Microbial Contamination Test for Live Biotherapeutic Products
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With our long-standing expertise in quality control of live biotherapeutic products, Creative Biolabs is always dedicated to offering microbial contamination tests for live biotherapeutic products for our global customers. Our mission is to provide individual support, quick response times, and technical expertise combined with the highest quality standards.
Microbial Contamination in Live Biotherapeutic Products
Microbial contamination in live biotherapeutic products may be a problem for researchers as well as pharmaceutical manufacturers worldwide. It results in the spoilage of the formula by breaking down active ingredients, affecting the potency, stability, and efficacy of the live biotherapeutic products. Common microbial contaminants include bacteria, yeast, fungi, virus, prions, protozoa, or their toxins and by-products. The contamination of pharmaceuticals with microorganisms may lead to harmful effects on the therapeutic properties and may potentially cause injuries to intended recipients.
Our world-class microbiologists use the latest techniques and can test for the full range of potentially harmful microorganisms. We could identify many bacterial contaminants isolated from various types of live biotherapeutic products, using a variety of methods, including "gold standard" agar plating, conventional biochemical methods, and further subjected to molecular (PCR-based) methods of identification. Finally, we will deliver accurate test results that will help your live biotherapeutic products all meet your quality standards and your cGMP acceptance criteria. Our microbial contamination test service helps minimize the risk of potential damage by microbes and ensures the safety and quality of your live biotherapeutic products are maintained.
Creative Biolabs' Microbial Contamination Test Services
The potential health impact of pathogens in live biotherapeutic products makes the absolute reliability of the test results indispensable. Now, Creative Biolabs could follow the USP recommendations for testing the presence/load of microbial contaminants in the live biotherapeutic products for our global customers. To help improve the safety and quality of products, we offer services for the total microbial count and a specified indicator of microbial contaminants.
Testing Items
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The level of microbial contamination.
- Total Aerobic Microbial Count (TAMC)
- Total Yeast and Mould Count (TYMC)
- Enumeration of bacteria and fungi present in the product.
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Presence/ absence of certain pathogenic microorganisms.
- Qualitative: Presence or absence of specified microorganisms
Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella species, Clostridium species.
- Semi-Quantitative: test for bile-tolerant Gram-negative bacteria
Samples
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Capsule
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Tablets
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Aqueous preparation
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Cream
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Inhaler
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Suppository
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Cosmetic and personal products
If you are ready to submit your samples for testing, please fill out the Sample Submission Form.
Medium Validation
Verify the suitability of the medium.
Test Methods Validation
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Membrane filtration
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Plate count
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Most probable number (MPN)
Test Standards
USP or others.
Deliverables
Upon completion of the test, a final report will be issued.
Advantages of Our Service
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An individually tailored service
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A dedicated team of technicians and scientists
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Multiple methods available to suit microbiology testing need
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Prompt testing and reporting of results
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Highest level of safety and efficiency
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Time- and resource-saving
Case Studies
Frequently Asked Questions
What is the USP test for microbial contamination?
The USP test standard is a comprehensive quantitative analysis of the product, including neutralization and recovery validation using specific microorganisms, and also includes determining the total aerobic microbial count and total yeast and mold count present in the product.
What is the microbial limit test for pharmaceutical products?
The microbial limit test (MLT) is performed to assess how many and which of certain viable microorganisms are present in non-sterile pharmaceutical, healthcare, or cosmetics manufacturing samples that range from raw materials to finished products. There are two parts to this testing: the total number of aerobic organisms (including yeast and mold) Detection of specific unwanted organisms.
Resources
Talented and capable staff at Creative Biolabs isolate and identify microbial contamination and provide a comprehensive evaluation against a wide variety of pathogens. Our independent microbiology testing services offer world-class capability for the development of live biotherapeutic products. If you would like to discuss any of our services in more detail, then please do not hesitate to give us a call or contact us online. We look forward to discussing your inquiry and finding the best solution for your needs.
For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.
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