An overview of the tooling selection process including common pitfalls, critical ques...
Time for a World Tooling Standard
Category: Tablet Compression | 16/06/2010 - 11:12:52
After two centuries, there's no reason to maintain two tablet compression tooling standards.
Tablet Compression Tooling Standards
If your business is in the tablet compression industry, then you are most likely using tablet compression tooling of the standard "B" and or "D" configuration, regardless of the country you are in. Tablet compression tooling is often referred to as tooling, or more commonly, punches and dies. Tools to compress bulk materials into a solid form to preserve, store, transport, and distribute materials have been used for hundreds of years. But in the late 1800s, Frank J. Stokes designed, engineered, and commercially produced the rotary tablet press using the same basic "B" and "D" type tool configuration that we know today. This configuration is the most common and is recognized internationally. Unfortunately, there are two types of B and D tooling; the American standard known as the TSM standard and the European standard known as the EU, or "Euronorm" standard. These two configurations are so similar that only a trained eye can distinguish them. Yet they are different enough that the two configurations cannot be interchanged.
To better understand the differences between the American and European tool configurations, it is helpful to know a little about tooling history. In the early 1900s, Stokes commercially mass produced the rotary tablet press using the common B and D type tool configuration. The Stokes tablet press was so successful that Stokes distributed tablet presses to practically every industrialized nation, soon making the Stokes tablet press the most common press in the world. Stokes contracted with the English company Thompson and Capper to manufacture the Stokes tablet press and tooling, which gave Stokes a more strategic European position. At some point, due to economical and political pressure, Stokes was forced to abandon its alliance with Thompson and Capper and concentrated manufacturing at its main facility in Philadelphia, Pennsylvania.
After Stokes cut ties with England, the trained English engineers and staff decided to compete with Stokes—then the world's leading manufacturer of tablet presses—by producing their own. The English facility took its name from the industrial complex in which it was housed, and so was christened "Manesty Machines Ltd." Manesty knew that it was going to be a difficult task to compete with Stokes. In order to compete, the Manesty staff reengineered the B and D tool design, enhancing it to better cope with the stresses and shocks common to tablet compression. While the new Manesty tool design looked very similar to the Stokes design, it was engineered to be unique only to the Manesty tablet press design and was incompatible with the more common Stokes machines.
It didn't take long for Manesty and their aggressive strategy to take the European market from Stokes. In the meantime, Stokes concentrated its efforts on maintaining the United States territory, growing its business by selling into the rapidly expanding pharmaceutical industry. Soon Stokes and Manesty became the major worldwide suppliers of tableting equipment and were divided not only geographically, but also by tool design.
With the acceptance of shaped tablets and the growing tablet compression industry in the late 1950s, the Stokes manufacturing facility became overwhelmed with new business and found it difficult to supply and maintain the demand for tooling. This resulted in lead times of more than six months. The growing pharmaceutical industry could not tolerate these extended lead times and requested tool drawings from Stokes to source tooling from local machine shops. Their request was met with resistance.
The industry decided to establish a committee of pharmaceutical manufacturers who reverse-engineered tablet tooling drawings and made the drawings available to the pharmaceutical industry. Major pharmaceutical companies, such as Upjohn, Smith Kline French, and Winthrop collaborated with the American Pharmaceutical Association to publish and distribute the Industrial Pharmaceutical Technology (IPT) Standards Manual, the first ever edition of tool standards. At the time of publishing, IPT was a working section of the American Pharmaceutical Association. IPT was consequentially dissolved and the manual renamed TSM, for "Tableting Specification Manual," currently published in the seventh edition.
Dale Natoli is Director of Natoli Engineering Company, Inc., and has over 31 years of worldwide experience in the tablet compression industry. Mr. Natoli has published many articles for major pharmaceutical trade publications as well as authored printed chapters in “Developing Solid Oral Dosage Forms”, Vol. 15 of the “Encyclopedia of Pharmaceutical Technology”, and the 3rd Edition of “Pharmaceutical Dosage Forms: Tablets”. In addition, he chaired and served as a board member for revisions in the 3rd Edition of the “Tablet Specification Manual” sponsored by the American Pharmaceutical Association. Currently, he presents lectures for universities, pharmaceutical associations and tablet manufacturers in the U.S., Europe and Asia. His topics of expertise include: tablet design, tool configurations and troubleshooting. Mr. Natoli is the driving force behind establishing new technologies and special tool configurations for the tablet compression industry. He continuously works to enhance tablet production, quality, and extend tool life.