Media Fill definition

Media Fill means a fill of bacteriological growth media into vials for validation purposes.
Sample 1Sample 2Sample 3
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.
Sample 1

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.

  • Your firm’s May 2016 trending data did not accurately report an aseptic operator’s personnel bioburden for personnel monitoring samples taken during Media Fill, batch 051616.

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

  • Media Fill TestThe Media Fill Test is a method for the validation of the aseptic implementations of filling processes.

  • Detailed Description of Fill and Finish Deliverables and Pricing Summary Service Description Units Unit Price Total Price Media Fill Validation 3 x 3000 - Non-GMP Aseptic Fill and Finish (Product and Placebo) ~400 vials/fill (OMS302 Product) - - † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION A.

  • 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.

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

  • Points to consider for an adequate Media Fill validation study design: Clearly state the aseptic processes covered by the study. Routine and nonroutine interventions should be simulated (e.g., glass breakage, shift change, transfers, procedures to keep product warm or cold, etc.).

  • Ensuring there is a process and an assigned individual who has training and documented competencies in place to review and interpret staff testing results related to Gloved Fingertip Tests(GFTs) and Media Fill Tests(MFTs) .

  • The price of these [*] will count toward the Preliminary Monthly Fees covered in Section 10.7. For clarity, Company will pay Supplier the price for the successful designated Media Fills under this Section 8.1. Supplier will bear the cost of any Media Fill failures and routine cGMP Media Fills following construction of the Dedicated Suite.

Related to Media Fill

  • Media Rights means all rights to negotiate, broadcast, and disseminate radio, television, motion picture, internet, webcast, and videotape broadcasting, telecasting, production, exhibition, or other sound, or visual exploitation of the Championships, on a live and/or delayed basis, by any means whatsoever, whether now known or hereafter developed; or otherwise distribute and exploit the Championships and/or any portion thereof in any manner in all forms of such media.

  • Online means transactions through electronic data-interchange whether real time transactions or otherwise, which may be through the internet, intranet networks and the like.

  • CSDCC means the China Securities Depository and Clearing Co., Ltd. “CSRC” means the China Securities Regulatory Commission.

  • broadcasting station means a station in the broadcasting service.

  • Media means physical devices or writing surfaces including, but is not limited to, magnetic tapes, optical disks, magnetic disks, large-scale integration memory chips, and printouts onto which information is recorded, stored, or printed within an information system.

  • CRM means the DDA Case Resource Manager.

  • Magazines means magazines and other materials printed on similar paper.

  • Catalog means the available list of tangible personal property or services, in the most current listing, regardless of date, during the life of the contract, that takes the form of a catalog, price list, schedule, shelf price or other form that:

  • Video means simulated movement created by the display of a series of images creating the illusion of continuous movement.

  • Channel means a natural or artificial watercourse with a definite bed and banks that conducts continuously or periodically flowing water.

  • EG means the Enforcement Guide;

  • Façade means the principal front or fronts of a building.

  • Games means games of chance.

  • CSDP means the Central Securities Depository Prague

  • EUMA means the “SAP Delivered Support Agreement” which sets out the terms and conditions under which SAP provides support to End Users and which will be provided by SAP on a deal by deal basis.