What is media fill aseptic process simulation, why media fill run is conducted in sterile dosage form filling.

Detail information on media fill aseptic filling Validation:

Media fill aseptic filling validation is a type of validation in sterile dosage form filled aseptically, where the product is filled in aseptic condition, media fill run has many different synonyms like, media broth fill, broth filling, media fill trial etc. It is a process of generating confidence on the filling, process and the line and the manpower and the equipment facility that the product being filled in the filling line in the particular clean room.

Media fill is a aseptic process validation and validation of filling line, operators, workers, and procedure adapted during filling of sterile product, to ascertain that the microbial contamination do not occur to products

Why is media fill Performed?

A sterile dosage form filled and packed container can only be confirmed as sterile only after it is tested, in order to test the sterile filled container, it has to be opened and the product is tested for sterility, the test for sterility is a destructive test. Each and every filled unit of a sterile dosage form cannot be tested for sterility while an assurance of product meeting the sterility can be done.

1.Ensuring the filling area, meeting the condition required for sterile drug product filling.

2. Ensuring the filling machine, personnel, do not add any contamination in the sterile product to being filled. (This is done by media fill run)

3. Cleaning and sterilization of equipment and filling machine parts utensils is effective.

4. The manufacturing process, filling process from starting point to the point of final closure of the sterile product container, does not add any contamination to the product.

5. Sterilization procedures are effective.

6. Surfaces and equipment decontamination processes are effective.

7. Aseptic techniques, interventions during the filling are properly done.

8. Training of persons is done for working in aseptic area knowledge of aseptic technique and its practices is done properly.

All these points are verified during the media fill run, or sterile process simulation run, with these assurances a product can be termed as meeting with sterile dosage form criteria.

Media Fill observation
                         Media Fill observation

Before conducting a media fill simulation following action points are required to be done:

1.Qualification of equipment in sterile filling clean room.

2.Protocol for media fill run, mentioning the detail information like, amount of media, preparation procedure for media, sterilization of prepared media for filling. Clear defining starting point of media fill, entry and exit procedure of personnel, sterilization procedure for filling equipment and ancillaries.

Cleaning and sterilization of Restricted access barrier systems, isolators.

Periodic interventions for air sampling, product sampling, fill volume setting, initial Qty of discard units.

3) Preparation of area and filling machine for media filling.

Important points in media fill simulation:

1.Media fill is done only for aseptically filled sterile dosage form.

2.Media fill simulation is not required for terminally sterilized product.

3.Same procedure and process is used as that of the actual production in media fill simulation.

4.It should be done on the actual filling line and at the actual spot in the clean room.

5.Media fill should be done in event of any changes done in procedure, machine or area.

7.During media fill the units which are removed as samples for testing by QC must be incubated along with the all filled units.

8.The damaged units during filling should be discarded, as that of routine practices.

9. The units with defects from outside where the media is filled and the container seems to be closed properly are required to be incubated for observation.

10.The good vials after media fill are the actual concerns, if there is any growth observed in the good vials the media fill is considered as failed.

11) A media should not be filtered through a bacteriological 0.2-micron filter or lower than this size of filters on the filling machine just prior to filling inside the containers.

12) Media should be sterilized by autoclaving, and it should not be sterilized by filtration.

Frequency of media fill:

1) Six months and as and when required in event of any sterility test failure result is obtained.

2) Inventing a line is ideal for longer time media fill should be done before starting of the production.

Media used for media fill aseptic process validation and its amount to be taken minimum in the container:

Soybean casein digest medium SCDM, is used for aseptic process simulation media fill, it is also called Trypticase Soy Broth (TSB) both are one and the same media, the concentration of media should be minimum 3% with adjusted with sterile water for injection for filling. A container should be filled to its 60 to 75 % of the total capacity till the neck.

Incubation and intermittent checking:

For the first 7 days media filled units are incubated at temperature 20 to 25 Degree Celsius, after that at 30 to 35 Degree Celsius for next 7 days.

Total incubation period of media fill units must not be less than 14 days.

Every after 3 days media filled vials or containers are verified for growth.

Container and closure leak test: should be done after 14 days and after inspection of growth.

Source: https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practice-regulations-production-and-process

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