Why Does Traceability Matter?
Why does traceability matter in my role?
Why does traceability matter in my supply chain?
Traceability ensures safety in any animal-derived product supply chain but is critically important for FBS. FBS is widely used in cell culture research and bioproduction as a source of growth factors, hormones, and nutrients that support the growth of various cell types. The safety and quality of serum depends on its sourcing, production, and handling processes.
Here’s a breakdown of considerations for FBS safety:
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Sterility: High-quality serum is sterile filtered often using 3 x 0.1 µm filters to remove bacteria, fungi, and mycoplasma.
Endotoxin Levels: Manufacturers test serum for endotoxin to ensure it is suitable for sensitive applications like immunological studies.
Batch Testing: Manufacturers may test serum before sale to verify functionality, performance and lack of contaminants.
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Traceability: Sera should be traceable back to its source, ensuring ethical collection and compliance with regulations.
ISO Certification: Suppliers may operate under ISO-certified processes for manufacturing and handling.
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Viral Contaminants: Bovine viral risk profiles differ across geographies.
Reputable suppliers mitigate the risk of viral contamination through screening and treatment processes.
Recommendations
Ensure your serum provider is ISIA Traceability Certified
Purchase serum through an authorized distributor when not buying direct
Check the Certificate of Analysis (CoA) for sterility, endotoxin, origin, and specific testing results