AdvantaPure announces the ability to deliver its single use/disposable manifold assemblies to customers with a certificate of sterility assurance to the level of 106. The tubing assemblies, which consist of molded manifolds and accessories such as filters and connectors, are used for batch filling and sampling in the manufacture and processing of vaccines and other pharmaceuticals. Validated sterility is achieved through gamma irradiation.
Offering superior material penetration, gamma irradiation is chemical free, residual free and post-process radiation free. The irradiation process destroys microorganisms and bacteria and does not require a quarantine period like some other sterilization methods. Products are ready for shipment and use immediately after sterilization.
AdvantaPure’s single use systems are manufactured from platinum-cured silicone or AdvantaFlex biopharmaceutical grade TPE in class 7, ISO-certified clean rooms. Combining tubing with proprietary molding techniques, complex and multi-legged manifolds can be produced. Connectors, filters, bags, and other components can be attached to form a complete system. The finished products are bagged, boxed, and shipped to a gamma irradiation services company, then returned to AdvantaPure and inspected before being shipped to the customer.
Filed Under: Drug Discovery