Pharmaceutical Bioburden Testing

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 methodology

Our bioburden testing services are conducted in accordance with the following industry-standard reference guidelines:

• ISO 11737-1 - Sterilization of medical devices - Microbiological methods - Part 1 - Determination of a population of microorganisms on products.
• USP <61> - Microbiological Examination of Nonsterile Products - Microbial Enumeration Tests.
• USP <62> - Microbiological Examination of Nonsterile Products - Tests for Specified Microorganisms.
• EP 2.6.12 - Microbiological Examination of Non-Sterile Products - Microbial Enumeration Tests.
• EP 2.6.13 - Microbiological Examination of Non-Sterile Products - Test for Specified Microorganisms.
• JP 4.05 - Microbial Limit Test.

Our laboratory utilizes the most advanced equipment and techniques to ensure accurate and reliable results, including:

• Automated colony counters.
• Incubators with precise temperature and humidity control.
• Laminar flow cabinets for sterile sampling and handling.
• Automated liquid handling systems.
• Real-time PCR instruments for rapid microbial identification.

Our Bioburden testing services

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.

Quality assurance and regulatory compliance

Our Pharmaceutical Bioanalysis laboratory is committed to the highest standards of quality and compliance. We maintain strict quality control measures, including:

1. Regular internal audits and external certification to ISO 17025 standards.
2. Participation in proficiency testing programs.
3. Continuous staff training and development.
4. Comprehensive data management and record-keeping procedures.

We also work closely with our clients to ensure that our bioburden testing services meet all relevant regulatory requirements.

Benefits to Our Clients

• Ensure product quality and patient safety by maintaining control over microbial contamination risks.
• Demonstrate compliance with regulatory requirements and industry best practices.
• Optimize manufacturing processes and reduce the risk of product recalls or regulatory actions.
• Obtain reliable data to support product registrations, technology transfers, and ongoing quality monitoring.
• Leverage our expertise and experience to streamline your microbial testing programs and reduce the burden on your internal resources.

Contact us today to learn more about how we can support your pharmaceutical quality assurance and regulatory compliance needs.