Sterile IV-Bags Filling and Closing Machine

The IVY SERIES is a state-of-the-art IV-bags filling and closing monoblock machine, engineered for aseptic production of intravenous (IV) solutions. Featuring a rotary transport configuration, the IVY machine is designed for efficient, handling of plastic IV-bags whethere they are single-chamber, dual-chamber, provided in-bulk, or in-tray formats. With a production capacity of up to 850 bags per hour (uph), the IVY SERIES is the ideal filling and sealing solution for sterile pharmaceutical production plants.

This combined liquid sterile production unit integrates a rotary filling system with a Class A containment solution (oRABS or Modular Isolator). The entire process operates under a laminar flow to ensure maximum product purity, meeting the stringent demands of cGMP guidelines, Annex 1, and 21 CFR Part 11.

Key Features & Advantages:

• Sterile Filling Versatility: Handles single- or dual-chamber IV-bags and supports bags in bulk or pre-configured trays.
• Powder Dosing Capability: Configurable with an auger screw powder dosing system (0.5 to 5g range) for applications requiring the separation of liquid diluent and active pharmaceutical ingredients.
• Integrated Aseptic Containment: Comes with a Class A Isolator/oRABS system, crucial for maintaining product quality and safety on an automated line.
• High Precision: Features a compact layout with 100% check-weigh for guaranteed dosage accuracy.
• Accelerated Compliance: One FAT, SAT, and validation process to significantly speed up market entry.
• Compact Footprint: Engineered for easy installation and optimal use of cleanroom space.

IVY SERIES Features

Technical Details: Isolated version

The meticulously designed isolator chamber adheres to the strictest cGMP standards and pharmaceutical protocols for aseptic material handling. It is a critical component ensuring the highest level of quality and safety for your sterile products.

The Comecer Isolator Package includes:

• Advanced Enclosure: AISI-316L stainless steel chambers with a Mirror Bright internal surface finish.
• Enclosure airtightness Class 3 ISO 10648-2.
• Ventilation and Air Filtration: Features an advanced ventilation system, UDAF H14 filters, and pressure transmitters to maintain Class ISO 5 air particle content during operational conditions.
• Decontamination: State-of-the-art VPHP (Vaporized Hydrogen Peroxide) generator and a specialized distribution system for an efficient decontamination.