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.

  • 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 [**].

  • Charge per each Media Fill Run is € *** In case it transpires that Subcontractor has data applicable to cover the Defibrotide process, so that Subcontractor won’t need to manufacture any Media fill run dedicated to the project, then only 25% of the media fill runs charges will be levied on Gentium (€ ***).

  • 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.

  • The Preliminary Monthly Fee will apply until the completion of the last successful Media Fill.

  • If a Recall or return results from a Media Fill Failure or the Products’ non-conformity with the Specifications, the Quality Agreement, this Agreement, cGMPs, or [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.

  • Gentium will be charged fully for each of the Media Fill run Subcontractor will have to manufacture dedicated to the project.

  • E.4.5.1 Reassignment of continuing staff within the school including teachers with employment rights returning to the school from leave of absence, and teachers returning to the District from leaves of absence as specified in Articles A.8.0 and G.16.

  • If Company delays the timing for the Engineering Run beyond more than [*] weeks from completion of the last successful Media Fill, Supplier may commence charging the Monthly Fees prior to the Engineering Run.

  • The Media Fill program will [*] and [*] and will be performed using Company’s primary packaging components.