Probiotic Stability Testing Service
Probiotic Stability Testing Service
Services
Online Inquiry

Probiotic Stability Testing Service

Probiotic Stability Testing

Comprehensive viability and shelf-life assessment to validate your probiotic product claims under real-world storage conditions.

  • Enumeration of viable cells (CFU/g or CFU/mL) at multiple time points
  • Accelerated aging studies under controlled temperature and humidity
  • Real-time stability monitoring for shelf-life prediction
  • Thermal, pH, moisture, and oxygen tolerance testing
  • Strain identity confirmation throughout the study period

How stable is your probiotic?

We quantify viability, identity, and bioactivity across storage conditions to back your product claims with robust data.

  • Accelerated and real-time protocols tailored to your product format
  • Compatibility testing with excipients, carriers, and packaging
  • Detailed shelf-life modeling and environmental tolerance summary
  • Reporting suitable for regulatory submission and QC validation
Comprehensive
Data-Driven
Compliant
Testing Approach

End-to-End Probiotic Stability Assessment

We combine accelerated and real-time protocols to model shelf life and validate formulation integrity under diverse storage conditions.

Viability & Potency Testing

Core enumeration and stress tolerance assays to monitor CFU counts and bioactivity over time.

  • Enumeration of viable cells (CFU/g or CFU/mL) at multiple time points
  • Evaluation of thermal, pH, moisture, and oxygen tolerance
  • Accelerated aging studies under controlled humidity and temperature
  • Shelf-life prediction models for finished formulations

Formulation & Packaging Evaluation

Assess how excipients, processing, and packaging impact probiotic survival and stability.

  • Compatibility with excipients, carriers, and other bioactives
  • Stability testing for powders, capsules, liquids, and coated formulations
  • Post-packaging survival studies under ambient, refrigerated, and frozen conditions
  • Impact of processing (spray drying, freeze-drying, encapsulation) on viability

Quality Control

Periodic strain identity verification using molecular methods (16S rRNA, WGS) to ensure no contamination or drift during storage.

Statistical Rigor

Replicate testing, kinetic modeling, and appropriate statistical analyses to generate reproducible stability curves.

Regulatory Alignment

Protocols designed to support alignment with ICH and EFSA stability guidelines for probiotic products.

Deliverables

What You Receive

A complete data package with actionable insights for formulation optimization and regulatory support.

Data Deliverables

  • CFU viability data at each sampling time point
  • Accelerated and real-time stability curves with confidence intervals
  • Shelf-life prediction models with kinetic parameters
  • Environmental tolerance summary (temperature, humidity, pH, oxygen)

Reporting & Support

  • Comprehensive stability study report (real-time + accelerated data)
  • Recommendations for formulation optimization and packaging strategies
  • Technical interpretation of results for regulatory submission or marketing claims
  • Strain identity confirmation data (PCR/sequencing) as applicable
Service Scope

Customizable Testing Parameters

Each study is scoped per project based on product format, target market, and regulatory requirements.

ParameterTypical Project Scope
Probiotic strainsLactobacillus, Bifidobacterium, or other strains as specified; single or multi-strain combinations
Study durationScoped per project; typical real-time studies months, accelerated months
Storage conditionsControlled temperature (e.g., 4°C, 25°C, 40°C) and humidity (e.g., 60% RH, 75% RH) as selected
Product formatsPowders, capsules, sachets, liquids, and coated formulations
Analytical endpointsViable cell count (CFU), strain identity (PCR/sequencing), pH, moisture content, encapsulation integrity
Replication and controlsTriplicate sampling per time point; internal positive/negative controls included
Workflow

How the Testing Process Works

A structured pipeline from sample receipt to final reporting, ensuring traceability and reproducibility at every step.

Sample Preparation & Baseline Assessment

Receive product samples and document initial CFU counts, strain identity, and physical properties (moisture, pH, appearance). Establish baseline for all subsequent measurements.

Accelerated Aging Study

Place samples under elevated temperature and humidity (e.g., 40°C/75% RH) with scheduled pull points to simulate long-term storage effects. Monitor viability, moisture, and other markers at each interval.

Real-Time Stability Monitoring

Maintain samples at recommended storage conditions (e.g., 25°C/60% RH, refrigerated, or frozen) and test at predefined intervals to generate actual shelf-life data over the product's intended period.

Viability & Identity Verification

Perform CFU enumeration on selective media, and confirm strain identity via molecular methods (16S rRNA sequencing or WGS) at key time points to rule out contamination or strain drift.

Data Analysis & Reporting

Compile all time-point data, model shelf-life kinetics, and deliver a comprehensive report with graphs, statistical analysis, and actionable recommendations for formulation or packaging improvements.

Applications

Industries We Serve

Our stability testing supports probiotic products across multiple market segments.

Validate Label Claims for Consumer Products

Ensure that CFU counts remain at the declared level through the product's shelf life, supporting both regulatory compliance and consumer trust.

  • Shelf-life claim substantiation for US and EU markets
  • Testing in capsule, tablet, powder, and liquid formats
  • Accelerated and real-time data for label accuracy

Ensure Viability Under Feed Storage Conditions

Probiotics in animal feed must survive ambient storage, pelleting, and potential heat stress. Our protocols simulate these conditions to guarantee stability.

  • Stability testing in feed matrices (meal, pellets, treats)
  • Thermal tolerance evaluation relevant to feed processing
  • Long-term storage studies at typical warehouse temperatures

Support Stability for Drug-Probiotic Products

For probiotic products intended as medical foods or live biotherapeutics, we provide the rigorous stability data expected by regulators.

  • Long-term and accelerated studies per ICH guidance
  • Compatibility with drug excipients and packaging materials
  • Full documentation for regulatory submission packages
FAQ

Frequently Asked Questions

Common questions about our probiotic stability testing service.

  • We conduct both accelerated aging studies (elevated temperature and humidity) and real-time shelf-life monitoring under recommended storage conditions. The specific conditions and duration are scoped per project based on your product format and target market.

  • Viability is measured by standard plate counting methods to determine CFU per gram or milliliter. We also assess tolerance to heat, pH, moisture, and oxygen, and confirm strain identity by molecular methods (e.g., 16S rRNA sequencing) when required.

  • Yes, we can include capsules, sachets, powders, liquids, and coated formulations in the same study for direct comparison. The study design will be customized to evaluate each format under identical storage conditions where feasible.

  • Yes, we model the kinetic data from accelerated studies to estimate shelf-life under real-time conditions. Predictions are delivered in the final report along with confidence intervals and are based on the specific formulation and packaging used.

  • Our protocols are designed to align with ICH, EFSA, and FDA stability testing guidelines for probiotic products. We do not guarantee regulatory approval but provide data that supports your submission or claim documentation.

  • The number of samples depends on the number of time points, storage conditions, and replication required. We will work with you to determine the appropriate sample size during the project scoping phase.

  • Yes, we routinely test multi-strain probiotic formulations. Strain-specific enumeration can be performed using selective media or molecular methods when strain-specific markers are available.

Scientific Literature

References

  1. Mahmoodian S, Fatemi SS, Shamsara M, et al. Impact of protectants and the method of preservation on the stability of potentially probiotic bacteria. Cryobiology. 2024;116:104912. View on PubMed
  2. Samara J, Moossavi S, Alshaikh B, et al. Supplementation with a probiotic mixture accelerates gut microbiome maturation and reduces intestinal inflammation in extremely preterm infants. Cell host & microbe. 2022;30(5):696-711.e5. View on PubMed
  3. Bharindwal S, Goswami N, Jha P, et al. Prospective Use of Probiotics to Maintain Astronaut Health during Spaceflight. Life (Basel, Switzerland). 2023;13(3). View on PubMed

Please kindly note that our products and services are for research use only.