Vol 1/Issue 4/July-August 2012 PhTechMed ISSN: 2278-1099

Tablet Compression Tooling: An Overview

Dhavalkumar N. Lunagariya*, Jatin kotadiya, Vishmit Mehta and Roopal Rathod

*Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat

Abstract
The compressed tablet is the most popular dosage form in use now a day. Size of tablets to be
swallowed range from a few millimeters to about centimeters. Tablets are often stamped with symbols,
letters, and numbers, which enable them to be identified. Tablets can be made in virtually any shape,
although requirements of patients and tableting machines mean that most are round, oval or capsule
shaped. More unusual shapes are more vulnerable to chipping or manufacturing problems. Tablet
diameter and shape are determined by the machine tooling used to produce them - a die plus an upper
and a lower punch are required. This is called a station of tooling. Tablet compression tooling is in
intimate contact with the tablets during compression. Smoother tablet production can be achieved by
using robust tooling. Selection of tooling material is based on the type of product and past experiences.
Different surface treatments can be used to increase tooling life and productivity. Some special design
aspects like tapered die bore and Bakelite relief are used to reduce the tablet defects. Proper
maintenance of tooling helps in achieving tablet quality standards with respect to the regulatory
requirements.

Key Words: Compression tooling, Punch, Die, Surface treatments

Introduction
Almost 70% of world’s pharmaceuticals are based
on solid dosage forms particularly tablets. For the
production of tablets those meet quality standards
in both senses- regulatory requirements and
customer needs, particular attention is required to
the manufacturing of tablets. When pilot scale
batches are transformed to the manufacturing
scale lots of problems are faced which cannot be
predicted at the formulation development stages.
Moreover these problems lead to decrease in
productivity. Due to lack of time constraints
reformulation is not possible and thus skilled
production staff is challenged to optimize the use
of equipments at its best by choosing robust and
accurate tooling for the smoother tablet Figure 1: Tooling terminology
production. Tablet compression tooling can be Angle of the punch head that contact first to the
considered as the heart of tablet compression work compression roller is known as Outside head
as the whole future work will depend on the angle, where as angle that contacts lift up cam
tooling selection and maintenance of it. (upper punch) and pull down cam (lower punch)is
Important Terminology known as Inside head angle. Neck is the part of
Punch-Punch head is the end part of the punch punch between head and barrel. Tip length is the
that moves in the cam tract. Flat surface of punch vertical distance between the end of punch tip and
head that is contacted by compression rollers at tip to stem radius. Rounded face of tablet is
the time of compression is known as head flat. formed by the curved part of punch tip face
Address for Correspondence known as punch cup. Land is the distance between
E-mail: [email protected]
Tel: +91- 9723032136
the edges of punch cup and punch tip. Key is used
Received: 08/08/2012 to align the punch in unidirectional vertical way in
Accepted: 19/08/2012 unusual (other than round) shapes of tablets.

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Die- Die Outer Diameter is the distance between The rotary tablet press using the basic “B” and
the two vertical edges of the die. Distance “D” type tool configuration was developed in late
between upper and lower end of the die is known 1800’s by Frank J. Stokes. These configurations
as die height. Die bore is the hollow cylindrical are accepted worldwide with slight modifications.
part of the die in which tablet is formed. Chamfer, There are mainly two standards for tooling-
the end part of the die bore having slightly higher American standard [TSM standard which was
diameter which guides the punch into the die bore. previously known as industrial pharmaceutical
To keep the die in properly aligned position in die technology standard (IPT standard)] and European
pocket die locking screw is used which locks the standard [Euro norm standard].International
die groove. organization for standardization (ISO) has also
Tooling Standards and Types of Tooling developed ISO 18084.2005(E) standard for
punches and dies.
Table 1: Types of tooling
Types of tooling
Tool parameter
BB(inch) B(inch) D(inch)
Upper punch length 5¼ 5¼ 5¼
Barrel ¾ ¾ 1
Head 1 1 1¼
Die outer diameter 1 0.945 0.945 1½
2 1 3/16 1 3/16 1 3/16
Lower punch length 5¼ 3 9/16 5¼
Depth of fill 11/16 11/16 13/16

Table 2: Differences in types of tooling in TSM and EU standards

Material of Construction of Tools carbon, high chromium (D2) steel types. AISI
Standard (S1, S5 and S7) and premium category (D2) is an air-hardening, high carbon, high
(D2 and D3) steels are used for the fabrication of chromium tool steel with extremely high wear
tooling. These designations are given by resisting properties. AISI (D3) is high carbon high
American Institute of Steel Industries (AISI). chromium, air hardening alloy tool steel with
Selection of the material is based on different excellent resistance to wear and abrasion. D3 tool
factors like history of the product to be steel has good through hardening properties and
manufactured, geometry of punch tip, dimensional stability combined with high
compression force, abrasiveness of material etc. resistance to tempering. AISI (O1) is an oil
Different grades of stainless steel (300 and 400) hardening, high quality non-distorting cold work
can be used for the corrosive products. tool steel. With combined manganese chromium
Different Heat treatments are given to the tools to tungsten O1 tool steel is characterised by giving
maintain the tool dimensions for longer period. high surface hardness after tempering, good
These includes molten salt bath, heating and dimensional stability in hardening, and good
quenching in electrically heated ovens under machinability.
vacuum and in heating furnaces. Other technique AISI (S1) is a high duty shock resisting alloy tool
like tip drawing can be used to draw down the steel containing tungsten, chromium and
hardness of punch tip. vanadium. In the hardened condition S1 heat
AISI (A1) tool steel is an air hardening steel resisting tool steel combines great hardness with
containing 5% chromium. It is an intermediate good toughness and shock resisting properties.
grade between the oil hardening (O1) and the high AISI (S5) is an oil-hardening silicon-manganese
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steel of medium carbon content especially adapted Electroless plating is used for deposition of nickel
for punches. AISI (S7) is a general purpose air- (Ni). Before performing electroless nickel plating,
hardening tool steel with high impact and shock the material to be plated must be cleaned by a
resistance. It has good resistance to softening at series of chemicals such as bases and acids, this is
moderately high temperatures. The ESR (Electro known as the pre-treatment process. Electroless
Slag Remelt) process removes most of the non- nickel plating is an auto-catalytic reaction used to
metallic inclusions in the steel S7 is used where a deposit a coating of nickel on a substrate. Unlike
highly polished or a very smooth finish is electroplating, it is not necessary to pass an
required. electric current through the solution to form a
Causes of Tooling Problems deposit. This plating technique is to prevent
Sometimes tablet compression tooling is corrosion and wear. Electroless nickel plating has
associated with certain problems. Causes for these several advantages versus electroplating. Free
problems can be divided into formulation from flux-density and power supply issues, it
problems and mechanical problems. Formulation provides an even deposit regardless of work piece
problems includes moisture content, abrasiveness geometry. Boron (B) and Teflon (PTFE) can be
of materials, humidity etc. uneven wear of added to nickel to enhance hardening of coating
punches, corrosion of punch faces, improper and lubricity respectively. Processing temperature
polishing and buffing, higher compression forces is below 2000 F but tooling must be hardened at
etc. can be described under mechanical problems. higher temperatures (300-9000F).
The wear and corrosion experienced during 2) Physical Vapor Deposition (PVD):
normal tableting operations due to formulation Physical Vapor Deposition (PVD) is a variety of
problems may degrade and roughen the tooling vacuum deposition and is a general term used to
surface and the tableting tooling does not perform describe any of a variety of methods to deposit
better and longer. Mechanical problems like thin films by the condensation of a vaporized form
uneven wear of punches may affect the dose of the material onto various surfaces. The coating
uniformity of the tablets. Corrosive and method involves purely physical processes such as
improperly polished punch cup faces may cause high temperature vacuum evaporation or plasma
the failure of the tablets to meet the quality sputter bombardment rather than involving a
standards. chemical reaction at the surface to be coated.
Surface Treatments and Tooling Coatings Variants of PVD include Cathodic Arc
Different coatings and treatments can be used to Deposition, Electron beam physical vapor
enhance the tooling properties like wear resistance deposition, Evaporative deposition, Pulsed laser
against the aggressive granules, corrosion deposition, Sputter deposition. Hard refractory
resistance and lubricity. Surface treatments are nitride coatings can be deposited by physical
mainly of following three types: vapor deposition. Titanium nitride (TiN),
1) Chemical plating: Chromium Nitride (CrN) and Diamond like
Hard chromium (Cr) is deposited by carbon (DLC) can be deposited by this technique.
electroplating. Chrome plating, often referred to Processing temperatures are above 9000 F. Higher
simply as chrome, is a technique of electroplating temperatures can cause softening of the tool
a thin layer of chromium onto a metal object. The material and cause distortion of the dimensions.
chromed layer can be decorative, provide 3) Ion Beam Enhanced Deposition (IBED):
corrosion resistance, ease cleaning procedures, or Hard nitride coatings can also be deposited by this
increase surface hardness. A component to be technique. Here the processing temperatures are
chrome plated will generally go through these lower than 2000F. Thus this technique may reduce
different stages like degreasing to remove heavy the possibility of distorting the dimensions. IBED
soiling, manual cleaning to remove all residual also eliminates the need of after polishing
traces of dirt and surface impurities, various requirements. IBED processing combines the
pretreatments depending on the substrate, benefits of thermal diffusion processing and
placement into the chrome plating vat, where it is conventional coating technologies because the
allowed to warm to solution temperature and coating atoms first penetrate into the substrate to
application of plating current, under which the form a case layer in the surface, and then are
component is left for the required time to attain grown out from this case layer as a thick coating.
thickness. A typical hard chrome vat will plate at IBED is a physical, non-equilibrium coating
about 25 micrometers (0.00098 in) per hour. process implemented by the simultaneous
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bombardment of a growing film with an cleaning, visual assessment is made to identify the
independently controllable beam of energetic repairing work. Refinishing of the punches is very
atomic particles. Because control of the ion beam much important to improve the punch life. Critical
is independent of the coating vapor flux, the areas for reworking after usage are punch cup and
energy of the ions in the beam can be varied over punch head. For this, grinding technique is used.
a wide range and chosen within a very narrow While finishing the punch head care should be
window. This allows a high degree of control over taken that head flat diameter must not be larger
coating nanostructure and optimization of coating than the neck diameter. If this diameter is larger,
properties such as interfacial adhesion, density, can cause breakage of the punch head and punch
morphology and internal stresses. Essentially a will be of no longer use. Necessary repairs are
line of sight process, sources of the reactant fluxes made and tools are polished automatically by
are located so that they simultaneously illuminate microfine polishers. Then tooling is checked and
the components to be coated. validated by computerized measuring systems
Wear resistance of the tooling is more with TiN, which record the dimensions against the tool
CrN, and DLC deposited by IBED. Hard manufacturers’ original specifications. If asked,
chromium plating has intermediate wear they are made available for inspection by auditors.
resistance. Nickel plating is more prone to wear. Tooling is lightly oiled and stored in specially
Special Design Aspects designed cabinets to provide mechanical
Tapered die bore: protection and easy access.
Capping is a main problem associated with the
tablets due to air entrapment while compressing
the granules. To overcome this problem tapered
die bore is used to escape the air from the granules
moreover this tapered end will reduces the
ejection force and smoother ejection of the tablets
from the die bore is achieved.
Bakelite relief:
Sometimes sticky materials adhere to the die bore
which causes problems like weight variation.
Bakelite relief, a sharp lower edge of lower punch
tip helps to scrap this adhered material and cleans Figure 3: Breakage of punch head
the die bore which is necessary for smooth lower
punch movement. Regulatory Aspects
Upper punch Air out Tablet compression tooling and other equipments
are regulated by the food and drug administration
(FDA). These regulations are found in the “code
of federal regulations: Title 21- food and drugs”
Bakelite relief specific regulations for equipment used are found
in part 211 “current good manufacturing practices
for finished pharmaceuticals” subpart D
“equipment” section 211.65 “equipment
construction”. Contact surfaces of the tools must
not be reactive so as to alter the established
quality and safety standards.
Tooling Vendors
Lower punch Quality of the tooling is dependant of the
Figure 2: Tapered die bore and Bakelite relief reliability of the tooling vendors. A good
Storage and Maintenance of Tooling relationship with tooling vendors helps in the
Proper maintenance is critical to enhance the life technical assistance for the tablet tooling
of punches and dies. Tooling is stored and secured problems. Joint approach of tooling vendors and
properly after completing the compression work. tablet production staff improves the quality of the
Punches and dies are removed from the machine tablets. No tool steel is perfectly beneficial to
and transferred to the tool storage area. Here it is particular product. Selection of tool steel is based
cleaned by ultrasonic cleaners. After cleaning, on the experience and trials. Efficiency of tooling
tools are rinsed and dried immediately. Following
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