Detection of impurities and inefficiencies are significant for the efficient functioning of clinical and pharmaceutical processes which are designed to meet a wide range of performance requirements.
FREMONT, CA: Sustained pharmaceutical production provides the potential for future flexibility, performance, and economic advantages over batch processing in the medicinal sector’s mechanism, development, and manufacturing. Major advancements in science and engineering have been made over the past century to promote the application of ongoing pharmaceutical processing. However, clinical ecosystem being an area of aseptic functioning needs to be regularly monitored and checked for maintaining the effectiveness of product and services. Furthermore, for efficiently carrying out the task, a varied range of microtubes are used by medical professionals in the clinical ecosystem.
Flexible tubing has achieved more appreciation in past few years as it provides small expenses and convenience, especially for single-use processes where confirmation, cleaning-in-place (CIP) or sterilization-in-place (SIP) costs and wastewater disposal can be reduced. In many activities today, silicone tubing is used to help in pharmaceutical processing, including liquid transfer, peristaltic pumping, and mixing.
As identification of contamination is crucial in the pharmaceutical industry, Freudenberg Medical, a global manufacturer of clinical equipment, components and tubing products for the bio/pharmaceutical industry, announced the availability of a complete Compendium of material testing and outcome for silicon tubing. The Compendium is available to customers upon request and covers two products: PharmaFocus Premium Silicone Tubing and PharmaFocus Premium Peristaltic Pump Tubing.
PharmaFocus Premium is an elevated quality silicone tube made from premium silicone resource developed specifically to satisfy the challenging therapeutics, bioprocessing, and peristaltic pump applications demands.
Jeff Hana, National Sales Manager Extrusion at Freudenberg Medical, said, "The Compendium tests provide companies with the results they need to confidently use PharmaFocus Premium in their processing. The testing verifies the purity of this tubing and provides the foundation for product-specific testing to build upon."
FDA-licensed external, non-biased labs conducted both trials, 21 CFR Part 58/cGLP, US Pharmacopoeia (USP), European Pharmacopoeia, ISO, and other relevant specifications evaluated systemic toxicity, sensitization, cytotoxicity, genotoxicity, implantation, endotoxins, particle assessment, and description of chemical substances. Moreover, concerning the silicone fibers, select testing was carried out on the completed products.