Managing BSE/TSE Risk in Prepared Microbiology Media: What You Need to Know
Written By: AnalytiChem |
In this article we’ll cover:
- Why BSE/TSE remains a concern for users of prepared microbiology media.
- How BSE/TSE risk is defined in regulatory terms, and why not all animal-derived materials are treated equally.
- What regulators expect in terms of traceability, documentation, and risk management.
- How BSE/TSE considerations are addressed in prepared microbiology media manufacturing.
- What customers should look for from a prepared microbiology media supplier during audits and inspections.
- How a risk-based approach supports compliance without unnecessary complexity.
What is BSE/TSE Risk in Relation to Prepared Microbiology Media?
Questions around prepared microbiology media and BSE (Bovine Spongiform Encephalopathy) and TSEs (Transmissible Spongiform Encephalopathies) are a common part of audits and documentation reviews.
TSEs, including BSE, are rare and fatal neurological diseases caused by prions—misfolded proteins resistant to conventional sterilization processes. Crucially, these agents are associated with specific high-risk animal tissues—known as specified risk materials (SRMs)—rather than with all animal-derived ingredients.
SRMs include tissues such as the brain and spinal cord. These materials are never used in the manufacture of prepared culture media; as most raw materials originate from low-risk tissues, such as milk or hides, the theoretical risk of TSE transmission is low.
What Do Regulators Expect Regarding BSE/TSE Risk?
Many traditional formulations of prepared microbiology media contain animal-derived components such as peptones, extracts, or enzymatic digests. These materials are long established, widely used, and sourced from reputable suppliers. However, their presence means identification, assessment, and control of potential risks must be demonstrated.
Due to the importance of the source material used in the production of prepared microbiology media, regulatory scrutiny focuses on the origin and type of tissue used. As a result, clear documentation and a well-defined risk management approach give auditors and inspectors confidence regarding sourcing, traceability, and regulatory compliance.
International guidance provides a consistent framework for managing BSE/TSE risk in animal-derived materials. Key references include:
These standards promote a risk-based approach, rather than routine batch-by-batch certification. This means demonstrating control through documented systems, rather than excessive testing. Best practice typically includes:
- A documented supplier policy or annual declaration.
- Full traceability of species, tissue type, country of origin, and veterinary status.
- Robust quality assurance processes to support customer audits and regulatory inspections.
While components such as peptones, bile salts, blood, or enzymatic digests are widely accepted and considered safe when sourced correctly, manufacturers are expected to demonstrate appropriate controls, including:
- Exclusion of specified risk materials from all formulations.
- Sourcing from countries with negligible or controlled BSE risk.
- Clear traceability and documented compliance with EMA, European Pharmacopoeia and ISO requirements.
Batch-specific BSE/TSE certification is generally not expected unless dictated by a specific product risk profile.
What Should You Look for in a Supplier of Prepared Microbiology Media?
When assessing suppliers of prepared microbiological media, customers benefit most from clarity rather than complexity:
- Clear assurance: A documented statement or policy confirming responsible sourcing and alignment with recognized global standards.
- Transparency: Confidence that the supplier can explain material origins and risk controls clearly.
- Reliable support: Timely, knowledgeable responses to documentation requests, particularly during audits.
- Ongoing compliance: Evidence that regulatory expectations are actively monitored and reflected in current practices.
AnalytiChem UK’s Director of Quality and Technology, Steven Brimble, recently produced an essential blog on evaluating and validating potential new suppliers of prepared culture media products. This article reflects our recognition of the practical issues laboratories face, which is why AnalytiChem’s Redipor brand consistently ranks among the top ready-to-use biological media products.
Our Commitment as a Trusted Supplier of Prepared Microbiology Media
At AnalytiChem, as manufacturer of the Redipor range of prepared microbiology media products, we understand that managing BSE/TSE risk is not about excessive testing, but about clear sourcing, traceability, and a well-documented risk assessment process. Regulatory compliance and transparency are essential—not only for successful audits, but for long-term confidence in microbiological testing.
Production of our Redipor range aligns with EMA, European Pharmacopoeia and ISO guidance, reflecting the same risk-based principles outlined above. This ensures that our prepared culture media products are safe, compliant, and supported by robust documentation.
By maintaining validated supplier declarations, certificates of origin, and documented risk assessments, we provide clear, consistent assurance that BSE/TSE risks are understood and appropriately controlled, ensuring the highest levels of customer confidence.
If you require our BSE/TSE policy, supporting documentation, or information on our Redipor products, then please contact us: our team is here to help.
