During the past few years, analytical techniques and equipment have moved out of the scientific laboratory and onto the manufacturing floor. According to Business Communications Co. Inc. of Norwalk, Conn., the overall instruments market will grow at an average annual rate of 4.1% during 1998 to 2003. The highest growth rate of any category will be in the area of ultraviolet and visible instruments, including spectrophotometers and spectrometers. According to the same source, the number and types of spectroscopic instruments used online in process-monitoring applications will also see an increase.
One of the mainstays of the online process monitoring area is near-infrared (NIR) analyzers. These analyzers may be used online for continuous and precise process measurement and control. New software packages have added many useful features to these instruments. A new Windows-based package from NDC Infrared Engineering, Irwindale, Calif., (phone 626-939-3896) captures data and plots measurement data for process analysis and gauge calibration. The software package is used in conjunction with NDC’s online NIR systems. For analysis of process trends, the software records process data, displaying a graphical plot in real time, and storing it for historical analysis. The graphical display makes it much easier to identify process characteristics, such as cyclic variations or the drift of parameters over time, that otherwise remain hidden in digital data. Events can be marked on the trend display and labeled, and data and complete graphical displays can be exported to other packages for further analysis and reporting. The graphical display allows users to identify rogue measurements—which would be difficult to spot in digital data—and allows them to be selectively ignored from calculations.
Foss NIR Systems, Silver Spring, Md., (phone 301-236-0157), which supplies NIR instruments to the dairy industry, has introduced a new Intact™ multi-test analyzer for the pharmaceutical and food industries.
Other spectroscopic instruments that have found applications for process monitoring and control are Fourier transform infrared systems and Raman instruments. Fourier transform infrared systems (FTIRs) and Fourier transform near-infrared systems (FT-NIRs), because of miniaturization and improved system configuration, are also finding their way to the food factory floor. Raman instruments have only recently begun to emerge into the process spectroscopy markets. Perkin-Elmer, Norwalk, Conn. (phone 800-762-4000 ext. 2522), has recently introduced dedicated FTIR units for the analysis of edible oils and for beer.
Epsilon Industrial, Austin, Tex. (phone 512-251-1500) offers Guided Microwave Spectrometry (GMS), a patented technology for inline composition analysis. The GMS system provides compositional analysis by measuring the change in the electrical properties of the microwaves (contained in the waveguide) as they are exposed to the process material. From the changes in the key electrical properties—dielectric constant, conductivity, and molecular relaxation time—an analysis of constituent properties is made. In addition to this real-time measurement, an ultra-rapid GMS measurement also can be made for a stationary mixture via a laboratory or at-line sensor. Because GMS is a non-contacting technology that measures the entire process stream (instead of only a small segment), the analysis of a representative sample is assured even if the mixture is nonhomogeneous.
Transfer of an innovative technology from the drug industry coupled with information management is said to give the food industry for routine quality control. The SafTest™ MAPP System, provided by Safety Associates, Inc., Tustin, Calif., (phone 714-258-8630), is based on membrane separation principles and provides routine quality control testing coupled with information management. The membranes permit separation of the desired analyte to be measured and removal of interferants in the food matrix. Using small sample and reagent volumes, instrument analysis, and rapid detection times, this technology is said to deliver micro-analytical product profiles (MAPPs) of 2–4 critical indicators of primary and secondary oxidation and lipolysis. Peroxide values, malonaldehyde, and free fatty acids are each determined quantitatively and can be measured directly on the food matrix, such as oils, meat or fish tissue, and finished food products.
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As consumers become more concerned about the quality and nutritional content of the foods they eat, the safety of those foods, and environmental preservation, food and beverage companies are facing a greater demand for instrumental measurement capabilities. Various online instruments provide a more accurate and real-time picture of food quality.
Coulometric analysis method and a device therefor. U.S. patent 5,909,114, filed 10/23/1997, issued 6/1/1999 to S. Uchiyama et al., assigned to Nakano Vinegar Co. Ltd. Describes a method of rapid coulometric analysis for the quantitative determination of a sample substance with high reproducibility without any application of voltage. It includes a galvanic cell and a device for use in said coulometric analysis. A wide variety of components can be analyzed by selection of electroactive substance introduced into the galvanic cell. The device enables a simple and easy analysis for food components such as glutamic acid, and ascorbic acid, and water quality measurements such as COD.
Method for detecting and/or determining ATP from mi croorganism cells in a sample. U.S. patent 5,908,751, filed 4/24/1997, issued 6/1/1999 to S. Higo and R. Tanaka, assigned to Toyo Ink Mfg. Co. Ltd. Describes a method for detecting and/or determining the ATP from microorganism cells in a sample. The method consists of centrifuging the sample and removing the supernatant, thereby forming a microorganism cell pellet; adding to the microorganism cell pellet a buffer containing a protease-free soluble protein and an ATP hydrolase and incubating the mixture at a pH of 6.0–8.0; extracting ATP from the microorganism cells with an added ATP extraction agent; and detecting and/or determining the ATP released from the microorganism cells by bioluminescence analysis. The method consists of a test kit for detecting and/or determining the ATP from microorganism cells, which comprises a reagent containing a buffer capable of pH adjustment to 6.0–8.0, a protease-free soluble protein, an ATP hydrolase, a reagent containing an ATP extraction agent, and a bioluminescence reagent.
Products & Literature
TEMPERATURE ACQUISITION MODULES for the popular Palm line of handheld computers allow users to collect temperature data for process analysis, laboratory research, quality control, and field service. The modules come in two models for ease of use and field deployment. The MT-20s module provides up to two channels of temperature input and clips directly to the Palm handheld computer’s base to create a mobile handheld temperature collection system. The ST-40s provides up to four channels of temperature input and connects to the Palm handheld computer using either the standard Palm HotSync cradle or the Palm HotSync cable. Both modules offer outstanding 1oC accuracy, support for J,K, T, and E thermocouples with a temperature measurement range from –200oC (-328oF) to 1,000oC. The temperature data may be uploaded to a desktop PC, and data files are saved in standard formats, allowing them to be opened by standard software packages. For more information, contact Tangent Systems, Inc., 8030 B England St., Charlotte, NC 28273 (phone 800-992-7577, fax 704-554-0820, www.versid.com) —or circle 361.
VACUUM CONCENTRATOR AND EVAPORATOR SYSTEM, the RC 10.10, is a centrifugal vacuum concentrator designed to rapidly concentrate biological and other samples in preparation for further analysis. The unit combines centrifugal force to prevent bumping and foaming with high vacuum and heat to remove the solvent. This results, it is said, in virtually 100% sample recovery with no contamination. Fifteen different rotors are available to spin everything from Eppendorf tubes to microtiter plates. A glass lid and an automatic bleeder valve are included to provide long life and performance. For more information, contact Jouan, Inc., 170 Marcel Dr., Winchester, VA 22602 (phone 800-662-7477) —or circle 362.
CHEMICAL STATION, the Purifier Class 100, has been designed for critical environments requiring Class 100 conditions in combination with chemical resistance. With a corrosion resistant interior of PVC and tempered safety glass, this total exhaust vertical clean bench may be used for applications involving acids or organic solvents. During operation, two built-in blowers draw room air through a pre-filter at the top of the cabinet and then through a HEPA filter. Class 100 air is then projected vertically across the work area. Air is captured in grills at the front and back of the cabinet and exhausted to the outside using ductwork and a remote blower. For more information, contact Labconco Corp., 8811 Prospect Ave., Kansas City, MO 64132-2696 (phone 816-333-8811, fax 816-363-0130) —or circle 363.
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COMPACT UV-VIS SPECTROPHOTOMETER, the UV Mini, is a new UV-Vis spectrophotometer that is said to provide features and performance comparable to standard models in a compact design. Standard on-board application modes include photometric, spectrum, and quantitation. It incorporates a universal sample compartment, which accommodates a complete line of accessories. For more information, contact Shimadzu, 7102 Riverwood Dr., Columbia, MD 21046 (phone 800-477-1227, www.shimadzu.com) —or circle 364.
Herbal and Botanical
The following information is part of a series that provides an overview of the international and U.S. regulatory requirements for a variety of food commodities. This month’s installment is on the regulatory and analytical testing requirements for herbal and botanical products. This information has been supplied by Perkin-Elmer’s food and beverage team. Perkin-Elmer supplies analytical laboratory instruments to perform a variety of tests. For more information, contact The Perkin-Elmer Corp., 761 Main Ave., Norwalk, CT 06859-0010 (phone 800-762-4000 ext. 2522; fax 203-761-2812; e-mail [email protected]; www.perkin-elmer.com).
FOOD OR DRUGS?
Whether herbs should be called food or drugs is a question considered frequently by government regulators and remains a regulatory “gray” area. The regulatory question arises because herbs have been safely consumed for centuries as seasonings and flavors and many are brewed into teas. Herbs have also been used for medicinal purposes throughout recorded history in the ancient cultures of China, and Egypt, and India. When herbal extracts are sold as dietary supplements for their positive health effects, should they be regulated as foods or drugs?
The primary difference between food and drug law is rooted in the concept of product safety; drug laws are stricter. Before a product is marketed, drugs must undergo a series clinical studies to determine their effectiveness, safety, interactions, and dosages. Historically drugs are defined as articles intended to cure, treat, or prevent disease. Medical claims were limited to drugs only. Disease prevention was forbidden on food labels.
Food laws generally recognize substances that have a long-standing history and exempt these products from further testing. These substances are sometimes called prior-sanctioned or GRAS (generally recognized as safe) materials. New substances are considered food additives and require proof of safety. This has a major impact on business practices associated with launching new products.
In the 1980s, government agencies began to officially recognize the relationship of the diet and risk factors for disease. The scientific evidence convincingly linked some food components as risk factors for disease (e.g., saturated fat and coronary heart disease). Other foods convincingly demonstrated a reduced risk of disease (e.g., fiber with cancer, calcium with osteoporosis, and omega-3 fatty acids with coronary heart disease). Now some health claims are permitted for foods.
As the regulatory climate became more favorable for health claims, herbal and botanical products began to be marketed extensively. These products appeal to consumers because they are “natural” and have value as an alternative medicine.
Herbal specifications, quality standards, and dosages are important considerations for the industry and regulatory agencies. Deaths have occurred because products have not been standardized. In 1997, the U.S. Food and Drug Administration (FDA) proposed to limit the amount of ephedrine alkaloids in dietary supplements (e.g., ephedra, Ma huang, Chinese ephedra, and epitonin) and require warning labels. An herbal ingredient, plantain, was withdrawn from the market because it was contaminated with another botanical. Cases of kidney failure and cancer resulted when Arisolochia was accidentally substituted for the herb Stephania.
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Codex Alimentarius. Herbals and botanicals are under discussion in the Codex Joint FAO/WHO (Food Agriculture Organization/World Health Organization) Food Standards Program. The WHO is an advisory group concerned with health issues, particularly those impacting developing nations. Herbal medicine is the focus of an initiative to improve health worldwide by 2000. There are 10 centers collaborating: Belgium, China, the Democratic Republic of Korea, Italy, Japan, the Republic of Korea, Romania, the Sudan, the U.S., and Vietnam.
In 1996, the Canadian government suggested that a list should be developed of the botanicals and herbs that are unsafe for food use. The Codex Alimentarius Commission decided that this topic is outside the scope of the Committee on Nutrition and Foods for Special Dietary Uses and deleted it from their work. The Commission also considered a recommendation that FAO/WHO establish a technical working group to study procedures for evaluating the safety of botanicals and herbs. This will be addressed in the future.
Europe. Any herbal preparation sold to treat disease is subject to the same quality, safety, and efficacy controls as any medicine. There are no EU-specific laws covering herbs or botanicals.
Germany. Germany has one of the more advanced scientific approaches to herbs. The Federal Health Agency has prepared monographs on 327 herbs and phytomedicines (botanical medicines). Each monograph contains information on approved uses, indications, contraindications, and side effects. There are 190 herbs and fixed combinations that have been proven to be effective for therapeutic use in Germany.
Herbs are regulated as dietary supplements along with vitamins, minerals, and amino acids. Please refer to section DS-5-1.doc for additional details.
The FDA has authority to regulate questionable herbal health claims, under the Dietary Supplement Health and Education Act of 1994 (DSHEA). In 1996, the FDA questioned label claims such as the following: “Stimulates wound healing by increasing fibroblasts” (echinacea); “Stimulates the growth of the body’s immune system” (echinacea and goldenseal); “Helps offset the distresses which cause stomach discomfort from motion or certain foods” (ginger); and “Stimulation of uric acid secretion can help provide symptomatic relief of rheumatic conditions” (stinging nettle).
USP. The United States Pharmacopeia (USP) is an organization that establishes standards for drugs, nutritional supplements, medical devices, and equipment. USP standards are well recognized by government agencies and are enforceable by the FDA. USP began focusing on herbs and botanicals in 1996. USP decided that appropriate standards must be developed for herbs to ensure product quality.
Information must be available for consumers to assure safe use. Identification tests, analytical methods, information sources, claims and potential health risks issues will be included in the standards. Since 1996, USP has been developing separate monographs on herbs. Final standards monographs on several botanical products are due by the end of 1998. Herbs that are considered for standard development include: Angelica, Comfrey, Cranberry Extract, Echinacea, Ephedra or Ma Juang, Feverfew, Garlic and Garlic powder,Ginger and Ginger Powder, Ginko Boloba, Ginseng, Golden Seal Root, Hawthorn, Kava Kava, Licorice, Matricaria Flower, Milk Thistle, Nettle Root, Saw Palmetto, St. John’s Wort (Hypericum), and Valerian
by JAMES GIESE
Code of Federal Regulations
A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients, Food and Nutrition Board Institute of Medicine National Academy of Sciences, Washington, DC June 1998.
Trends in Food Science and Technology, 7 (4): 139-142.
The U.S. Herbal Supplements Market - Executive Summary, Products and Market, from Packaged Facts, November 1997. (http://www.profound.com)