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Choosing the Correct Tool

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Material Specification

Michael Oxford, Research and Design Engineer at I Holland explains how I

Holland recently helped pharma group Accord Healthcare improve tablet
production.

The Companies The company has been instrumental in

Accord Healthcare is involved in the introducing many innovative and unique
manufacturing and distribution of developments to the industry. Working closely
pharmaceutical products to over 35 European with its customers, I Holland helps to ensure
countries. clients operate the best possible tablet
manufacturing processes.
It has one of the largest market footprints of any
European generics and biosimilar company The Product
and is listed as the fastest growing generics One of the products Accord Healthcare
and biosimilar company in the world. manufactures is a 12.5mm Flat Bevelled Edged
tablet embossed with central break-line.
Accord Healthcare’s vision is to become
a top 5 pan-region generics company by Problem 1
2021. Their mission is to generate sustainable Previously, Accord Healthcare used standard
growth in sales, volume and company Tungsten Carbide dies to compress this
value, in the areas of generics, added value product but due to ‘black spots’ appearing on
medicines, biopharmaceutical and specialty the tablet walls after compression, the usage
pharmaceuticals, whilst ensuring that their of Tungsten Carbide dies was suspended in
patients get access to high-quality affordable 2008 and over the years either premium steel
medicines. They are also committed to dies or powder metallurgy dies were used to
developing the skills and capabilities of their compress the product.
people.
At the time it was believed the problem was
Headquartered in the UK, the company has being caused through the added resistance
an extensive supply chain through its four UK during tablet ejection, or through a reaction
based sites, helping to ensure a consistent with the Tungsten Carbide material itself.
supply of life-saving medicines for patients,
whilst supporting customers to react quickly to Tungsten Carbide dies have been adopted as
dynamic market conditions. an industry standard for dies when the highest
level of wear resistance is required. It features
With a history of over 70 years, I Holland has a high compressive strength with an extremely
built and maintained its position as one of the high wear resistance. This helps to reduce die
World’s leading suppliers of tablet compression bore wear and ringing and lasts longer than
tools to pharmaceutical, nutraceutical and conventional die steels.
confectionery industries across the globe.

www.iholland.co.uk
Although it is a common tooling material used system’s quickset fixtures are optimised to
within the pharmaceutical industry, normal be fast and repeatable, measuring tooling in
Tungsten Carbide uses Cobalt as a binding all critical dimensions. This allows the data to
material, this can have reactive properties be transferred to software systems (such as I
with acids and certain materials found within Holland’s Tool Management system) creating
formulations and can cause corrosion inspection reports.
resulting in black spots on the tablets.
The reports confirmed that the clearance
I Holland has developed a Tungsten Carbide between the punch tip outer diameters and
grade that uses a special binder in replacement die bores were well within specification . This
of cobalt, the binder has exceptional corrosion eliminated this as a cause of the delamination.
resistance meaning it makes an excellent
option if both corrosion protection and The next process was to use surface finish
resistance to abrasive wear are required. analysis. A form Talysurf was used to measure
the surface finish of the die bores to ensure
Problem 2 they were manufactured to Eurostandard
During manufacture, an additional problem specifications. The I Holland Eurostandard
experienced by Accord Healthcare was technical document (in existence since 1992)
capping and delamination of the tablets. advises tablet manufacturers on tablet tooling
Capping is when the top of the tablet separates terminology, configuration and procurement
horizontally when ejected from the press. and includes the latest technical specification.
Delamination is when the tablet splits apart
along the layers. It was found the die bore surface finish was in
specification for all the measured dies, so a
There can be several possible causes for this ‘roughening’ of the die bore was not a cause of
outcome during tablet production: the issues.

• Burred/clawed punch tips Finally, analysis of the sample tooling took

• Too many fines in the granulation place using iNSPECT 2.0. Punches and dies
• Weak granule should be visually inspected to establish if the
• Worn Die bores (Die ringing) tablet production process is running well and
• Compression occurring too low in die identify whether any tooling maintenance
bore is required. This assessment should also be
• Over/under pressure being applied carried out under magnification for any signs
• Air Entrapment in the tablet body of damage, wear or corrosion, and to validate
the cleaning process.

The Investigation Carrying out an assessment will establish

In order to find resolutions to the problems if the production process is working as it
being experienced during the manufacture of should, giving clues to problems with the
this product I Holland undertook a trial using tablet press or tooling itself, and if any tooling
their new non-marking HPG-TC (Tungsten maintenance is required. Typical equipment
Carbide) dies. that should be used for the inspection includes
high magnification lenses and microscopes.
Sample dies from several sets (ranging from I Holland’s iNSPECT 2.0, visual camera system
2007-2018) were supplied to I Holland for was used in this trial. Due to the high mirror
analysis. The first step was to use dimensional finish of tablet tooling, it has been specially
analysis of the dies through the ‘Approve’ developed for the close inspection of punch
system. This works by using a combination tips and tablets. Any system that is used should
of technologies/measuring equipment to be precise and give a clear high quality image
accurately determine the dimensions of that can be used to identify any problems.
punches and dies to micron level. The Approve

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The Trial specialist powder metallurgy grade steel with
A compression trial was undertaken on-site uniform carbide distribution and small carbide
at Accord Healthcare using I Holland’s newly size giving extremely high wear resistance over
developed special grade of Tungsten Carbide. and above that of premium steel, but it is less
The trial included manufacturing 4 batches of wear resistant than Tungsten carbide.
tablets with a production time of around 5 hours
and 1.6 million tablets per batch. Inspection of Analysis has shown that the life expectancy
5 specific dies took place after each batch to of the dies has always been inadequate due
monitor any change in die bore appearance, to the compromise of material selection
for example, signs of wear, and photographs required to overcome the black marks. This has
were taken for record and stored to enable necessitated in sets of dies being discarded
comparisons to be made during the trial. due to capping and delamination problems
with the tablets.
Solution 1
After the trial using the new Tungsten Carbide Conclusion
dies , no black marks were found on the tablet The results of this trial established that through
side walls. using material specifically developed for wear,
in this case I Holland’s specially developed
Analysis on-site showed that the dies and Tungsten Carbide material, problems like black
punch tips had sufficient clearance when fitted marks caused through corrosion and capping
to the press. The temperature influence (27.3oC issues are eliminated from production. In
at full speed compression) was checked during addition, the specially developed Tungsten
the site visit and determined not to contribute Carbide dies have very high wear resistance
to the cause of the capping and delamination therefore allowing Accord healthcare to use
or black marks on the tablets (i.e. there was the most wear resistant material available
no heat created through friction that could minimising issues with production.
have melted the granule). The press produced
240,000 tablets per hour with a batch size of 1.6 To clearly define why any production problems
million tablets. like black spots or capping are taking place, it
is important to consult with a trusted tooling
Solution 2 expert. With extensive technical know-how
Following extensive analysis of the supplied and many years of analysis the correct tooling
dies, I Holland recognised that the main specifications can be implemented resulting in
cause for the capping and delamination was improved tablet production.
through die bore ringing. The rings can either
be in the form of one ring which is caused by
an abrasive granule, or by two rings which
indicates tip deflection. ‘Die bore ringing’,
takes place in the die bore where the tablet
is compacted. The wear appears as a double
ring due the upper and lower punch tips flexing
and bending within the clearance between the
tips and the die bores during full compaction.
The tablet when formed within these rings
can have issues when being ejected from the
die causing capping and delamination of the
tablet.

Analysis of the rings on the old dies revealed

that the depth of the die bore ringing varied
between 3 and 17 microns, the deeper depth
being with Premium HPG steel dies as opposed
to the HPG Powder Metallurgy Dies. These use a

www.iholland.co.uk