Bioburden testing is an important part of the pharmaceutical manufacturing process as it helps to identify and quantify the presence of microorganisms in the product, raw materials, or manufacturing environment. At our pharmaceutical bioanalytical laboratory, we offer comprehensive bioburden testing services to ensure the quality and safety of your pharmaceutical products. We utilize state-of-the-art testing methods and a team of experienced microbiologists to deliver reliable and actionable results.
Our bioburden testing services are conducted in accordance with the following industry-standard reference guidelines:
Our laboratory utilizes the most advanced equipment and techniques to ensure accurate and reliable results, including:
We offer a wide range of bioburden testing services to meet the needs of our pharmaceutical clients, including:
Total Aerobic Microbial Count (TAMC) -Quantification of the total number of aerobic bacteria present in a sample.
Total Yeast and Mold Count (TYMC) - Quantification of the total number of yeast and mold present in a sample.
Test for Specified Microorganisms - Identification and enumeration of specific microbial species, such as Escherichia coli, Salmonella spp., Pseudomonas aeruginosa, and Staphylococcus aureus.
Bioburden Monitoring - Routine monitoring of the microbial load in your manufacturing environments, including air, surfaces, and equipment.
Method Validation - Validation of your in-house bioburden testing methods to ensure compliance with industry standards.
Customized Bioburden Testing - Tailored solutions to address your specific bioanalytical requirements.
Our Pharmaceutical Bioanalysis laboratory is committed to the highest standards of quality and compliance. We maintain strict quality control measures, including:
We also work closely with our clients to ensure that our bioburden testing services meet all relevant regulatory requirements.
Contact us today to learn more about how we can support your pharmaceutical quality assurance and regulatory compliance needs.
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