Pharmaceutical Tubing: Requirements, Types and Applications in the Life Science Industry

What Defines a Pharmaceutical Hose?

A pharmaceutical hose ( discover our models ) is distinguished by simultaneously meeting multiple technical and regulatory requirements:

• FDA 21 CFR and/or USP Class VI approved materials: ensure that hose components do not migrate into the product.

• Smooth internal surfaces: minimize the possibility of particle accumulation and microbial proliferation.

• Chemical resistance: compatible with process fluids and cleaning agents (acids, bases, alcoholic solutions).

• Traceability: certificates of conformity, extractables and leachables available for process validation.

• Absence of plasticizers, latex and potentially toxic substances.

Materials Used in Pharmaceutical Hoses

The most commonly used materials in the manufacture of pharmaceutical tubing are:

• Platinum silicone: the gold standard. Transparent, flexible even at low temperatures, FDA and USP Class VI approved. Withstands autoclave, gamma, and ethylene oxide sterilization. Ideal for peristaltic pumps.

• PTFE: maximum chemical resistance. Used when silicone is incompatible with the fluid. Very low friction internal surfaces.

• C-Flex and Pharmed: thermoplastic elastomers with excellent performance in peristaltic pumps, high transparency and low extraction.

• TPE (Thermoplastic Elastomer): an alternative to silicone with good chemical resistance and competitive prices.

• Pharmaceutical PVC: for less demanding applications or single-use transfer systems.

Key Standards and Certifications

A pharmaceutical hose must be supported by documentation that allows its qualification and inclusion in the process validation protocols:

• FDA 21 CFR 177 (food and drug contact materials)

• USP <87> and <88> (in vitro and in vivo biocompatibility tests)

• USP Class VI: the strictest USP standard for plastic materials

• ISO 10993: Biocompatibility of medical devices

• REACH and RoHS: European regulations on hazardous substances

• EC 1935/2004: for food contact in Europe

Applications of Pharmaceutical Tubing

The pharmaceutical hose is present in multiple stages of the process:

• Transfer of API and liquid excipients

• Aseptic dosing and filling systems

• Peristaltic pumps in fermentation and purification processes

• CIP/SIP lines

• Purified water (PW) and water for injection (WFI) production systems

• Single-use bioreactors (single-use bioprocessing)

• Flexible connections in cleanrooms

Selection Criteria: Which Pharmaceutical Hose Do I Need?

To choose correctly, consider:

1. Chemical compatibility with all fluids that will be circulated (including cleaning fluids)

2. Minimum and maximum operating temperature

3. Working pressure and vacuum

4. Intended sterilization method

5. Application in peristaltic pump (if so, the hose must be specifically designed for this)

6. Transparency requirements (visual traceability of the fluid)

7. Certifications required for the validation process

Conclusion

Selecting the right pharmaceutical tubing is a technical decision that directly impacts patient safety and your facility's regulatory compliance. Don't settle for generic tubing when your process requires it. Consult with specialists and always demand traceability and certification documentation.

By Tecno Products