Microbiology testing is critical for ensuring that your different product type meets the required microbiological limits and determining the Antimicrobial Effectiveness Test (AET), Microbial limit test, as well as identifying microorganisms and contamination. Our dedicated microbiology laboratory is on standby to provide qualitative and quantitative assessments of non-sterile products using USP, FDA/BAM, and in-house methods. With over 40 years of experience in this field, we help our clients determine the tests that best fit their needs and support their products’ compliance with relevant regulatory requirements or support on research products microbiologically.

Our laboratory is fully equipped with microbiology testing instruments to provide different qualitative and quantitative assessments of non-sterile raw materials and finished products with reference to various national / international standard protocols e.g. USP, FDA/BAM that also comply with the various regulatory requirements.

Microbiology testing is critical for ensuring that your different product type meets the required microbiological limits and determining the Antimicrobial Effectiveness Test (AET), Microbial limit test, as well as identifying microorganisms and contamination.

We have more than 40 years of experience in microbiological testing of various chemical & pharmaceuticals products as well as food products that best suits and satisfy clients’ need.

Microbiology: Testing Methods

USP CHAPTER

TEST
<61><62> Microbial limit test – Suitability Testing
<60> Burkholderia Cepacia Complex
<2021><2022> Nutritional and Dietary Supplements Testing and absence of a specified organisms.
<51> Antimicrobial Effectiveness Testing
<61> Microbial Enumeration Testing
– Total Aerobic Microbial Count
– Total Yeasts and Molds Count
<62> Bile Tolerant Gram Negative Bacteria
<62> Escherichia coli (E.coli)
<62> Salmonella
<62> Pseudomonas aeruginosa
<62> Staphylococcus aureus
<62> Clostridia
<62> Candida albicans
<85> Bacterial Endotoxins
<2021> Microbial Enumeration Tests—Nutritional and Dietary Supplements

-Total Aerobic Microbial Count

-Total Yeasts and Molds Count

-Bile Tolerant Gram Negative Bacteria
<2022> Escherichia coli (E.coli)
<2022> Salmonella
<2022> Staphylococcus aureus
<2022> Clostridia

What is Microbiological Testing?

Microbiological testing includes:

  • Sterility testing
  • Total fungal counts
  • Total bacterial counts
  • Bacterial endotoxin testing by LAL test
  • Microbial limit tests
  • Detection of pathogens
  • Vitamin assay
  • Antibiotic assay
  • Preservative efficacy testing etc.
Microbiological Testing Advantages

Microbiological testing plays an important role in the Raw materials, production samples and finished products also.

Microbiological testing is required for presence and absence of any specified organisms, microbial enumeration, as well as detection for bacterial endotoxins under aerobic or anaerobic conditions. It is useful to detect any micro contamination occurs in products in various industries like pharmaceuticals, chemicals, food and medical device etc.

Microbiological testing is very useful in epidemiological diagnosis that will guide us on early detection and  timely treatment necessary for the situation by using the right antibiotics. It is also useful in various scientific teaching and research.

Method Qualification & Release Testing

What is method qualification, and why is it significant? Method Qualification is an integral part of any microbiological test system. It allows us to determine the appropriate diluent/dilution factors/enrichment media required to neutralize any inherent antimicrobial properties of drug products and ingredients (tested according to USP chapters <51>, <61> and <62>) when sample preparations are challenged with specific, viable test microorganisms.