Factors to Consider in BioPharma & Pharmaceutical Applications
Regarding critical applications in the Pharmaceutical and Biopharma industries, the Tubing you choose plays a vital role. The right tubing needs to meet stringent requirements for sterilisation, performance, and safety, especially regarding extractables and leachables. But how do you decide whether Silicone or Thermoplastic Elastomer (TPE) Tubing suits your specific needs? Let’s explore their similarities and differences to help guide your decision.
Tubing Manufacturing Method:
Silicone Tubing is made from a Thermoset material. During the manufacturing process, the raw silicone compound is extruded into the tubing and then heated. This heat triggers a chemical reaction that permanently sets the tubing’s shape.
On the other hand, TPE is a Thermoplastic material, which means it behaves differently when exposed to heat. Unlike silicone, TPE Tubing can change shape if reheated, making it heat-sealable and weldable – features that offer significant advantages in some applications.
Temperature Resistance:
Temperature tolerance is another important consideration.
- SILICONE: AdvantaPure’s Unreinforced Silicone Tubing (APST) is designed to perform in extreme conditions, withstanding temperatures ranging from -100ºF to 400ºF (-73ºC to 204ºC).
- TPE: AdvantaFlex TPE Tubing can operate effectively between -88ºF and 275ºF (-66ºC to 135ºC), which, although slightly less versatile than silicone, is still adequate for many Biopharma and Pharmaceutical processes.
Hardness:
The hardness of the tubing affects flexibility and durability.
- SILICONE: Shore A hardness of 50, offering a softer, more flexible material.
- TPE: Shore A hardness of 65, providing a slightly stiffer feel while still maintaining flexibility.
Validations & Extractables:
When working in highly regulated industries like Pharma and Biopharma, material purity is essential. Both Silicone and TPE have undergone rigorous testing for validation, but there are subtle differences:
- SILICONE: Platinum-cured silicone Tubing is purer than peroxide-cured silicone, offering fewer extractables – substances that could leach out of the material into the product. AdvantaPure’s APST Silicone Tubing meets strict standards including USP, ISO, CFR, EP, 3-A, and NSF.
- TPE: Similarly, AdvantaFlex Biopharmaceutical-grade TPE Tubing has been validated against standards such as USP, ISO, CFR, and EP, though it may have slightly different extractable profiles compared to silicone.
Connection Methods:
Both materials allow for sterile connections, but TPE offers an extra benefit:
- SILICONE: Requires sterile connectors to attach to other tubing and equipment.
- TPE: While it also uses sterile connectors, TPE has the added advantage of being sterile weldable, eliminating the need for connectors in certain setups and reducing costs.
Unique Features of TPE Tubing
TPE brings several distinct features to the table:
- Sterile weldable, allowing for quick and cost-effective connections.
- Heat sealable, offering flexibility in sealing processes.
- Pre-sealed tubing ends are readily available in stock.
- No silicone oils, reducing contamination risks.
- Lower permeability compared to silicone, making it a better option when minimising gas transmission is essential.
Unique Features of Silicone Tubing
Silicone also has its own set of strengths:
- Extremely flexible, allowing for easier handling and routing in complex systems.
- Can endure temperatures ranging from -100ºF to 400ºF, making it suitable for a wider range of applications.
- NSF-51 is listed, providing an additional layer of compliance assurance.
- Available in 36 different sizes, offering more versatility.
Common Features of Both Materials
- Both silicone and TPE Tubing share several important features:
Mouldable into leak-proof tubing manifold connections and BioClosure® container closure assemblies. - Available with validated sterility assurance, comprehensive validation packages, and extractable test portfolios.
- Made without any animal-derived ingredients, ensuring biocompatibility and compliance with industry regulations.
By weighing these factors – manufacturing methods, temperature resistance, hardness, validations, connection methods, and unique features – you can better determine whether silicone or TPE tubing is the right choice for your Biopharma or Pharmaceutical application. Both materials offer key advantages, and understanding their distinctions will help you make the best decision for your specific needs.
