Contamination Identification Testing, Detection & Analysis
Impurities and contaminants at even the smallest levels have the potential to cause safety issues and concerns, impede product performance, and damage brand reputation. When this happens, individuals and manufacturers need to be able to determine the source of contamination in a fast and efficient manner. Avomeen’s team of experienced and consultative scientists can analyze contaminants down to the parts per million, billion, and sometimes trillion level.
Contamination is unpredictable and can originate from unexpected sources. Contamination can present in many different forms, and may be present in finished products as particulates, impurities, discoloration, changes in product appearance, stains, metallic fragments, degradation products or reaction by-products. Contamination issues occur across industries, and can impact industrial and consumer products, biopharmaceuticals, food and beverage products, dietary supplements, and more.
Avomeen’s talented and capable staff relies on their comprehensive understanding of material science to isolate and identify impurities down to trace levels, and work with you to determine the contamination source and find a solution to the problem. Our consultative team can also assist your team in put new quality control checks in places such as batch-to-batch testing, refined product development methods, raw material supplier analysis, and more to help prevent or minimize the risk of potential contamination in the future.
We have proven methodologies for specific substances that we use to effectively detect, isolate and identify the material and its source. For example, one method may involve a comparison study between a control and suspect sample. This study is dependent upon the sample matrix and the suspected level of contamination. Often, we begin with a general screen of the control and suspect sample using GC/MS and LC/MS. Then, depending on the test results, we could separate the contaminant from a large amount of sample and analyze it using FT-IR and NMR spectroscopy. Once identified, we begin to work further with your staff to identify where the contamination originated, develop a solution, and put checks in place to help prevent the contamination from occurring again.
Comprehensive Trace Elements & Contamination Analysis Services
Chemical Migration Testing – Chemical migration is often required to establish that a material complies with food contact regulation migration limits. Our scientists stay up-to-date on regulatory guidance and are highly skilled in performing overall migration studies, specific migration studies, printing ink migration studies, and more.
Off-Color, Off-Flavor and Off-Odor Investigations – Contamination often presents as off-color, off-odor, or off-flavor, all of which are critical attributes to product appeal. Such issues can be the result of packaging failures, ingredient breakdown, or deviations from standard processes. Avomeen’s team of skilled scientists employ a wide range of instrumentation to identify the source of contamination resulting in out-of-specification colors, flavors, and odors.
USP 2232/233 Elemental Impurities Testing – Ingredients from natural sources, including herbs and other botanicals, are subject to contamination from water, soil, agricultural components, air pollution, and processing procedures. FDA regulates both finished dietary supplement products and dietary ingredients, however, unlike drugs, compliance with USP standards is voluntary in the U.S., and compliance can only be enforced for supplements that claim to meet USP/NF standards. Finished dietary supplements that claim to meet USP/NF standards should be analyzed per the methods in Elemental Impurities – Procedures <233>, and should be analyzed by General Chapter <2232> Elemental Contaminants in Dietary Supplements for the four major elements of toxicological concern: arsenic, cadmium, lead, and mercury. Our consultative, regulatory experts can help you navigate the regulatory requirements and ensure your product is safe and conforms to regulatory guidance.
Environmental Analyses – Synthetic chemicals can contaminate food, clothing, and the environment. A variety of chromatographic techniques are available to identify and characterize contaminants in environmental samples at trace levels.
Extractables & Leachables Studies – Extractable studies provide data regarding a “worst case” scenario, and can help in material selection and early risk assessment, while leachablesstudies evaluate chemicals that leach into a product under normal use. With a proprietary polymer additive library to aid in the identification of extractables, our skilled team of scientists provide best-in-class extractables and leachables study data.
Impurity Identification – Impurities can include degradation products, leachables, and synthetic impurities, all of which can impact the safety and efficacy of a product. Avomeen’s teams of scientists have decades of experience identifying and characterizing impurities.
Litigation Support – For litigation cases involving product contaminant analysis, several of our veteran chemists have experience as chemical expert witnesses. They are skilled at explaining complex analyses and results in an easy-to-understand manner in a courtroom setting.
Mycotoxin Testing Services
Mycotoxins are naturally occurring toxins that are produced by certain molds, and can cause a variety of adverse health effects in humans and other animals. Mycotoxins can accumulate on food commodities as well as animal feed and natural raw materials that are used in a variety of applications, including dietary supplements. They have also been found to be present in other products that are made from naturally-occurring agricultural commodities, including tobacco products and tea leaves. Avomeen can analyze a wide range of sample matrices for a number of mycotoxins by validated LC/MS-MS methods. Specifically, our methods are validated for the following mycotoxin contaminants:
- 3-Acetyldeoxynivalenol (3-AcDON)
- Aflatoxin B1 (AFB1)
- Aflatoxin B2 (AFB2)
- Aflatoxin G1 (AFG1)
- Aflatoxin G2 (AFG2)
- Alternariol (ALT)
- Deoxynivalenol (DON)
- Diacetoxyscirpenol (DAS)
- Fumonisin B1 (FB1)
- Fumonisin B2 (FB2)
- Fumonisin B3 (FB3)
- Fusarenon-X (FUSX)
- HT-2 toxin (HT2)
- Neosolaniol (NEO)
- Nivalenol (NIV)
- Ochratoxin A (OTA)
- T-2 toxin (T2)
- Zearalanol (ZEA; a combination of α-zearalanol and β-zearalanol)
- Zearalenone (ZON)
- Antifungal thiabendazole (THIA)
For more information about mycotoxin applications and testing methodology, check out this blog.
Case Study – Product Contamination Analysis
Industry: Specialty Chemicals Manufacture – Contamination Testing
Problem: Major Batch Contamination of Oil Product
Solution: A perfume manufacturer noticed that one batch of their perfume oil had an unknown white powdery residue in the oil. Due to the properties of the contaminant and the oil, the manufacturer was unable to filter the particles out of the product, leading to production delays.
Avomeen used its proprietary extractions methodology, along with Gas Chromatography, Fourier Transform Infrared Spectrometry, and Liquid Chromatography/Mass Spectroscopy to separate and identify the residue from the oil. We were able to determine that the chemical properties of the powder were closely related to the ingredients in the perfume oil mixture. Avomeen’s contamination analysis determined that the residue was a byproduct of reactions/degradation of the ingredients present, not a result of a foreign contaminant. We then helped them reformulate their product to improve their products ingredient compatibility.