Bausch's new Type 529 Semi-Automatic IV Bag Filling and Closing Machine is different from any you've known before for aseptic packaging of infusions, parenteral drugs and other pharmaceutical and biotech fluids.
The 2nd generation Type 529 handles IV bags from 10 ml to 10 liters made of any materials, producing up to 1,600 aseptic bags per hour depending on volume.
The commercially viable alternative to traditional aseptic vials is a new concept in aseptic filling. Nothing stands between the way of the laminar air flow and the open bag, so the machine design is perfectly suited for isolator or cRABS applications.
It also has the flexibility to expand as production needs grow. As higher outputs are required, additional semi-automatic filling/closing stations can be added. Up to four filling/closing stations can be integrated within the machine footprint using the original electronics, IPC and HMI. Even with four stations, the easy-to-use semi-automatic system requires only one operator depending on IV bag volume.
This makes it ideal for hospitals, laboratories, biotech companies and manufacturers that require equipment that is user friendly, easy to clean, flexible and cost efficient.
Bausch Advanced Technology Group can equip the Type 529 IV Bag Filling and Closing Machine with a number of options to meet individual requirements. The company offers a choice in dosing technology – mass flow, peristaltic pump, servo-operated pinched valve and rotary piston pumps – all with process control technology, if required. The system can be adapted to many closure types (for hard ports or flexible tubing) or sealing technologies (High Frequency, ultrasonic, heat). For highly sensitive products, the Type 529 can be equipped with an air evacuating and pre- and/or post-gassing system. To ease sanitation, a clean-in-place (CIP) or sterilize-in-place (SIP) system can be integrated. Nothing is in the path of the laminar flow unit and the opening of the bag to allow air flow.
To maximize product safety, the Type 529 IV Bag Filling and Closing Machine features a fully integrated automatic closing system that eliminates possible contamination. All product contact parts are 316L stainless steel or FDA-approved synthetics. All contact parts can be autoclaved, which eliminates the need to irradiate parts during sanitation.
The system meets or exceeds FDA, cGMP, PIC and GAMP pharmaceutical guidelines.
Its flat colour touchscreen control panel (Siemens or Alen Bradley) provides an intuitive user interface that is easy to learn and easy to use. To operate the semi-automatic system, an operator need only insert the bag – the system automatically fills, closes and handles the closures or seal.
Changeovers are fast and simple. Volume changes are accomplished via the touchscreen control panel. Size part changes can be accomplished in only 15 minutes without tools. Type 529 machines may be combined with semi-automatic IV bag inspection machines as well as IV bag check weighing and leak test machines.
