Silicone Tubing Sterilization Methods: CIP, SIP, Autoclave & Gamma

When to use each sterilization method, compatibility considerations and best practices for maintaining tubing integrity.

Introduction

The choice of curing method for silicone tubing significantly impacts its purity, performance and regulatory compliance. This article provides a detailed technical comparison to help engineers and quality teams make informed decisions.

Platinum-Cured (Addition-Cured) Silicone

Platinum-cured silicone uses a platinum catalyst in an addition-cure reaction. This process produces no harmful by-products, resulting in tubing with exceptionally low extractables and the highest purity levels. Key advantages include:

• Lowest extractable levels (critical for pharma and biotech)
• No peroxide decomposition by-products
• Superior transparency and clarity
• Compliance with FDA, USP Class VI and ISO 10993
• No taste or odor transfer

Peroxide-Cured Silicone

Peroxide-cured silicone uses organic peroxides as catalysts. While less expensive, the curing process can leave peroxide decomposition by-products (such as 2,4-dichlorobenzoic acid) that may extract into the transferred fluid. This makes peroxide-cured tubing less suitable for critical pharmaceutical and biotech applications.

Comparison Summary

Property	Platinum-Cured	Peroxide-Cured
Extractables	Very Low	Higher
By-products	None	Peroxide residues
USP Class VI	Compliant	May not comply
Cost	Higher	Lower
Transparency	Excellent	Good

Recommendation

For food, pharmaceutical, biotech and medical applications, platinum-cured silicone tubing is strongly recommended due to its superior purity and regulatory compliance. Peroxide-cured tubing may be acceptable for less critical industrial applications where extractables are not a concern.

All Rekky silicone tubing is platinum-cured. Browse our product range or request a quote.