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Manufacturing IVF Media – Quality from Beginning to End

Using the right media is critical for supporting the development of gametes from 2PN embryos to blastocysts during the in vitro fertilization (IVF) workflow. Media used for handling and culturing these sensitive specimens require high quality raw materials, dialed-in manufacturing processes, and thorough quality testing to ensure they not only perform well, but keep the specimens safe. In this blog post, we will outline the extensive steps FUJIFILM Irvine Scientific takes to provide media that is consistent, accurate, safe, and effective.
Overview
The media production process can be simplified into these key steps:
- Raw Material Qualification
- Executing the Work Order
- Line Clearance
- Formulation and Media Production
- Quality Control and Inspections
- Quality Assurance Review and Closeout
Every step in the process is as important as the next, each requiring thoughtful consideration and dedication from everyone involved. Starting with the procurement of the highest-grade raw materials, we adhere to the most comprehensive regional and regulatory requirements for consistency in our finished goods.
Quality Products Start with Quality Ingredients – Raw Material Qualification
Producing high quality media and solutions begins with ensuring the raw materials we use hold up to the strict standards we require for our products. Before raw materials are ordered, we rigorously screen all of our suppliers for their reliability and compliance to robust quality systems. After the raw materials are received, we then start a secondary quality control analysis, checking for any present endotoxins, moisture in powder materials, and that the material is properly labeled.
Build it Right the First Time – Executing the Work Order
Preparation is the key to success, and "work orders" prepare everyone for the rest of the process. Raw material staging, lot number verification, expiration date checks, and more, are critical in preventing surprises before manufacturing can begin.

A Clean Space with a Clear Purpose – Line Clearance
The production queue never ends, and there is always new media to be made. Line Clearance is the process of cleaning up anything from previous production runs, checking the calibration of all equipment, and ensuring only relevant materials and documents specific to the product being made are present on the processing line. Additionally, our manufacturing takes place in an ISO 5 clean room that meets FDA and EU regulations for pharmaceutical sterilization and filtration.
Putting it All Together – Formulation and Media Production
Media production can be a complicated process that involves specific timings, checks, and techniques. Aside from detailed directions for our experienced technicians, there are manual and electronic witnessing steps throughout the process to cross-check work, ranging from raw material weighing, to fill volume checks, to in-process test results. For added consistency, we perform a filling simulation bi-annually to validate our filling processes and confirm maintenance of sterility. Throughout the whole production, internal and external audits are done to make sure the processes are being followed correctly.

Is It Working? – Quality Control (QC) and Inspections
Once the product is manufactured, many QC tests are completed to verify its quality. The Certificate of Analysis test reports on key indicators that confirm the product is performing as expected; such as pH, appearance, endotoxin, sterility, and mouse embryo assay. Additional testing may be done if a certain test comes back out of specification or we increase internal standards of that product. Once a product passes QC testing, it is ready for kitting and final review. Packaged products are then inspected for damage, label defects, and seal integrity.
Final Check – Quality Assurance Review and Closeout
Despite all the checks and tests that have already been completed, a Quality Assurance reviewer performs one final inspection. After going through such a long and winding process, a fresh set of eyes reviews the batch paperwork and looks for inconsistencies in production, final bottle count, documentation, and more. Once approved, the product is finally ready to ship to our customers!
ALL IN on Quality
Being ALL IN is a team effort, and it means having a mindset for zero errors from the beginning to the end. Our quality systems are crucial for preventing, reducing, and handling the unexpected, allowing our products to be exactly what our customers expect.
For more ALL IN, check out our landing page to learn how quality, innovation, and service is at the center of everything we do.