Pharmaceutical engineering is coming under increasing scrutiny worldwide. The U.S. places strict regulations on the fabrication process, which require constant production sampling from the line to assure quality control. One of the newer players in the biomedical fabrication industry is single use technology. Single use manifolds utilize the ease of TPE resin technology to easily sample an entire line with minimal interference or need for additional sterilization.
Biomedical pharmaceutical manufacturing equipment is not in itself regulated, but the industry recognizes the inherent regulation implied by end product particulate regulations. The only existing US regulation on manufacturing equipment reads as follows: “Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.” (US 21 CFR Part 211.65(1))
Single Use tubing and barb clamps are already quickly becoming the industry standard for batch filling. The flexibility and high-temperature melt rate of TPE (thermoplastic elastomer resin) have allowed it to race to the forefront for single use technology. Barb clamps have overtaken standard tie clamps due to their unique ability to provide full 360° compression at the joint.
Joining the TPE and single use fabrication model is the single use manifold. Manifolds are a necessity on the modern pharmaceutical production
line and the single use model is preferable for a number of reasons. They eliminate the need for sterilization equipment and remove the human component from the production line sterilization and validation equations.
Further, they bring down production costs by reducing human interaction with the manifold equipment, both with regard to installation and product streams. Adding TPE sealant and welding systems into the production line allows the manufacturer to customize the processes on the line to feed a manifold system as well.
Have any questions? Call our office at 240-457-4413 and talk with a knowledgeable representative at Accuflow Systems today! We will work with you to find a solution that is both efficient and cost effective.