Frequently Asked Questions

If a sample does not meet the specifications provided an OOS notification will be sent out to the Partner to inform them of the results. At which point a copy of the OOS report can be requested as well as any retesting.

Preservative Efficacy Testing, aka PETs or Challenge Testing, is performed to evaluate your product's antimicrobial properties. To perform this test, the lab introduces a known quantity of a known species of organism into the product and measures those organisms' viability over a 28 day period. A successful test will yield no less than a two-log reduction in counts from day zero (0) to day fourteen (14), and no increase in counts from day fourteen (14) to day twenty-eight (28).

While PET's are great at helping you understand your product's antimicrobial properties, this test is not a Stability Test or Shelf Life Test.

Stability and Shelf Life testing measures the concentration of the active ingredients in the product. It also monitors its organoleptic properties such as color, smell, taste, viscosity, appearance, and efficacy over time. This test is performed by collecting enough finished product samples for the duration of the testing, placing half of the samples in a stability chamber, set at 40 degrees C and 75% relative humidity. The other half of the samples are placed in a controlled environment mimicking the natural conditions of the target market in which the products are to be sold. The former is known as the accelerated shelf-life test, and the latter the real-time shelf-life test. A profile of physical characteristics and actives tests is conducted according to your label claims, at 0, 3, 6, 9, 12, 18. 24, and 36 months. The real-time samples are pulled according to these months, and the accelerated portion of the tests will occur based on the Arhenius formula, which dictates how many days in the chamber are equivalent to real-time days.

The purpose of the stability study is to learn how the product fairs over time and how long you can expect the product to meet its quality specifications.

When you submit a sample for analysis under a particular turnaround time, you expect your laboratory partner (ARL) to make every effort to meet this schedule. So, how are turnaround times measured, and why are results sometimes “late”? This article is intended to demystify turnaround times (TAT’s).

Let’s explore how we can work together to mitigate delays and risk:

ARL’s On-time Rating Is Greater Than 97.7%!

We are very proud of our on-time rating, but we continually strive to do better.

Microbiology Testing Is Measured in Calendar Days

Samples submitted for routine microbiological testing (Complete Micro Profiles by USP 2021/2022 and 61/62) constitute a large percentage of the testing that we perform at ARL. For more than 25 years, we have set up these samples the same day they are received by scheduling swing and night shift microbiology teams. Routine micro is measured in calendar days. Once the testing has begun, these living, breathing organisms do not care what day of the week it is; they just do their thing 7 days a week, and so must we. Please note that calendar days are measured in 24-hour periods. The day we received the sample is Day Zero; the next day is Day 1.

Chemistry Testing Is Measured in Business Days

The turnaround times for samples received for analytical testing, such as HPLC, GC, ICP, etc., are measured in business days. Chemistry tests require the direct attention of an analyst throughout the testing process. For this reason, analyses are scheduled and batched so that they can run most efficiently. This efficiency allows us to reduce consumable costs and equipment usage times, which allows ARL to offer the most competitive pricing. Good efficiency equals quick TAT’s and cost savings.

Our goal in the chemistry labs is to schedule analyses in such a way that the testing portion of the analysis is completed within a timeframe that allows sufficient time to conduct follow up testing, if necessary. This further allows time for quality review and verification of accuracy and method suitability. Please note that business days are measured in 24-hour periods, Monday to Friday. The day we received the sample is Day Zero, the next day is Day 1.

Special Projects and Samples Sent to Outside Labs

The TAT for special projects, such as stabilities, method validations, suitabilities, or testing that we con not perform in-house, are discussed with our partners on a case-by-case basis according to current workloads, equipment availability, and personnel.

You may log in to our Laboratory Information Management System and see real-time data for your testing or contact a member of our Partnership teams for assistance. Please send an email to [email protected], call 801-847-7722, or Chat with us online.

ARL offers thousands of analyses, many of which can be tested in 1, 3, and 5-days. In times of critical urgency, we recommend calling one of our Partnership team members at 801-847-7722 to discuss your specific needs and ensure that we can meet your expectations. ARL's on-time rating is greater than 97%, so there's a good chance that we can fulfill your needs, but we never want to over-commit and under-deliver.

While we have been known to “pull rabbits out of the hat,” ARL is technically closed on weekends. Technicians schedule their hours in order to ensure they meet all due dates, which may require weekend work on occasion. Our microbiology team is also required to conduct all transfers over the weekends, so we do have a small crew here.

Should you need special consideration for one of these days, please feel free to reach out to us. We will do all we can to accommodate your needs wherever possible.

Absolutely! ARL offers free local courier services at all of our locations around the country. Please reach out to our Partnership team members by email [email protected], call 801-847-7722, or Chat to request a pick up.

One of the best things you can do to help us help you is to provide sufficient sample for duplicate or even triplicate testing. Nothing slows down testing more than to have to request additional material from our partners. However, what that means is that we generally have lots of product left over for retention. These retention samples are stored at room temperature (unless otherwise indicated) for at least 30 days, after which they are discarded. Any controlled substances are treated as required by law prior to discarding.

You may request additional testing for a sample. Please reach out to our Partnership team members by email [email protected], call 801-847-7722, or Chat to discuss your specific needs. Depending on the analysis you are adding, this may extend your turnaround times. We will do all we can to move things along as quickly as possible.

Analytical Resource Laboratories offers thousands of analyses, each one requiring a different amount of material for testing. Your customized quote will detail the quantity needed for each analysis. However, a good rule of thumb is "the more the better." Nothing slows down testing more than to have to request additional material from our partners. The following is a very general rule. Please consult your customized quote for more specific information.

• Routine Micro—50g
• Heavy Metals and other minerals—10g
• Vitamins and other HPLC, GC testing—10g
• FTIR—10g
• HPTLC—10g

Analytical Chemistry and Microbiology are as much an art form as they are a science. We wish the testing were as simple as putting in the sample and hitting a button, but unfortunately, it is not. Matrix interferences, unsuitable calibration curves, or incorrect specifications may necessitate repeat testing. On occasion, technical or analyst issues occur, which may also require follow-up testing and verification testing. In such instances, additional samples may be required. A good rule of thumb regarding the amount of material to submit to the lab for analysis is “the more the better.” Nothing slows down testing more than to have to request additional material from our partners.

Analytical Resource Laboratories LabTracker LIMS (Laboratory Information Management System) allows our partners to submit samples, view the in-process status of a sample, and view certificates of analysis online. Additionally, our FAQs page provides a wealth of information, and we have a team of individuals working on video tutorials that we feel will be great resources for our partners.

Retesting of samples can be requested within 30 days after the sample was received. Most retesting is done in duplicates or triplicates and the retesting is billed if the new results are statistically confirmatory.

If they are not statistically confirmatory the retesting is not billed!

ARL is committed to “doing it right, on time, every time.” However, sometimes there are issues that arise that do not allow for on-time reporting. Here are the most common reasons:

Wrong sample submitted

Wrong Sample. On occasion, partners submit the wrong sample, and we are only able to identify this issue after we run the initial testing, and our Out-Of-Specification investigations (OOS) is conducted. We get it. We all make mistakes on occasion. No worries. We work the problem, and move forward.

Unsuitable method for the sample matrix

Unsuitable Matrix. Unfortunately, running analytical tests is not as simple as putting a product in a machine and pushing a button. (How we wish it were that simple.) Analytical chemistry is as much an art form as it is a true science. Filtering through complex matrices to find the analyte of interest takes real skill and experience. We make every effort to validate our methods across diverse products and matrices, but there is no such thing as a “one-size-fits-all” method. As a third-party contract lab, we literally see thousands of diverse and unique products every month. Each one is tested and scrutinized individually, one-by-one. Sometimes, these steps take longer than anticipated.

Detection of suspect positive pathogens and analyses that are Out of Spec (OOS)

Suspect positive pathogens. We learn in Microbiology 101 that microorganisms are living, breathing organisms that adapt to their environment and strive to survive. Interpretation of literally in-numerable species of organisms and identifying the pathogen of interest can be challenging, since many organisms may initially look very similar to one another. As our highly skilled microbiologists read and interpret results, proper protocol dictates additional steps to verify what they are seeing, and smelling (yuck!). These steps take time, even days, to complete. While we sincerely regret the delay in testing, our integrity and dedication to “doing it right” is our guiding force. Please know that if your results take longer than expected, it is only to protect YOU and mitigate YOUR risks.

Note: In February 2021, we will be announcing some very exciting news and rolling out publications regarding rapid pathogens testing by PCR. This is a joint venture between ARL and BioMerieux. This technology will help us reduce micro turnaround times even further!

Incorrect specifications, or specifications not provided

Specifications not provided or incorrect. When testing products for a particular analyte, knowing your manufacturing specifications for that analyte is very important. Label claims are not specifications because they do not account for overages and degradation rates. So, please let us know what you are expecting so that we know where to go looking. Products need to be diluted and prepared for analysis and, if we are “shooting in the dark,” we may have to retest the sample multiple times or carry out an unnecessary OOS investigation, all of which are wastes of time. Accurate specifications will greatly reduce delays in testing.

Quality controls and quality retesting error

Random error is an expected and inevitable part of laboratory testing. Because ARL is committed to the quality of the results released to you, controls are always run alongside your samples to catch these potential sources of error. If a quality control fails to meet acceptance criteria, the entire affected batch will need to be rerun. Although this unfortunately may cause delays for you, it is necessary in order to provide high-quality results you can have confidence in.

ARL can currently test for the following unbound Amino Acids: Alanine, Arginine, Aspartic Acid, Cystine, Glutamic Acid, Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Threonine, Tyrosine, Valine.

Bound amino acids are incorporated into proteins or attached in some secondary form. unbound amino acids are not.

There are a few different technologies that can be employed to test for Amino Acids; UPLC, HPLC, and LCMS. Theoretically, each of these technologies should produce identical results, however, the detection limits will vary.

ARL has obtained ISO/IEC 17025:2017 accreditation in Cannabinoid testing. Our most common panel contains 5 major and 10 minor cannabinoids. For the full list, please contact our Partnerships team.

ARL has performed extensive development and validation steps to ensure that we can test a wide variety of products and matrices. There is a great chance we can test your product.

As a DEA-registered laboratory, any product containing > 0.3% THC will need to be reported to the DEA.

Fourier transform infrared spectroscopy, or FT-IR, works by measuring the interactions between infrared light and chemical bonds to create a “fingerprint” for specific compounds and products. Samples can be compared to a library of these “fingerprints” to evaluate the identity.

Our library is vast and ever-expanding, but it does not contain everything. Standards may be purchased upon request.

Please contact your ARL partner representative for more information.

ARL offers ten (10), five (5), and three (3) day TAT’s on FT-IR analysis. One (1) day, or even same-day is available through special request. Call your ARL representative for assistance.

While FTIR is a powerful tool, it is always best to utilize orthogonal testing methods to create a robust testing profile. ARL’s HPTLC analysis is a great option for identification of herbal and plant materials. Please contact your ARL representative for information on additional test methods.

Current Good Manufacturing Processes (CGMP) require that every ingredient be verifiable through either empirical analysis in the finished good, or through proper identification and testing of raw materials, with clear and concise Master Batching Records (MBRs) and traceability. However, if the ingredient is testable in the finished good state, by a valid method, it is best to test it than to rely on MBR’s. Contact your ARL representative for help evaluating your specific needs.

ARL works closely with the American Kratom Association to ensure that we are up to date on the latest regulation and trends in Kratom. A typical profile of testing for Kratom may include a Complete Micro Profile, Heavy Metals, and Kratom Alkaloids including Mitragynine, 7-Hydroxy-Mitragynine, Speciogynine, and Paynantheine.

ARL offers ten (10), five (5), and three (3) day TAT’s on Kratom test packages. One (1) day, or even same-day is available through special request. Call your ARL representative for assistance.

Interpretation of microbiological results can be confusing. We want coliforms and pathogens such as E. coli, Staphylococcus aureus, Salmonella, Listeria, Clostridium, etc., to be "Negative" or “Absent.” Period!

Total Plate Count and Yeast and mold should generally be "low," with results of < 10 CFU's/g (less than 10 colony-forming units per gram) or < 100 CFU's/g. A result of < 10 CFU's/g means that we did not see any colony growth after 10 g of product was diluted into 90mL of solution (1:10 dilution), and allowed to incubate on the appropriate agar medium. This result does not mean that the sample is Negative or Absent for Total Plate Count, just that the way the test is setup does not allow us to detect numbers lower than 10.

These terms mean that the product was diluted into a nutrient-rich growth solution, incubated, and given every opportunity for even one CFU to grow, and nothing grew.

It is important to remember that, in microbiology, we are working with living, breathing organisms that are susceptible to environmental conditions. When we consider colony-forming units (aka counts) from one sample to the next, it is common to see those numbers ebb and flow. It is essential to look at results on a log basis (factors of 10) rather than small variations in counts. For example, let's say that you submit three samples of “Product A,” lot 12345, and get a Total Plate count of 500 CFU’s (colony forming units), 1,300 CFU’s, and 800 CFU's in your three samples. In the microbiology world, these three numbers are statistically equivalent. But wait, you might say that 1,300 is three times greater than 500! Remember, these are living, breathing organisms and are susceptible to their environment during raw material batching, blending, packaging, storing, etc., and counts do ebb and flow. In the micro world, we look at data in terms of factors of 10.

If you get a result of < 10 CFU’s/g in one sample and 50,000 CFU’s/g in another, let’s chat. These results are greater than a factor of 10 apart and warrant investigation.

Probiotic products contain viable bacteria that are beneficial to the digestion system of humans and other animals. The setup and testing procedures for probiotics are very different than standard microbial testing methods. The dilution schemes are much higher; the agar medium contains a distinct nutritional profile different from the typical routine microbiological analysis. The incubation requirements are particular as well. Most probiotics need to be incubated anaerobically (little to no oxygen in the chamber). Some are obligate anaerobes, meaning that they cannot tolerate any oxygen while growing. Others are micro-aerophilic, meaning that they can grow in the presence of some oxygen but prefer little oxygen. Additionally, some probiotics need to be "activated" before testing.

It is important to note that most probiotics will die off at room temperature over time. For this reason, many probiotic products recommend that the consumer keep the product in the refrigerator to slow down this depletion. Heat accelerates this depletion much more rapidly.

With so many variables that factor into the final test result of a probiotic product, it stands to reason that some products with an extensive blend of species can be complicated. Consistency in your manufacturing, storage conditions of raw materials and finished products, raw material expiration dates, etc., all factor into the final test result.

Analytical Resource Labs offers several microbiological packages. The most commonly requested packages are Complete Micro Profile by USP 2021/2022 for Dietary Supplements, and Complete Micro Profile by USP 61/62 for nonsterile pharmaceutical products.

Complete Micro Profile by USP 2021/2022 is our most popular package and is used extensively for Dietary Supplement products. This method includes Total Plate Count, Coliforms, E. coli, Staphylococcus aureus, Salmonella, Yeast, and Mold. We recommend adding Pseudomonas aeruginosa for liquid samples.

Complete Micro Profile by USP 61/62 includes Total Aerobic Microbial Count, Bile Tolerant Bacteria, E. coli, Salmonella, Pseudomonas aeruginosa, Total Combined Yeast and Mold, Candida albicans, and Clostridium species. ARL partners typically include a full suitability and methods validation for their specific product as well.

Many companies use Bacteriological Analytical Manual methods (BAM) for food products or Personal Care Product Council (PCPC, formerly known as CTFA) for cosmetic and personal care products.

ARL follows approved and validated compendial methodologies, as well as in-house validated methods. Our team is happy to explain the differences, advantages, and disadvantages of each method. However, the determination of which method to use is dependent upon your product and industry requirements. We can help you with evaluating your testing options.

Most ARL partners request testing of raw materials to validate purity, potency, and safety before converting them to in-process or finished good blends. Some of the most commonly requested analyses on raw materials include FT-IR or HPTLC for purity testing, HPLC and GC for potency, and ICP and microbiological analysis for safety.

Many variables determine which tests to perform. In general terms, however, if you are claiming an active in the finished product, it is best to test the raw material that provides that active to verify that it does contain the correct and required potency of the active to meet the final label claim. Each raw material should be tested for microbial content, and verified by either FT-IR or HPTLC to ensure that the material received is correct.

Any label claims made on a finished product must be substantiated, and most of ARL’s partners run a Complete Micro Profile on every lot of finished product. For more information, see FAQ “How can I test my finished product good for raw materials that do not have testable markers?”

Environmental Monitoring is a process by which a manufacturer employs protocols to mitigate cross-contamination and microbial contamination. Surface swabbing of machinery either for bacterial content or the presence of ATP are great ways to identify the effectiveness of your cleaning processes.

Many of ARL’s partners test the surfaces of their production machinery for microbial content or the presence of ATP. ATP bioluminescence is a rapid detection system that detects carbon bonds found in raw materials and bacteria. This rapid test will help determine if your cleaning process is sufficient for your needs. This test does not specify the presence of bacterial contamination but will give a general review of your cleaning effectiveness. To identify pathogens, a microbial swab must be used.

In addition to monitoring residual materials and bacteria, many luminometers can test for allergens and other contaminants. ARL’s partners have had great success with the Hygeina system from Hardy Diagnostics, but several great pieces of equipment are in the marketplace.

Selecting the locations and frequency of swab testing depends on many variables, including your production schedules, the types of products you run, and your risk tolerance. ARL’s experienced team can help you determine a proper testing cycle.

Most of ARL’s partners use a swab to test a section 2" wide by 2" deep and then either submit the swab to the lab for bacterial enumeration or run the swab in an ATP Luminometer. There is wisdom in swabbing product contact surfaces that are most challenging to reach and clean. Chances are that these areas are not cleaned as well or frequently as perhaps they ought to be. Testing these areas will help identify risks in your production and cleaning processes and help your team formulate best practices for cleaning and sanitizing.

Please note that the swabs used for microbial evaluation and ATP bioluminescence are different, and you will want to make sure you are using the correct swab for the job. If you are submitting the swab to ARL for evaluation, we are happy to provide the swabs to you. Please give us a call.

The answer to this question depends on the types of products you manufacture. It is best to run an Environmental Monitoring program for a while, collect data, and evaluate that data against the facility's risks associated with that level of cleanliness. Once you identify your current level of cleanliness, you will then determine where your sanitization process can improve. Many of ARL’s partners have varying specifications for different types of production surfaces. ARL’s experienced team can help you formulate a plan to determine those specifications.

There are two main ways to test the quality of the air in your facility. The first is through a metered air sampler that deposits a specific amount of air onto an agar plate for evaluation, and the second and more commonly used way are “settle plates.”

Settle plates, also known as sedimentation plates, are used extensively in the Dietary Supplement and Pharmaceutical industries to determine the level of contamination in a manufacturing facility. Many of ARL’s partners place these plates in three (3) locations throughout a production room, remove the lid, and expose them to the open air for 10 minutes. Afterwhich, the lids are placed back on the plate and wrapped with parafilm. Each plate should be clearly identified with the name of the room, specific location in the room, duration of exposure (begin and end times), date and time of the collection, and the individual's name that performed the test. Plates collected through open exposure or metered air sampler are sent to the lab for incubation and enumeration.

Analytical Resource Laboratories’ primary goal is to “do it right, on time, every time.” We employ every effort to help our partners mitigate risks and sometimes, this requires additional follow-up testing. Should a sample show evidence of pathogens such as E. coli, Salmonella, Pseudomonas aeruginosa, Clostridium, Staphylococcus aureus, and others, we take proper steps as outlined in the methodologies to verify their presence or absence. These steps may include biochemical analysis, API, BacSeq ribosomal RNA sequencing, and PCR analysis. Protocols may also call for repeat testing based on larger sample sizes. From these follow-up analyses, we will provide accurate results.

Analytical Resource Labs is pleased to announce its transition to PCR testing of pathogens that significantly reduces pathogen retesting. See our ARL Insight article here.

ARL designs its quality systems to reduce and eliminate cross-contamination. We employ the highest standards for personnel training and systems and processes. Each sample tested is run in tandem with positive and negative controls to help identify cross-contamination potential. ARL’s partners are welcome to discuss our extensive quality systems with a member of our quality team.

The US National Library of Medicine National Institutes of Health state that there are about 30,000 named species of pure culture that have been physiologically identified. However, it is believed that this number is dwarfed by the suspected total number of varying species in our world today. Some estimate this number to be in the Billions. With so many species of organisms, it stands to reason that many exhibit the same characteristics by traditional microbiological and biochemical analyses. For this reason, the lab reports inconclusive or the possibility of multiple types of bacteria. Scientists are working to identify as many species as possible, especially with the advancements brought forth by PCR testing. ARL is committed to offering more specificity as technologies improve.

When you test for a particular pathogen, the report will either state Positive or Present if that pathogen is detected.

We perform Mineral and Heavy Metals analysis by ICP-MS. The most significant 25 nutritional minerals include: Be, Na, Mg, Al, P, K, Ca, V, Cr, Mn, Fe, Ni, Cu, Zn, Ge, As, Se, Ag, Cd, Sb, Hg, Pb, B and Ba, however we can test many, many more.

There are three main technologies used to detect minerals: ICP-MS, and ICP-OES, and ICP-AA. Each technology uses a different detection system and has their own particular sensitivities and specialties. ARL uses ICP-MS for is extremely low detection limits and flexibility in testing methods.

Detection limits are specific to analyses, however the MDL precision and accuracy of our methods are best at 1 ppb (parts per billion) and higher.

The two most common reporting units for minerals and heavy metals are PPM (parts per million), and PPB (parts per billion). Some of our partners prefer to report in mcg/serving in order to demonstrate compliance to California’s Prop 65 regulations.

ARL’s Heavy Metals profile includes Arsenic (As), Cadmium (Cd), Lead (Pb) and Mercury (Hg), which are the standard four in the industry.

ARL recommends that our partners refer to California’s Prop 65 regulations to determine if their products meet the requirement. If you have questions, please give us a call and we may be able to point you in the right direction.

ARL offers ten (10), five (5), and three (3) day TAT’s on heavy metals and minerals testing. One (1) day, or even same-day is available through special request. Call your ARL representative for assistance.

The contents of a Nutrition Facts Panel are controlled by the FDA and are very specific about what needs to be listed. Supplement Facts Panels are far more flexible, and to a great degree are determined by the manufacturer or distributor of the finished good.

• Source of Protein and Fiber
• A full ingredient list

Yes, ARL can provide both insoluble and soluble fiber data.

ARL offers ten (10) and five (5) day turnaround times on Nutrition and Supplement Facts analyses?

ARL offers several packages, depending on the specific analytes required in your testing.

You must use the package that best fits your regulatory needs.

ARL offers several packages, depending on the specific analytes required in your testing. You must use the package that best fits your regulatory needs. Please contact us to discuss your particular needs.

Analytical Resource Labs tests for many Vitamins, however the product matrices can have an effect on which vitamins are detectable in the product. Unfortunately, there is no single method that will detect every vitamin. However, our methods encompass the most common forms of vitamins including:

• Vitamin A—beta carotene, retinyl palmitate, retinyl acetate
• Vitamin B—B1 (thiamin HCl), B2 (riboflavin), B3 (niacin, niacinamide), B5 (pantothenic acid), B6 (pyridoxine HCl), B9 (folate)
• Vitamin C—ascorbic acid (calculations for various salt forms as well, ex: calcium ascorbate)
• Vitamin D—ergocalciferol (D2), cholecalciferol (D3)
• Vitamin E—tocopherol, tocopherol succinate, tocopherol acetate
• Vitamin K—K1