At Plastikon Healthcare we provide custom blow molding and aseptic liquid fill contract manufacturing in a one-step process using BFS technology for a range of customers, in a variety of industries. Manufacturing is completed in our FDA registered, Class 10K or 100K cleanrooms. Plastikon operates in compliance with ISO 13485:2003, and ISO 9001:2008, and strictly follow the FDA’s Current Good Manufacturing Practices (cGMP) per 21CFR 210-211 and Quality Management System per 21CFR-820. In addition, we are environmentally sensitive with ISO 14001:2004 certification.
Our BFS system utilizes LDPE or pharmaceutical grade resin to produce custom bottles filled with sterile liquid, emulsions, or creams in volumes from 0.2-mL to 1000-mL We operate three filling suites that are capable of producing up to 10,000 units per hour. Our formulation capabilities include bottom to bottom transfer and recirculation with filtering and homogenization options. We use validated methods for formulation development and our engineering staff and PMP certified project managers can work with our customers from concept to final product. Our on-site Laboratory Services ensures quality standards are met throughout your product lifecycle with raw material, in-process, finished product, and stability testing.
For more information about our custom BFS capability, see the table below, or contact us directly.
