Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Probiotic Testing | CFU Enumeration & Strain ID | NABL Accredited

A probiotic supplement that fails to deliver the labelled CFU at end of shelf life is unsupported under FSSAI Section 53 and exposed to marketplace delisting and consumer dispute. Backed by the Arbro Group's unbroken NABL accreditation since 2003, Auriga Research delivers probiotic viable cell enumeration and strain identification at the rigour required by FSSAI, EFSA, and the international probiotic industry.

Probiotic claims are regulated under the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, FSMP, Functional Food and Novel Food) Regulations 2016, with viable cell counts referenced against AOAC 989.10, ISO 27205 / ISO 29981, and USP <62> / IP 2018 for pharma-boundary probiotics. Our scope covers single-strain and multi-strain enumeration on selective media for Lactobacillus, Bifidobacterium, Bacillus, Saccharomyces, and Streptococcus thermophilus, with 16S / 18S rRNA strain identity, mandatory FSSAI pathogen exclusion (Salmonella, E. coli, S. aureus), and optional EFSA-pattern antibiotic resistance and gastric-bile survival assays.

Probiotic samples are received under cold chain and registered in YLIMS for full traceability; enumeration begins within 24 hours of receipt to preserve viable count integrity.

Reports in 7–10 working days | Express: 7 days available
Get a Quote Call +91-7428116100

Testing Parameters

Each parameter is mapped to its method or pharmacopoeial reference so QA and regulatory teams can match scope to FSSAI / ISO / USP requirements at a glance.

AOAC 989.10

Lactobacillus Enumeration

Selective MRS agar (anaerobic, 37 °C / 72 h) for L. acidophilus, L. rhamnosus, L. casei, L. plantarum, L. reuteri. Strain identity confirmed on suspected colonies.

ISO 29981

Bifidobacterium Enumeration

TOS-MUP / BSM selective agar under anaerobic conditions for B. lactis, B. bifidum, B. longum, B. breve. Confirmed by Gram stain and 16S rRNA.

AOAC

Bacillus Spore Count

Heat-shock at 80 °C / 10 min followed by MYP agar plating for B. coagulans, B. subtilis, B. clausii spore enumeration.

Plate Count

Saccharomyces boulardii

YPD agar with chloramphenicol — selective enumeration of S. boulardii in yeast probiotic supplements.

Plate Count

Streptococcus thermophilus

M17 selective agar at 42 °C for S. thermophilus in synbiotic and fermented-food supplements.

16S rRNA

Bacterial Strain ID

16S rRNA gene amplification and Sanger sequencing for strain identity confirmation against curated databases (RDP, GenBank, EzBioCloud).

18S / ITS

Yeast Strain ID

18S rRNA and ITS region sequencing for Saccharomyces and Kluyveromyces strain identification at species level.

qPCR

Strain Quantification by qPCR

Strain-specific quantitative PCR for hard-to-culture probiotics or where mixed-strain enumeration on selective media is ambiguous.

ISO 6579-1

Salmonella (Probiotic)

Mandatory pathogen exclusion test on probiotic supplements — FSSAI requires absence in 25 g.

ISO 7251

E. coli (Probiotic)

Mandatory pathogen exclusion test — FSSAI requires E. coli absent in 1 g of finished probiotic supplement.

Antibiotic Sensitivity

Antibiotic Resistance Profile

EFSA-recommended antibiotic susceptibility testing on probiotic strains to confirm absence of transferable antibiotic resistance.

Survival

Gastric & Bile Survival

In-vitro simulated gastric (pH 2.0) and bile (0.3% bile salt) survival assay — supports functional claim substantiation on the probiotic label.

How It Works

1

Get a Quote

Share your product type and the parameters you need tested. Your dedicated SPOC will confirm the testing scope, the applicable method, and the exact sample quantity required for your specific panel before you dispatch anything.

2

Send Your Sample

Dispatch your sample with a completed Test Request Form to the nearest Auriga lab. Each sample is individually bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt. Testing begins within 24 hours of sample registration.

3

Testing and QA Review

Your sample is tested against the confirmed validated method by Auriga's scientific team. Every result passes through a formal internal QA review and sign-off before the report is generated.

4

Receive Your NABL Report

Your NABL-accredited test report is delivered digitally within the committed turnaround time. Reports carry Auriga's NABL accreditation under ISO/IEC 17025:2017 and are accepted by FSSAI under the Health Supplements Regulations 2016, BIS, and international buyers. You can track your sample status in real time through YLIMS at any point in the process.

Turnaround Time

Panel Standard TAT Express
Single-strain CFU enumeration 7–10 working days 7 days
Multi-strain CFU enumeration (≥ 3 strains) 10–14 working days On request
Strain identity confirmation (16S / 18S rRNA) + 3–5 days Available
FSSAI pathogen exclusion (Salmonella, E. coli, S. aureus) 7–10 working days 5 days
Gastric / bile survival functional assay 10–14 working days
Antibiotic resistance profile (EFSA pattern) 14–18 working days On request

Who Needs This Testing

  • Probiotic and synbiotic supplement brands launching on Amazon, Flipkart, Blinkit, Zepto, and BigBasket — marketplaces require CFU substantiation before listing.
  • Probiotic manufacturers preparing FSSAI Form B nutraceutical licence applications under the Health Supplements Regulations 2016 with declared CFU counts.
  • D2C gut-health, immunity, and women's wellness brands needing strain identity authentication beyond supplier certificates of analysis.
  • AYUSH-licensed probiotic and traditional medicine brands needing IP 2018 / USP <62> pharmacopoeial pathogen control alongside CFU enumeration.
  • Brands building shelf-life dossiers — pairing probiotic CFU enumeration with stability testing through the labelled expiry period.
  • Contract manufacturers and CDMOs running batch release CFU enumeration on every probiotic SKU produced.
  • International probiotic brands and importers needing EFSA-pattern antibiotic resistance and functional survival data to support cross-border claims.

Why Auriga for Probiotic Testing

Unbroken NABL accreditation since 2003

Arbro Group has held NABL ISO/IEC 17025 accreditation continuously since 2003 covering selective culture, anaerobic incubation, and pathogen control scope.

Selective media for every major strain

Validated selective media for Lactobacillus, Bifidobacterium, Bacillus, Saccharomyces, and Streptococcus thermophilus — multi-strain probiotics enumerated strain-by-strain.

In-house 16S / 18S rRNA sequencing

Strain identity confirmation without dispatch to external sequencing partners — faster turnaround on strain authentication and dispute resolution.

Cold chain sample handling

Dedicated cold chain sample receipt protocol — registered in YLIMS with full audit trail; enumeration begins within 24 hours to preserve CFU integrity.

FSSAI + USP / IP scope on the same sample

Both food-side (FSSAI) and pharma-side (USP <62>, IP 2018) microbial control on the same probiotic sample — covers AYUSH-licensed probiotic claims.

Functional and resistance assays

Optional gastric / bile survival and EFSA-pattern antibiotic susceptibility on request — supports functional claim substantiation and international compliance.

Frequently Asked Questions

What probiotic testing is required for nutraceuticals in India?
Probiotic supplements sold in India must comply with the FSSAI Health Supplements Regulations 2016, which requires that any declared CFU (colony-forming unit) count on the label be substantiated by viable cell enumeration of the declared strain. Tests include strain-specific viable cell counts, identity confirmation, absence of pathogens (Salmonella, E. coli, Staphylococcus aureus), and stability of CFU counts through shelf life. Auriga also provides 16S / 18S rRNA molecular identification for strain authentication.
Which probiotic strains can Auriga enumerate?
Auriga validates viable cell counts for Lactobacillus species (L. acidophilus, L. rhamnosus, L. casei, L. plantarum, L. reuteri), Bifidobacterium species (B. lactis, B. bifidum, B. longum, B. breve), Bacillus species (B. coagulans, B. subtilis, B. clausii), Saccharomyces boulardii, and Streptococcus thermophilus. Multi-strain formulations are enumerated on strain-specific selective media. Strain identity is confirmed by 16S rRNA (bacteria) or 18S rRNA / ITS (yeast) sequencing.
What methods are used for probiotic enumeration?
Viable cell counts use selective culture media following AOAC 989.10 and ISO 27205 / ISO 29981: MRS agar with vancomycin or bile selectivity for Lactobacillus; BSM / TOS-MUP agar for Bifidobacterium under anaerobic conditions; MYP agar for Bacillus; YPD with chloramphenicol for Saccharomyces. Multi-strain probiotic blends are enumerated by combining selective media with strain-specific colony morphology and 16S confirmation.
How long does probiotic testing take?
Standard turnaround for single-strain CFU enumeration is 7–10 working days (anaerobic incubation cycles for Bifidobacterium extend this slightly). Multi-strain probiotic enumeration takes 10–14 working days. Strain identity confirmation by 16S rRNA sequencing adds 3–5 working days. Express service at 7 working days is available for FSSAI registration and marketplace listing deadlines.
What sample quantity and cold chain is required?
Send at least 30 g of finished product or 60 dose units in sealed retail packaging. Probiotics must be dispatched under cold chain (2–8 °C) with adequate ice packs and tracking — viable counts decline rapidly at ambient temperatures. Lyophilised (freeze-dried) probiotic capsules tolerate brief ambient transit but should still be kept cool. Air-shipped samples should arrive within 48 hours of dispatch.
What CFU declaration is typical on probiotic labels?
Most probiotic supplements declare CFU counts in the range of 1–50 billion CFU per serving (10⁹ to 5×10¹⁰ cfu/dose). FSSAI requires that the declared CFU be present at end of shelf life, not just at manufacture. Practical formulation builds in an overage (typically 2–3× the label claim) so that real-world stability loss during storage still leaves the labelled CFU available at end of shelf life. Stability testing through the claimed shelf life is essential for defensible CFU claims.
How often should probiotic testing be repeated?
Every probiotic supplement batch should be released against the CFU spec at manufacture — this supports FSSAI compliance and label claim defence. Stability testing through the full shelf life is required at least once per formulation. Re-verification is mandatory when: (a) the probiotic strain supplier or culture house changes; (b) the formulation or excipient base changes; (c) the packaging (especially moisture-barrier blister or sachet) changes; (d) the manufacturing site or process changes. Annual independent verification supports marketplace and FSSAI surveillance defence.

Get Your Probiotic Testing Quote

NABL-accredited probiotic CFU enumeration, 16S / 18S rRNA strain ID, and FSSAI safety panel on the same sample. Express turnaround for marketplace launches.

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