Quality Assurance Standards & Testing

Quality research starts with quality materials. That’s why SeraPrime is committed to providing only the highest quality fetal bovine serum to our clients. We’re proud to be a partner in your groundbreaking work, and we do not take that responsibility lightly—it’s why we have a series of rigorous quality tests performed during FBS production. Our meticulous FBS quality testing process ensures you are getting serum that meets the highest possible quality standards, so you can be confident in your batch’s performance under a variety of lab conditions.

The SeraPrime difference includes:

➤ High-Quality Source Selection: We carefully select FBS from reputable sources that are annually inspected, USDA/APHIS certified with Global certification. cGMP protocol is followed with full documented geographical traceability of all components. Rigorous supplier audits are conducted to maintain traceability of all sources.
➤ Aseptic Collection Techniques: Aseptic collection techniques and follows strict protocols to minimize contamination risk during blood collection.
➤ Standardized Processing: SeraPrime standardizes clotting times and processing temperatures, using automated processes where possible to ensure batch consistency.
➤ Effective Filtration: Multi-stage filtration processes within ISO 13485 and ISO 9001 certified facilities including 0.1 µm final filters, at SeraPrime to effectively remove particles and microorganisms.
➤ Comprehensive Testing: We conduct comprehensive FBS quality testing for viruses, mycoplasma, and endotoxins on every batch.
➤ Optimal Storage Conditions: Our FBS is stored at -10°C or colder, using temperature-monitored freezers. Backup power solutions are in place to prevent temperature fluctuations during storage.
➤ Consistent Batch Quality: Batch consistency tests and adjust processes based on findings to ensure uniformity.
➤ Accurate Labeling: Robust labeling protocols include batch numbers, processing dates, and detailed contents, all using barcoding systems to reduce human error and enhance traceability.
➤ Comprehensive Documentation: We maintain comprehensive electronic records for each batch, including source, collection, and processing details.
➤ Regulatory Compliance: SeraPrime stays updated with relevant guidelines and standards (including USDA and APHIS) and ensures all production processes are compliant with evolving global standards.

Adhering to these processes for every batch is what makes SeraPrime an industry-leading FBS supplier. 

Contact us today to place your order or learn more about our FBS quality assurance standards.
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