Media Fill definition

Media Fill means a fill of bacteriological growth media into vials for validation purposes.
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Media Fill means an evaluation run conducted with media to test the sterility of the manufacturing process in accordance with the applicable Specifications and current FDA and EU aseptic requirements.
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Examples of Media Fill in a sentence

  • All Development (Simulation), Media Fill (including Process Simulation batches for the Intermediate) and CTM batches are comprised of one (1) Intermediate batch and one (1) Product batch.

  • This media fill process qualification for injectable suspensions includes the homogenization process in the ISO 5 LAFW for the maximum duration and the aseptic fill in the ISO 5 environment as outlined in SOP ST-004 Media Fills (Exhibit 4A-1), and the Media Fill Master Validation Plan (Exhibit 4A-2).

  • Grade A monitoring for Viable and Non-Viable Particle took place, during entire Media Fill exercise.

  • If the parties mutually agree (or in the absence of mutual agreement, a third party laboratory determines pursuant to Section 6.1(b)) that Product fails to conform to the Specifications, this Agreement, the Quality Agreement, cGMPs or Applicable Law and the non-conformity arose other than from a Patheon Factor and Client’s rejection of the Product did not result from a Media Fill Failure, Client shall be responsible for [**].

  • Media simulation test:Provision for aseptic media simulation was in place.The Media Fill Test batch manufacturing record was spot checked.

  • Lack of Media Fill Studies Your firm has not performed aseptic process simulations (i.e., media fill studies).

  • Samples collected from the final rinse with WFI are tested for conductivity, endotoxin, TOC and bioburden.Incubation room:Qualification of the incubation room for Media Fill was performed.Lyophilizer:Lyophilizer was undergoing CIP/SIP before each run.

  • A specific record would have a random error introduced but a large number of records should have the error corrected.

  • Areas inspected included sampling booths, dispensing areas, aseptically filling areas and primary and secondary packaging areas.Pharma III (Ground Floor) Aseptically Filled VialsThe Vial Filling Line Media Fill protocol and report were reviewed.

  • It is requested to participate in 3 Media Fill Test to be certified for aseptic operations.

Related to Media Fill

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