Microbial Contamination Test (TVAC & Pathogens)

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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 contamination testing is performed for non-sterile products in which harmonised pharmacopoeia or client-supplied methods are used that determine the bioburden within the sample

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
    • C. albicans
    • Clostridium

Our Methods of Microbial Limits Test

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

Sterility Assurance

Services Summary : –
Zexa Labs is a leading provider of sterility assurance test services for pharmaceutical and cosmetic manufacturers for both sterile and non-sterile products. Most tests follow as per IP / USP or EP and similar international standard.
For convenience in finding routine quality control test services, the links below may contain test services not traditionally associated with formal sterility assurance programs but are aligned routine test services for many medical device and pharmaceutical products.

Bio-burden tests determine the total number of viable microorganisms in or on a medical device, container or component. It is performed on any product that requires control and/or monitoring of bioburden counts, usually as part of a sterilization program. This test acts as an early warning system for possible production problems that could lead to inadequate sterilization. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.

For clarification, product bioburden is intended for medical devices, containers and components. However, we also offer standard plate counts and microbial enumeration studies for powders, solutions and similar products where reconstitution and filtering may be required. Tissue products may also be assessed for bioburden.

Product Sterility : –

Offering both traditional cleanroom and LAFs product sterility tests, Zexa Labs can uniquely assist customers with the right test facility to meet your product sterility test needs. Dedicated Cleanrooms are designed and utilize for performing the sterility testing. LAFs are generally used for injectable and drug products that are aseptically processed and have a low or no tolerance for a sterility test failure.

For some sterilization processes, a surrogate product or indicator may be used. Most commonly the use of a biological indicator (BI) or spore strip saves both test time and product cost. BI sterility tests at Zexa Labs are performed similar to product sterility but require a shorter incubation time and low volumes of media, allowing for a more cost effective sterility test to verify sterilization load processing.

Testing Locations
Baddi, Himachal Pradesh

Contact Us
If you have additional questions about pharmaceutical testing or would like to consult with experts at Zexa Labs, just send us a request or call us at + 0179 545 6944.

Testing Options
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, fill out the Sample Submission Form.

Total Bacterial Counts:

Total bacterial count indicates the number of microorganisms present in a sample. The number of microorganisms should not be greater than the specified guide values that are expressed in CFU (colony-forming units) per gram or milliliter.

Total Fungal Counts:

It indicates fungal count present in a sample. Monitoring this is important to know about the fungal contamination in pharmaceuticals.

Detection of Pathogens:

Detection of pathogens in pharmaceuticals finished products and raw materials is important for the safety and well-being of the consumers.