Equipment 101: a tableting perspective: an overview of the opportunities and challenges in the dietary supplement market.
Following proposed FDA requirements, companies would be required to establish and use a quality control system that encompasses manufacturing, packaging, and label operations. Specifications would be required for every step in the manufacturing process where control is necessary to ensure that a dietary supplement contains the quality, strength and composition it claims.
However, despite any legislation or regulatory controls, quality standards must first be met at the initial stages of processing and production.
With the growing trend toward dietary supplements and complementary medicine, there will be a subsequent growth in the supplement industry. Therefore, it is easy to see why precision manufacturing is fast becoming a prerequisite for success.
With more than 250 million people in the U.S. currently taking some form of dietary supplement and/or vitamin(s) on a regular basis and a growing trend toward complementary medicine, Americans are consuming more dietary supplements in record numbers. Recent national surveys show that 70% of Americans take supplements because they make them feel better, and nearly as many take them to either help prevent illness or to help them get well when they are sick. The same surveys indicate that 88% of consumers use vitamins.
According to FDA, there are well over 30,000 dietary supplements now available on the U.S. market alone, with thousands more likely to be added each year. Annual sales for the natural products industry is over $20 billion, which growing at a rate of 20% a year. Given the demographics of an aging population, this factor, among others, mirror the huge potential market for dietary supplements. For example:
* Two out of three older Americans believe that taking vitamins or other supplements is essential for people their age.
* A majority of adults aged 50 or older supplement their diets with vitamins, minerals or herbs.
* More than 60% of people believe that food alone may not be enough to meet their nutritional goals.
* A majority of older adults perceive dietary supplements as an important investment in their health.
* Close to 50% of older adults get dietary supplement recommendations from their doctors.
Tablet Presses and the Nutritional Market
Given the current and future rise in dietary supplement use, equipment manufacturers are poised to offer reliable solutions for a manufacture's needs. Since tablets have become the most common, significant and simplest method of administering medication, high performance tableting machines have come to play an essential role in helping to produce products that maintain and increase the standards of health around the globe. Therefore it is necessary to know some of the basics.
Compacting describes the manufacturing of large batches of small or medium sized products via compression. It can be used to process a wide range of different substances and semi-manufactures.
Examples would include the compressing of all types of granules into tablets and tabs, with dosage accuracy on a microgram level. A list of precisely defined parameters can be activated or deactivated based on the product involved. Entire batches can be produced within extremely tight tolerance limits, including, in the case of tablets, hardness, thickness, disintegration time and weight.
What to Look for in a Tablet Press
Choosing the best tableting machine model, tools, hardware and software for integration with management systems, and peripheral devices, are basically standardized according to the desired applications and products being manufactured. Significant amounts of data must be considered to reach a final decision, and actual usage trials are often necessary to solve specific problems or meet special needs.
The general result is a decision in favor of a machine which, though serially produced, has case-specific equipment added. For the production department, this could mean a double-sided rotary press with the greatest number of punches and dies to maximize the hourly output of large batches. Alternatively, a development department may require a highly flexible single-sided rotary press for short test runs.
In the end, everything boils down to one crucial point--where the tool meets the material being compressed. This is where the product is ultimately created, and here, everything must be perfect. To accomplish this level of perfection requires precisely defined output from three complex systems: the machine, the tools and the control system.
A machine's primary function is to provide the necessary force required for the compression of the raw materials. Its second function is to operate in a manner, which will yield maximum productivity.
The tools directly impact the raw material, thereby generating the actual product. Ensuring a substantial part of overall process uniformity are the tools' direct responsibility.
Regulating and monitoring the entire process is the primary function of the control system. Additionally, it modifies the process within set tolerance limits should variations occur. An exceptional product is a direct result of absolute control over the whole process.
The optimum requirements for tablet presses used in the manufacture of supplements and vitamins call for a combination of key features. These include versatility, flexibility and utility. First and foremost, a tablet press suitable for supplement/vitamin production must have the ability to compress various types of materials, since the natural ingredients used in their processing can range from powders to various herbal materials.
A machine capable of processing even the most challenging of products should have precision control capabilities as well as the ability to produce economical small batches of tablets and high volume products.
Desirable attributes include ease of operation and cleaning, minimal space requirements, rapid changeover times and long term reliability.
Machines must be able to produce supplements and vitamins in a variety of different sizes, shapes and colors, including single, double and triple layer tablets. It should also be noted that Galenics and contract production capabilities are of particular importance when dealing with varied product sizes and quantities. A basic checklist for choosing a suitable tablet press should include the following items:
* Rapid die table changeover for increased productivity
* High productivity of small batches for research and development
* Minimal space requirement
* User-friendly operation
* Economical maintenance
* The latest machine technology and sturdy design
* Menu-driven operation with touch-screen controls
* Comprehensive validation
* Process data documentation
* Batch recording
* Maximum working safety and operating security
* Maximum precision, even under static, dynamic or thermal stresses
* High performance capabilities
One final factor to consider is the level of experience, support and service available from the machine's manufacturer. In addition to machine quality and performance, look for an entire range of services created to assure trouble-free installation and operation, including live 24/7 support. These services should encompass everything from machine installations, to training, validation and trouble shooting, spare parts inventory and consultation.
By Michael Fazio Product Manager Fette America Rockaway, NJ
About the author: Michael Fazio is the product manager for Fette America, Rockaway, NJ, which is a direct extension of Fette GmbH of Schwarzenbek, Germany. For more information, contact Fette America at 973-586-8722; Fax 973-586-0450; E-mail: email@example.com; Website: at www.fetteamerica.com [ILLUSTRATION OMITTED]
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|Title Annotation:||Packaging & Equipment Showcase|
|Date:||Sep 1, 2003|
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