Studies

Processing of media fills

Media fills are performed to ensure that aseptic production processes are not affected by microbial contamination. These serve to qualify and validate aseptic filling processes in the manufacture of sterile pharmaceuticals, including patient-specific preparations. Media fills confirm that

  • you apply suitable methods and processes,
  • that your personnel is qualified,
  • that the required quality of the pharmaceuticals you manufacture is guaranteed

 

This process validation is a key factor in drug safety. Labor LS offers you a wide range of supporting services for this purpose:

  • Incubation and evaluation of media-fills in qualified incubators
  • Growth controls incl. validation with regard to packaging influences
  • Identification of germs in case of positive findings
  • Storage and maintenance of home germs in our strain collection
  • Creation of test sets for personnel qualification
  • Further processing of media fills for filling with solids
  • Further processing of media fills for the sterile production of empty containers
  • Preparation of validation plans according to Annex 1 and 15 of the EU GMP Guidelines

With our extensive know-how in the areas of industrial hygiene and microbiology, we are your ideal partner when it comes to successful process validation.

Your contacts on this topic

We would be pleased to advise you and prepare an individual quotation for you! For more information and enquiries, please contact our team of experts:

Lisa-Antje Büttner
Challenge Tests and Validation Projects
+49 9708 9100-162
lisa-antje.buettner@labor-ls.de

Jonas Helmreich
Challenge Tests and Validation Projects
+49 9708 9100-164
jonas.helmreich@labor-ls.de