Bacterial identification & source indication of contaminants:

SRI is a full microbiology testing laboratory and conducts microbial

identification tests. Correct identifications at genus and species level are
important in solving microbial problems. We have provided this service
to the pharmaceutical, medical device, cosmetics, food and other
industries. The identification is offered at two levels:

• biochemical utilization test and

• 16s ribosomal (genetic) analysis

The contaminants or repeatedly found colonies in the process area and during the environmental
monitoring can be identified and then the interpretation of possible source of the contaminant
indicated. This has proved to be a valuable input to the Pharmaceutical, Biotechnology and Food
industry enabling clients to take corrective action and ensure quality assurance protocols.

Microbial Limit Test:

a. Microbial Limit Preparatory Testing:
This test is designed to validate the test method that will be
used in routine microbial limit testing of the product.

This test exhibits that the product does not inhibit the
microorganisms that may be present. Six representative
microorganisms namely, Staphylococcus aureus,
Escherichia coli, Pseudomonas aeruginosa ,Salmonella,
Candida and Aspergillus are used to demonstrate the
ability of the test method to recover microorganisms that
could be present in a product.

Microbial limit validation test is required only once per product unless the product formula or
manufacturing process has gone through a modification.

b. Microbial Limit Test:

This test is designed to determine total aerobic microbial count and yeast and mold count. This test
demonstrates that the product is free of Staphylococcus aureus, Escherichia coli, and Pseudomonas
aeruginosa, Salmonella, C. albicans and A. niger.

c. Microbial Limit Confirmatory Test:

To confirm the presence or absence of Staphylococcus aureus, Escherichia coli, Pseudomonas

aeruginosa, Salmonella, C. albicans and Aspergillus niger, microbial identification is performed. It can
be tests like coagulase test and oxidase tests or complete microbial identification.

Standard Plate Count:

 The standard plate count procedure provides a standardized mean of
determining the density of heterotrophic bacteria in samples. This is an
empirical measurement because organisms occur singly, in pairs,
clusters, or packets, and no single growth medium or set of physical
and chemical conditions can satisfy the physiological requirements of all
organisms in a sample. Different Standard Plate Count that is
performed are:

• Aerobic bacteria & fungi,

• Aerobic bacteria only
• Membrane filtration (liquids)
• Lactobacillus
• MPN coliform count and

• Molds & yeasts

↑ Top Submit Query

Bacteriostatic activity:
This test has applications in the cosmetic industry
or where initial sensitivity studies are to be
performed.

The most commonly employed methods are the

tube dilution method and agar dilution methods.
Test products that are not clear or precipitate the
growth media are tested by agar a dilution method
which is about same as tube dilution method
except dilutions are plated on agar.

The tube dilution test is the standard method for determining levels of microbial resistance to an antimicrob
agent. Serial dilutions of the test agent are made in a liquid microbial growth medium which is inoculated with
standardized number of organisms and incubated for a prescribed time. The lowest concentration (highe
dilution) of test agent preventing appearance of turbidity (growth) is considered to be the minimal inhibito
concentration (MIC). At this dilution the test agent is Bacteriostatic.

Bioassays:
Typically the bioassays are meant for determining the potency a
the method used are either turbidimetric or agar diffusion techniques

In addition to the standard methods available for vitamins a

antibiotics, we also develop methods and conduct bioassays wh
are tailor-made to suit the client requirements or new produc
Products tested include:

• Foods
• Soft drinks
 • Multi-vitamin preparations and

• Pharmaceutical preparations
The agar diffusion technique is primarily for certain antibiotics used within the animal health industry, although
other standard procedures, listed within the various pharmacopoeias can be performed.

Bioburden Test:
Bioburden testing on the products provides indication of microbial levels, thus
allowing for control and higher confidence level in the process and products.
Bioburden test determines the number of viable microorganisms in a product.
The test is designed to suit the type of product, e.g. vortexing or sonication or
extraction or filtration or plated directly. The choice of media and growth
conditions are selected carefully.

The bioburden testing procedure is evaluated for its overall ability to recover
organisms. Thus, bioburden test protocol is validated for recovery efficiency.

Product efficacy and market claim support:

SRI offers a range of efficacy tests to support products claimed as

• bactericidal
• sporicidal
• germicidal
• virucidal
• tuberculocidal and

• fungicidal

Specialized tests are conducted using specific microorganism/s, in case the substantiated label claims
effectiveness of a disinfectant against specific microorganism/s are other than the designated te
microorganism/s mentioned.

SRI does the enumeration of Probiotics and Lactic acid bacteria like Lactobacillus acidophilus, Lactobacill
rhamnosus, Lactobacillus plantarum etc. in formulated products and bulk powders.

Medical Devices – Microbiology testing:

 Medical devices require to be tested for checking their bioburd
as well as give confidence on sterility assurance duri
manufacturing. SRI undertakes this testing for different produc
like medical instruments, surgical dressings and devices. Devic
based on other technologies like nanotechnology also require
be checked for detection of microorganisms or whether they c
handle the bioload, as may be the function of the device.
example where such testing is required is in the spec
nanotechnology based devices used in washing machine
refrigerators, AC etc.

Filters are also used for water purification and are based on various techniques like UV-disinfection, ozonizatio
ion exchange and membrane filtration. The filters are checked for anti bacterial efficacy against a number
challenge organisms like E.coli, Salmonella, Shigella, Vibrio, Staphylococcus, Pseudomonas and Micrococc
luteus

Microbiological evaluation of New Chemical Entities (NCEs):

SRI addresses the vital need to support the pharmaceutical industry
by conducting in-vitro microbiological studies to evaluate various
parameters for New Chemical Entities. New drugs designed and
produced through combinatorial chemistry and in-silico designing
require, as one of the screening an in-vitro microbiological approach.
SRI has requisite expertise in conducting this tail-end critical
research work to check out the anticipated properties of the NCE.

Microbiology Stability Studies:

SRI undertakes accelerated storage stability trials, more as evaluation of
products in pipeline or for non conventional products and devices. We also
conduct stability studies under the specified conditions by client.

Various criteria for microbiological product stability are considered like,

chemical, physical properties and their influence on stability studies, selection
of appropriate validated monitoring methods, the difficulties that may arise with
certain types of products and the limitations of certain test procedures,
interpretation of test results, documentation of testing protocols, accelerated
storage conditions and their limitations as well as the influence of packaging on
stability.
Microbiology Challenge Test:
 These are specialized microbiology evaluation studies usually
for products under development or for validating a production
process for pharmaceutical, nutraceutical, food, medical
devices.

The process or equipment and/ or product are challenged with

known microbial culture to determine the effect or validate the
anticipated results or for observations and corrective actions.
These studies and evaluation exercises form one of the most essential part of product and process
development.

Time Kill Test / Studies:

Time Kill Test is a microbiology evaluation method to assess
the Antimicrobial Activity of a known antimicrobial test
material or disinfectant or a new antimicrobial material.

The Time Kill Test is a method to evaluate the reduction in

microbial population by a disinfectant or an antimicrobial
agent. Various microorganisms can be used for the study
depending upon the type of analysis and test material.
However, usually Staphylococcus aureus, Salmonella
cholerasuis, Pseudomonas aeruginosa, E. coli, Aspergillus
niger and Trichophyton mentagrophytes are used either singly
or in combination.
The representation of results is in terms of percent and/ or the log reduction. The initial Total Viable
Count or microbial population is compared to the viable count with respect to time.

Minimum Inhibitory Concentration (MIC):

This test determines the lowest concentration of the
product inhibiting visible growth of microorganisms. MIC
test determines antimicrobial activity of a material against
specific bacteria.

The MIC is performed at SRI with different widely

accepted methods. Depending on the type and properties
of the sample, a particular method is selected. The
different methods are:

• Reading the zone of Inhibition or sensitivity test

• Agar-well method
• Tube dilution method

• Agar dilution method

The lowest concentration (highest dilution) of test agent preventing appearance of turbidity (growth) is
considered to be the minimal inhibitory concentration (MIC). At this dilution the test agent is
Bacteriostatic.

SRI also performs test for determining the Minimal Bactericidal Concentration (MBC) or the
Minimum Lethal Concentration (MLC) of an antibacterial which is defined as the maximum dilution
 of the product that will kill a test organism.

Water Testing – Microbiology:

Microbiology testing of water is done to determine the presence
and / or estimate the total or specific microbial load. Various
microbiology test performed for water are:

• Aerobic Plate Count

• Coliforms – Fecal
• Coliforms – Total
• Cryptosporidium
• Cyclospora
• Giardia
• E. coli
• Enterococci
• Fecal Streptococci
• Heterotrophic plate count
• Klebsiella
• Listeria
• Potability
• Pseudomonas aeruginosa and

• Yeast/ Mold Count.

The methods used for conducting the tests are as per standard guidelines and also depend of the
type of water under consideration.