BSE and or TSE Materials Policy - Regulatory Information
December 6, 2021
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DATE: 6-DECEMBER-2021   Last Updated: 9-AUGUST-2026

BSE and TSE Statement

MICROSOLV confirms that, as of October 2021:

  • No raw materials used in MICROSOLV products are derived from animal sources.
  • No animal-derived materials are used during manufacturing processes.
  • Products do not come into contact with animal-derived substances during manufacturing, storage, or transportation.

Based on this information, MICROSOLV products are considered free from:

  • Bovine Spongiform Encephalopathy (BSE)
  • Transmissible Spongiform Encephalopathies (TSE)

Additionally, MICROSOLV declares that its products are Dioxin-Free.


Why BSE and TSE Compliance Matters

Many pharmaceutical, biotechnology, clinical, and medical device organizations require confirmation that materials used in analytical workflows are free from animal-derived substances associated with BSE and TSE risks.

This information is commonly requested for:

  • Supplier qualification programs
  • Regulatory submissions
  • Quality audits
  • Risk assessments
  • Pharmaceutical manufacturing support
  • Biotechnology applications

What Are BSE and TSE?

Transmissible Spongiform Encephalopathies (TSE)

TSEs are a group of rare, progressive neurological diseases associated with abnormal protein structures known as prions.

Examples include:

  • Bovine Spongiform Encephalopathy (BSE)
  • Scrapie in sheep
  • Variant Creutzfeldt-Jakob Disease (vCJD) in humans

Bovine Spongiform Encephalopathy (BSE)

BSE, commonly known as Mad Cow Disease, is a form of TSE that affects cattle.

Because of historical concerns regarding animal-derived materials, many regulatory and quality systems require documentation confirming the absence of BSE and TSE risks within manufacturing processes and raw materials.


Regulatory and Quality Support

This policy helps support organizations that require documentation regarding:

  • Animal-derived materials
  • Supplier qualification
  • Pharmaceutical quality systems
  • Biotechnology compliance programs
  • Product safety assessments

Customers requiring supporting documentation may reference the MICROSOLV BSE/TSE-Free Declaration.


Key Takeaways

  • MICROSOLV products are manufactured using synthetic or non-animal-derived materials.
  • No animal-derived materials are used during manufacturing, storage, or transportation.
  • Products are considered free from BSE and TSE-related materials.
  • MICROSOLV also declares its products to be Dioxin-Free.
  • Supporting documentation is available for customer qualification and compliance needs.

📄  Download the MICROSOLV BSE and TSE-Free Declaration (PDF)


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