Tablet Tooling

There are several tablet manufacturers mainly from Europe who utilize a standard configuration for punches and dies under the banner of Euronorm, however, each manufacture tend to have their own individual features and tolerances. This has led to a situation where tooling was not completely interchangeable for the tablet manufactures. The manual is also a valuable document for education and training and at all levels for reference and guidance. Included are full specification for Eurostandard B and D type tooling (Round and Shaped).A common terminology for tooling and explanatory diagrams and charts relative to tabletting tooling.

Type of tooling systems: Eurostandard IPT Standard / TSM (Testing Standard Manual) Standard

Advantages of Standard Tooling: Tooling can be interchange between presses of different manufacture. Standardized tooling makes it possible for multi- national companies to interchange tooling and discuss technicalities on the same level. Tablet manufactures can reduce their tooling inventories. Standard inspection equipment and validation procedures can be used. Tooling purchasing procedures are simplified. Tooling suppliers can standardize their equipment and procedures for manufacture, hence keeping costs to a minimum and optimizing manufacturing lead times. A uniform quality of tooling can be maintained. N.B: Of course there will always be a need for special tolerance and additional features for specific applications. Problems Resulting from Improper Specification: Problems stemming from dimensional specification may affect tablet quality and productivity. Such problems can also substantially reduce the life of tooling, impair the efficiency of the machinery and even cause extensive and costly damage. Some specific examples are: Incorrect punch barrel diameter Incorrect punch barrel to tip concentricity Improper clearance of punches and dies in their sockets. Unnecessarily tight clearance of punch to the die. Excessive clearance between punches and dies Excessive variation in punch length. Incorrect steel selection Improper heat treatment procedure. Misuse of machine pressure Improper handling and storage of punches and dies.
www.pharmatechbd.blogspot.com

Tooling Identification: Serial Tooling No. type 1 2 3 D 25.4mm D Special B 16mm 4 BB 13mm 5 BB Special Maximum Tablet Dia Punch length 5.25" 133.65mm Punch Head Dia 1.25" Punch Barrel Dia 1.0" 25.4mm Die Outside Dia 1.5" 38.1mm Die Height 0.9370" 23.8mm Operating force in Ton 10

5.25" 133.65mm 5.25" 133.65mm 5.25" 133.65mm

1"

0.75" 19mm 0.75" 19mm

1"

1.1875" 30.16m m 0.945" 24mm

8mm

16mm

22mm

0.8748" 22.22m m 0.8748" 22.22m m 0.8748" 22.22m m

6.5

6.5

www.pharmatechbd.blogspot.com

TOOLING IDENTIFICATION FIGURES

25.27 31.5

133.6

25.35

D BB
24 22.22

B
30.1 22.22

38.1

19

133.6

25.27

31.5

Die Gauge

BB 24

B 30.16

D 38.1

www.pharmatechbd.blogspot.com

133.6

25.35

23.81

133.6

19

TERMINOLOGY OF TOOLING: The size and shape of a tablet as well as certain identification markings are determined by the compression machine tooling. Each tooling set consists of an upper punch, a die and a lower punch. Normally the upper and lower punches are the same configuration, except the lower punch stem or tip is longer to enable complete penetration up through the die to eject the compressed tablet. Since each tablet is formed by a tooling set, the tooling must meet many requirements to satisfy the needs of dosage uniformity, production efficiency, and esthetic appearance. Punch is the main part of tooling that is used to press into the die hole from both side of the die vigorously with an effective force. Die is the another main part of tooling that is used to make a tablet by the compressive force into the die hole of the both upper and lower punch of the tooling. TERMINOLOGY OF THE PUNCH: Head Flat Outside Head Radius/Angel

Inside Head Angel

Working Length

Overall Length

Anti Turn Key

Optional on Rounds standard on shapes and multi punches. Barrel to stem Chamfer

Fig:-01: Upper Punch TIP FACE BLENDED LAND

Cup Depth
www.pharmatechbd.blogspot.com

Fig:-01: Cup Depth

STEM

Tip Straight BARREL TO STEM RADIUS

BARRE L

BARREL TO NECK RADIUS NECK HEAD NECK TO HEAD

HEAD O/D Fig:-02: Lower Punch Head: The end of the punch, which guides it through the machines cam track. Head Flat: The area of the head that receives the full force of the compression rolls at the time that the tablet is being Formed Outside Head Angle/Radius: Contact area with the machine cams and initial contact with pressure Rolls. Inside Head Angle: Area of contact with the pull down (lower) and lifting (upper) cams. Neck: Clearance provided for the cams. Barrel/Shank: The surface controlled by the turret punch guides to ensure alignment with the Die. Tip: The end of the punch that is compatible with the die bore, and responsible for the size, shape, profile and embossing detail of the tablet.

www.pharmatechbd.blogspot.com

Tip Straight: Area of the punch tip effective inside the die bore. Stem The lower punch tip, which allows for movement within the die bore for the metering of the granules, Compression and ejection of the tablet Cup Depth Measurement of cup from the extreme tip edge to the lowest point of the tip face. Working Length The length of punch from the bottom of the cup to the head flat. Overall Length Nominal reference length, as measured from the rim of the tip to the head flat. [Cup Depth + Working Length = Overall Length] Relief/Undercut Mechanical clearance between the stem and the die bore. The sharp edge between the tip straight and the Stem acts to clean the die. Key To prevent rotational movement of upper punches to ensure alignment to shaped and multi-hole dies. Keying Angle Relationship of the punch key to the tablet shape. The tablet shape, take-off angle and the turret rotation Will influence the position. Land Area between the edge of the punch cup and the outside diameter of the punch tip. Major Axis Length of a shaped punch tip/ tablet. Minor Axis Width of a shaped punch tip/ tablet.

TERMINOLOGY OF THE DIE DIE BORE PROTECTION RADIUS DIE GROOV O/D

O/D

Fig: DIE

www.pharmatechbd.blogspot.com

Chamfer Entry angle of the die bore. Die Bore The zone where the tablet is made. Die Groove Groove around the periphery of the die to allow the die to be fixed in the tablet press. Die Height or Depth :Overall height of the die. Die Outside Diameter (O/D) Outside diameter of the die, compatible with the die pockets in the machines. Hard Metal Dies Dies fitted with a bush or liner made from a much harder/ wear resistant material such as Tungsten Carbide or Ceramics. Protection Radius To prevent damage to the die locking screw and burring to the outside diameter of The die. Taper: Gradual increase in the die bore from the point of compaction to the mouth of the bore, to assist ejection. Also remove the entrapment of air into the granules. OTHER TERMS FOR TOOLING: Abrasion: Cause premature wear of contact surface. Corrosion: A chemical reaction of contact surface causing and discoloration. Clearance: The difference from nominal size to provide optimum working conditions between Interacting parts. Hardening: A process of heating steel at high temperatures from a soft condition to a hard condition. Tempering: A process of heating to strengthen hardened steel. Tapered Dies: Tapered dies are used to eliminated tabletting problems such as capping and excessive ejection force The conical opening allows air to escape from the compressing zone between the die wall and the upper punch tip therefore reducing diameter, reducing damaged to the tablet such as capping or Lamination. Tapers can be applied to both ends of the bore to enable dies to be inverted.

TAPER TAPER LENGTH

Fig: Taper Die NOTE: Applying tapers are an extra manufacturing cost and are recommended only to solve the aforementioned.
www.pharmatechbd.blogspot.com

PUNCH/DIE CLEARANCE & PUNCH TIP TOLERANCE

MAXIMUM CLEARANCE TOLERANCE ZONE FOR PUNCH TIP HIGH LIMIT FOR TIP LOW LOMIT FOR TIP

MINIMUM CLEARANCE

UPPER PUNCH TIP NOMINAL DIE SIZE LOWER PUNCH TIP

LOW LIMIT FOR DIE BORE HIGH LIMIT FOR DIE BORE

TERMINOLOGY OF TABLETS: Bevel angle Bevel Depth Bisect Line Capping Coatings Counters/Islands Cup Depth Engraving Flashing Major Axis Minor Axis Picking Quadrisect Lines: Sticking :Angled edge of flat beveled edge tablet. : Cup depth of flat Beveled edge punches. : Score across the tablet to enable the tablet to be broken into two parts. :Laminar separation of the tablet. :Sugar or film coating applied to tablets. :Isolated mesas formed by certain characters, such as B and 8 :Measurement of cup from the tablet wall to the profile. :Normally referred to the punch face to produce tablets with detail in relief. :Semi-compressed material formed around the perimeter of the tablet. : Length of a shaped tablet/punch tip. : Width of a shaped tablet /punch tip. : Compressed granule that has adhered to the detail on the punch face. : Score on the tablet to enable the tablet to be broken four pieces. : Granulation adherence to the punch face.

www.pharmatechbd.blogspot.com

SHAPED TABLETS:

Figure: Shaped Tablet ROUND TABLET:

BEVEL ANGLE

Figure: Round Tablet

www.pharmatechbd.blogspot.com

KEY AND KEYING ANGLE:

Minimum Key Position from Head To Flat

Maximum Key Position from Head To Flat

Key Length

Key Width

The anti- turnkey is to guide punches with shaped and multi- tips into shaped or multi-hole dies. The key positions from the head flat-to avoid any contact between the key and the cam track of the machine. Key length standardized to suit the majority of tablet machines and for effective contact during punch movement. Total Key position from head flat-to avoids any contract between the key and punch guide seals. Key width/key height to operate with clearance in punch guide keyways. Keying angle angular relativity between key and punch tip to allow optimum presentation to tablet take off fence at the point of ejection.

www.pharmatechbd.blogspot.com

A B C D E F G H I

-MANESTY, CADMACH -KILIAN -FETTE, HORN -KORSCH -COURTOY, KIKUSUI -AWERICAN MACHINE -MISCELLANEOUS - MISCELLANEOUS -UNIVERSAL

Figure: Keying Position For Shaped Tablets (Capsule shaped)

www.pharmatechbd.blogspot.com