Microbial Limits Test

The presence of a large number of microbial in non-sterile products may cause adverse events, so microbial safety is very important for drugs. Microbial safety must be considered at all stages of the development, manufacturing, and subsequent storage and use of the drugs. The microbial limit test (MLT) can evaluate how many specific microorganisms are present in non-sterile pharmaceutical samples from raw materials to final products, the test can determine if certain microorganisms are exceeded quantitative limits.

The microbial limits test (MLT) described in USP <61> and <62> are consists of two parts. The quantitative phase, Microbial Enumeration, determines the total number of aerobic organisms as well as a total yeast and mold count on a product. The qualitative phase of a microbial limits test is known as the Test for Specified Microorganisms. This test is designed to determine the presence or absence of specific objectionable organisms in a product.

Microbial Limits Test

CD Formulation laboratory is cGMP-compliant and equipped with state of the art analytical instruments. We have experienced analysis experts who can work with our formulation and manufacturing team to provide you with microbial limits test services. Our microbial limits test is performed in accordance with pharmacopeia methods, in particular USP<61> and USP<62>. The accurate and robust data generated of microbial limits test, which can help you to make an appropriate risk assessment for your finished drug products.

Our Microbial Limits Test Services

  • MLT Method Suitability Test
  • Microbial Enumeration (Total Aerobic Microbial Count and Total Combined Yeasts and Mold Count)
  • Screening Test for Specified Microorganisms
P. aeruginosa E. coli
S. aureus Salmonella
Bile tolerant gram negative bacteria C. albicans
Clostridium B. cepacia complex (Bcc) 

Our Methods of Microbial Limits Test  

  • Membrane filtration method
  • Standard plate count
  • Pour plate method
  • Most probable number
  • Direct enrichment
  • Membrane filtration enrichment

Deliverable

  • Data analysis
  • Provide full study report

Our Advantages

Microbial Limits Test

How to Contact Us?

If you have a requirement about microbial limits test services, please contact us by phone or email, our colleagues will reply to you within three working days.

References

  1. Guideline I C H H T. Impurities: Guideline for Residual Solvents Q3C (R5) [J]. Current Step, 2005, 4: 1-25.
  2. Ratajczak M, Kubicka M M, Kamińska D, et al. Microbiological Quality of Non-sterile Pharmaceutical Products[J]. Saudi Pharmaceutical Journal, 2015, 23(3): 303-307.

Online Inquiry

Please note: Our products and services can only be used for research purposes. Do not use in diagnostic or therapeutic procedures!
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