First, the pharmaceutical industry has seen a significant shift of investments in solid dosage production equipment towards generics and contract manufacturing. As the companies in this segment of the market are, by nature, strongly focused on cost reduction, great emphasis has been placed on productivity, flexibility and process yield (that is, minimal product loss). Equipment cost and reliability, as well as fast on-site assistance have also become key selection criteria. Research and development-based companies have also been forced to follow this cost reduction trend.
Secondly, the meteoric growth of new pharmaceutical markets in the Middle East and the Far East (India, China and South Korea, for example) has resulted in investments in solid dosage equipment in these regions to surpass the investments made in North America and Europe. This puts an increased pressure on equipment price and has resulted in several Western based companies moving the design, manufacture and assembly of their equipment to Asia.
Finally, with the increased potency of new APIs, there is a growing need for better protection of the operator against the effects of pharmaceutical product processing. Operator exposure can be reduced either through the use of Personal Protective Equipment (PPE) or by making the equipment highly contained. The latter approach is the preferred solution, primarily for ergonomic reasons and because it offers a more efficient way of protecting the environment in general, as well as the facility and other personnel.
Technology BreakthroughsAlthough the operating principle and fundamental design of the rotary tablet press have not changed for decades, multiple machine design improvements have been developed and implemented by various suppliers to reduce cost and lead time; and, more importantly, to increase productivity, flexibility and safety performance.
The last 10 years have also seen a significant effort to design complete tablet production lines to handle potent and toxic drugs. As the powder in-feed, tablet handling, sampling and tablet collection all have to be performed under “high containment” conditions, it became imperative to design complete lines integrating the peripheral equipment, such as the powder discharge station, tablet deduster, metal detector, dust extractor and tablet analyzer. Initially, the most common technique was to build isolators around the equipment and provide Wash-in-Place capability. However, the latest design trend is toward containment at the source and off-line washing, as these concepts allow equipment to be smaller, easier to install and operate, and lower priced.
In its continuous quest for cost reduction, the pharmaceutical industry will continue to push for a further increase in operational efficiency. This can be accomplished through higher speeds, faster cleaning and product changeover, and fully automatic unmanned operation. Flexibility will also be developed further as the complexity of tablets increases, with the emergence of special tablets, such as multiple-layer tablets and core-coated tablets.
But most of all, future developments should focus on advanced process control to guarantee improved and constant tablet quality. This is one of the basic requirements to help realize two crucially important new concepts, which will shape the future of solid dosage production: continuous processing and real-time release. The implementation of new control strategies and the implementation of new types of sensors into tablet presses are vital means to this end. With the advent of promising new devices such as NIR sensors, progress is being made, but these are just the early stages of the new developments that are required.