What is media fill simulation?
A media fill (also known as process simulation) test is a critical microbiological test carried out to assess the performance of an aseptic manufacturing procedure by replacing the pharmaceutical or beverage product with a sterile culture media.
What is media fill PPT?
The Media fill or Broth fill technique is one in which a liquid microbiological nutrient growth medium is prepared and filled in a simulation of normal manufacturing operation.
How often is media fill testing required?
How often are media-fill tests of personnel required? Minimally, USP Chapter <797> requires media fill validation initially upon hire, then annually for low- and medium-risk compounding, and twice annually for high-risk compounding.
What is a media fill Challenge Test?
The purpose behind media-fill challenge testing is to prove that pharmacy personnel are adept at preparing sterile compounds. As such, a media-fill challenge testing system should be able to detect blatant deviations from the accepted standards of aseptic technique and sterile compounding procedures.
Why nitrogen is not used in media fill?
Use of nitrogen can affect the growth of microorganisms or better to say growth promotion properties in media. Hence you can get a false negative growth in the filled unit. So, it is not accepted doing vacuum break through nitrogen in lyophilizer .
What is media testing?
Media testing: measure the performance of alternative media plans before making your decision.
Why compressed air is used in media fill?
As an example, if your product manufacturing employs Nitrogen or Argon purging, for media fills you must choose to purge the broth with compressed air. This way you ensure that contamination if any due to wrong aseptic practices / interventions etc.
Why media fill is important?
Media fills performed to validate an aseptic process at a specific facility should be done by an operator who previously has been trained and qualified in aseptic techniques (e.g., proper gowning, disinfection practices, handling sterile materials). Media fills are an important element of operator qualification.
What is Grade A cleanroom?
Grades A through to D refer to cleanroom cleanliness for the Pharmaceutical Industry for European, Australian and some Asian countries. Grade A is the cleanest, for sterile operations, through to Grade D for packing or support operations. These Grades can be related to the ISO Classes.
What does USP 795 mean?
USP 795 indicates that “areas used for sterile preparations shall be separated and distinct from the nonsterile compounding area.” Now, areas for sterile preparations are covered under USP 797 and USP 800, and require a completely separate ISO suite, so that automatically sets up a separate sterile compounding area.
What is the standard operating procedure for media fill validation?
Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility. A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution.
What is media fill test for sterile API?
Media fill test is done to verify the sterility of the sterile manufacturing process. Media fill validation for sterile API is different from the sterile formulation media fill. There are different processes in the sterile API manufacturing as filtration, crystallization, drying, milling etc.
What is a media fill in drug manufacturing?
A media fill is one part of the validation of an aseptic manufacturing process. To lay down the procedure to challenge the aseptic techniques used for sterile drug product processing using media fill.
How to prepare positive and negative control during media fill validation?
During media fill validation the positive control shall be prepared. Prepare the vials containing sterile media is as per procedure mentioned in the negative control procedure. Add 10-100 CFU culture of different organism in the vials and incubate the vials at respective temperature to get luxuriant growth.