Sterile Express Media Service

Tested sterile media manufactured in an ISO 5 environment

Sterile Express Media Service (SEMS) from FUJIFILM Irvine Scientific is the first service of its kind for small lots and pilot-scale lots of tested sterile, non-GMP media. Up to 100 L, flexibly and rapidly manufactured in a Grade A/ISO 5 environment, your media is shipped in as little as 15 business days.*

  • Isolator technology provides an aseptic manufacturing environment
  • Sterility testing according to USP71 and ISO 13408 requirements
  • Media remain in a Grade A/ISO 5 environment throughout the manufacturing process, reducing risk for contamination of media for critical applications
  • Non-GMP, small-scale liquid formulations, manufactured using the same qualified raw materials used for GMP manufacturing

Sterile non-GMP media provides an extra measure of control and security for valuable cells and helps streamline the successful development of cell and gene therapies and clinical drugs.


*Pending sterility confirmation.

Feature Benefits
Small-scale liquid formulations:
  • Sterile small lots and pilot-scale lots to test the feasibility of media during scale-up in applications that do not require GMP-grade media
  • Non-GMP, small-scale liquid formulations, manufactured using the same qualified raw materials used for GMP manufacturing
  • Batch size up to 100 L; standard as well as custom media packaging available to accommodate specific process requirements
Confirmed sterility:
  • Isolator technology provides an aseptic environment for media manufacturing
  • Media remains in a Grade A/ISO 5 environment throughout the manufacturing process, reducing risk for contamination of media for critical applications
  • Trial small volumes of sterile, non-GMP media for scale-up process, before progressing to higher volume requirements of GMP manufacturing
  • Media are released for rapid shipping pending sterility confirmation
Broad range of media support:
  • Manufacturing of customers' proprietary formulas, modified FUJIFILM Irvine Scientific formulas, and classical formulas with or without modifications
Extensive technical support from Manufacturing Support and Services:
  • Dedicated scientists provide formulation support based on 50 years of media experience
  • Access to experienced support team for formula review, optimization, and consultation ensures a smooth transfer to GMP manufacturing
Quality raw material and technology:
  • Utilization of the same tested and qualified raw materials and milling technology used in our GMP manufacturing environment supports your small-scale media needs
  • Raw materials are monitored in accordance with ISO 13485:2016 standards and meet manufacturing Quality Assurance measures
  • Extra security during manufacturing through Environmental monitoring and 21 CFR-Part 11 compliant data logging
Quality Control testing:
  • Testing appearance, pH, and osmolality of products free of charge
  • Each lot of media is confirmed sterile according to USP71 and ISO 13408 requirements



Contact a Media Specialist today to learn more about Sterile Express Media Service and our other cell culture media services.

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