Frequently Asked Questions
Accelerated shelf-life studies are valuable tools for providing expedited data on shelf-life determination. However, accelerated studies are not applicable to all food/beverage products. To attain the accelerated data, products are stored at increased temperature and humidity conditions. Therefore, products that will melt, breakdown or change physical characteristics in this environment are not going to withstand the accelerated storage regimen. A Q Laboratories analyst can help you determine on a case-by-case basis if your product is a candidate for an accelerated study. A point to remember – regulatory bodies may accept accelerated data and allow you to package and market a product based on that data, but ultimately will require the real-time data to confirm shelf-life. Therefore, a real-time study always must be performed to confirm the accelerated study data.
Do I have to perform a neutralization study on my product(s) before conducting an Antimicrobial Efficacy (AET) study?
If a drug, cosmetic, or health and beauty care product possesses antimicrobial properties due to the presence of a preservative or because its formulation creates natural preservative action, this antimicrobial property must be neutralized to recover viable microorganisms during the AET study. The ability of the AET procedure to detect challenge microorganisms in the presence of a suitably neutralized product to be tested must be established. In most cases the neutralization study only needs to be performed once per product type. A change in formulation may require an updated neutralization study.
Yes, we can come to your facility and perform a walk-through audit helping you determine particular zones and critical control points, where environmental sampling should occur. Q Laboratories has a Preventive Control Qualified Individual (PCQI) on staff to assist with this process. Our PCQI can demonstrate proper sampling technique during the initial program design. We also can help you determine what tests to perform, whether for spoilage organisms, or pathogens such as Listeria and Salmonella, and provide guidance on sampling intervals. As an added value to our customers, we can ship you a cooler with the supplies you need to perform the sampling. Your team performs the sampling, ships the samples to us using the supplied cooler and cool packs. We receive and test the samples and send the cooler back to you for future sampling intervals, restocked with any supplies necessary.
Probiotics are a popular ingredient used in a myriad of products including yogurt, tea and coffee, pet food, dietary supplements and beverages. Potential health benefits of consuming probiotics include gut health and immune system fortification. Many different microorganisms are utilized as probiotics including multiple strains of Lactobacillus and Bifidobacterium. Manufacturers are required to verify the levels of the probiotic ingredient(s) in their products and whether the probiotics survive processing and shelf-life. Q Labs has a team of dedicated scientists who specialize in the recovery and isolation of unique and/or difficult to culture probiotics. We can also design and execute a shelf-life study on your products to verify survival of the probiotics over the life of the product.
Yes, Q Laboratories utilizes ICP-MS technology to perform elemental impurities testing on raw materials and finished products to help you comply with both USP and ICH Q3D requirements.
Yes. We can perform microbiological analysis, including USP chapters 2021 and 2022, and FDA-BAM. We can qualify your raw materials using USP and FCC guidelines or work from an existing Certificate of Analysis (CofA). We also provide stability storage and analysis, nutritional analysis, active ingredient identification, and method development and validation services.
Yes, we utilize state-of -the-art MALDI-TOF technology to identify a vast array of organisms to help you gain the information you need to eradicate and prevent further contamination.
Q Laboratories is the premier validation laboratory in the world for rapid pathogen detection technology, performing studies for food diagnostic products and methods to gain approval from organizations such as AOAC, MicroVal and AFNOR. Therefore, we have unique access to the latest cutting-edge technologies available. Based on this experience we often can guide clients to a rapid method that has demonstrated proficiency for a particular food matrix or product type. If you have a unique matrix that has not been evaluated during a validation study, we can perform a verification study against a number of rapid detection options to assure the method is fit for purpose for your product type.
A Method Validation demonstrates competency of an assay, instrument, or method for a wide variety of food matrices and environmental samples with an expert laboratory through certification bodies such as AOAC International, MicroVal and AFNOR. A Method Verification is conducted by an expert laboratory to ensure that the assay, instrument, method produces accurate and reliable results for a specific food matrix or environmental sample for internal verification.