Tubing and hose applications in the pharmaceutical industry can range from simple drain lines for non-potable water, to the transfer of USP (United States Pharmacopoeia) sterile water for injection, to finished product filling. The choice of tubing or reinforced hose material depends not only on what will flow through it, but at what temperature, whether it involves pressure or vacuum, whether the application is single or repeated use, and other factors.
Platinum-cured silicone tubing is a popular choice for many pharmaceutical and biopharmaceutical uses because of its purity. It is made without animal-derived ingredients and offers far fewer extractables – substances that can leach out of a material and contaminate the flow within – than other materials. This is, naturally, of great concern because the finished product is often something that will be consumed, injected, applied, or inhaled by a living being.
Another benefit of silicone is its ability to withstand temperature fluctuations from as low as -100°F to as high as 500°F (-73°C to 260°C) without affecting the tubing's flexibility or other performance characteristics such as tensile strength and hardness. Silicone tubing offers cleanliness and adaptability for an industry that sees constant changes.
TPE (thermoplastic elastomer) is another material commonly used in the pharmaceutical market, namely for processing applications. It offers purity and can have an extractables profile that's cleaner than platinum silicone, but it cannot handle a temperature range as wide as silicone. TPE does, however, offer other benefits that are quite useful including the ability to be heat sealed, welded, and molded.
PVC, fluoropolymer, TPR (thermoplastic rubber), polyethylene, and polypropylene are other tubing materials useful to the pharmaceutical industry. Though none offer the purity of platinum-cured silicone or all of the reforming advantages of TPE, they each have their own advantages.
PVC, for example, is a relatively low cost tubing material that is chemical resistant. Fluoropolymer tubing (PTFE, FEP, PFA, PVDF) provides a non-stick surface and high temperature resistance. TPR works well in peristaltic pumps. Polyethylene and polypropylene are both manufactured from ingredients that conform to FDA standards and offer chemical resistance.
Because the pharmaceutical industry is highly regulated and its finished products are so critical, specifications for tubing are exacting and must be followed. Many of the products used in pharmaceutical processing applications must meet strict guidelines and standards such as USP Class VI, FDA CFR 177.2600, and ISO 10993. It's an industry that regularly undergoes process improvements and changes, and it's unlikely that will change in the near future.
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