Program: Applied Biotechnology Master's — Research and Development
Host Company: PPD, a part of Thermofisher Scientific
Location: Middleton, Wisconsin (onsite)
Student: Prazila Shrestha
Microbial limit testing plays a crucial role in quality control across various industries. Its main objective is to assess microbial contamination in a product or raw material, ensuring that it adheres to established microbiological specifications and standards, thus guaranteeing consumer safety and product quality. To conduct microbial limits testing, samples are collected using aseptic techniques, and the microorganisms present are enumerated. The results are then compared to the established microbial limits to determine if the product meets the required criteria for quality and safety. Overall, microbial limit testing is an essential quality assurance step in ensuring that products are safe, effective, and compliant with industry standards. The best way to keep the lowest possible microbial burden in finished products is ensured by routine, correctly carried out microbial limit testing and strict adherence to Good Manufacturing Practices (GMP) during product manufacture, storage, and shipping. MLT determines the presence of specific microbial species in a product and the quantity of pathogen-free, aerobic, viable microorganisms. A product’s compliance with specific compendial requirements for microbial burden and user safety is determined by the results of microbial limits testing when taken as a whole. MLT may also consider how time and/or storage may affect the integrity and safety of the product. The type of the product and the intended use of the product will determine the final testing frequency. Microbial limits testing aims to determine the quantity and type of viable microorganisms present in non-sterile pharmaceutical, healthcare, or cosmetic manufacturing samples, ranging from raw materials to finished goods. This will help us to take some measures during the production process depending on the results from MLT.