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All in a Day’s Work
Contract labs handle problems your in-house lab can’t
by Kevin Trankler, PhD
What is this unknown material? What’s causing the off flavor in our product? Can you find the source of this off odor? Does my product contain pesticides or allergens? When such questions arise and unfamiliar problems occur, food and beverage manufacturers may need outside help to find reliable answers. For problems that can’t be solved in house, contract laboratories are often the answer.
There are many reasons a company might need to outsource food chemistry testing. A manufacturer may not have the analytical capabilities, such as specialized instrumentation, within its in-house laboratory. Kerri LeVanseler, PhD, is technical manager of the chemistry laboratory at NSF International (Ann Arbor, Mich.), an independent nonprofit organization committed to protecting and improving public health. She says companies often outsource analytical services to specialized laboratories to take advantage of their higher volume and expertise.
“If another lab can perform the test accurately and more cost effectively, it makes sense to outsource,” says Dr. LeVanseler. Additionally, even extensive in-house laboratories face capacity issues; overflow or emergency work may need to be performed elsewhere. In some instances, a company may need an outside lab to provide independent testing as a third-party provider.
Routine and Non-Routine Testing
One of the most important questions for a company to ask is if the quality issue requires routine or non-routine testing. Routine analytical testing methods are provided by numerous facilities, many of which are specialists in their particular method or matrix. This means that a higher level of experience and knowledge is available in those areas. Rather than specializing in one technique, a non-routine laboratory has experience solving obscure problems using a variety of investigative analytical methods.
Routine food chemistry tests can range from nutritional analysis and genetically modified organism testing to testing for pesticides, mycotoxins, and acrylamide. Allergen testing is becoming more common and can be a difficult field. “In some areas our scientific techniques are not on par with people’s sensitivity,” says Dr. LeVanseler. For example, she adds, current tests for the presence of corn may not screen the substance for the level at which an allergic person would react.
A non-routine project for one laboratory may actually be routine for another contract facility. “Silliker Laboratories is a big network of international laboratories. For the most part we are a routine high-volume laboratory,” says Sneh Bhandari, PhD, technical director of chemistry at Silliker’s Illinois facility (Homewood, Ill.). “Non-routine tests are also performed if they have the potential to become high volume.”
Jerry King, PhD, of Midwest Laboratories, Inc. (Omaha, Neb.) agrees. “If we only run a certain analysis very infrequently, we cannot make money. The investment in time, instruments, standards, validation, etcetera, needs to be paid off in repeat analyses. If we only get a single sample for a new or unknown method, it is not worth setting up to run the method.”
What should a company do when it doesn’t know what methods of testing are needed? What if the problem cannot be solved using the usual approaches? Chemir Analytical Services (Maryland Heights, Mo.) has been solving difficult problems for almost 50 years. Some examples of non-routine issues Chemir has investigated include:
- unexpected odors;
- unknown black specks or other contaminants;
- off tastes for no apparent reasons; and
- legal challenges.
If a company has a non-routine problem, the first question it should ask a contract analytical laboratory is if the lab has ever tackled this sort of project before. “Experienced scientists understand the pitfalls of solving unusual or strange problems with analytical chemistry,” says Carolyn J. Otten, PhD, director of specialized services at Chemir Analytical Services. Unlike in Hollywood’s CSI laboratory, the answers are not always apparent.
When choosing a customized laboratory, it is important to ask who will actually be performing the work, including both the analysis and the data interpretation. For unique challenges, investigational scientists must design and either supervise or perform the testing. Accreditations and regulatory registrations—if required—are important.
The laboratory facility itself must have the proper tools. A wide variety of instrumentation is important. This diversity of analytical techniques is useful when looking to identify an unknown material or seeking the source of a strange odor or flavor.
Quality and Communication
When choosing a lab, it is important to look for accreditation, which reflects the lab’s commitment to quality. “We prefer to see ISO 17025,” says Dr. LeVanseler, “but this level is not always available. If the facility we are considering does not meet this accreditation, we audit the facility to make sure they are meeting our standards.”
When asked what a client looks for in a contract testing lab, Dr. Bhandari does not hesitate: “Accuracy and quality. They should also ask about communication support. A client should not be left in limbo if there are further questions about the data and results.” Turnaround time is always important to the client, but accuracy and quality must come first. “Quick data may not be dependable, leading to questions and concerns that can take even more time to address,” Dr. Bhandari adds.
Consider the communication policy of a contract analytical facility before beginning a project. Who is your first contact with the company? Can they listen to the specific needs of your project and ask the right questions? When faced with customer complaints or legal challenges, a food manufacturer may need frequent updates and the direct availability of project managers or chemists for discussions. Confidentiality policies should also be considered.
Another key question: can the facility provide litigation support? “We sometimes try to avoid analyses that could have litigation impacts since we may not carry the necessary expertise or certification to provide adequate support in a court of law,” notes Dr. King. Chemir Analytical Services’ technical directors have presented testimony in depositions and trials in product liability, personal injury, and intellectual property cases. “We train our directors in the expert witness role by bringing in attorneys for mock trials and depositions,” says John Herries, PhD, senior director of analytical services for Chemir Analytical Services.
The Final Deliverable?
In the end, the best result is a solution to your problem. These results are best presented in a comprehensive report that includes original data, along with scientific interpretations. When appropriate, certificates of analysis should also be included; however, these are less relevant in non-routine, customized projects.
Turnaround time and cost are also important considerations. If your company is experiencing a manufacturing emergency, time may be of the essence. Be prepared for increased costs for expedited services. Rush costs may be balanced against manufacturing down time or potential legal challenges, however.
When comparing contract laboratory fees, make sure you are looking at similar investigative analyses. A customized laboratory will cost more than a routine lab. Be sure to make apples-to-apples comparisons when evaluating costs or comparing proposals from different labs.
Challenges for Contract Laboratories
The food and beverage industries are acutely aware of the need for reliable, accurate, and high quality contract laboratories. The GMA SmartBrief, a daily email newsletter, cites food safety as a key concern for the industry as members respond to consumer worries about domestic and international food sources. “Laboratories cannot sit idle,” says Dr. Bhandari of Silliker. “Sometimes the current situations result in clients needing testing tomorrow for a substance we’ve never heard of.”
Current consumer worries about food safety have made an impact on contract analytical laboratories, which are experiencing an increase in inquiries and sample volume. “Our methods and our results have been under close scrutiny by our clients and regulators,” says Dr. King. “We have had to develop or modify methods to meet the analytical requests on matrices where the method was not amenable.”
Media exposure of potential hazards has also become a challenge, Dr. King adds. He cites the example of last year’s pet food recall. “It was originally reported that aminopterin was the cause of the pet food problem, and laboratories scrambled to validate methods for aminopterin, and then, just as quickly, the focus shifted to melamine and cyanuric acid.” Laboratories work hard to respond in such instances but “as soon as the scare is gone, the tests are no longer requested and the instruments stand underused until the next scare arises.”
The challenge for both routine and non-routine contract analytical testing laboratories is to stay abreast of the issues affecting the industry. Also important is balancing the need for high quality, reliable data, and interpretations with the quest for timeliness and low cost. A client seeking to hire a contract analytical laboratory should consider these challenges and choose the best fit for its current needs.
Examples of Testing Services
When choosing a contract laboratory, ask for examples of similar problems solved. The following are some examples of case studies from Chemir Analytical Services and NSF that show how a contract laboratory can assist in solving complex problems and developing new products.
Unusual problems may require looking beyond the food or beverage product to the packaging and product-packaging interactions. For example, Chemir Analytical Services has tackled many projects involving examining extractables and leachables. Similar to FDA-required testing for pharmaceuticals, extractables and leachables analyses are designed to identify chemicals that can be released or migrate from product or packaging components.
Extractables and leachables may be organic substances, such as packaging raw materials, additives, or stabilizers, or inorganic substances like metal oxides or acids that can come from packaging components. A combination of capabilities and diverse instrumentation will allow a contract lab to include development and validation of methods for a variety of material components such as polymers, metals, foils, inks, adhesives, labels, liners, seals, and coatings.
Contamination concerns can be a difficult challenge for analytical laboratories, even those with considerable experience in the analysis and characterization of unknown contaminants in food and beverage products. An initial characterization of the sample includes determining the chemical fingerprint using solvent extractions and Fourier transform-infrared spectroscopy, as well as finding its elemental profile using a scanning electron microscope equipped with an energy dispersive X-ray analyzer. Often, however, further testing is required to fully identify the source of contamination.
“When an individual has consumed something and experienced a burning sensation or become sick, it’s difficult to go back and determine a chemical reason,” says Dr. LeVanseler of NSF. “Proper selection of sample preparation, instrumental technique, and the use of non-contaminated foods as controls may help to identify a chemical that should not be present.” When a contamination issue could potentially turn into a legal case, it is important to choose an analytical partner experienced in presenting testimony with solid, unquestionable data.
Identifying the reason for quality questions may require the detective work of an outside analytical laboratory. When off-quality problems occur, fingers point to product content, processing machinery, storage areas, or even a change in packaging materials. “Investigations begin with asking questions about potential culprits and, often, the client already has some ideas as to why the product has been compromised,” says Dr. Otten.
Testing may include a combination of analytical techniques such as solid-phase microextraction (SPME) and gas chromatography/mass spectrometry (GC/MS). The GC/MS analysis is used to identify organic volatile and semi-volatile components in a product. SPME/GC/MS is the technique of choice for the analysis of small, relatively volatile compounds, such as those that are capable of producing flavors and odors. After foreign analytes are detected and identified, they can be used to try to determine a potential source of the off taste or unexpected odors or colors.
For example, we recently analyzed a food product containing an off flavor. The processor suspected that the secondary packaging material was the contamination source. A comparison analysis of a control batch, the contaminated batch, and the suspected packaging source was performed using SPME/GC/MS. An expanded view overlay of the extracted ion chromatograms. The results clearly identified the secondary packaging as the source of the offending components.
Sometimes, analytical labs are asked to help develop new ways to market, preserve, or package food and beverage items. For example, a company may be interested in developing a spray or coating to preserve freshness in produce. Contract analytical facilities can de-formulate a competitor’s formula and make suggestions for reformulation of new products. These are complex projects that may require multiple stages of investigations. The exact analytical techniques vary depending on the scope of the analysis. The goal of a quantitative de-formulation would be to identify and quantitate major and minor components >0.5% based upon the available analytical data. This provides a working recipe for formulators to begin pilot batches.
Dr. Trankler is director of technical services at Chemir Analytical Services. Reach him at email@example.com or (314) 291-6620.