Understanding Lab Requests

We’ve Got Questions — You’ve Got Answers.

(No pop quiz later, we promise.) Have you ever been contacted by your testing lab with questions you weren’t expecting? It’s fairly common for a lab to contact a customer when they need more information about the sample being tested. These requests allow us to get the information we need to perform the correct testing against the correct specifications before we get too far in the process.

For instance, we might ask for the serving size of the product. If we are doing a protease HUT assay, we will need to know if the 100,000 HUT spec is per gram, per capsule or any other serving size—we’ll need you to specify.

Pro tip: Including this information on the submission form will save time and help us have the appropriate target specs for the product.

Since many enzyme assays have a narrow range for the method to test within, getting an accurate assay starting point will help us find the exact activity on the first test run. When the activity range is too broad for the assay, then results may be reported with < or >  activity. This shows the upper and lower limits of the standard curve, instead of the exact activity. Unfortunately, if you need an exact reading, we have to run the assay again, resulting in an additional charge for the second run.

Sometimes we ask for a larger sample. Customers have asked, “Why do you request a 50-gram sample?” Sample size is important, because we need an amount that is representative of the batch or ingredient that will be used in production. A 50-gram sample allows for multiple assays, in addition to any microbiology testing that may be needed. Micro testing often requires 11 grams to just get started and other tests need to be weighed separately. The 50-gram sample also gives us enough to perform investigative testing, too. For example, a difference in particle sizes in the blend may require the lab to grind the sample to create uniform particles before testing. Having a large enough sample will allow for any retesting that may be necessary for your quality-control purposes, too.

Just think of SORA Labs as an integral part of your team. Our goal is to help solve testing issues when they happen, and the more information we are given early in the process, the better. Providing raw material certificates of analysis (if available) supplies us with a reference if questions arise during testing. We strive to run the correct testing the first time, saving time and money in the long run. Let SORA Labs be your partner in quality. Contact us today!

Understanding Botanical Testing

When ordering botanical identity testing, it is important to provide as much information as possible to ensure the lab will perform the correct identity testing. When completing the sample submission form, it is critical to distinguish botanicals as either whole herbs, or the specific plant parts of whole herbs or extracts. For extracts, the best chance to successfully identify the raw material is dependent upon listing the correct extraction solvents used, the ratio of the solvents, flow charts, and an accurate description of the extraction process.

A lot of time and money can be wasted if an extract is compared to a whole herb sample. Extracts cannot accurately compare to whole herb standards and generally will fail the ID test. Accurate results require more than just listing the genes’ species information on the submission form. Providing comprehensive information will allow the testing lab to better understand the sample so that it can be successfully identified.

Since Amazon recently released new testing requirements, many botanical testing questions have arisen. Since most botanical identity testing methods are designed for raw materials, these methods are not usually appropriate for finished products. The chemical marker of the botanical may be seen on an HPLC or other chromatography method, but determining the mg or quantity is not always possible once several botanicals are blended in the finished product. As science progresses, and more testing methods are developed, it may eventually be possible to help solve this testing gap. Currently, though, determining the label claims for blended herbs is almost impossible.

To ensure your finished product formulation meets label claims, verify that the manufacturer tested the raw materials before they were used in the finished blend. A raw material certificate of analysis from the original supplier isn’t conclusive; Identity testing needs to be completed on each raw material ingredient when it is received at the manufacturer. Testing the raw material identities, in addition to the manufacturing batch records, will help establish that the supplement product being sold is a quality product.

Producing a high-quality product can be challenging but using a trusted testing lab can take some of the pain out of the process. SORA Labs wants to be your partner in quality! Contact us today to discuss your product and let us quote all your testing needs 

Safeguarding the Quality Process—It Starts at the Beginning

A few years ago we published an article in Natural Product Insider called Proper
Raw Material Qualification Prevents Garbage In, Garbage Out. This article still rings
true today. The process of testing the raw ingredients and vendor qualification will
help ensure the finished product meets label claims and is not contaminated.

Recently, a customer sent in a botanical shake product that failed an irradiation
screening test called pulsed photo stimulated luminescence or PPSL. This screening
reveals if an ingredient or blend has been irradiated to kill microorganisms.
Irradiation methods are not acceptable for ridding supplement products of
microorganisms. Testing the botanical raw materials before blending, would have
found the single irradiated component and saved this blend before manufacturing
the product on a larger scale—a costly mistake! It’s important to note that there are
other acceptable ways to kill microorganisms in botanical ingredients, such as steam
sterilization.

A few more examples of how raw ingredient testing is integral to finished product
quality include testing for heavy metals, pesticide residue, contaminates including
microorganisms and active ingredient potency. The raw ingredient can be tested
before the manufacturing process to identify a marker that cannot be introduced
during manufacturing. Additionally, microbiology testing, some potencies or other
markers may also need to be verified during blending or again before shipping the
finished product. Failing to test raw ingredients before manufacturing can lead to a
failing test result in the finished product. This results in an out-of-specification
(OOS) investigation that prompts a review of the raw ingredient results. If the raw
ingredient was not tested for contaminates or potency level, then there is often a
scramble to determine where the unwanted result is coming from. Going back and
testing all the raw ingredients in the blend after manufacturing, is costly and time
consuming. This is why a good vendor qualification program is essential to
manufacturing quality products and following the FDA’s GMPs is a necessary and
required practice.

Vendor qualification and testing of raw ingredients is a key step in producing a
quality finished product. Without initial qualification of raw ingredients, the
blended finished product is at risk for contamination or low potency. Also, ensuring
the finished product meets label claims may require testing at various stages in the
manufacturing process and on-going stability testing if an expiration date is listed.
Consistently safeguarding the quality process may seem like a daunting process, but
SORA Labs is here to help! We can help take the stress and worry out of your raw
ingredient testing, by helping to make sure that only the best goes into your finished
product. Contact us today for a testing quote!

Why Working with an ISO 17025 Accredited Lab Helps Solve Some Out-Of-Specification Testing Mysteries

There are many reasons why ISO 17025 accreditation is important for testing labs.  Overall, ISO provides guidelines and acts as a roadmap for being a top-quality testing lab.  This includes many requirements that must be met for every aspect of lab operation.  Staff members must meet stringent training and proficiency standards to prove they are qualified to perform specific tests.  Equipment installation qualification and calibration is monitored to ensure that testing is conducted with precision. 

There are also procedures in place to investigate lab results that are outside the customer specifications.  The out-of-specification (OOS) process is a commonly questioned procedure that customers seek to understand. Here’s some helpful information on understanding OOS results and how they are handled by the lab:  First of all, we want to ensure that we have not made a mistake that would cause the OOS results. We look internally to discover if there is any type of lab error before reporting the results back to you, the customer.  Next, we follow a checklist to verify several aspects of the testing process such as: 

  • Making sure that reagents used were not expired 
  • Check standards or reference materials were within passing criteria
  • The submission form is reviewed to ensure that we had a clear understanding of the testing ordered and correct specifications were entered
  • All calculations were correct
  • Physical inspection of the sample to make sure there was no damage or mishandling

Once a thorough review is conducted and the analyst is questioned about possible issues with sample preparation or anything out of the ordinary during testing, then we can report the results. 

When utilizing contract testing, sometimes there may be limited information given to the lab regarding the sample, especially when working with a blend. Providing the lab with a copy of the label, a list of co-ingredients in the blend or any additional information can be extremely helpful.  For example, we may report that an enzyme blend has a low recovery of the lipase activity. After performing our internal OOS and reporting the low lipase results, the customer receives the report and calls to explain that the blend also has betaine HCL.  This is valuable information because there is a known interference with acidic ingredients and the lipase activity testing method since this method is a pH-based titration. Having this information up-front would have given the lab understanding and key information in documenting the OOS results.

Working together as a team, we can better determine any legitimate reason for low results. Generally, we find that there may be a valid explanation for the OOS results and knowing more about the product up-front will save time and headaches in the long run.  Working with a contract lab that has experience and is willing to help solve the mysteries of blended supplement products is invaluable. SORA Labs is here to help—call us today!

Understanding Enzyme Testing: Tips from the Experts

When contemplating test methods for enzymes, it’s important to understand that enzyme activity assays have many compendial and non-compendial units associated with them. While the enzyme industry has gotten closer to standardizing supplement raw materials to the activity units listed in the Food Chemicals Codex (FCC) and the United States Pharmacopeia Dietary Supplements Compendia (USP-DSC), they still have some distance to cover.
When purchasing a raw material or blend of enzymes, it’s a time-saving measure as a manufacturer or marketer, to confirm that the specifications are sold in compendial units, whenever possible. This limits the need to find or use a conversion when trying to determine if the material passes your quality review process. If you are purchasing an enzyme that is sold with only an industry method, then we can advise you if we can run the specific method you need for the material. Understanding the test method before-hand will save you time, hassles, and allow for a smoother finished product release process later down the line.

Here is a list of common compendial units from the FCC or USP.

  • Common fungal & plant activity units:
    • Proteases: HUT/g, PU/mg, PC/g, SAP/g
    • Lipase: FIP/g or LU/g
    • A-Amylase: DU/g
    • Cellulase: CU/g
    • Lactase: ALU/g
  • Common animal enzymes-all USP compendial units
    • Pancreatin: Shows three activities in pancreatin Amylase, pancreatin Lipase and pancreatin Protease all listed in USP/mg.
    • Pepsin: FCC or USP/mg is sold in ratios like 1:10,000, etc.
    • Trypsin: USP/mg
    • Chymotrypsin: USP/mg
  • Industry methods or non-compendial activities:
    • Nattokinase FU/g: –Knowing the country of origin is key to running the correct method. The most common method is from Japan, but there are also Korean and Chinese methods.
    • Superoxide Dismutase (SOD):
      • McCord Fridovich method: </> 8000 MCF/g (ONLY raw materials)
      • Dojindo Kit: < 1 unit/g and a common material specification is 14,000 IU.
    • Serratiopeptidase: This industry method is similar to British Pharmacopeia method.
    • DPPIV Units:-Protease activity
    • AAIU Units:– Alpha-amylase Inhibition activity
    • PPI Units: Tolerase G protease activity

For more information and a robust list of enzyme activity assays, check out our enzyme testing flyer .
A common misunderstanding when customers are ordering enzyme activity testing is for them to request activity in “USP units”. Generally, “USP units” are associated with animal-derived enzymes. When testing fungal or plant enzymes, the actual activity unit and not the general nomenclature should be requested.
Supplying the raw material certificate of analysis (cofa) and quantity of the raw included in the blend will allow us to easily determine what units and theoretical activity are necessary for the product testing. Since having the correct assay run on the material is the key to obtaining results that are accurate for the product, partnering with an experienced specialty testing lab will go a long way to ensure the quality of your product. Contact us for a quote today!
Here are some helpful links to calculators on our website:

Making Sure You Get Results—How a Quality Agreement Works

Outsourcing for analytical testing is common and is routinely needed for methods that in-house labs don’t have the capabilities to run themselves. As part of the supplier qualification process, a quality agreement should be developed so both parties have a clear understanding of their responsibilities. The quality department in each company should agree and sign this mutually beneficial document. The quality agreement will outline commitments, communication responsibilities, notification requirements, as well as documentation procedures related to quality management. This is an important way to strengthen the supply chain and put the focus on quality.
The lab’s responsibilities may include items such as:
• Running compendial or scientifically valid test methods.
• Notifying the client regarding changes in the Quality Management System (QMS) that can affect testing of the client’s products.
• Notifying the client of planned and unplanned deviations.
• Maintaining confidentiality of client information and test results.
The client’s responsibilities may include items such as:
• Selecting samples that give the best representation of the material being tested.
• Using proper handling, storage and shipping procedures to protect the integrity of the sample until it arrives at the lab.
• Supplying accurate information when submitting testing samples.
• Taking responsibility for final product release and related specifications.
The quality agreement should also include language about communicating any changes that either party requests and agreeing on these changes as they occur. All items outlined can be negotiable and drafted for the specific partnership.
Having a quality agreement can provide peace of mind that everyone involved is doing their part to ensure a quality product in the end. SORA Labs wants to be a trusted and valuable extension of your quality team. Talk to us today about creating quality agreement with us!

And the Most Popular Question About Probiotics Is…?

Customers often ask us if probiotics are shelf stable and our answer is always the same; only testing can determine the shelf stability of a particular probiotic product. While the ingredient manufacturer should have data on their products, once you blend the raw material with other ingredients, then stability needs to be confirmed.

Stability testing is required when an expiration date is listed on the product label. The International Council for Harmonization (ICH) has guidelines for various storage conditions to use when trying to prove stability or the shelf life of a product. Many products can simply be held a few months at accelerated heat and humidity conditions to prove product stability for the future expiration date. However, specialty ingredients, like probiotics and enzymes, are more sensitive to these extreme conditions and will show a more rapid decline than if they were just stored on a shelf in ambient conditions. For these products, the data from the accelerated study may not be accurate.

One way is to label the first batch of probiotics or enzymes with a manufacturer’s date and then run the ambient 25˚C/60% RH real-time stability study over the years needed to prove the shelf life. This allows future batches to list an accurate expiration date.

But it’s important to note that many factors can affect meeting label claims of these specialty products. Moisture, heat, pH, product handling, storage and co-ingredients in the blend can all be detrimental to full recovery of the active ingredients. It takes testing during the product development stages to determine what active ingredients can be tested successfully. Then when the product is finally manufactured the stability testing can be established and monitored throughout the shelf life.

SORA Labs is here to help! We offer on-site, stability storage in real-time conditions of 25ᵒC ±2 /60% RH ±5 and can quote other conditions that may be needed. Let us quote your next stability project!

Testing Probiotics—Just the Facts, Please!

A popular question at SORA Labs is: What is the correct probiotic testing method for enumeration? Since there are so many methods available, it can be confusing to the customer to choose a method. A successful testing strategy starts by asking your supplier what method they use for enumeration. Then verify if that method is run routinely in the lab and if the lab shows proficiency with the method. This process ensures that the same method is verifying the material and offers less variance if the material doesn’t meet the label claim.
If you are attempting to verify probiotic blends, however, then more research will need to be done. The supplier, again, may have a method that can be used for quality control testing, but in many cases, the testing lab will play a larger role in determining the best method to use on the blend. This can be a major undertaking, and customers don’t often realize that they need to plan for this research and development step. This could take additional time and resources to figure out the best testing for the product.
Probiotics are also not usually as simple as just putting the sample in the box and shipping it to the lab. Communication between all parties will be needed to determine the testing protocol, when considering which probiotics are in the blend. Next, the product can be tested using one or two general probiotic methods to see which has the best overlapping growth for all the bacteria in the blend.
Because of these complexities, consideration of the test method for the product, should not be an
afterthought. Pre-planning is crucial to a smooth manufacturing process with no delays in quality control testing or meeting delivery goals. Using an experienced lab, like SORA, can also take the stress out of working with specialty ingredients. Let SORA Labs help you with your next probiotic testing project!

Getting Testing Right Every Time—A Guide to Ordering for Successful Outcomes

Looking for a simplified way to figure out your testing needs? Here is a chart of SORA Labs billing codes and associated microbiology testing, which shows how test results will be formatted.
Using this chart can help you determine which microbiology test to order to match your given specification and turn-around-time (TAT) required.

Micro Spec Charts:

AOAC Petrifilm™ Methods

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Pour Plate Methods (FDA/BAM or USP)

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Rapid Biolumix Methods

These methods report </> your specification and are not quantitative

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Occasionally, customers need a certificate of analysis (cofa) to be updated due to a specification
issue. Here is one scenario:
Question: Can a cofa be updated to reflect a microbiology specification of negative on Escherichia coliform (E.coli) instead of <10 cfu/g?
Answer: No, because the E.coli test that reported as “negative” was not ordered.
How to place the right testing order: If you need Staphylococcus aureus (S.aureus) to report as negative/10g, then you need to order test codes B0191 or B0371 (see chart). Both these test codes have results that can be reported as negative. The B0371 Biolumix® option will only report as negative or positive, whereas the pour plate method will give you an actual count if there is S.aureus present in the sample.
Quality control is a continual process. Understanding which method to order to give you the
required results can be a challenge because of the many microbiology method choices. We’re the experts—Let us know what specifications you need and we can suggest the best method to meet your requirements. We are here to help! Call or email us anytime!

Enzyme Testing in Finished Products

SORA Labs has been testing enzyme activity assays and probiotic enumeration  for more than 30 years. In fact, we were the first lab to add enzyme activity assays to an ISO/ICE 17025:2015 scope of accreditation in the U.S. Most of the methods we use come from the USP/FCC, BP, JP and other compendia, which are designed for raw material testing. One question we hear frequently is if it’s possible to test enzyme activities in finished products containing an enzyme blend. The answer is YES! We can test enzymes in finished products, however, like most analyses, it’s not as straight forward as raw material testing. Based on these experiences, we have put together a list of common interferences seen with finished product enzyme testing.
1) Combined Protease Effect: This occurs when several proteases are mixed together in a single blend. The protease activity of each enzyme is magnified by synergistic effects and boosts the protease activity. Enzymes are standardized to a single activity but may have other non-standardized activities present. These non-standardized activities are called side activities and can cause the proteases to show higher than expected results.
2)Enzyme/Carbohydrate Interference: The most common observation of this phenomena is with lactase but can be seen with other enzymes also. Lactase results often fall below label claims because of carbohydrates in the blend.
3) pH Co-Ingredient Interference: Enzyme activity assays are pH and temperature- controlled reactions. When the assay conditions are altered, the reaction may be affected, and the method may not perform correctly. Ingredients like betaine HCl, lemongrass, calcium carbonate, ox bile, and other high or low pH ingredients may swing the pH of the reaction solution outside the ideal method pH. Sometimes adjustments can be made to allow the reaction to run, but this is not always the case.
4) UV Co-Ingredient Interference: Many enzyme activity assays have a UV-Vis endpoint. If botanicals or other chemical ingredients are included in the enzyme matrix finished product, these ingredients may cause UV interferences. Methods that look for a change in UV absorbance could show inaccurate readings if these co-ingredients have similar UV characteristics.
Providing as much information about your product before testing begins will help determine possible interfering ingredients. When a testing lab is an extension of your team, you have a tremendous asset, because all these interference scenarios can be proven with testing.
We often use small sized, formulation-specific, lab blends, which allow us to remove the interfering ingredient(s) and then test the activity again. If the recovery is improved and the results meet label claims, then the product interference is confirmed.
We can also perform spike studies and measure the recovery of a known enzyme spike. Adding a known amount of enzyme into the finished blend and then testing for activity, will help determine the interference. When only partial recovery of the spike is observed, then this shows that there is interference with the testing.
Getting the blend testing and interferences figured out at the product development stage is very important to preventing product delays later in the process. Once products are ready to be shipped, then it is often a stressful scramble to understand why label claims are not being met. SORA Labs is here to help! Let us test your products so you can understand any interferences that are present. Remember, understanding your product’s unique characteristics early on, will help set the stage for successful manufacturing and sales.