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By Dr. Jérôme Freissmuth
In 2013, the pharmaceutical industry will continue to witness major changes and challenges. Considering global economic uncertainties, increasing healthcare costs and expiring patents, the industry appears to be in a state of turmoil. At the same time, markets are diversifying and new fields of growth are opening up. Rapid development of the emerging markets, progress in drug research, the rise in generics production, the availability of high-potency drugs and innovations in manufacturing processes will sustainably modify the global pharmaceutical landscape.
According to a recent survey, global annual spending on pharmaceuticals is set to reach almost $1.2 trillion U.S. dollars in 2016. The so-called “pharmerging” markets account for more than two-thirds of the world population. Doubling their spending on pharmaceuticals over the next five years, these markets will reach 30% of global expenses by 2016, as population growth and rising incomes contribute to the dramatically higher use of medicines. Improved access to drugs is supported by a broad range of governmental healthcare policies and programs. Due to increasing cost pressure and increased local demand, production is being relocated to the emerging markets. In many cases, this also applies to the production of generics. While the share of the industrialized nations in global pharmaceutical expenditure will continue to decline, spending on generics will increase due to expiring patents accompanied by higher generic use for off-patent molecules.
Biologics will also contribute to higher spending, as research brings clinical advances for the treatment of patients all over the world. Cutting-edge developments in personalized medicine have led to sophisticated solutions tailored to stratified groups. We observe a global trend towards combining pharmaceuticals with medical technology applications. The development of new drug delivery devices increasingly focuses on patients’ individual needs. Some of the devices such as inhalers are necessary applications to transport the active substance to where it is needed. Tools such as insulin pens have been optimized, in particular with respect to convenience and ease of use, while the equipment generally tends to be smaller and much safer to handle. In this sense, medical technology applications improve the quality of patients’ lives. At the same time, drug delivery devices are used as a targeted measure for product differentiation. The availability of high-potency treatments has also exploded in the past decade. High-potency active pharmaceutical ingredients (HPAPIs), for example, is a fast growing segment, and is projected to grow at a compound annual growth rate (CAGR) of 9.9% through 2018 .
To keep pace with these advances, engineering expertise is required to design equipment that can handle, package and secure such substances. Pharmaceuticals, biopharmaceuticals, vaccines and anti-virals must be manufactured and packaged with the utmost caution and attention to detail. It is with these requirements in mind that we see five particular trends emerging in the field of pharmaceutical processing and packaging equipment, namely: a rising demand for pharmaceutical quality and safety through inspection technology; the ability to handle potent substances; adapting lines for small batch sizes and research purposes; an increasing use of single-use components; and the need to improve productivity by optimizing manufacturing processes with respect to Overall Equipment Effectiveness (OEE).
Ensuring Pharma Quality and Safety
Strict pharmaceutical quality and safety standards such as the FDA’s Process Analytical Technology (PAT) guidance, as well as Good Manufacturing Practice (GMP) set the framework for pharmaceutical manufacturing processes. They aim at reducing the risk of product recalls and, most importantly, are designed to safeguard consumers’ welfare. In order to comply with these regulations, the industry requires reliable and high-end inspection technology equipment to be integrated in their production lines. Since 100% control has become obligatory, manufacturers are continuously challenged to increase output and improve efficiency, as well as inspection accuracy; the main focus will be on fully automated solutions. Manual and semi-automated devices remain in use for research purposes, customized smaller batch applications and the re-inspection of rejects from fully automated machines. Physical inspection via spectroscopic methods, pressure decay or high-voltage can be used to detect leakages and fissures of containers.
Quality control is essential for liquid and solid pharmaceuticals such as syringes, ampoules, vials, as well as tablets and capsules. One of the most common and reliable methods for particle inspection is the “static division” (SD) technology. It derives its name from the ability to differentiate static from moving objects, using light transmission to detect moving particles by measuring dynamic light fluctuation. Projecting light through the liquid onto an optical SD sensor enables the differentiation between particles contained in the liquid and immobile objects. The SD technology is also suited for inspecting filling levels. In turn, sophisticated high-speed cameras allow for the reliable detection of particles and cosmetic container defects. The combination of these two inspection methods provide for best inspection results.
Machines based on x-ray technology provide the means for comprehensive quality and weight control of capsules. These technologies are advancing rapidly due to software development and new imaging capabilities. More recently developed inspection platforms are able to check simultaneously all quality features like weight, foreign particles, deformation of capsule top and bottom, as well as length in real-time and at high throughput rates. The exact process control adopts several functions of visual systems for error identification and provides significant benefits such as reduced reject rates and the prevention of packaging errors.
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