1. FDA 21 CFR 177.2600: The Gold Standard for Rubber Articles

The U.S. Food and Drug Administration (FDA) sets strict limits on substances that can migrate from equipment into food or drugs.

• The SOSHH Commitment: Our PU10 and PUAS series are specifically formulated to meet FDA 21 CFR 177.2600 requirements for repeated use.
• Zero Migration: Unlike low-grade PVC or rubber, our high-purity TPU contains no harmful plasticizers or phthalates, ensuring that your Active Pharmaceutical Ingredients (APIs) remain uncontaminated.

2. EU 10/2011 & EC 1935/2004: European Excellence

For manufacturers exporting to Europe, compliance with EU 10/2011 (Plastic materials intended to come into contact with food) is a mandatory requirement.

• Rigorous Testing: SOSHH connectors undergo migration testing to ensure they remain inert even when exposed to aqueous, acidic, or fatty substances.
• Traceability: We maintain full batch traceability for all our raw materials, supporting your plant's Internal Quality Management (IQM) systems.

3. Sanitary Design: Beyond the Material

A material can be "FDA compliant" but still fail a hygiene audit due to poor design. This is where the Sanitary Design of SOSHH connectors excels.

• Mirror-Smooth Interior: Our connectors feature a non-porous, ultra-smooth bore. This prevents powder "hang-up" and inhibits the growth of biofilms and bacteria.
• Crevice-Free Joints: Especially when paired with our TC Quick-Clip system, our connectors eliminate the "dead zones" created by traditional hose clamps, making Clean-In-Place (CIP) cycles 100% effective.

4. Chemical Resistance to Sterilizing Agents (SIP/CIP)

Pharmaceutical lines undergo frequent sterilization. A connector must withstand aggressive cleaning chemicals without degrading.

• Chemical Stability: SOSHH TPU is resistant to a wide range of common cleaning agents and disinfectants.
• High-Temperature Resilience: For lines requiring steam sterilization, our PUHT (High-Temp) series maintains its structural integrity and compliance at elevated temperatures.

Temp) series maintains its structural integrity and compliance at elevated temperatures.

Regulatory Quick-Check: SOSHH TPU Performance

Conclusion: Minimize Risk, Maximize Compliance

In a highly regulated environment, "good enough" isn't enough. By choosing SOSHH FDA and EU-certified flexible connections, you are not just buying a connector; you are investing in a risk-mitigation strategy that protects your brand and your consumers.