Media Fill for Validation of Aseptic Procedures

Media Fill for Validation of Aseptic Procedures

Published: 9th Jun 2023, 12:28

Drugs are produced by the aseptic process. The goal of aseptic processing is to make a product that is free of microorganisms and toxic microbial by-products, such as bacterial endotoxins. To ensure aseptic processing, pharmaceutical industries perform Media Fill.

Media fill is a component of aseptic manufacturing process validation. It is carried out by replicating the manufacturing process by substituting a sterile microbiological growth medium for the drug solution. It determines whether aseptic procedures are adequate to prevent contamination during drug production.

What is the purpose of the media fill?

The media fill evaluates the aseptic assembly and operation of critical sterile equipment, qualifies and evaluates the operators' technique, and demonstrates that the environmental controls are adequate to meet the basic requirements for producing a sterile drug through aseptic processing.

The number of units filled in Media Fill should correspond to the actual batch size. The simulation run sizes should be sufficient to accurately assess the potential for commercial batch contamination and mimic commercial production conditions. The media fills should be designed to simulate the entire product fill situation in terms of equipment, processes, Environmental Monitoring, personnel involved, areas, and time required for both filling and holding.

To qualify the process, three consecutively successful simulations should be performed. Process simulation should generally last no less than the length of the actual manufacturing process.

Culture Media Use in Media Fill

When it comes to choosing growth media, convenient and ISO 11133-compliant media should be used.

Soybean Casein Digest Medium(SCDM) is the most preferred media because it promotes the growth of both gram-positive and gram-negative bacteria, yeast, and mould.

The media chosen must be shown to promote the growth of gram-positive and gram-negative bacteria, as well as yeast and mould. The evaluation media must pass a growth promotion test. Control organisms should include relevant strains of test microorganisms identified as suitable for use in the growth promotion test by relevant pharmacopoeias. Growth promotion tests should show that the medium can support the recovery and growth of a small number of microorganisms, i.e., 10–100 CFU/unit or less.

Now the most amazing thing is that TM Media provides SCDM as well as all other Culture Media requirements for Media Filling. Our Culture Media are as per harmonized guidelines and promote the growth of the microorganisms. Along with the quality, we provide convenience too. SCDM is delivered in a "Ready-to-Use Bag". Two ports provided on the 5-liter bag make it easy to use. The needle port enables the desired amount of media to be drawn using a syringe or a pump at the appropriate times, whereas the spike port allows you to draw the entire media at once. 

Incubation Time and Examination of Media-Filled Units

During Media Fill, the incubation temperature should be suitable for the recovery of bioburden and environmental isolates and should never exceed 20-35oC. The temperature of the incubation chamber should be kept within ±2.5oC of the target temperature. The incubation period should not be shorter than 14 days. If two temperatures are used for the media-filled units' incubation, the units should be incubated for at least 7 days at each temperature, beginning with the lower temperature. Units are incubated inverted for the first half of the incubation period before being returned to an upright position for the remaining time.

Line Speed During Media Fill

Each media fill run should evaluate a single line speed. High line speed is most appropriate for evaluating manufacturing processes that involve frequent interventions or a significant amount of manual manipulation. Slow line speed is generally appropriate for evaluating manufacturing processes involving prolonged aseptic exposure of the sterile drug product and containers or closures.

Fulfilling Microbiology Needs of the Pharmaceutical Industry

TM Media provides high-quality, tailored pharmaceutical solutions to ensure that your work meets compliance and regulatory requirements.

We offer products manufactured in accordance with USP/EP/JP/IP standards for a variety of activities such as media filling, sterility testing, environmental monitoring, and many others. Our "Absolute EM" category is dedicated to environmental monitoring.

In addition to a wide range of Culture Media, we also provide Lab Consumables and Equipment such as Swabs, Petri Plates, Air Samplers, Anaerobic Jar System, Membrane Filtration Funnel, the Manifold System, and many more.

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