Media Filling Process in Sterile Pharmaceutical Production

Media filling, also known as broth filling, is a method in which microbiological nutrient growth medium is created and then filled in a simulation, which is a normal production process.

Usually, a microbiological growth medium such as SCDM (Soybean-Casein Digest Medium) is processed and then managed to simulate an ordinary manufacturing process with similar type of exposure and potential contamination. Incubation is carried out in the last pot.

This container is then monitored for turbidity – an indicator of microbial contamination. In simplest terms, this is exactly what comes up.

Media fill verification is required by drug regulations. This is for several good reasons.

First of all, a sterile product is normally defined as devoid of living organisms. Since it is not practical to examine each unit to verify sterility, the risk of contamination is tried to be reduced. Some of these efforts include monitoring of finishing, pressure differentials, HVAC, cleaning procedures and associated schedules.

Regardless of the large number of precautionary measures in place, contamination is always present.

This is mainly because aseptic processing is a controlled (but non-sterile) process and sample numbers are also extremely small. This means that only major contamination will most likely be detected.

Another reason for media fill verification is that although aseptic manufacturing conditions need to be repeated, they are impossible to perform exactly like the manufacturing process of making a batch of pharmaceutical products.

Also, when it comes to aseptic processing, the biggest risk comes from the cleanroom workforce. Typically, operators have to attend media fills. It is also important to carry out environmental monitoring activities during aseptic filling operations. Environmental monitoring activities include:

– Regulatory references determining microbial conditions

– Air sampling with the aid of passive or active sampling methods while the process is being carried out. At the end of the process, surface sampling should also be done.

– Monitoring of personnel during the aseptic procedure

– Microbiological monitoring including air, personnel and surfaces

– Particle monitoring should be performed during media filling.

– Routine procedure should be strictly followed when there is a need to increase the number of sampling locations.

It is normal to take into account worst-case conditions that may occur in production runs.

The purpose of the media fill verification protocol is to establish documented evidence that the process used for aseptic processing is capable of consistently producing expected results, within the prescribed limits when conducted according to the latest standard operating procedures. The validation protocol mainly describes the general procedure of media filling.

Below are standard steps for verifying the integrated line using the media fill test. They include:

1. SVP Line cleaning.

2. Dispense of Soybean Casein Digest Medium for a 150 L lot size.

Preparation of 3rd batch 150L.

4. Filling and then sealing.

5. Incubation of the final vessel and inspection of media filled units.

6. Interpretation of results.

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