Understanding FDA Regulations: Thermostatic Bellows Element Fill in Sanitary Steam Traps

The FDA “Approval” Misconception

A common misconception in the pharmaceutical equipment industry is that the FDA directly “approves” individual components such as sanitary valves, steam traps, or bellows fill materials.

This is not accurate. The FDA doesn’t actually “approve” any manufacturers’ valve, steam trap, steam trap bellows fill, or any other component for use in a pharma plant for that matter.

How the FDA Actually Regulates Materials

Instead of directly approving components, the FDA collaborates with international organizations to establish material guidelines and classifications.

They work closely with the International Council for Harmonization (ICH) to provide comprehensive industry guidance on suitable materials for pharmaceutical manufacturing equipment.

This collaborative approach mirrors the FDA’s methodology for regulating elastomers and thermoplastics used throughout the pharmaceutical industry.

ICH Q3C Guidelines: Solvent Classification System

The International Council for Harmonization has established a robust framework through its ICH Q3C document, which addresses the classification and appropriate use of solvents in pharmaceutical manufacturing.

This guidance extends to manufacturers of pharmaceutical equipment and establishes a three-tier classification system based on toxicity levels:

Class 1 Solvents (High Risk)

• Considered most toxic to human health
• Should be avoided whenever possible in pharmaceutical manufacturing
• Require special justification if used

Class 2 Solvents (Moderate Risk)

• Limited toxicity concerns
• Acceptable with proper controls and limitations
• Require concentration limits in final products

Class 3 Solvents (Low Risk)

• Includes only safe solvents that don’t hurt humans at regular pharmaceutical amounts
• Considered the safest category for pharmaceutical applications
• Minimal restrictions on use

Steriflow Valve’s Approach to Compliance

At Steriflow Valve, we prioritize regulatory compliance and patient safety in our MK93 series steam traps. Our bellows fill fluids contain a proprietary blend of alcohols that have been carefully selected to meet Class 3 solvent classification criteria as defined by FDA and ICH Q3C guidelines.

Our Commitment to Accuracy

While our bellows fill fluid meets the stringent criteria established by the FDA and ICH Q3C as a Class 3 solvent, we maintain complete transparency: we cannot and do not claim FDA approval for our traps or any individual components. This honest approach ensures customers have accurate information for their regulatory compliance efforts.

Industry Standards and Regulatory Framework

The pharmaceutical equipment industry operates within a complex regulatory environment where multiple organizations contribute to safety standards:

• FDA: Provides overarching regulatory framework
• ICH: Develops harmonized international guidelines
• ISO: Establishes international quality standards
• USP: Sets pharmaceutical compendial standards

This multi-organization approach ensures comprehensive safety standards while promoting international harmonization of pharmaceutical manufacturing requirements.

Key Takeaways for Pharmaceutical Manufacturers

1. Verify Claims: Be cautious of suppliers claiming “FDA approval” for individual components
2. Understand Classifications: Focus on ICH Q3C solvent classifications when evaluating bellows fill materials
3. Documentation: Ensure suppliers provide proper documentation of material compliance with relevant guidelines
4. Regulatory Alignment: Work with suppliers who understand and accurately represent regulatory requirements

Conclusion

Understanding the distinction between FDA approval and compliance with FDA-endorsed guidelines is crucial for pharmaceutical manufacturers. While the FDA does not approve individual steam trap components, the ICH Q3C classification system provides clear guidance for material selection. At Steriflow Valve, we ensure our bellows fill materials meet Class 3 solvent criteria, providing you with compliant, safe solutions for your pharmaceutical applications.

References

• ICH HARMONISED GUIDELINE IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R7), Current Step 4 version dated 15 October 2018
• S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) August 2018 ICH Revision 4
• FDA Biologics Guidance