Background

A pharmaceutical manufacturer specializing in peptide purification required tubing capable of safely transferring several aggressive solvents used during purification.

The media included:

• Acetonitrile (ACN)
• Trifluoroacetic Acid (TFA)
• Dichloromethane (DCM)
• Methyl tert-Butyl Ether (MTBE)

These chemicals are widely used in peptide purification, HPLC preparation, solvent exchange, and intermediate washing.

However, because these specific media combinations were not included in conventional physical property or compatibility tables, laboratory validation was required before production implementation.

Challenge

The customer faced several technical concerns:

• Compatibility with highly aggressive organic solvents
• Stable performance during continuous pumping
• No visible swelling or degradation after prolonged immersion
• Maintaining fluid purity during pharmaceutical processing
• Reliable operation despite limited published compatibility data

Selecting an inappropriate tubing material could lead to contamination, dimensional instability, leakage, or premature failure.

CJAN Solution

Based on the customer's application requirements, CJAN supplied two tubing options for evaluation:

• PTC Tubing (without autoclave sterilization)
• PTK Tubing

Instead of relying solely on theoretical compatibility charts, the customer conducted practical validation under actual process conditions.

The testing program included:

Immersion Test

Samples were immersed in the target solvents for compatibility evaluation.

Inspection focused on:

• Surface condition
• Dimensional stability
• Appearance
• Flexibility

Pumping Test

Both tubing types were installed on the customer's pumping system.

Evaluation included:

• Continuous solvent transfer
• Mechanical integrity
• Leak prevention
• Operational stability

Test Results

Both CJAN tubing products successfully passed the customer's validation program.

Observed results included:

✓ No visible degradation after immersion

✓ Stable pumping performance

✓ No leakage during operation

✓ Maintained structural integrity

✓ Suitable for peptide purification solvent transfer

The successful validation provided confidence for implementation in pharmaceutical purification processes.

Why Practical Validation Matters

Chemical compatibility charts are valuable references, but they cannot cover every solvent mixture, concentration, operating temperature, or process condition encountered in pharmaceutical manufacturing.

For critical applications such as peptide purification, practical testing often provides the most reliable confirmation of material suitability.

This project demonstrates the importance of combining engineering knowledge with real-world process validation.

Typical Pharmaceutical Applications

Validated fluoropolymer tubing is commonly used for:

• Peptide purification
• HPLC systems
• API production
• Solvent transfer
• Chromatography equipment
• Laboratory purification systems
• Pilot production lines
• Pharmaceutical R&D

Why Choose CJAN Fluoropolymer Tubing

CJAN provides tubing solutions designed for demanding chemical applications.

Key advantages include:

• Excellent chemical resistance
• High purity fluid contact surfaces
• Wide operating temperature range
• Low extractables
• Smooth inner surface
• Suitable for pharmaceutical and laboratory processes
• Engineering support for compatibility evaluation

Conclusion

Real-world testing remains one of the most effective methods for verifying tubing performance in pharmaceutical applications involving aggressive solvents.

Following immersion and pumping evaluations, both CJAN PTC and PTK tubing demonstrated reliable compatibility with acetonitrile, trifluoroacetic acid, dichloromethane, and methyl tert-butyl ether, supporting their suitability for peptide purification processes.