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100% found this document useful (3 votes)
4K views139 pagesTableting Specification Manual
APHA Guide
Uploaded by
albertoisaacpinedaCopyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
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| Tableting Specification
Manual
Seventh Edition
(Previously refered 1 asthe
IPT Standard Specifications for Tableting Tools)
4
Scr Pharmacists Association
APRA
Washington, D.C. Managing Edtor
Linda L Young.
Interior Design
Walter Hikers, Je
CAD. tustetions
Glen they, Trevor Higgins, Bill Hnatuk, Rickard Kirk, Todd Martin, Dale Natoll, Paul Sehaa
Printing
Vitor Graphics, In.
{© 2006 American Pharmacists sociation
{© 2003, 2001 1995, 1990, 1981, 1971
Al ngs reserved
Ph was founded in 1852 asthe American Pharmaceutical Associaton.
Published by the American Pharmacists Assocation
2215 Constiation avenue, NW
Washington, C 20037
vevvaphaneorg
Tocommenton tis book by e-mail, send your message tothe publisher a aphabooks @aphanetong
Notice of Copyright: No part of this publication may be reproduce, store in a rere jstem, or transite in any form,
‘or by any means—eletroni, mechanical, photocopying, recording, oroerwise—widhout writen permission from the pub
lisher (wt tae exeepion of ertain forms on which permission to copy is stated thereon,
Notice of Liability: The publisher and the Tableting Specification Steering Commitee have made every eft to ensure the
accuracy and completeness of the information presented inthis publication. Hower, the publisher, steering commitee
members, editors, contbutrs, an reviewers cannot beheld responsible fo the continued usrency of de information, any
Inadvertent ears or omission, or the aplication of this infomation. Therefore, the named pres shall have no ability ©
any person oe eny wih regard to claims, loss, or damage caused or alleged to be caused, dey or inet, by the use of
information contained herein
rary of Congress Catlogingn-Publiation Data
“Tate petcaon mana —Th
poem
"previo rere ts the I standard speciation for alent"
Indes inde.
ISBN 5021207841
I. ables (eine) —Stndards—Uned tues. 2. bling Standards United utes.
IDs 1, Tales—sanaris. 2 Equipment and Suples—suandars
4. Techn, Plarmaceutal—iastumenatin. QV 87 T113 2005],
i meriin Pharmacists ssciton
S201 1262005 |
61s.19—ea2
asons4
How to Order This Book
By phone: 80048780729 (domestic)
Online: eww pharmacist.com
VISA®, MasterCard®, and American Express® cards accepted. Contents
List of Figures
List of Tables
Acknowledgments
Preface,
Introduction.
SECTION 1: Guidelines for Using This Manual
‘Tooling Terminology.
‘blr Manvlactring,
Tooling Speciation
Standardization: Is Purpose and Advantages
SECTION 2: TSM Tooling Specitications and Design Options
Effet of Tooting Dimensions on Tablet Manufacturing...
‘Tooling Design Option. 7
‘Tooting for Automated High Throughput Munuacuring
“Tooling Specification Figures and Tables (Index)
SECTION 3: Tablet Design
‘able Terminology
‘Tablet Identiaton.
‘Tablet Printing.
Tablet Detail Dravings
SECTION 4: Tool Steels, Compression Forces, and Fatigue Failure
Too Sees
Chemical Composition of Steels
Hardness of oo Stes.
‘oong Coatings
Punch Cup Force Ratings.
Fatigue Falure of Punch Tips
5
a
a
2
cn
7
B
5 SECTION 5: Tooling Procurement, Inspection, and Maintenance
‘Standand Operating Procedures.
Punch and Die Maintenance.
Lletronletnspecton of Tooling
SECTION 6: Troubleshooting Tablet Production Problems
Advantages of Quality Tooling,
“ublet Problems
“oolng Problems.
‘Turret Guideway Wea...
APPENDIX
“Tablet Press and Tooling Manufacturers and Distributors
98
a
us
5
m
a7
129, List of Figures
Figure 1
Figure 2
gure 3
Figure 4
gure 5
Figure 6
Figure 7
Figure 8
Figure 9
Figure 10
gure 11
Figure 12
Figure 13
igure 14
Figure 15
Figure 16
igure 17
igure 18
gure 22
Figure 25
Figure 24
Figure 25
Figure 26
Figure 27
Figure 28
gure 29
Figure 30
Figure 31
Figure 32
Figure 33
Figure 34
Figure 35
igure 36
gure 37
Figure 38
Fiore 39
Figure 40
Figure 41
Figure 42
Figure 43
Punch and De Terminology.
‘TM Production Tol
Rotary Tablet Press Oe.
Top View of Tabet Press Cycle
(Overall and Working Lengths.
‘Comion Head Configurations ofB Type Punches
Common Head Gonfigrations of D-ype Punches
Standard B-lype Upper Punch :
Standard B-ype Lower Punch,
Standard D ype Upper Punch
Standart ype Lower Punch
Special Punch Tip Options.
‘Special Punch Barrel Options.
Standant 0.945 Die
Standard 13/16 Die
Standard “D" Die.
‘Tapered Dies and Die Groove eli
Line DIES nnn
Punch and Die Clearances . .
Common Configurations and Dimensions for Punch Keys
Comparison of TSM and EL19 Beype Tooling
‘Terminology for Round Tables.
Profiles of Convex, FEB.E, and FERE. Tables.
Terminology fr Shaped Tables,
‘Comaoa Tablet Shapes. ven
Applying Tablet entiation to Punch Pace.
Maximum Identification Area fr Round Tables
Soke Specifications and Stroke Distortion
‘Techniques to Prevent Picking in Pad Area... .
‘Techniques to Prevent Picking in eninulas and Corners
Sample Designs for Bold Characters
‘Sample Desiga for Narrow Characters.
Guidelines fr Film Coating.
Types of Bie LiNES ers
Guidelines for Pune ip Land. i
Toughness and Wear Resistance haractristis of Tool Stel
Abrasine Wear Rats of Tooling Materials and Coatings
Sires Versus Oyele Life for Too Stel.
Sample Tablet Toting Approval Form.
Quote/Order Form.
Punch and Die inspection sheet
“Tablet Tooling Usage and Repair Card
Punch Tip Deletion List of Tables
ible 1
Table 2
Table 3
Table 4
ble 5
Table 6
ible?
bles
Tible9
Table 10
Table 11
Table 12
Table 13,
‘able 14
Table 15
“able 16
‘able 17
‘ble 18
Table 19
“able 20
Table 21
“able 22
Rotation Direction of Tablet Press, 10
Maximum Tablet Sizes for Standard Dies 36
Standard Clearances for Normal Applicaton of Round Tol a7
‘ualable Key Space and Maximum Stem Lengths snr 0
Interchangeable Toling for Rotary Tablet Presses
3/4” Punch Bare and 0.945" Die. — 4
Interchangeable Toling for Rotary Tablet Presses
3/4” Punch Bare and 1.1875" Die ronson 2
Interchangeable Tooling for Rotary Tabet Presses:
1" Punch Barrel and 1.500" Die 7 7
‘Tooling Dimensions for Special Rotary Tablet Presses,
Standart Biset Speciation. 7
Punch ip Tabulations.
‘Minion Land Widths
{Chemical Composition of Too Stels
‘pica Hardness Readings for Tool Steals
Fanetion() of Common Steel Coatings...
Comparison of tel Coating Processes
Engineering Requirements for Tablet
Punch Cup Compression Fores for TSM Round Tooling 85
Punch Cup Pressure Ratings Versus Shape Factors 87
Puneh Cup Force Ratings Versus Cup Depth fr 30° FEBLE, Tooling 8
Polishing Compounds and Too 107
Production Problems with Tablet Qual 116
Production Problems with Tooling, Acknowledgments
‘The American Pharmacists Assocation (APRA) wishes to acknowledge the individuals listed below for ther assistance
{in producing this new edition, although space limitations prevent our listing each person's speci conebution, we
thank each member of the stering commit for suggesting revisions and additions to the manual, and for diligently
partcpating in numerous rounds of critiquing and refining the new material. We also thank the reviewers and
Contributors for providing information about industry processes and tablet tooling oF presses, and/or for reviewing
preliminary copy
APhA is indebted to all she listed individuals for theie dedication tothe tablet manufacturing industry and for their
‘generous conebusions of tie, knowledge, and materials
Tableting Specification
‘Stooring Committee
Members
en hey
‘oma gern
Han Exe,
‘Treo Higgins
[ella ited
Noting, gan
Bil Hatok
Merck a, tn Geir)
Maple Gln, Pennsyvania
Richard ik
Blzabeth Carbide De Co, Ie
Meteesport, Penna
Raf Larsen
Phe ne
Groen, Connecticut
Seen Melean
Sevens Industries
Farming, Nev Jersey
rere). Murray
[ORSCI mere Ie
South Easton, Massachusetts
Dale Nata
‘Natl Engineering Co ne.
Sunt hares, Missouri
Sean Selly
Fete america
Rockaway, Ne Jersey
1 Seplee
Jorma of Nee Consumes Padus
Fort Washingon, Pennsyania
Tony Yan Zebroeck
Nr Ine Pharma Stems
Cumbia, Maryand
Reviewers
(ary Barnabas
Manes
Mersey Sid, England
Gary Bubb
sw
Lebanon, New Jersey
‘Wolang Crees
IM Allan Gi & CoG
on Calg), Germany
Michael Glodek
Merck & Ca ne
est Point, Fesyvan
Gerald jak
Elzabeth Carbide De Co Ie
Meesport, Peansant
Wolfgang Langer
ORSCH Aerie
South Easton, Massachusetts
Joe Male
{Compression Components & Services,
uc
Huntingdon Valley Pearse
Contributors
Sten Deakin
[Holland Lied
Notingham, England
‘rood Deutehman
eamalyTehinolgies LLC
Plan iy Ohi
Dave Holeran
Nao Engincering Company Ine
Saint Cates, Misourt
Rodney S Hese
former of Was Engineering te
ofinan Estates, ins
nce tn
‘Natl Engnering Company Ie.
Sin Cares, Missourt
ea martin
‘Thomas aglnerng Ie
Hotiman states, iis
wi Preface
‘The Tableting Specification Manual is the
sole reference on US, manvfacturing specifications
for tablets and tablet tooling. Some international
tablet tooling manufacturers have also adopted the
TSM specifications as industry standards. Furthermore,
‘most international tablet press manufacturers produce
presses that mectthe TSM tooling specications,
With each edition of the manual, the publisher
and the steering committe have siriven to update
tooling standards as the echnology of tablet presses
and tooling continues to evolve. Members of the
committee represent tablet tooling manufacturers
and distributors, tablet press manufacturers and
distibutoes, and pharmaceutical companies, The
committee's ongoing mandate i to identify (1) whether
new tooling specifications are needed, (2) which, if
any, specifications shouldbe revised, and (3) what new
topics would be beneficial to those who manufacture
tablet tooling o presses ano those who workin tablet
reduction,
In the fith edition, the committee announced an
impending revision to make barrel diameters of B
and D lower punches the same as that of the upper
punches, The commitee also decided that compeession
force ratings should be based on $7 and SI tool sts
to reflect the predominant use of these steels in tablet
tooling
This new edition makes the revised barrel diameters
of B and D lower punches official by incorporating
the revised dimension in the speciation drawings
1 American Pharmacists Assocation
for punches. The committee also is recommending
that upper and lower punches have a barel-to-neck
chamfer and that all new punches have domed heads,
‘his ein aso discusses automated high-thraughput
presses and provides high-performance standards
{o maintain the presses" optimal performance. The
“Ieoduetion” discusses these and other advancements
in more deta.
Ineach eiton, individuals from major pharmaceutical
companies and tablet press manufacturers oF
distributors are asked to review proposed revisions
This peer review process ensures feedback from a broad
cross-section of the tablet manufacturing industry. The
process aso ensures that the tooling interchangeably
lables are updated with new press models, The
individuals listed in the “Aeknowledgments” provided
these valuable series for the new edition,
‘The mission of the publisher andthe steering commitiee
isto mainain the manval asthe enmplete guide to (1)
tooling design and specications, (2) tablet design, (3)
appropriate compression forces for various types of
tooling (@) proper maintenance of purchased taoing
and (5) troubleshooting of production problems, All
who have contributed to this and past editions have
helped produce specifications that further standardize
US. tablet tooling and wo compile guidlines for tablet
design and tooling maintenance that have universal
appeal
"—abletng Specification Steering Commitee Introduction
‘The frst ediion of the Tableting Speciation Manual,
published in 1971, ofered the first industry-wide spec-
fications for tablet tooling. The specifications, which
were developed under the direction of the Industrial
Pharmaceutical Technology (IPT) section of APA's
Academy of Pharmaceutical Sciences, are often referred
to as the “IPT standards." Because the IPT section
no longer exists, APhA and the Steering Committee
{ntcoduced the term “TSM standards” Inthe fourth
edition.
Objectives
‘The infoemation inthis edhion should ai all personnel
involved in tablet manufacturing, ablet design, tooling
‘manufacturing, and press manufacturing to
‘+ Communicate eal about the base and special ea
tures of production tooling. aswel asthe basic com:
ponents and operations of tablet press
+ Communicate clearly about the base configurations
and design considerations of tables
‘+ Understand the advantages of using presses that are
‘ompatbe with TSM specftions
+ plement methds o ensure standardization of tol
ing
Depending on ther information needs, purchasers of
‘the seventh edition also hae ready access to guidelines
that wil help them to
+ Understand toting dimensions, including tolerances
and clearances, andthe purpose of tooling specca
+ Understand the performance standards for automated
igh throughput presses
Understand the factors that affect tablet design and
‘ha to use this knowledge to ereate optimal tablet
designs
‘Understand the properties ofthe various tpes of tal
steals and how the compression forces fo which they
are subjected atthe lifecycle of toking
+ Determine the maximum punch cup frees for con-
«cave capsule, ova, and compourd-cup oval oling 25,
‘wel as those fores for FEREE, and 30° FFB oling
+ Lenghen the serve feof toting by reducing prema
ture wear and excessive breakage
+ Determine the causes of common tablet and toting
problems, and implement methods to reduce or ei-
inate the problems by selecting the appropriate tooling
options
‘+ Anterchange tooling appropriately between diferent
‘makes and models of tbls presses
Onder tooling from mpl suppliers
+ vid the cost work stoppages and poor quality tab:
Jes that can result frm using poor-quality punches or
‘missing good quality toting
Section Topics and
Guideline:
‘Tis manval offers basic information for personnel new
to the industry, specications fr tooling requirements
and design options, technical information on tablet
design and tool tel, detailed information on procuring
and maintaining tooling, and guides for troubleshooting
production problems. A summary of the topes in
each section is presented here so that readers can
quickly identify their areas of interest, New or revised
{information i also highlighted.
Section 1: “Guidelines for Using
This Manual”
Section 1 provides basic information about tablet
‘manufacturing, able tooling, and toling specications,
including the rationale for standardization of tools.
Specifically these guidelines define toling terminology,
‘seuss the most common punches and dies, compare
round and shaped tablet tooling, explain the functions
ofthe various positions on a rotary press, explain
the concepis of clearances, tolerances, and reference
dimensions, explain how to interpret spec
drawings, and explain the problems asso
‘nonconformance of tooling to TSM specications.
Section 2: “TSM Tooling
Specifications and Design Options”
Section 2 contains the specification drawings for
‘punches and dies, optional designs for punch tps and
‘ies, and toting interchangeably tables. Revisions or ations to this section include
+ Expanded definitions of industry terminology
+ Discussion of addtional tooling options: rotating
punch heads, multiple tip punches, dust cups, bellows
+ Revisd drawings of head configuration of Bype and
Datype punches (Figures 6 and 7)
+ Revised punch speitication drawings (Figures 8-11)
Oficial revision ofthe arel diameter of B and D
lower punches to match the diameters ofthe upper
pnches (Figures 9 and 11) (Inereasing the bare!
diameter of lower punches to match that of upper
pnches wil help reduce wear of punch tips, lower
punch seals, and guideways, as well as binding of
lower punches. The revised barre diameters ae based
on 2001 inch [.025-ilimetr] tip to bared (LR)
concentric)
Recommendation for abarrelo-neck chamfer for
‘upper and lower punches (Figures 9-11)
Recommendation of domed heads for new punches
(igsres 9-10)
Updated toting interchangeaiy ables (Tables $8)
+ Torque vives for screws used to assemble keys (Fg
ure20)
“Tooling Design Options” in Section 2 discusses the
‘enefs of punch barrel ehamfers and domed punch
heads
Section 3: “Tablet Design”
Section 3 defines tablet terminology and provides
supporting illustrations, identifies the factors that
‘let tablet design, provides guidelines for optimal
‘ublet design, and provides sample designs for bod and
‘numeral characters
Revisions or addons to his section include
+ Expanded defniions of tablet terminology
4+ Res discussion of stroke speiientons and distr.
‘ion supported by new en ilsraons
+ tustatin offacfaced beve-edged (ERBE) tables
‘on Figures 22 and 23,
Section 4: “Tool Steels,
Compression Forces, and Fatigue
Failure”
Section 4 provides information on the types of to teks
and their uses, coatings and treatments to increase
fooling ie, maximum punch eup eompresion forees
for ound toling based on finite element analyses, a
x
calculation method for determining maximum punch
cup forces for shaped tooling, and fatigue failure of
punches supported by a‘aigue curve,
Revisions and additions this section include
‘+ Toughness and wear resistance yas for O1 and A
Sues
Chemical composition raves for 408 and O1 steels
+ Disussion of toling coatings and textments, includ
ing the coating processes, comparison of thei fne-
‘ions and wear ressance, and engineering require-
‘ments forthe various coatings
Section 5: “Tooling Procurement,
Inspection, and Maintenance”
Section 5 provides 2 template fora standard operating
procedures program. instructions for setting up a
tablet and tooling directory are supported by forms
for obtaining approval ef toling drawings, aswell 3s
forms for ordering, inspecting, disbursing, and repairing
tooling. This section zIs0 provides comprehensive
idles for maintaining ol
Revisions to ths section neude
*+ Discussion of electronic inspection of tooling, inlud-
‘ng basiedesriptiors of the various systems, their
advantages and disadvantages, and the names ofcom-
mercially aalable pes
Section 6: “Troubleshooting Tablot
Production Problems”
Section 6 i the most comprehensive troubleshooting
‘guide to tablet compressing problems available
lablet manufacturers, Tae preventive and corrective
measures presented in this section include base rules
for avoiding production problems, factors that affect
punch if, the possible uses and corrective actions
for common tablet and toting problems, and a method
‘of determining wear of turret guidewnys by measuring
‘uneh ip deflection,
‘The publisher and the stering committee will
continue to wack technologeal advances in the tbl
manufacturing indus and dent emerging topics of
interest. Readers are ao ive parpte In this
questo Henne inéematon nee.
Suggested topics should be seat to the Tableting
Spectcation Manual; Books and Elecwoni Products
Department, American Pharmacists Assocation;
2215 Constitution avenue, NW; Washington, DC
20037-2985. E-mail suggestions can be sent to
aphabooks @aphaneor.
‘© American Pharmcits Association Guidelines for Using This Manual
‘Special Notice to Readers: Unless indeaed other
‘se gues and tet ilusations inthe manual are
not dea to scale. Further, unless indeed other
vise the dimension sted in figures and bls are
fen fist in inches, flowed by the equialen mi-
Timers in brakes.
‘The frst sep in Leeming any industry ie mastering ie
terminology. With this in min, the Steering Commitee
has adopted list of standard, industry-acepted terms
for tablet manufacturing. An understanding ofthese
terms wil provide a foundation on which persons
new to the industry can build a working Knowledge
of the basic tablet categories, tooling types, press
operations, and tooling specification drawings. For
those who have industry experience, the information
i this section could be a useful reference for ensuing
cleat communication berween production staf, tablet
designers, toting supplier, and press m
Tooling Terminology
‘The following definitions ofthe standard terminology
for tooling (punches and dies) are iustrated in Figure
1 age 3)
Abbreviations
IPT: Industrial Pharmaceutical Technology (obsolete
term replaced with TSM)
Ms Tableting Speyfication Manual
APhA: American Pharmacists Association (publisher of
the Tablet Specification Maral)
uropean union
PEA: Finite clement analysis
kN iloNewton
Ip: Hilopond
0.0.: Outside diameter
LD. Inside diameter
WL: Working length
OL: Oval length
General Terminology
Abrasion: The ac of wearing of contact surfaces.
Alpha/Numerie Characters: A B,C, ete/1, 2,3,
Anneal: «proces of heating a ste followed by slow air
‘cooing te change the steel’ microstructure, usualy to
soften
Angle: A igure that i formed by two fines diverging
feo a eommon point,
Are: A segment of circle
Axis: sagt ine serving to orient a geometric objet.
Barrel: The aren between the neck and stent of a
punch,
Barl-to-Stem Chamfer: The beveled aca located
between the barrel and barrel-to-stem radius.
The chamfer allos for the proper insertion ofthe
nck turret ol seals
Barrdl-to-Stem Radius: The area at she junction
ofthe barrel and stem, which provides a curved
teansion from the tp length tthe barrel
Bevel: Te angle ofa ine that meets another at any
angle other than a right
Blend: 1 form a rounded surface atthe point where
two surfaces come together to form an ange
Bore: Toform a ole through an object.
fo remove and round off a sharp
Burr: A rough or eased edge
Capping: A tablet defect in which air tapped during
compression creates a layer of granulation with air
between the granules, whieh in turn weakens the
structure and allows 2 expping fracture (lhe table top
and/or bottom curvature breaks off at or above the
band. (Channfer: A cu or bevel appli oan edge or corner.
Chipping: A deft inthe tablet in which a pice has
broken ofthe edge
Clearance: The diference in sae between interacting
pars, which creates a working space henween the pars
and allows for thelr designed fee movement.
Concave: Having a surface that curved lke the ine
surface ofa sphere.
Convex: Having a surface that is curved ike the exter
surface ofa spire.
Concentricity
centerpoint.
he measurement from a common
Corrosion: A chemical reaction of contact surfaces,
whieh causes piting and discoloration,
Delaminate: A defect in layered tablet in which the
layers spit apart,
Dimension: The numeric measured distance.
Ductitity: The ease that metal flows during the high
pressures of compression,
Finite Element Analysis (PEA): A sophisticated
‘omputer program tha is capable of modeling complex
shape configurations and performing accurate stress
analyses to determine the maximum force loading
that the punch tip can be subjected to and sill permit
infte tabletng cytes,
Flashing: 4 slight imperfection in a tablet in which
the material has been compressed above the land in
the clearance between the punch tp and the die bore,
causing raised ede
Formulation: The result of bringing together al the
Ingredients in a recipe (ee definition below) for a
pharmaceutical, food, oF nutritional product tha i
‘manufactured by blending (mixing) followed by
compressing or molding the mixture of ingredients.
Force Tip Ratings: Maximum force loading that 2
punch tp can withstand and permit infinite tabletng
‘ycles, The rating is derived from a mathematical
‘equation
Granulation: Structure of the granules (particles)
ofthe components of a pharmaceutical product after
blending
Hardening: A process of heating steel at high
temperatures, then cooling it to transform the steel
{roma soft (annealed) condition toa hard condition,
Identification: The application of letters, numbers,
andor symbols to an objets surface.
Industrial Pharmaceutical Technology (IPT)
seetion: The group who developed the fst industy
‘ide tooling standards—the IPT standards—which
‘wore renamed the TSM standards
KiloNewton: The unit of force use in measurement of
the lading applied o subjected to inorder to compress
the tablet the specified weight and thickness,
Kilopond: The unit of foree used to measure the
Fracture pont of tablet
Lubricant: A substance applied to moving parts to
decrease he friction generated betwen ther,
Milligrams: The unit of measurement used to
determine tablet weight
ik: A common lubricant used on a table press during
: Material thai used to assist in
bung the tip faces to remove built up residue
Product: The final blended material that is to be
processed into is final dosage form (tablet, capsule,
vial, et).
Recipe: The formula and contents forthe ingredients
(civ and inactive) and their quanties fora tablet
Relief (Undereut): The area of increased mechanical
clearance,
‘Tip Rolief: The undercut between the punch stem
andthe tip.
Bakelite Relief: A special, designed undercut to
prevent material buildup in the die bore.
Buropean Dust Cup Relief: A special, designed
‘undercut on the punch bare that allows attachment
ofa standardized dust cup with aprecut ole that is
Standardised 16 the groove sel
Rockwell Hardness: A measurement of the hardness
of steel The Rockwell seale is customarily used for
‘measuring oo steels
‘Score: embedded line inthe tables that allows the
lable to break when force is applied adjacent to the
area Thisterm inludes bisect and quarter scores,
Sharp: Term used to describe a comer or ege that is
not broken or rounded
Soft Zone: The area on tp fae that receives unequal
{© American Pharmacies Atocaion FIGURE 1. PUNCH AND DIE TERMINOLOGY
> pr eonar
soe HO MAE > —ee Hono Le
ene MOUS seats
Sin
UPPER (rma)
PUNCH
OX seomar
fee er
‘UPPER PUNCH FACE (OPTIONAL)
KEY POSITION
1
si BAREL—TO-STEM
(ew raL wa) MEER
(oPTONAL)
Te STRAT
NEOK-T0-FEAD RADUS
Il PAE OMER
ne OE
team gage CAT —~ omen
ro SHOULDER
DIE I on Le (enon)
oR
teicTs
Nex |
= TT Heap
hes ool—
pete TSM=Nt 4
force during the compression eyele, which may
result ina sor surface hardness ofthe tablet fa the
corresponding area
Sticking: A tablet defect in which material adheres to
the smooth surface of the punch tip face.
Surface he degree of smoothness required for
‘component, measured in mierons,
‘Tableting: The function of compressing a volume of
granular material into a hard form.
Tableting Specification Manual (1SM) Standards:
Standard specifications for tooling developed by the
pharmaceutical industry, tablet press manufacturers,
and the American Pharmacists ASsociaton for the US.
‘market
‘Tablet Specifications: The fin! parameters for weg,
thiekness, and hardness that are determined for any
sven table,
‘Tablet Thickness: The combined height of the
upper and fower punch tip cups and the band,
along with the expansion ofthe materials afer the
‘compression ofthe tablet, determines the total
thickness of tablet
‘Tablet Weight: The amount of materia pected for
the tablet, which is determined by the final volume
fil within the die
‘Tablet Hardness: The amount of force required
fracture a table, measured in kloponds
‘Taper: A gradual increase in the ize ofthe de bore that
extends rom th point of compaction othe chamfer of
‘he bor,
‘Tempering: A process of reheating and cooing see!
‘hat follows the hardening process. Tempering toughens
the tel but reduces its hardness.
Reading obtained when
measuring certain tooling dimensions with an
instrument. The TLR. isthe difference between the
highest and lowest readings noted on the indicator dial
during one complete rotation,
‘Tolerance: The authorized deviation from a tooling
dimension measurement. The deviation allows for
practicality of manufacturing toting.
‘Tooling: The collective term for the upper pune, lower
punch, anda die
‘Tooling Compatibility: The ability to inerchange
tooling between diferent types of presses
Steels used fo manufacture tablet
‘Tooling Steel
tooling.
‘Toughness: The ably to withstand great strain without
breaking,
‘Wear Resistance: Te ability o withstand abrasion
Tablet Press Terminology
‘Cam Track: The mechanical track that guides the
punches (lifting and lowering them into the dies) during,
‘rotation of the press turret,
Compression: The function of pressing material
‘together into a compact form.
Precompression: The function during the tablting
cjele In which the material is tamped to expel
tapped ai
Main Compression: The function during
the tableting eye in which the material is Tully
compressed io it specitied form,
Die Locke The de-fxng screw that secures adie in the
machine die table
Die Socket/Pocket: A recess (recesses) in the die
table into which the die is secured. The recess allows.
positional location of te de
Die Table: A component of the press's turret that
contains recesses into which dies are placed,
Dwell Time: The length of time that compression
tools (punches and dies) are subject to maximum
compression force from the compression or
recompression elle.
jection: The function of pushing the compressed.
tablet ut ofthe die bre
Fill: The function of ranular material entering the die
‘ore during the tablet process,
Punch Guides: the bores in the turret that bold the
‘punches, allowing them to ride trough the cam track.
‘The guides control the punch barrels surface, thus
‘ensuring the punch’s alignment withthe de
Punch Tip Deflection: The wal tip movement within
the punch guide due the clearance between the barrel
‘and the punch guide Sore atthe point where the punch
isabout to enter the de bore.
Punch Bntry: The ditance within the die at which the
tablet is compressed.
© Armarcan Phamaciss Assocation Serape Off: The function of removing excess granular
‘maleril from top of the de bore to allow forthe exact
‘measure volume fl onthe tablet press turret during
the ablting proces,
‘Station: A punch guide postion within de abet press
turret, which consists of an upper punch, a lower
punch, and ade
‘Tableting Gyles The process of compressing tale,
which includes the fil, crae off, compression, ejection,
and take-of functions.
‘Tablet Press: The equipment used to mechanically
‘ompres granular material int a hae fem,
Rotary Tablet Press: Equipment that uses
4 rotating turret to cycle the tooling through the
tabletng ele
Single Stroke Press: Equipment that uses
4 stationary table and eecenrie cam to cycle the
tooling through the tableing oe.
‘Take-Off: The function of removing the compressed
ejected tablet from the tablet pres turret during the
tablting process.
‘Turret: The reatng device in a tablet pres, composed
ofthe cam tack and die table, which holds and sligns
the tooling through the tableting ejele
Punch Terminology
Barrel: The area between the neck and stem of
pune
Barrel-to-Neck chamfer: The beveled area located
between the barrel and barrel-to-neck radus. The
shhamfer can rece eae of pinch gies
Barrel-to-Neck Radius: The area atthe junction
ofthe barrel and neck, which provides a smooth
transition from the bare the neck
‘arrel-to-Stem Chanafer: The beveled area located
between the barrel and barre-o-stem radius. The
chamfer allows for Ui proper insertion of the upoee
‘or lower punch ino the ol se
Barrel-to-Stem Radius: The area at the junction
ofthe barrel and stem, which provides 4 curved
transition fromthe ip length othe barrel
Bellows: A pleated sealing device that contracts and
expands upon application and removal of pressure. A
bellows covers the extended potion of the punch barrel,
(© American Pharmacie Asoction
providing better seal and, thus, beter protection fr
lubrication contaminating the product.
(Cup: The depression or eavity within the punch tip.
3 Acup design in whieh multiple
So megeente rm fhe caps cee Poin ates
fhe cup dare, or or mer as
Standard Cup: A cup desig in which a single are
$ gered fom the cups enter pot acts the
caps ameter nora, or major a,
Hat-Faced Bevel-Bdged (FRBE.): A cup
onfigurion eonsising ofan angie betneea he
sup'sand the tales fat fice anda and. A 30"
3erel preferred to maximie the sen of punch
Zips. When the bevel ls hist applied ts contact
tren withthe able face fa sharp Beveled ede
Flat-Faced Radius-Baged (F. cup
ronfiguration similar to EBLE consi of
‘ads between the cu's andthe table's Mt face
ind a land The ras fom the tablets periphery
3rland should not exe the comparable 30" Deve
Sse forthe FEB. design fo ensure the stent of
ch eds.
‘Cup Depth: The distance fom the cups lowest poiat
(usually the center point ofthe eup) to its highest
poiat (usually the highest point of the land), This
‘messurement doesnot ince identifeatonembassing
anddebossing.
(up Radius: A single are generated from the table's
centerpoint across the table's diameter, minor as, or
major axis
Fluted Barrels: Punch barrels wih machined grooves
tha! prevent build up of materia inthe punch guides
ead: The end of the punch that guides and postions
through the abet press's cam track
Head Angle, Inside: The area ofthe head that isin
ntact vith the wrk portion ofthe cam track —that
is the pulldown cam for lower punches and the
liking cam forthe upper punches.
Head Angle Radius, Outside: The ares of the head
‘atin contat wath the tablet pres cams and has
the inal eontaet with pressure roles
Head Plat: Te at arex ofthe punch head
Head 0.0. The outside diameter of the punch
head, The OD. estends the effective area of contact
between the eam and both the inside head angle and
the ouside head anleradvs
ooked Tip: A delet ofthe puneh tip caused by wear
in which the edge curl inward tard the puneh face.
5 FIGURE 2. TSM PRODUCTION TOOLING _
ts) “> ] 8)
ss0 a0
tion} F083 Ban] fos
82 AND B-TYPE UPPER PUNCH TYPE UPPER PUNCH
a ee
eer es
40 18)
hs ahs
(aay (2a)
0945 DE T = 1.1875 0E 7
1
5250 520
os feo] O88) ssf 888)
room| Gea)
1000 1000 12500
wo. | (549) ~ = i ———
B2-TYPE LOWER PUNCH B-TYPE LOWER PUNCH D-TYPE LOWER PUNCH
OE owe
(SCALE 1:1),
‘0 Now: For sPeone pss vooas,
aracr HLT eres
a i see
"uso
(2400) TABLE 8, PAGE 44.
0.945 DE 1.1875 DIE “DE mee TSM-N2 Interchangeable Upper Punches: Keyed punches
that can be inserted info any station ina press turret
because of the precise positioning ofthe key in relation
to the puneh tp,
Key A device tha is inserted into the punch barrel and
protrudes into the turret guide, thus preventing the
rotational movement ofthe punch, which allows for
Precise alignment ofthe punch tpt the die bore.
Woodruff Key: 4 half-round ke that is pressed into
broached machined grove inthe punch barrel,
Hi-Pro Woodruff Key: A halfround key with side
tabs that is pessed ita a broached machined groove
In the punch bare
Fixed Parallel Key: A standard flat key that is
screwed ino the broached machinod grove in the
punch arse
‘Keying Angle: The relationship of the key and the
punch tip shape to allow for proper ejection of the
tablet.
Land:
Land, Tablet: & narrow plane perpendicular to the
‘ables band, which eretes 2 junction between the
band and the eup radius
Land, Tip: The are between the edge of the punch
cp and the OD. af the punch ip
Land, Blended: The broken edge between the land
and the ip face
Leng:
Working Length (WL): The tengo the punch
Tom boro oft cap tote bead fa The
‘orig lng of he upper an lave pinches
“onl able hs and weight
‘Overall Length (04): The tl ped eng as
messare rm shed at othe dof hep.
"Neck: The relieved area herween the head and barrel,
which provides clearance forthe cams,
Oil Cups: A circular ep inserted onto the punch stem
{o collect exces lubrication and prevent it from dripping
down the punch onto the ip.
(Oil Seals: Seals that are placed into the upper and
loner punch guides to prevet lubrication from exting
the guides and material from entering them,
Punch: A rod-shaped tool, usually made from ste,
which is used in producing tablets and other hard
© American Phonmacits Associaton
products. The collective description for the device
Includes the head, neck, are, stem, and tip. The face
of the tip forms the mold surfce for producing detail
‘dogo, corapany name, identification code, etc) on the
tablet face (Set “Tablet Terminology” in Section 3)
Lower Punch: The punch inserted into the turret
below the die
Upper Punch: The punch inserted into the turret,
above the die
Radius: A line segment that join the center point of a
sphere with any point on ts surface.
Corner Radius: The curvature used to ciminate
sharp corners on peripheral surfaces where two
Tins or curves meet,
Barrel-to-Stem Radius: The comer radius located
between the punch barrel andthe stem,
End Radius: The radius located at either end of an
oval-shaped tablet,
Neck-to-Barrel Radius: The corner radius cated
between te punch neck andthe barrel
Neck-to-Head Radius: The corner radus located
between the punch neck an the inside head angle.
‘Seal Groove: A groove on the punch barrel that secures
2 sealing device, such as an oil/ust cup or bellows,
‘whieh prevents posible contamination of the product
during te precompression and compression phases
Stem: The area of the punch opposite the head,
beginning atthe tip and extending to the point where
the fll diameter of dhe barrel begins. If «chamfer I.
present, the bare usualy reaches is ull ameter just
shove the chamfer,
‘Tip: The end ofthe punch that is compatible with the
die bore. The tip determines the size; hap, profile,
and identification ofthe tablet
aving, Debossing: An engraving
om that is depressed into the tip face
below is surace ee Seton 3)
Tip Bageaving, Embossing: An engraving
ideseaton that provides above she suri of &
tptace Se Seto 3)
“Tip Fae: The aca within the cup's perper.
‘Tip Land: The area betwoon te edge of the
cup andthe OD. of the punch tp
‘Tip Length: The stright portion ofthe stem that
i effecive inside the de Bore. On lower punches,
the tip length allows vertical movement within the
neh die bore forthe metering of volume, compression of
‘granulation, and ejection ofthe tablet
‘Tip Straight: The are of the tip length that extends
from the end ofthe tip to te pele
Die Terminology
Die: A too that serves as the mold in which the prot
is compressed 19 form the desired peripheral (outer)
‘Sie and shape of a tablet
Die, Lined (Insert): A die fited with an insert
‘made from a much harder, more wear-resistant
‘material such a tungsten carbide ora ceramic.
Die, Tapered: A die in which the sizeof the bore
pradvaly increases from the point of compaction of
the granulation tothe chamfer ofthe bore.
Die Bore: The cavity within the die where the
{able i compressed. The cavity's shape and size
determine the same forthe able
ie Chamfer: Eniy angle onthe di bore edge.
Die Groove: The groove around the outer periphery
ofthe eenter ofthe die, whic allows thee to be
Fixed inthe tablet press
Die Height: The overall height of the de, which is
compatible with the height ofthe die sockets inthe
tablet press.
Die 0.D.: The ouside diameter ofthe de, which is.
compatible with the diameter of the die sockets in
the tablet press
Die Protection Radius: The undercut area between
the de groove and OD.
Tablet Manufacturing
Producing a tablet witha unique design often increases
4 product's recognition among consumers. Although
tablets can be produced in a variety of shapes and
sizes, limitations ast their configuration do exit, The
litng factors are usually related to characterstis of
the tooling and the press used to produce the tablets
Some categories of tablets are easier to manufacture
and comprise the majority of ables on store shelves.
Tablet Categories
Definitions of tablet terminology are based on the
geometric properties of the most common tablet
shapes; therefore, these definitions are placed in Section
3, "lblet Design” Fr the scope ofthis section, tablets
ae broadly categorized as ether “rounds” or “shapes.”
Figures 22-25 in Section 3 are erass-referenced in
the following txt o illustrate examples ofthe tablet
categories,
Round Tablets
Round tablets include primarily convex and fat-fced
tablets (se Figure 22, page 52). Frequently, industry
people use the term concave to describe both the
oncave surface ofa punch cup and the surface ofthe
tablet produced. Technically the punch cup i usually &
concavity and therfore produces a tablet wit a convex
surface; however, convex cups that produce concave
tablets do exist.
Convex tablets can be Further cateported according
to their cup depth Figure 23 (page 58) shows convex
tables with shall, standard, deep, extra-deep, and
‘modified-ball cup depths. Fatfaced tablets can be
further categorized as Mat-faced plain, fa-faced bevl-
edged, nd Hafod sg Ge Fre 25, page
56)
Shaped Tablets
“Tablets that have geometric configurations other than
those listed for rounds are refered to as shapes (see
gure 25). Figure 24 (page $5) uses three common
geometric configurations to ilustrate the terminology
for shaped tales. To produce a tablet with a particular
configuration, the tablet shape is reproduced in the
tooling used to manufacture the tblets. Before the
method of reprodvetion can be discussed, a thorough
understanding of tbe tooling is requized.
Modern Tablet Tooling
‘The function of tablet tooling sto produce tables with
predetermined physical characters, such as shape,
‘thikness, weight, and hardness. To achieve this, the
die cavity, or bore, filed with 2 granulation or powder
to depth that is determined by the position ofthe
lower punch. The lover punch's position determines
the amount of granulation used in each tablet. The
‘upper punch tip i then guided into the bore and force
is applied tothe punch heads, thereby compressing the
material into tab. The tablets shape is determined
bythe configuration ofthe de boreal dhe punch tps.
‘The tale’ thickness and hardness are determined by
© American Phomacss Asoc the amount of compression force applied tothe punch
heads, whereas its weight is determined by the amount
‘of granulation loaded into the de before compression
‘The basi design of tablet punches and dies used in
rotary tablet presses has changed very little since
these presses Were first mutketed in the hte 1800s
‘Only minor changes, such as refinements to the head
and tp radius, tighter tolerances, and higher surface
finishes, have boen made. In the U.S. tablet industry,
three types of punches and three types of dies are used.
preominantly in production presses to produce large
‘quaatites of tbls for market dsiibution,
Punches
Punches ae classified according to their overall length,
barrel diameter, andthe LD. ofthe punch head. These
dimensions as well as the other specification for tablet
tooling, aFe nominal: that is, each dimension has a
specified measurement, but is actual measurement
alter the tools produced may vary fom its speciation
The allowable variance from a nominal dimensio
called its tolerance range, is discussed later in this
‘section under “Toling Specifications.”
‘The punches most commonly used in production
presses are the B-ype and D-type punches (ee Figure
2, page 6). B2-1ype punches are used predominantly in
afer older models of presses that are no longer being
‘manufactured. During the researh stage of anew tablet
design, Faype puneies and dies (not pictured) and a
single-sation laboratory press are used to determine
the approximate amount of compression force and
‘granulation necded to produce a tablet with the desired
physieal characterises,
B-type Punches have a reference overall length of
5.250 inches [133.35 millimeters] and a head OD. of
inch (25.40 milimeters}. These dimensions are the
same forthe upper and lower punches. Although the
barrel diameter ofa B-ype punch i often said to be 3/4
{nc {19.05 milimetes) the speci barrel diameter
for the upper—and now the lower—punch i 0.7480
‘inch (19.00 mieters]
‘B2-Aype Punches usually havea barrel diameter of 3/4
inch [19.05 millimeters). Table 8 (pages 44-49) lists
barrel dlameters of B2-type punches for specific press
models). This punch has a head OD. of ¥ inch [25.40
millimeters}; however, the overall engths ofthe upper
and lower punches differ. The upper punch i 5.250
Inches [133.35 millimeters] long, whereas the lower
‘punch is 3562 inches (90475 millimeters} long
‘© American Pharmacie Astocohon
D-type Punches have the same reference overall
length as B-type punches (5.250 inches [133.35
millimeters)), but the head O.D. of D-type punches
is 1.250 inches [31.75 millimeters}. Again, D-iype
punches are often said to have a bareel diameter of 1
Inch (25.40 milimeters|; however, the specified barrel
diameter for the upper—and now the lover—punch is
(0.9980 inch [25.35 milmeters}.
Dies are classified according to their outside diameters
(oe Figure 2, page 6).
‘The 0.945 Die, as the name indicates, has an OD. of
0.945 inch (2400 millimeters). This size die can be
used with B- and B2-ype punches. The des commonly
relerredtoas "BB die”
‘The 1.1875 Die, sometimes referred to asthe “13/16
i,” hasan OD: of 1.1875 inches [30.16 millimeters]
land also can be used wih B- and B2-ype punches. This
\ 440-3V LIEV
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{© American Pharmac Asotin ‘The main compression step gives a tablet its final
characteristics, The final tablet thiekness is determined
by the distance between the punch rollers, which
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HONNd HAMO7 AdAL-C GHVGNVLS “Hl SHNDIS FIGURE 12. SPECIAL PUNCH TIP OPTIONS.
3/16 476)
125 MICROINGH MAX.
(UNDERCUT DIAMETER
BY .020 [51] #.005
UNDERCUT UPPER PUNCH TIP
UPPER PUNCH TIPS CAN BE MANUFACTURED TO INCLUDE THE SAME TYPE OF
UNDERCUT FOUND ON LOWER PUNCHES. UPPER PUNCH UNDERCUTS PROVIDE A
UP FOR BETTER RETENTION OF DUST CUPS.
015 R
ier 030
ts}
a
BAKELITE RELIEF
SOME MATERIALS TEND TO LEAVE A THIN FILM ON DIE BORE SURFACES. THIS
FILM CAN BUILD UP TO A POINT WHERE BINDING OCCURS BETWEEN THE LOWER
PUNCH TIPS AND DIE WALLS. BAKELITE RELIEFS PROVIDE A DEEPER,
SHARPER RELIEF THAN A STANDARO UNDERCUT, AS WELL AS AN ANGULAR
BACKDRAFT THAT HELPS KEEP DIE WALLS CLEAN.
DIS. KO TS —N1D
\© Arnoncon Pharmacists Acsaciton FIGURE 13. SPECIAL PUNCH BARREL OPTIONS
bust CUP
EUROPEAN DUST CUP RELIEF
(SEAL GROOVE)
A REUSABLE AND INTERCHANGEABLE DUST CUR WHICH FITS IN A SPECIAL GROOVE (SEAL
GROOVE) MACHINED IN UPPER PUNCH BARRELS, CAN BE SUPPLIED. THE OUST CUP HAS A
CIRCULAR HOLE SiZ20 TO MATCH THE GROOVE DIAMETER, THUS ELIMINATING THE NEED TO
PUNCH HOLES IN THE OUST CUPS. PUNCH BARREL OUST CUP RELIEFS OFFEA AN ALTERNATIVE
METHOD OF ATTACHING DUST CUPS TO UPPER PUNCHES. THE REFERENCE CONFIGURATION
BELOW 1S COMPATIUE WT MOST PRESSES.
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REFERENCE DUST CUP RELIEF
0041.0) 7 RADUS MAY BE NOREASED 0.077120) FA
FEE 1S USED AND THE UPPER PUNCH ENTRY SLANTED 70 295 (5)
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