When it comes to biopharmaceutical manufacturing, fill-finish can be a challenging process with any errors potentially leading to safety issues, production failures and loss of product. At SP, we understand that sterility, accuracy, speed and compliancy are key. That’s why we offer high-quality, dependable fill-finish solutions that are easily integrated and meet the expectations of cGMP, Annex 1, and regulatory agencies such as the FDA.
Our fill-finish systems offer complete versatility, including filling liquid or powder in bulk or ready-to-use (RTU) vials and covering multiple container closure types for different product dosage forms. Our customers benefit from superior accuracy and repeatability throughout the entire batch, either with statistical sampling or 100%, non-destructive In-Process Weight Control (IPC), with minimal reduction in processing speeds.
The SP i-Dositecno BI or MI Micro-Line™ have got you covered.
SP i-Dositecno BI Micro-Line™ - Rotary filling, stoppering and capping equipment with a simple mechanical driven design that can fill up to 50 upm.
SP i-Dositecno MI Micro-Line™ - Rotary fill-finish with intelligent servo-driven motion-controlled design for the smoothest operation. Capable of processing at speeds up to 200 upm.
All SP i-Dositecno BI or MI Micro-Line™ systems are designed to meet your needs.
• Built to cGMP and compliant to GAMP5
• Easily process multiple vial formats thanks to high-quality Polyoxymethylene Copolymer (POMc) change parts for quick changeover
• Aseptic liquid dosing system by peristaltic pump or ceramic / SS rotary piston, micro-dose and solid powder filling by micro-auger for exceptional accuracy and precision