Drug Microbial Limit Testing Service
- For Total Aerobic Microbial Count (TAMC), samples are inoculated onto Soybean Casein Digest Agar.
- For Total Yeast and Mold Count (TYMC), samples are inoculated onto Sabouraud Dextrose Agar.
- For the detection of other pathogenic bacteria, we use specific selective culture media and incubation conditions.
- Oral preparations: liquid formulations (syrups, solutions, suspensions), semi-solid formulations (gels, pastes), and solid formulations (tablets, capsules, powders).
- Injectable drugs: parenteral solutions, emulsions, or suspensions requiring microbial quality assessment.
- Topical drugs: creams, ointments, gels, and transdermal preparations.
MtoZ Biolabs provides a professional Drug Microbial Limit Testing Service to help clients detect microbial contamination in raw materials, excipients, and finished pharmaceuticals products, and to verify compliance with regulatory requirements. Even low levels of microbial contamination can compromise drug stability, alter pharmacological properties, or pose direct risks to patient health. Microbial limit testing is mandated by international pharmacopeias, and is required for oral, parenteral, and topical drug products. By providing reliable microbial quality data, the Drug Microbial Limit Testing Service helps pharmaceutical companies maintain compliance, avoid costly recalls, and safeguard patient safety.
Testing Provided by MtoZ Biolabs
1. Total Aerobic Microbial Count (TAMC)
💠Agar Plate Method: Direct inoculation of the sample onto nutrient agar plates to enumerate colony-forming units of aerobic bacteria.
💠Membrane Filtration Method: Passing the sample through a sterile membrane filter, which is then incubated on nutrient agar to allow recovery and counting of microorganisms.
💠Most Probable Number (MPN) Method: Statistical estimation of microbial load based on growth patterns in liquid culture media when direct enumeration is difficult.
2. Total Combined Yeast and Mold Count (TYMC)
💠Agar Plate Method: Spreading or pouring the sample onto Sabouraud dextrose agar or other suitable media for yeast and mold growth.
💠Membrane Filtration Method: Concentrating microorganisms by filtration, followed by incubation on selective agar for fungal growth assessment.
3. Screening Test for Specified Microorganisms
Conducted using specific selective culture media and incubation conditions to detect the presence or absence of pathogenic bacteria such as Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Salmonella, Bile-tolerant Gram-negative bacteria, Candida albicans, Clostridium, Burkholderia cepacia complex.
Analysis Workflow
1. Sample Preparation
Pharmaceutical product samples are prepared under aseptic conditions to avoid external contamination.
2. Sample Inoculation
3. Incubation
Inoculated plates are incubated under defined temperature and time conditions to allow microbial growth if present.
4. Observation and Enumeration
After incubation, plates are examined for microbial growth. Colony-forming units are counted if present.
5. Result Interpretation
Findings are compared with pharmacopeial specifications to assess compliance.
Figure 1. Workflow for Drug Microbial Limit Testing Service
Service Advantages
✔️Advanced Laboratory Infrastructure
Equipped with state-of-the-art microbial testing platforms, sterile environments, and validated methods to ensure accuracy and reproducibility.
✔️Experienced Scientific Team
A professional microbiology team with extensive expertise in pharmaceutical quality control and microbial safety testing.
✔️Customized Solutions
Flexible testing protocols tailored to specific drug formulations and client needs, from routine batch release testing to specialized microbial investigations.
✔️Reliable and Timely Reporting
Streamlined workflows and strict quality assurance processes ensure fast turnaround times without compromising reliability.
✔️One-Time-Charge
Our pricing is transparent, no hidden fees or additional costs.
Sample Submission Suggestions
1. Acceptable Sample Types
We accept raw materials, excipients, and finished non-sterile preparations, including but not limited to:
2. Sample Quantity
Exact amounts may vary depending on dosage form and requested tests.
3. Packaging Requirements
All samples must be sealed in sterile, contamination-free containers to avoid external microbial interference during transport.
4. Storage and Transportation
Samples should be shipped under conditions that maintain their integrity. Temperature-sensitive products must be transported with appropriate cold-chain protection. Avoid repeated freeze-thaw cycles and prolonged exposure to extreme conditions.
5. Documentation
Clients should provide detailed information about the product, including dosage form, active ingredients, intended use, and any specific microbial testing requirements.
*Note: If you have special sample types or require additional guidance, please contact us for personalized support before sample preparation.
Related Services
Biopharmaceutical Stability Analysis Service
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