Don’t have a lot of time to wait for test results…read this!

Ever heard the phrase, “Time is Money?” In the dietary supplement industry, like any other industry, products need to be shipped to the customer to complete the sale.  And, since shipping the product is generally dependent on quality control approving the test results for release, time is of the essence. 

Being organized and having a plan will help keep things moving quickly. One idea for improving the quality control process is to review all incoming raw materials and determine what testing can be completed before the blending process. Heavy metals, residual solvents, pesticides, identification, potency or assay, microbiology and other testing can be completed on the raw material. For example; heavy metal levels should not be affected by the manufacturing process, so screening the raw materials should provide accurate results when the product is released. This can be a huge time saver in the long-run.

If so much testing can be done at the beginning of the process, then what are we waiting on? Often, microbiology testing is the last step to complete before the product can be shipped. And since microbiological contamination is common in the manufacturing process, microbiology screening needs to be completed on the raw materials and again on the finished product before it is shipped. Technology and science have come a long way and this has given us rapid micro test methods, which can be completed within 48 hours.  Although these tests are not appropriate for every product matrix, they can be used with many products. This rapid testing saves time and can potentially save money.

Potency and label claim testing are also required for finished products. These tests are often complicated in the supplement matrix. Since USP/FCC methods are usually designed for the raw material matrix, once these ingredients are blended together, interferences may be found where recovery may be difficult. Testing is the only way to determine what potency markers are possible to measure. Once you know your product, you can tailor the appropriate finished product testing for the final release specifications.

Getting organized; testing your raw materials; and having a plan for finished product release testing, will go a long way in shipping your products faster. Additionally, using an ISO 17025 accredited testing lab that is proficient in the methods you require will also reduce the delays. And in those rare instances when everything seems to go wrong, SORA Labs can RUSH the testing you need to get you out of a bind!

Enzyme Testing in Finished Products

SORA Labs is an excellent source in the dietary supplement industry for insight on enzyme activity testing. We have been testing enzyme matrices for many years and are one of the only labs in the U.S. with enzyme assays on our ISO 17025:2005 scope of accreditation. One question we commonly receive is if it’s possible to test enzyme activities in finished products containing an enzyme blend. The answer…YES! We can test enzymes in finished products; however, like almost all analyses, it is not as straight forward as raw material testing. During our many years of experience in enzyme blend analysis, we have noticed the following phenomenon:

1) Combined Protease Effect: Occurs when different proteases are in the same blend.  In essence, they help each other out and boost all protease activities—this is known as "side activities"

2) Enzyme/Enzyme Interference: Enzymes are used to break down various substances. In enzyme blends, we often see the enzymes working against or breaking down each other. This is very common when high protease activity is blended with lactase. Lactase often falls below label claims because of the proteases acting on/or digesting the lactase.

3) Co-Ingredient Interference: Many times co-ingredients (Betaine HCl, Lemongrass, Calcium Carbonate, etc.) affect the pH of the entire mixture. Many enzyme assays are pH based and the varied pH can provide results that are not the most accurate representation of your product.

Testing raw materials can eliminate the risk of side activities or interferences, which can result in skewed results. Testing your raw materials is recommended to ensure you are putting only the highest quality ingredients in your product, and this should be followed with testing of your finished product. Most enzymes will test close to label claim; however, finished product testing will provide an accurate representation of the activities that are seen in your product, rather than activities that have been calculated by input.

Arsenic, Cadmium, Lead, and Mercury…Why Should You Care?

Heavy metals—What are they and why should you be concerned about them? The elements known as heavy metals include arsenic, cadmium, lead and mercury. These elements can be present in the soil that your materials are grown in or found in facilities where your products are produced. These contaminates can pose a health risk to your consumers and could even cause poisoning if they are consumed in high enough quantities. Due to their high health risk, the FDA requires testing for these analytes to be compliant with their GMP regulations. You may be asking yourself some questions regarding this testing and SORA Labs is here to answer them! Some of the most commonly asked questions and their responses are below:

Q: What stage of manufacturing can you test for heavy metals?

o   Raw Material

§  When you test your raw materials, you are more likely to catch a “bad” ingredient before you add it to your blend and ruin your entire batch. 

o   Finished Products:

§  Finished product testing confirms that the product meets required standards once all ingredients are blended and no heavy metal contamination occurred during the manufacturing process.

Q: Why Choose the ICP-MS method?

§  There are other methods that can be utilized for heavy metals analysis, however, ICP-MS allows the laboratory to achieve lower detection limits when compared to ICP-OES. This lowered detection limit allows for more accurate and precise data on your product.

§  Prop 65 requires certain limits of heavy metals to be met. Some prop 65 results can be obtained by ICP-OES; however, the serving size becomes a large factor. By using ICP-MS the factor of serving sizes becomes less of a deterrent. We are now able to achieve prop 65 levels on a larger variety of serving sizes.

If you have any remaining questions, please do not hesitate to contact us. SORA Labs would love to assist you with making sure your consumers are getting a top quality product! We offer ICP-MS heavy metal and mineral testing along with many other assays, ID and contaminate testing needed in the dietary supplement industry.  Visit our website today!

In the wake of the CBC retraction of the November 2015 dietary supplement report due to testing inaccuracy, questions are being asked about the function and processes of third party laboratory testing. With so many different labs offering testing, how is one to know if the accepted practices are being followed? What makes a lab trustworthy in their methods? What could have happened that caused the tests to go wrong?

 

What is required of a lab to receive their accreditation? There are many factors that go into receiving an ISO 17025 accreditation. These are just a few examples of some practices that must be followed for a lab to be accredited:

 

For a lab to be ISO 17025 accredited, they are required to do proficiency testing, which means testing the same sample by multiple analysts, preferably between different labs and comparing the RSD% (Relative Standard Deviation) of the results. There are tight ranges for these results that show proficiency.

 

ISO 17025 accreditation is specific to certain lab tests and not all tests that a lab runs are within their ISO 17025 scope of accreditation. The ISO 17025 certificate for each lab lists the accredited tests. This accreditation is considered to be the lab’s expertise.

 

The Preventive/Corrective Action system (PCAR or CAPA) is used for any lab issue to improve all company practices. ISO 17025 accreditation requires continual improvement, so when a lab error is found, a PCAR is then generated to solve the problem for future testing.

 

Out of Specification (OOS) results require a lab investigation as part of the ISO 17025 guidelines and Good Lab Practices (GLP). Each lab is responsible for accuracy, so when results are out-of-spec, the lab will double-check many things including: sample handling practices; reagent expiration dates; if equipment calibration is up-to-date; dilution factors; and testing calculations. In addition, the lab should verify that the method was followed as written and if it was valid for the sample matrix. Along with other considerations, it is important to ask if the sample appeared to go fully into the solution? If a lab error is found, retesting and retraining should be conducted. Since this investigation takes additional time, samples that are OOS will be delayed due to this process.

 

 

What steps should a lab take to make sure that their results are accurate? What are some suggestions for avoiding mistakes?

 

SORA double-checks the results of each testing run against a known "known or reference standard." For enzyme activity assays, this standard is just an extra sample of "known value" included the run to ensure that it is being performed according to procedural guidelines. This result is recorded and the RSD% is calculated. The result must fall within a range set by the validating method for the entire run. If the known or reference standard falls outside of the given range, the run is considered invalid and all results are thrown out—invalid results are not reported to the customer.

 

Labs should follow the practice of validating the method on a new sample matrix. This can be a long expensive process, with testing often expected on a fast turn-around time, so this process is rarely done. A quick check for method performance can be done on the new sample matrix using "spike recovery" testing. Spike recovery testing involves adding a known amount of the chemical you are looking for in the sample matrix and then seeing what your method recovers on the matrix. The results can help you decide if the method will work on the new sample matrix.

 

Issues can also occur during testing if the wrong method was used to run the sample. There may be several potential methods of testing for the same compound so it is always a best practice to ensure that the correct testing method is being used before beginning.

 

As Stuart Phillips, a scientist at McMaster University who studies the effects of protein supplements on humans, says: "Like anything else in life, I think when a lab gets something wrong, [it can happen for a number of reasons like] human error, contaminated dirty glassware, [or] machine malfunction." Though things could potentially go wrong, taking the proper precautions and following the accredited procedures will help keep mistakes to a minimum and help ensure correct testing results.