Compact. Flexible. Precise.
These are three key requirements when it comes to the construction of systems designed for the manufacture and filling of infusion bags for use in clean rooms.
Whether you are using thermo-contact or high-frequency welding, or flat or tubular film material, the manufacturing of infusion bags has to fulfil the highest quality standards.
An innovative line for the production of IV bags with integrated filling
Thanks to its newly-developed IV Express, welding-technology specialist Kiefel meets the needs of the market to perfection. The compact, stainless-steel design reduces the area required for set-up, while ensuring maximum output rates with minimal occupation of floor space. The system permits the flexible production of different sizes of IV (intravenous) bag, in 2x, 4x and 6x configuration, along with multi-chamber bags with peel-open seal. Maximum productivity can be achieved with a minimum of retooling, as the system works in short production cycles with high processing reliability.
The filling unit is integrated into the system. Highly-precise dosing technology ensures accurate filling. Oxygen or other gases can be supplied. Monitoring and testing units can be used in accordance with the corresponding application.
A printing unit (heat-embossing or laser) can of course also be added.
Yet another advantage of the IV-Express is the way that it minimises film-material waste.
System performance is backed up by clear figures: The Kiefel IV-Express with thermo-contact welding system manufactures (in 4x configuration) up to 4,800 infusion bags per hour. Occupying floor space of just 18 square metres, it manages to produce approximately 270 articles per square metre per hour.
Compact design for clean-room use
Clean-room technology is used to protect manufacturing processes and products from impurities contained in the ambient air. It is indispensable in the manufacture of pharmaceutical products.
Maximum equipment hygiene needs to be observed even when there are numerous such items of equipment in a large clean-room. This requires the use of carefully designed and classified clean areas with ideal operating conditions. The compact stainless-steel design of the IV-Express meets the requirements of GMP Class C with respect to hygienic purity and space-saving.
The machine can also be supplied complete with a clean-room cabin permanently attached to it: The compact cabin is designed on the principle of turbulent mixed ventilation in accordance with GMP Class C "at rest", corresponding to class 7 in accordance with ISO 14644-1, and class 10,000 in accordance with US. Fed. Standard 209e, and GMP Class C "in operation", corresponding to Class 8 in accordance with ISO 14644-1. In order to create optimum conditions, the integrated pure-air units are operated at an airflow rate of 0.45 m/s.
Integrated filling
Maximum hygiene and sterile conditions need to be observed during the manufacture and bottling of liquid pharmaceutical products. Further requirements include precise dosing and maximum quality for the end-products concerned. Infusion bags are not totally dimensionally stable while they are waiting to be filled, which supposes certain extra conditions where gripping and handling technology are concerned
The Kiefel IV-Express is equipped with a built-in station for the precise, automatic filling of bags. It operates to a filling accuracy of ±-1%. The filled infusion bags are sealed with robot precision. Another advantage, likewise offered by the IV-Express, is the possibility of using different sealing systems. A further key component of any quality-oriented production system for pharmaceutical products is an integrated CIP/SIP system.
KIEFEL at MD&M West, Anaheim, Feb 14 – 16, 2012 , booth number 4143
KIEFEL in the UNITED STATES:
KIEFEL TECHNOLOGIES Inc.
200 International Drive, Suite 105
Portsmouth, NH 03801 , USA
Phone: +1 (603) 929-3900
Fax: +1 (603) 926-1387
info@kiefeltech.com
www.kiefeltech.com
KIEFEL is a world leader when it comes to the design and manufacture of machines used to process plastic foil materials. The company offers core expertise in the fields of moulding and joining technology. As a supplier to reputable manufacturers in various sectors, Kiefel GmbH services customers in the automotive, medical technology, refrigeration and packaging industries.
The head office of KIEFEL GmbH is in Freilassing/Germany. The company also runs its own network of sales and service centres in the United States, France, the Netherlands, Russia, China, Brazil, Indonesia and India, and is represented by sales partners in more than 60 countries worldwide.
Kiefel GmbH is a member of the Siegsdorf-based Brückner Group, a world-leading supplier of machines and plant systems for use in the plastics processing industry. The group has some 1,400 employees. Brückner is a world market-leader in stretched-foil systems, and its range of products also includes production systems for the manufacture of extruded and smoothed flat foil materials, with an equally-large range of services to match. Group member-company PackSys Global is a manufacturer of equipment for the packaging industry, specialising in production lines for use in the manufacture of tubes, lids, screw-in adapters and containers.
