Tablet mass variation

Uniform tablet mass is achieved by accurately filling each die cavity with product, and keeping the product
within the cavity until the upper punch lowers and applies pressure to bind the particles together. There are
many factors that can negatively impact the accuracy of the fill mass during the filling operation.

The various causes have been categorised into four main groups.

1) The lower punches

As only the lower punches are utilised during the die filling operation, all checks are associated with the
lower punches. Although similar problems can be experienced with the upper punches, these punches
impact tablet thickness and tablet hardness, not tablet mass.

The punches and dies are manufactured to very tight tolerances. Regular maintenance checks and measuring
of the tooling are critical in maintaining these tolerances. This will eliminate the tooling as a possible cause
of errors with regards to tablet mass, (tablet diameter and tablet thickness).

Any wear to the head flat of the punch negatively impacts the working length (often referred to as the
Critical length) of the punch. Worn punches become slightly shorter, (see Fig 1.0).

Fig 1.0 varying lower punch length

Variation in the thickness of the lower punch head flat, (see Fig 1.1) mainly due to wear, will result in erratic
movement of the lower punch, resulting in changes in the dosing volume and therefore the tablet mass.

Fig 1.1 variations in punch head flat

If some of the break pins or punch plungers are not set correctly, this may result in a small amount of
uncontrolled movement to some of the lower punches, especially when the flight or safety cams have not
been installed correctly.
If the lower punch guide holes in the turret are either dirty or damaged, they will cause friction on the body
of the punches resulting in restricted movement of the punches leading to varied tablet masses.

The underside of the punch head (punch inside head angle) makes contact with the security cams and the
pull-down cam. Any wear or damage to this section (see Fig 1.2) may result in erratic movement of the lower
punch, and therefore varied tablet masses.

Fig 1.2 worn inside head angle of punch head

Any small uncontrolled movements of the lower punches can result in tablets being produced out of
specification. To highlight this, see the example below:

A small round shallow concave tablet of 100 mg, with a diameter of 6.5 mm and a cup depth of 0.25 mm
would have the dosing set to 4.70 mm to achieve the nominal mass, (see Fig 1.3).

If the tablet press reject limit is set to 5 %, then any tablet greater than 105 mg or less than 95 mg would be
rejected, (see Fig 1.4).

The graph below, (see Fig 1.5), displays the changes in tablet mass for every 0.1 mm change in vertical height
of the lower punch. Therefore, any movement of the lower punch by 0.3 mm would result in an out of
tolerance tablet being produced and needing to be rejected.

To illustrate this, the thickness of a standard piece of A4 paper is 0.10 mm; the uncontrolled movement of a
lower punch by the thickness of less than 3 pieces of A 4 paper will result in an out of specification tablet
being compressed.

Fig 1.3 tablet parameters Fig 1.4 tablet tolerance

 Mass change

Vertical movement 0.5 mm 110.37 mg

Vertical movement 0.3 mm 106.22 mg
Vertical movement 0.2 mm 104.15 mg
Vertical movement 0.1 mm 102.08 mg
Nominal 0.0 mm 100.00 mg
Vertical movement 0.1 mm 97.93 mg
Vertical movement 0.2 mm 95.86 mg
Vertical movement 0.3 mm 93.79 mg
Vertical movement 0.5 mm 89.64 mg
Fig 1.5 punch movement

2) The press components

Worn cams or loose cams such as the fill cam, the weight adjustment cam / dosing cam, the flight or safety
cams and the pull-down cam, can all result in uncontrolled movement of the lower punches.

If the inner guide track in the fill cam is worn, (see Fig 2.0) this allows for erratic movement of the lower
punch resulting in varied filling of the die cavities.

Fig 2.0 fill cam inner guide track

The pull-down cam is an important cam and is situated immediately after the dosing cam. This cam guides
the lower punch head down by approximately 3 mm, and in doing so, it allows the product in the die cavity
to also drop by an equivalent amount (3 mm), (see Fig 2.1 a). When the tip of the upper punch enters the die
cavity at the pre-pressure station, the tip forms a seal and prevents any product from escaping the die
cavity. When the cam is worn, the lower punch is no longer pulled down and the product stays level with the
top of the die cavity, so as the upper punch tip touches the product, small amounts of product are forced
out, (See Fig 2.1 b) resulting in product loss and inaccurate tablet mass.
 Fig 2.1 a, correctly set pull down cam Fig 2.1 b, worn pull down cam

The “tail over die” or “die cover seal” is designed to form a cap over the open die cavities as they pass
between the force feeder scraper and the pre-pressure station. This plate prevents the escape of product
from the top of the die cavity due to centrifugal force. If it is not level on the die table and seals off the die
cavities, small quantities of product will be lost from the die cavity.

If the product scraper blade is worn, not set correctly, or jammed in an up position (usually from compacted
product), it will result in poor levelling of the die cavity and variations in dosing.

If an incorrect fill cam (too small) is fitted to the press, it can result in insufficient overfill of each die,
resulting in inaccurate dosing.

A faulty bearing in the force feeder can cause the associated feeder paddle to rotate erratically, varying the
quantity of product delivered to the die cavities, resulting in varied tablet masses.

3) The product

The product ideally should be free flowing as it passes through the hopper and force feeder. Restrictions in
the flow will result in variations in the filled dies.

To highlight the quantity of product that flows through the tablet press hopper and force feeder, an example
is given below:

With a tablet mass of 650 mg and a tablet press output set to 120 000 tph (2000 tabs / minute) a flow rate of
1.3 kgs per minute or 21.6 grams per second is needed.

A large variation in the particle size distribution, (see Fig 3.0), can have a negative impact on the uniformity
of fill. This occurs because the die volume determines the fill mass, and larger size particles separate
themselves from the finer particles, resulting in varying fill masses per die volume. This is especially
problematic in smaller sized tablets.
 Fig 3.0 particle size distribution graph

Segregation due to density changes in the product, especially at the beginning and end of the batch run, can
result in varied tablet masses, mainly due to a large variation in the particle size of the product, as
mentioned above.

Bridging or rat holing of the product in the bulk container or in the hopper of the tablet press restricts the
flow and can result in varied tablet masses.

4) The operator’s input

If the speed of the turret of the tablet press is set too high in relation to the rate that the product can flow
unrestricted through the hopper and force feeder, starvation of product to the die cavities will take place
and tablet masses will vary.

If the speed of feeder paddles in the force feeder is too slow, then delivery of product to each die cavity is
inadequate and will result in under filling of the die cavities.

If the control system parameters are set too wide, there will be no adjustment or correction to the tablet
mass. This is especially true for the rejection limits which may allow out of specification tablets to pass
through to the channel for the good tablets.

Excessive vibration of the tablet press can result in small quantities of product escaping from the die cavity,
especially if the die seal plate is not correctly installed.

Excessive vacuum or dust extraction around the peripheral of the die table can result in the loss of product
especially if the die seal plate is not correctly installed.

If the compression zone at the pre pressure station is set too high, for example if the upper punch
penetration is less than 2 mm, then the lower punches come into contact with the lower compression roller
first. This guides the punch upwards, pushing the product up in the die cavity and allowing it to escape,
resulting in product loss and varied tablet mass.

The upper punches pass through the lowering cam and the punch tip enters the die cavity just prior to the
punch head coming into contact with the upper pre-pressure roller. When installing the dies for shaped
tooling, it is critical that the alignment is perfect between the die bore and the tip of the upper punch. If this
is not the case then the upper punch does not enter the die cavity freely but is rather forced in under
pressure. This sudden downward force sprays a small amount of product out from the die cavity, (see Fig
4.0), producing an under weight tablet.

Fig 4.0 loss of product from one die