At Quantus, our Media Fill Testing process involves four key steps:

• Sample Receipt: We log and inspect all media fill samples upon receipt, ensuring they are intact and free from visible contamination.

• Incubation: Samples are incubated at specified temperatures to encourage microbial growth if present. This includes dual-phase incubation to thoroughly test for contamination.

• Analysis: After incubation, samples are meticulously inspected for any signs of microbial growth. Results are documented and communicated promptly.

• Control Testing: We use negative and positive controls to validate the accuracy and reliability of the media fill test, ensuring your test results are dependable.

Quantus provides media fill testing services across a range of industries, including pharmaceuticals, biotechnology, medical devices, and more. For a detailed list, please visit our Industries We Serve page.

Media Fill Testing is crucial in pharmaceutical manufacturing because it simulates the aseptic production process using a sterile microbiological growth medium. This testing helps identify potential contamination risks, ensuring that aseptic processes meet stringent standards to protect product integrity and patient safety.

Our Media Fill Testing services adhere to Good Manufacturing Practice (GMP) guidelines and meet FDA standards for sterility testing. 

Our services adhere to several critical standards and guidelines to ensure the highest quality in Media Fill Testing and safety in your aseptic manufacturing processes:

• USP <797>: Pharmaceutical Compounding - Sterile Preparations, which outlines the requirements for preparing compounded sterile products.

• USP <71>: Sterility Tests, detailing the protocols for ensuring sterility in pharmaceutical products.

• FDA CGMP: Current Good Manufacturing Practice regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities   .

Quantus ensures the reliability of Media Fill Testing results through a comprehensive evaluation process that includes equipment checks, operator technique assessments, and environmental controls. We use negative and positive controls to validate the accuracy of the tests, ensuring that your results are dependable and accurate.