The Benefits of the Media Fill Test in Sterile Pharmaceutical Manufacturing

Absolute sterility of pharmaceutical preparations is necessary for the desired efficacy and safety of all medicinal products. Therefore, best manufacturing practices obligate pharmaceutical companies to consistently conduct Media Fill Tests (MFT) to verify the appropriate microbiological states of their aseptic manufacturing processes. The Media Fill Tests are fundamental microbiological tests that are conducted to simulate the normal production conditions by replacing pharmaceutical products with culture media.

The tests are a proven way of detecting microbial contamination, validating the production methods, testing product quality, commencing root-cause investigation, and testing sterility. Moreover, the tests are invaluable in risk management plans as they allow pharmaceutical companies to have actual information on the final product safety.

Media Fill Testing Method:The use of the media fill test in sterile pharmaceutical manufacturing has been known for decades now. Nonetheless, the standard practice in Media Fill testing of having several thousands of containers run at ago has been found to be a potential source of errors and an extremely time-consuming process. Therefore, new Media fill testing techniques have been devised, including the Tryptic Soy Broth Culture Medium test, which offers a color indicator that optimizes and facilitates the reading steps, reducing the chances of false positive readings.

The color indicator media fill test is now preferred to other tests because the indicator works effectively for a broad spectrum of microbiological growths. In the Tryptic Soy Broth test, the compound is affected and reduced by the metabolic activities of the microorganisms, allowing turbidity and contamination to be observed with a color range from PINK to YELLOW, if any growth occurs during the incubation period.

Procedure for the Media Fill Test:A standardized media fill test in sterile pharmaceutical manufacturing should flawlessly simulate the preparation and dispensing of the pharmaceutical product and allow for detection of potential contaminants. Here are standard steps for the Tryptic Soy Broth Media Fill test:1. Exactly 20 mL of Tryptic soy broth (TSB) should be added to a sterile elution vial. TSB is typically a general purpose medium for cultivating a broad range of microorganisms.2. Then, 2 mL should be transferred from the elution vial media and added to an evacuated vial. Exactly 6 mL simulate kit media should be added to the evacuated vial, and the process repeated at least 4 times.3. Next, exactly 0.8 mL TSB should be withdrawn from the simulated kit vial with 3 or 5 mL syringes. This process should be repeated 6 times.4. The 0.8 mL withdrawn from the simulated kit vial (also called simulate doses) should be added to aseptic evacuated vial.5. The Total Process should be conducted 4 times and the simulated kit vials and the 4 combined dose vials (giving a total of 8) should be incubated for 7 days at a temperature of 30-35ºC.6. Finally, the vials should be checked for growths.

Advantages of Color Indicator Media Fill Tests:The manual reading of media fill test is usually a complicated process which requires competent technicians and a huge amount of time to manually read thousands of filled units. Hence, the manual operation often results in the risks of failed readings. The introduction of the color indicator media fill test in sterile pharmaceutical manufacturing has introduced remarkable ease, enhanced contamination detection, and diminished the number of false negative and false positive results. Apart from the TSB color indicator test, pharmaceutical companies can also use the Soybean-Casein Digest Medium.