should measure the
cap seat, body passage, and body seat of every bore in
your tool set. Then compare those measurements to the
acceptable ranges that your equipment supplier provided.
Always replace tooling that falls outside the recom-
mended wear tolerance. Just one worn or damaged hole
may prompt defects to reach an unacceptable level.
By understanding how tooling design and condition
affect your process, you can run a better capsule filling
operation. When in doubt, don’t hesitate to contact your
capsule supplier. Most reputable suppliers are happy to
provide technical assistance. T&C

Reference
1. For a discussion of the genesis of these tooling stan-
dards and the prospects for unifying them, see “Combine
the TSM and ISO standards” by Dale Natoli on page 64
of T&C’s October 2010 issue.

Stephen W. Lee is technical service manager at CapsCanada,

1893 SW Third St., Pompano Beach, FL 33069. Tel. 800 440
6470, fax 954 979 6390. E-mail: [email protected]. For
16 years, he has worked in the dietary-supplement and phar-
maceutical manufacturing industries, specializing in manufac-
turing and filling two-piece capsules. He holds a Bachelor of
Science in business management from the University of Red-
lands, Redlands, CA, and is a member of Tablets & Capsules’
Technical Advisory Board.