4.0 Definitions and Abbreviations – Media Fill Test:
| Aseptic | Absence of viable microorganisms |
| Aseptic Filling | Part of aseptic processing in which a .. ... |
| Aseptic Process Simulation (APS) | A means for establishing the capability ... |
| Aseptic Processing | Assembly of sterilized components and pr ... |
| Aseptic Processing Area | An area that has defined environmental c ... |
What are the aspects of media fill simulation that are acceptable?
performance of media fills –but this is not always bad! Aspects that are usually acceptable -Simulation of procedures, interventions, maximum number of personnel -Frequency of simulations -Simulation of container/closure combinations (bracketing is accepted provided worst case combinations are tested)
What is a media fill?
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 a successful media fill trial?
A successful media fill should never be used to justify aseptic processing practices that pose unnecessary contamination risks In summary, the goal of a media fill trial is to demonstrate that a manufacturer can follow the routine aseptic production process using sterile media in place of a drug product without resulting in contamination.
Should the process simulation test extend over the whole filling period?
that “where filling takes place over extended periods ie longer than 24 hours, the process simulation test should extend over the whole of the standard filling period” (Clause 4.1.2) Filling times -The premise is that media fills will follow manufacturing conditions as closely
What is a media fill test intended to simulate?
Aseptic process simulation, also known as a media fill trial, estimates the contamination risk of an aseptic production process by using sterile culture media in place of the product constituents.
What is media fill Challenge?
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.
What is media fill PPT?
What is Media Fill ? 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.
Why is it a good idea to complete a media fill test?
A media fill test is required by United States Pharmacopeia (USP) and state boards of pharmacy to prove that the aseptic technique process can produce a sterile product without contamination.
What is a media fill test intended to simulate quizlet?
According to the section of USP Chapter <797> regarding Personnel Training and Evaluationin Aseptic Manipulation Skills, media-fill testing is used to. assess the quality of the aseptic skill of compounding personnel.
How do you investigate media fill failure?
Review the history of media fill for the product last time for contamination. Review the batch filled with the same filling line since last media fill test. List all possible root causes of failure. List the batches to be held, those are suspicious and require re-analysis.
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.
What is aseptic process simulation?
Aseptic Process simulation, sometimes known as a media fill, is a tool that is used to assess the capability of an aseptic process to deliver a drug product that is sterile and free from microbiological contamination.
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 a fill test?
Media fill test is a process simulation testing which is carried out in the same manner as that of normal production except that an appropriate microbiological growth medium is used in place of the drug.
What is media testing?
Media testing: measure the performance of alternative media plans before making your decision.
Is media fill required for terminally sterilized products?
❖ Media fill is not required for terminally sterilized (TS) product(s). Even when TS product shares the same filling line with other aseptic product, the media fill for TS product is not required.
What are aseptic processes?
Aseptic processes are methods or procedures that are undertaken in a sterile environment. The aseptic sterile environment is maintained through specialized equipment that prevents microbial material from technicians, raw materials, or machinery from contaminating medical devices or products.
Why are aseptic media fill simulations important for aseptic products?
Stability is a suspended state where there is no change. In terms of FDA regulations, stability covers five FDA categories: chemical stability, physical stability, therapeutic stability, toxicological stability, and microbiological stability of a medical device or product.
How do you perform an aseptic process simulation (media fill simulation) test?
The FDA advocates videotaping media fills to identify any improvements in personnel practices for the aseptic processes. The media fill simulations (also known as process simulation tests) use sterile trypticase soy broth under conditions simulating (as closely as possible) the manufacturing, processing, and filling requirements of a product.
When should media fill simulations be performed?
The media fill simulations are a “one-time” evaluation of the aseptic processing operation. Media fill simulations are performed when a new filling line or new product container is introduced to an aseptic process. For the initial qualification of a fill line or product, three consecutive, separate, and successful media fill runs are required.
What are the acceptance criteria for media fill simulation tests?
When media filling first started, the acceptable rate of positives (containers with microbial growth after aseptic processing) was 1 out of 1000 (0.1%). Later that number became 1 out of 3000 to account for 95% confidence of a contamination rate of 0.1%. Currently, a single positive out of 4750 is preferred.
Summary
Overall, an aseptic process prevents contamination by the exclusion of microorganisms. Media fill simulations are one of three main components to aseptic process validation and equipment qualification for aseptic processes.
1.0 Purpose
The purpose of this SOP is to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test.
2.0 Scope
This guideline includes guidance for the Microbiology laboratory and environmental monitoring department activities during initial and routine semi-annual aseptic process simulations (media fill Test) for new and existing products and processes.
3.0 Responsibilities – Media Fill Test
Assuring site procedures are in place to address all requirements in this SOP.
4.0 Definitions and Abbreviations – Media Fill Test
An intervention that is an integral part of the aseptic process and is required for set-up or routine operation and/or monitoring, e.g., aseptic assembly, container replenishment, environmental sampling, etc. inherent interventions are required by the batch record, procedure, or work instruction for the proper conduct of the aseptic process
6.0 Procedure – Microbiology Laboratory Procedures For Aseptic Process Simulations (Media Fill Test)
Preventive Maintenance Program (PM) shall be in place for incubators, environmental monitoring test equipment, and laboratory instrumentation used during Media Fill Test studies, and all PMs must be current prior to using any equipment and instrument.
Process specific microbiological test and method requirements before running aseptic process simulations
If media is to be filled directly after a product run without changing equipment or parts in the fluid path, a protocol must be prepared to validate the effectiveness of the fluid path flush to eliminate any growth inhibition in media filled after the flush.
Microbiology and environmental monitoring requirements for every Media Fill Test
Protocols shall contain all requirements as per this SOP and as per the SOP – Aseptic Process Validation. Microbiology and environmental responsibilities shall be specified in the protocol.
What is media fill testing?
Media fill testing is the method of assessing the technique and competency of personnel who manipulate and create compounded sterile preparations. To maintain the purity of samples, compounds and other materials, compounding personnel must be sufficiently skilled at “aseptic manipulation.” This refers to the ability to execute filling, transferring and handling tasks without contaminating the material — known as compounded sterile preparations (CSPs) — at hand.
What is the USP for media fill?
The United States pharmacopeia general chapter <797> (known as “USP <797>”) outlines a guideline for media fill testing requirements and recommendations for facilities. The minimum requirement is testing upon hire — and then an annual revalidation for applications denoted low- and medium-risk, and a twice-annual revalidation for high-risk ...
What does "pass" mean in media fill?
A “pass” test shows no contamination and a successful media fill execution. Follow up. Personnel with fail results must be scheduled for additional training to bring their technique into compliance. Assigning these personnel to mentors to work with them until they are able to pass the test may also be considered.
What Is A Media Fill?
How to Select Medium For This Test?
When This Test Should Be Performed?
How Much Size Should Be Validate It?
- 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. Microbiological growth medium is used in place of the drug solution during media fills to test whether the aseptic procedures are adequate to prevent contami...
Incubation Period For This Medium?
- Selection of nutrient medium should be made based on dosage form of the product and selectivity, clarity, concentration and suitability for sterilization of nutrient medium.
How Many Units Should Be Pass For Satisfactory Results?
- This test or an equivalent test is performed at least annually by each person authorized to compound in a low-risk level environment under conditions that closely simulate the most challenging or stressful conditions encountered during compounding of low-risk level CSPs. The process of simulation test should be performed as part of validation by running three consecutiv…
Reference
- The number of containers used for media fills should be sufficient to enable a valid evaluation. For small batches the number of containers for media fills should at least equal size of product batch.