Microbial Limit Testing Or Microbial Examination Of Non Sterile Products

Welcome to Microbiology Testing Services of Shubhda Research Institute –Simulation Studies information page.

The information and outline given below is only for presenting the gist of the method to sponsors intending to test their product and is purely for educational purpose.


Microbial enumeration tests are performed based on as per Pharmacopeias;

USP <61> and<62>,

 EP Chapter 2.6.12 and 2.6.13,

BP Chapter B1 and B2,

 JP XV 1st Supplement

Pharmacopeial Harmonization

Microbial examination of pharmaceutical drug or chemical used as raw material, intermediate product or finished product in powder form, oral suspension or tropical solutions, or in form of tablets, capsules and emulsions.

Samples are tested for:

Total Aerobic Microbial Count ( TAMC)

Total Yeast and Mold Count ( TYMC)

Tests for specified microorganisms Test (pathogens);

S. aureus

P. aeruginosa

E. coli

Salmonella spp.

Bile tolerant gram –ve

C. albicans

Clostridium spp.

Food sample are o tested as per ISI standard and BIS standard for :

Total Aerobic Microbial Count( TAMC)

Total Yeast and Mold Count (TYMC)

Absence of Pathogens

Turn Around Time: 10 days.

If your firm wants to perform the “Simulation Study” simply Contact our Lab today
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