Microbial testing

This test quantifies the total viable anaerobic microbial population in dietary supplements, botanical raw materials, and food ingredients using the culture-based enumeration methods described in USP <2021> (Microbial Enumeration Tests). Anaerobic organisms, including spore-forming bacteria such as Clostridium species, are not detected by standard aerobic plate count (TPC) methods and require dedicated anaerobic incubation conditions to enumerate. This test provides a quantitative count of viable anaerobic bacteria, reported as colony-forming units per gram (CFU/g), and is used for raw material qualification, finished product release testing, and compliance with microbial limits specifications.

A representative sample is prepared by homogenization in a buffered diluent and serially diluted under conditions that minimize oxygen exposure. Dilutions are plated onto non-selective nutrient agar using pour plate or spread plate technique and incubated under strict anaerobic conditions — using an anaerobic chamber or gas-generating anaerobic jars — at 30–35°C for a minimum of 48–72 hours, per USP <2021> specifications. Following incubation, colonies are counted and the anaerobic viable count is calculated and expressed as CFU/g. Results are evaluated against the applicable microbial limits for the product category per USP <2021> or the customer's specification.

Standard aerobic total plate count methods will not detect obligate anaerobic organisms, which can include pathogenic spore-forming bacteria such as Clostridium perfringens and Clostridium botulinum. These organisms are a known risk in soil-associated botanical ingredients, animal-derived proteins, and fermentation-derived raw materials. A dedicated anaerobic viable count per USP <2021> provides the additional layer of microbial safety assurance required for high-risk matrices and for brands seeking comprehensive microbial characterization beyond standard aerobic testing panels.

This assay detects and quantifies Bacillus cereus, a spore-forming bacterium that can cause foodborne illness or spoilage. Common in plant-based ingredients, protein powders, and shelf-stable formulations, B. cereus testing ensures microbial safety in raw materials and finished products.

Samples are homogenized and cultured on selective agar media specific for B. cereus, followed by incubation and colony enumeration. Confirmation may include biochemical tests or PCR. The method follows AOAC or FDA BAM (Bacteriological Analytical Manual) protocols.

Results are reported in CFU/g. Values are compared to industry standards and microbial limits based on product type (e.g., <100 CFU/g for powders or functional foods). This assay helps prevent safety risks and spoilage issues during storage and distribution.

This assay detects and quantifies bile-tolerant gram-negative bacteria (BTGN) in raw materials and finished dietary supplements using the method described in USP <2021>. BTGN testing helps ensure the absence of objectionable organisms and supports compliance with microbial limits in dietary products.

Samples are diluted and plated on MacConkey agar or another selective medium as specified by USP <2021>. Plates are incubated under aerobic conditions, and characteristic colonies of gram-negative, bile-tolerant bacteria are enumerated. Confirmatory testing may be performed as needed.

Results are reported in CFU/g. Values are compared to USP <2021> acceptance criteria, which typically require BTGN to be absent or ≤10³ CFU/g depending on the product category.

This assay detects the presence of Candida species (typically Candida albicans) in dietary supplements, food products, and raw materials, following USP <2021>/<2022> Microbial Limits Tests. It ensures products are free of objectionable yeasts that may pose health or quality risks.

Samples are prepared and enriched in growth media, then plated on selective agar designed for yeast and mold. Colonies with morphology consistent with Candida are evaluated and confirmed using biochemical or molecular identification methods per USP protocols.

Results are reported as Absent/Present per g (or per mL). USP specifications generally require the absence of Candida in specified sample sizes for dietary supplements and raw materials. This testing verifies compliance with pharmacopeial standards and ensures consumer safety.

This assay detects and quantifies Clostridium perfringens, a spore-forming anaerobic bacterium associated with foodborne illness and contamination of protein-rich or plant-based ingredients. Testing for C. perfringens ensures product safety, particularly in powdered foods, botanicals, and digestive health supplements.

Samples are enriched and cultured under anaerobic conditions using selective media such as TSC (Tryptose Sulfite Cycloserine) agar. Suspect colonies are confirmed via biochemical tests or PCR. The method aligns with AOAC, ISO 7937, or FDA BAM protocols.

Results are reported in CFU/g. Values are compared to safety thresholds (e.g., <100 CFU/g for most food products) to verify compliance with microbiological specifications and regulatory requirements.

Coliform bacteria are indicators of sanitation and possible fecal contamination in food products.

Samples are plated on coliform-specific media and incubated. Colonies are identified by color or biochemical markers and reported as CFU/g or CFU/mL.

Presence suggests inadequate sanitation or contamination during production.

This test detects the presence or absence of Cronobacter species (formerly Enterobacter sakazakii) in dietary supplements, powdered food products, and raw materials using Polymerase Chain Reaction (PCR). Cronobacter is a foodborne pathogen capable of causing severe and potentially fatal infections — including meningitis and septicemia — particularly in neonates and immunocompromised individuals. PCR-based detection provides rapid, highly specific identification of Cronobacter DNA, enabling faster results than traditional culture-based methods. Results are reported as detected or not detected per the tested sample size, in accordance with applicable regulatory standards.

A representative sample is enriched in a non-selective broth at 37°C for a defined incubation period to resuscitate and amplify any viable Cronobacter cells present. Following enrichment, DNA is extracted from the broth using a validated nucleic acid extraction procedure. The extracted DNA is subjected to real-time PCR (qPCR) using primers and probes targeting Cronobacter-specific genomic sequences. Positive and negative controls, including an internal amplification control, are run concurrently with each batch to confirm assay performance and rule out PCR inhibition. Any presumptive positive result is confirmed by a secondary method per applicable regulatory guidance.

Cronobacter is a regulated pathogen in powdered infant formula under FDA 21 CFR Part 106 and is subject to zero-tolerance requirements in many food categories. Its ability to survive desiccation makes it a persistent risk in dry powder supplement and food matrices where standard hygiene controls may be insufficient. PCR-based detection offers significantly faster turnaround than traditional culture methods while maintaining high sensitivity and specificity, enabling timely release decisions and rapid response to potential contamination events.

This test screens for Escherichia coli, a bacteria that indicates fecal contamination and can pose serious health risks.

Samples are cultured on selective media and confirmed using biochemical or molecular methods. Reported as presence/absence or CFU/g.

E. coli should be absent in final products. Any detection raises safety concerns.

Tests for a broad family of bacteria including pathogens and spoilage organisms, often used as a general hygiene indicator.

Samples are plated on violet red bile glucose agar or similar selective media. Results reported as CFU/g or CFU/mL.

Elevated levels suggest contamination or poor sanitation practices during production.

This assay quantifies total viable lactic acid bacteria (LAB) in supplements, functional foods, and fermented products. It is commonly used to verify probiotic content, assess fermentation performance, or monitor microbial composition in gut health formulations.

Samples are diluted and plated on selective media such as MRS agar, then incubated under anaerobic or microaerophilic conditions at controlled temperatures. Colonies characteristic of LAB are enumerated after incubation. Testing follows ISO or USP microbiological methods.

Results are reported in CFU/g or CFU/mL. Values are compared to formulation targets or probiotic label claims to confirm viability and consistency across production batches.

This assay enumerates viable Bacillus coagulans spores in probiotic raw materials and finished products following Method J.4.0002. Results confirm probiotic strength and validate label claims for CFU content.

Samples are prepared, serially diluted, and plated onto selective agar media under specified growth conditions. Colony-forming units (CFUs) are counted after incubation. Method J.4.0002 defines standardized conditions for recovery, ensuring reliable and reproducible results.

Results are reported in CFU/g (raw materials) or CFU/serving (finished products). Testing confirms probiotic viability, verifies stability over shelf life, and ensures compliance with label claims.

A specific assay for Listeria monocytogenes, a pathogenic species that can cause listeriosis.

Enrichment, selective plating, and confirmation through biochemical or molecular methods. Reported as presence/absence per 25g.

Must be absent in food products due to its risk to pregnant individuals and immunocompromised populations.

This test detects Listeria spp., a group of bacteria that includes species harmful to immunocompromised individuals.

Samples are enriched and plated on selective agar, with further testing to confirm genus. Results are typically qualitative.

Listeria species should be absent in ready-to-eat products to meet regulatory standards.

This panel includes Total Plate Count, Yeast & Mold, Coliforms, E. coli, Salmonella, and Staphylococcus aureus. It provides a comprehensive screen for microbial load, spoilage organisms, and key pathogens to ensure product safety and compliance.

Samples are prepared and plated on selective and non-selective agar media appropriate for each organism. Incubation times and conditions follow USP, AOAC, and FDA BAM guidelines. Confirmatory biochemical or molecular methods are used where necessary for pathogen identification. All tests include appropriate controls and duplicate runs.

Results are reported in CFU/g or as Detected / Not Detected depending on the assay. Values are assessed against regulatory limits and industry standards (e.g., USP <2021>, <2022>, <2023>) to verify safety and microbial integrity.

This assay provides microscopic identification of up to three distinct mold types present in a sample. The analysis determines the morphological characteristics of each mold to the genus or species level, depending on visibility and growth pattern.

Samples are cultured under controlled incubation for approximately five days to promote mold growth. After incubation, distinct colonies are microscopically examined, and up to three mold types are identified. Additional identifications can be performed upon request if more than three species are present.

Results are reported as a list of identified molds per sample. Testing supports contamination assessment, validates product safety, and helps pinpoint sources of microbial spoilage.

This assay detects the presence of Pseudomonas aeruginosa, a Gram-negative bacterium that can indicate poor sanitation or post-processing contamination. It is considered an opportunistic pathogen and is of particular concern in cosmetic, pharmaceutical, and some food products due to its ability to survive in moist environments and resist certain preservatives.

Samples are enriched in a selective broth and plated on differential agar designed to isolate P. aeruginosa. Colonies with characteristic morphology are further confirmed through biochemical or molecular identification methods.

Results are reported as Present or Not Detected. Detection of P. aeruginosa may trigger regulatory or quality concerns, especially for personal care products or RTE (ready-to-eat) foods. Absence indicates acceptable microbial quality under most manufacturing and hygiene standards.

This panel includes Total Plate Count, Yeast & Mold, Coliforms, E. coli, Salmonella, and Staphylococcus aureus. It provides a comprehensive screen for microbial load, spoilage organisms, and key pathogens to ensure product safety and compliance.

Samples are prepared and plated on selective and non-selective agar media appropriate for each organism. Incubation times and conditions follow USP, AOAC, and FDA BAM guidelines. Confirmatory biochemical or molecular methods are used where necessary for pathogen identification. All tests include appropriate controls and duplicate runs.

Results are reported in CFU/g or as Detected / Not Detected depending on the assay. Values are assessed against regulatory limits and industry standards (e.g., USP <2021>, <2022>, <2023>) to verify safety and microbial integrity.

This test detects and quantifies yeast and mold, common spoilage organisms in food and supplements that can affect shelf life and safety.

Samples are plated on selective agar and incubated to allow growth of yeasts and molds. Results are reported as CFU/g or CFU/mL.

Low levels indicate clean processing and storage. Elevated levels may lead to spoilage or product recalls.

This assay detects Salmonella, a pathogenic bacteria that can cause severe foodborne illness.

Enrichment followed by plating on selective media and confirmation through biochemical or PCR testing. Reported as presence/absence per 25g.

Salmonella must be absent to ensure product safety and compliance.

This assay screens for the presence of Shiga-toxin producing Escherichia coli. STEC strains produce Shiga toxins (Stx1, Stx2) that can cause gastrointestinal illness and complications such as hemolytic uremic syndrome (HUS). Testing is critical for high-risk foods such as leafy greens, sprouts, ground meats, and ready-to-eat products.

Samples are enriched and analyzed using validated microbiological methods (culture, PCR, or immunoassay-based) to detect E. coli strains carrying Shiga-toxin genes. Confirmatory testing differentiates pathogenic STEC from non-pathogenic E. coli.

Results are reported qualitatively as “Not Detected” or “Detected.” Testing ensures compliance with FDA/USDA guidelines, verifies food safety, and protects against outbreaks.

This assay screens samples for the presence of Shigella species, pathogenic bacteria associated with foodborne illness. Detection of Shigella is critical for assessing safety in foods, supplements, and raw materials.

Samples are analyzed using validated microbiological screening techniques appropriate for the sample matrix. Controls and confirmatory steps are applied as needed to ensure reliable detection.

Results are reported qualitatively as Detected or Not Detected. Testing supports food safety programs, regulatory compliance, and contamination risk assessment.

This test identifies Staphylococcus aureus, a bacteria that produces toxins and is associated with improper food handling.

Samples are plated on selective media and confirmed through coagulase testing or molecular assays. Reported in CFU/g.

Low or absent levels are expected. High counts may indicate unsafe handling or contamination.

This assay detects and enumerates sulfite-reducing Clostridia, anaerobic spore-forming bacteria that can indicate contamination risk in foods, supplements, and raw materials. These organisms are commonly monitored as hygiene and safety indicators, particularly in low-oxygen or heat-processed products.

Samples are prepared and analyzed according to USP 2022 methodology. Testing involves anaerobic incubation on selective sulfite-containing media that supports growth of sulfite-reducing Clostridia. Colonies exhibiting characteristic sulfite reduction are enumerated and reported.

Testing supports microbiological quality programs, verifies compliance with pharmacopeial standards, and helps identify contamination risks associated with anaerobic spore-formers.

This test estimates the total number of viable aerobic bacteria in a product, indicating overall microbial load and hygiene quality.

A sample is diluted, plated on general growth media, and incubated under aerobic conditions. Colonies are counted and reported as CFU/g or CFU/mL.

Low counts suggest good hygiene and handling; high counts may indicate poor sanitation or contamination.

This test detects and quantifies yeast and mold, common spoilage organisms in food and supplements that can affect shelf life and safety.

Samples are plated on selective agar and incubated to allow growth of yeasts and molds. Results are reported as CFU/g or CFU/mL.

Low levels indicate clean processing and storage. Elevated levels may lead to spoilage or product recalls.