Silicone Tubing & Biocompatibility

Silicone is widely used across biopharmaceutical processes for its inert nature and hydrophobicity, making it highly biocompatible.1 And since it’s composed of silica, a substance found in sand, silicone has excellent durability, making it able to withstand extreme chemical and thermal conditions.

When choosing components for your workflow, high-purity, robust, biocompatible silicone tubing always delivers in aseptic transfer applications like upstream, downstream, and fill/finish activities.

How Is Silicone Tubing Manufactured?

Peroxide and platinum curing are the two primary methods for producing silicone tubing, and the chemical properties of cured silicone rubber vary based on the curing agent used. Let’s explore the differences.

Peroxide-Cured Silicone Tubing

Peroxide curing requires lower temperatures in production, making it easier for operations. It offers an extended shelf and usage life for silicone tubing. And while it leverages cheaper, more attainable raw materials that make peroxide curing more cost-effective, the material yellows over time due to the peroxide catalyst.

Platinum-Cured Silicone Tubing

Platinum curing offers high purity and zero yellowing over time. The lack of peroxide byproducts makes platinum-cured silicone tubing the preferred material choice in biopharmaceutical, pharmaceutical, and food and beverage industries. Further, platinum curing offers higher tensile and tear strength. The curing process requires relatively high temperatures and achieves superior quality.

Platinum-Cured Silicone vs. Peroxide-Cured Silicone

Compared to peroxide curing, platinum-cured silicone tubing offers numerous advantages and is always ILC Dover’s top choice. This type of tubing offers exceptional purity and clarity as well as minimal leaching of byproducts. Platinum catalysts modify the crosslink density of the silicone polymer, resulting in improved physical properties, including ultra-smooth surfaces that minimize the growth and presence of bacteria.

While peroxide curing has benefits—namely low production costs—quality control issues will always have more significant financial impacts. Peroxide produces toxic byproducts during curing, posing a greater risk to handlers, users, and products.

Pure water (WFI) is often used to wash components and tubing, but it’s mostly ineffective when it comes to peroxide-cured tubing. The contaminants, along with other byproducts, continue to leach from the silicone and accumulate on outer surfaces. This process is worsened by autoclaving, which uses saturated steam in sterilization.

Overall, platinum-cured silicone tubing is the right way forward in the bioprocessing industry, where product integrity is paramount.

How Does ILC Dover’s Platinum-Cured Silicone Tubing Benefit Contract Manufacturers?

Now that you’ve chosen platinum-cured silicone tubing, we want to discuss what ILC Dover presents regarding biocompatible silicone tubing and beyond. Our tubing is designed and validated for critical bioprocessing applications in which quality and sterilization are essential. We specialize in crafting robust solutions for equally robust products, meaning rugged and reliable tubing that passes validated protocols and quality control procedures for continuous containment.

  • Assured product integrity and compliance with low extractable profile
  • Passes biological reactivity tests, medical device evaluations, and more
  • Improved operational efficiency, consistent flow rates, and a longer pump life

Our platinum-cured silicone tubing is available in bulk or can be assembled on single-use fluid transfer assemblies. We also engineer single-use liquid bags to store, transfer, and sample bioprocess fluids. ILC Dover is a total solutions provider, delivering the bags, what connects the bags, and what’s in the bags for a comprehensive, customer-centric liquid handling portfolio.

  • Simplified vendor management
  • Superior customization capabilities
  • 600+ approved components and 100+ parts with dual sources
  • Ability to self-manufacture components

ILC Dover has partnered with Qosina, a global supplier of OEM single-use components to the medical and pharmaceutical industries, to ensure a constant supply of single-use bioprocess systems. We’re focused on powering business continuity without neglecting consistency, quality, or integrity. By outsourcing supply chain operations to Qosina, we can respond to aggressive customer demands and timelines.

  • Proven solutions and track record of ILC Dover and Qosina
  • Delivery consistency, fast design turnaround, and lower lead times
  • Ready to ship domestically with low minimum order quantities

Fluid integrity. Consistent flow rates. Reduced downtime. Our biocompatible silicone tubing delivers more than just strength. Contact ILC Dover to learn more about platinum-cured silicone tubing.

Sources:

  1. https://onlinelibrary.wiley.com/doi/full/10.1002/app.50969#

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