Tooling standardization in the tablet-manufacturing industry is a topic that has concerned tableting professionals for decades. I Holland, authors of the 1992 Eurostandard, the most widely adopted tooling standard globally, has been striving for some time to promote a consensus in this area.
Why was a standard needed?
Conception of the Eurostandard began in the 1970s when conversion from Imperial measurements (inches) to metric measurements (millimeters) first began to take effect, creating a recognized need to reduce variables in tooling specifications/standards set by original equipment manufacturers (OEMs).As European tablet-press manufacturers started to gain ground in the 1980s against UK press manufacturer Manesty's former market domination, German DIN standards began to be applied to tablet tooling. DIN standards were designed for general engineering components, limits, and fits, but the clearances created by this system are not always appropriate for tablet tooling.
The incongruity occurs because the powder compaction process is different compared with typical mechanical processes that benefit from contact lubrication using general engineering components. The DIN system did not address the issues a dedicated tooling standard could have addressed.
In 1990, I Holland invited prominent tablet-press and tooling manufacturers to come together to formulate a dedicated standard. Unfortunately, however, there was little received interest—possibly because of fears of losing competitive advantages. Despite this setback, the first edition of the Eurostandard was developed and published in 1992. By the time the second edition was released in 1996, the Eurostandard had been adopted as the accepted standard for the vast majority of tablet-tooling markets outside North America.
Simultaneously, during the mid1990s, a group of French pharmaceutical companies and tooling manufacturers contacted the International Organization for Standardization (ISO), to investigate the possibility of establishing a European standard for tablet tooling. This exercise culminated in the formation of the internationally acknowledged ISO 18084.2005 (E) for punches and dies.