Steel & O’Brien knows that the pharmaceutical industry is among the most demanding markets. Errors are unacceptable when making life-saving drugs and other medicines for human consumption. That’s why standard sanitary fittings are not up to the task — only ASME BPE compliant fittings and parts will do.
Sanitary fittings used in the pharmaceutical industry serve as crucial connections between equipment to transfer ingredients and other materials. These must meet a number of standards with regard to their tolerances and cleanliness to ensure the safe and effective production of drugs and medications. These standards are even more stringent than those for the food and beverage sector, and as such pharmaceutical fittings and tubing exist in their own unique category.
Steel & O’Brien BPE fittings are used in the pharmaceutical end market for the ultra-pure processing of vaccines, medicines, supplements and more. Our broad line of pharma fittings, pharma valves and tubing meets the high-purity demands of bioprocessing equipment (BPE) specifications regarding dimension, surface finishing, materials and tolerances. In addition, our ASME BPE compliant fittings meet strict material marking and documentation, capping and bagging requirements.
Steel & O’Brien high-quality, easy-to-clean, 316L stainless steel BPE components and parts are available in numerous styles, sizes and surface finishes. Our fittings are available with a variety of elbows, tees, crosses, reducers, ferrules and clamps. We also offer ASTM-A270 BPE tubing made from 316L material. While our inventory is enormous, we understand that you may need something a little different. Steel & O’Brien can custom fabricate and finish fittings with unique requirements. Your products will be manufactured and shipped quickly, ensuring that your project is completed on time.
Although they might appear to be the same at first glance, there are a number of differences between pharmaceutical valves and the standard types of sanitary fittings. First and foremost, they must comply with a unique set of BPE fittings specifications as detailed by the ASME. These require fittings to be held to much tighter tolerances, cleaner interior finishes and stricter material requirements. They must be permanently marked with information including material type, country of origin, surface finish and more on the outside of each fitting.
Valves for the pharmaceutical industries also undergo a more stringent process for quality assurance. They must be inspected with a niton gun to verify its chemical composition. This is because having the proper materials is a crucial element of ensuring the quality and safety of the finished products.
Even seemingly smooth steel has numerous microscopic imperfections that can lead to contamination when used in pharmaceutical production. This is why fittings used in the industry must adhere to strict standards for the finish of their interiors. This is expressed in terms of the roughness average (Ra), typically measured in microinches. Generally, pharmaceutical fittings feature finishes of either 20Ra or 15Ra. The latter is achieved through the use of electropolishing, which uses an electrochemical process to remove metal from the interor to even out the surface as much as possible.
Companies that produce fittings that meet or exceed ASME-BPE standards are awarded a PE Certification by ASME. This is after the company is audited by ASME and its quality system and products are found to be in compliance. ASME has a dedicated committee specifically for governing BPE standards.
Given the fact that human lives are at stake, pharmaceutical companies must ensure that the fittings they use in their operations meet or exceed all relevant standards. As a leading manufacturer serving this demanding sector, Steel & O’Brien has the knowledge and capabilities to make sanitary simple for our customers while adhering to the highest standards of quality. To learn more about what we can do for you, get in touch with us today.
