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.

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

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*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