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Microbiology & Shelf-Life

Microbiological testing and shelf life studies in a dedicated Class 10,000 suite.

Overview

Scope of microbiological testing

Our microbiology department runs in a dedicated Class 10,000 suite with separate pathogen and non-pathogen streams, unidirectional sample flow and its own air handling. Culture-based confirmation runs alongside real-time PCR screening, which lets us release negative results faster without losing confirmatory rigour.

We also design and run shelf-life and challenge studies, the work that decides what expiry date you can honestly print on a pack.

Matrices we handle routinely

  • Ready-to-eat and cooked foods
  • Dairy, paneer and frozen desserts
  • Meat, poultry and seafood
  • Beverages and packaged water
  • Cosmetics and personal care
  • Pharmaceutical dosage forms
  • Environmental swabs and air samples
  • Raw agricultural produce
Scope

What we test

Indicator organisms

  • Total plate count / aerobic count
  • Yeast and mould count
  • Coliforms and E. coli
  • Enterobacteriaceae
  • Staphylococcus aureus
  • Bacillus cereus and Clostridium perfringens

Pathogen detection

  • Salmonella spp., ISO 6579-1
  • Listeria monocytogenes, ISO 11290
  • E. coli O157:H7
  • Vibrio cholerae and V. parahaemolyticus
  • Cronobacter sakazakii in infant formula
  • Campylobacter spp.

Molecular methods

  • Real-time PCR pathogen screening
  • Meat and fish species identification
  • GMO screening and quantification
  • Probiotic strain confirmation
  • Rapid negative release in 24–48 hours
  • Confirmation of PCR positives by culture

Sterility & pharma micro

  • Sterility testing, USP 71 membrane filtration
  • Bioburden and microbial limits
  • Bacterial endotoxins by LAL
  • Antimicrobial effectiveness, USP 51
  • Environmental monitoring of clean rooms
  • Water system microbiological validation

Shelf life & challenge

  • Real-time shelf-life studies with defined pulls
  • Accelerated studies with kinetic modelling
  • Microbial challenge studies (inoculated pack)
  • Preservative efficacy verification
  • Water activity and growth-potential assessment
  • Expiry date recommendation report

Hygiene monitoring

  • Surface and equipment swabs
  • Personnel hand and glove swabs
  • Settle plates and active air sampling
  • ATP verification cross-checks
  • Cleaning validation programmes
  • Multi-outlet hygiene scorecards
Methods

Representative parameters and limits

A sample of the accredited scope. The full annexure, with every method reference and measurement uncertainty, is issued with your quotation.

ParameterMethodTypical LOQTAT
Total plate countISO 4833-110 cfu/g4 days
Yeast & mouldISO 2152710 cfu/g6 days
Salmonella spp.ISO 6579-1Absent / 25 g5 days
Listeria monocytogenesISO 11290-1Absent / 25 g7 days
Salmonella, PCR screenReal-time PCR, AOAC-RIAbsent / 25 g48 hours
Sterility testUSP <71> membrane filtrationNot applicable15 days
Preservative efficacyUSP <51>Not applicable30 days
Surface swab, TPCISO 18593 + ISO 4833-11 cfu/cm²4 days
Questions

Frequently asked questions

Because the organism has to be enriched, isolated and biochemically confirmed, and that biology does not negotiate. We can give you a PCR screen result in 48 hours, which is reliable for releasing a negative lot; a PCR positive is always confirmed by culture before we report it as a detection.

Yes and it is worth doing before you print the pack. We look at the matrix, the water activity, the preservative system and the intended storage, then propose pull points, the parameters at each pull, and the acceptance criteria. You get a written protocol before the first sample goes into a chamber.

Sometimes, and sometimes not. Accelerated data is a modelled estimate and we report it as one. For products where microbiological safety rather than sensory quality is the limiting factor, or where a buyer audit is involved, real-time data is usually the only defensible answer. We will say so before you spend money.

In their original unopened retail packs wherever possible, in an insulated box with gel packs, maintaining 2–8°C for chilled products and frozen state for frozen products. Sampled portions must be drawn aseptically into sterile containers we supply. Temperature on arrival is recorded and appears on the report.

We do, surface swabs, settle plates, active air sampling and personnel swabs, on a mapped sampling plan with fixed locations so results are comparable month to month. The report ranks locations by trend, which is far more useful than a list of counts.

Shelf life to be established before launch?

Bring us the product and the storage conditions you intend to print. We will design a study that will hold up to a buyer audit and tell you upfront how long it takes.

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