The scope of our company is the design and construction of automated welding lines for production of IV solutions bags, including technical assistance to our customers in the selection of the plastic container based on the product to be filled in the same.
We build automatic thermos welding lines suitable to make IV bags in PP “Polyolefin” materials (PVC Free) suitable for the pharmaceutical industry in the IV solution, to be filled automatically or semi automatically and suitable to be sterilized after filling at 121°C.
In addition we also design and build semi-automatic filling machines for IV solutions suitable for PP as well as PVC flexible bags.
It is also possible to supply the full production line, with bag forming, filling and sealing totally automated.
Thanks to our many years of experience in the construction of equipment in this product line, it gives us the possibility to offer reliable machines, with an “on line” support for technical assistance as well as remote software updates, without the need to send our engineers for the technical assistance.
All mechatronic components and devices are commercially available, and thus to facilitate the customers in sourcing the spare parts directly from the local market, and reduce maintenance and operating costs of our lines.
Our thermowelding lines can manufacture small volume bags, 100/250/500 ml or 500/1000 ml bags, with possibility to expand volume up to 2000/3000 ml bags.
The machine can be equipped with different types of printers, based on the customer’s needs, we can supply hot stamping printers of our production, and alternatively we can integrate the printers requested by our customers.
In compliance with GMP rules our machines are designed to be installed in Class “D” – ISO 8 – Class 100’000 clean rooms.
The machine is suitable to work with 190-250 microns PP films, double wound films are required. Bags are made 2 at the time, once the bags are formed, the same are separated without any scrap to be removed and this is reducing the waste below 2 % in production.
The machine can process most of the PP films available for IV’s production from major PP films suppliers.
The tubing’s used are supplied on reels, and are cut to length during production, depending on the bags requirements. The standard size of the tube is 6,2 x 8,2 mm, but it may vary depending on customer’s needs.
Main characteristics of the Welding line
- 1’500 bags per hour with 1 operator
- Installed power: 10KW/16A – 400 V 3P + 1N
- Absorbed power: 6 KW
- Cooling chiller for mold installed on the machine
Films from following manufacturers are validated for production with our machines:
- Renolit Nederland B.V.
- Selaed Air USA
- Polycine GMBH Germany
Polyolefin films are in conformity with Class VI EUPH and USP for primary container for IV solutions terminally sterilized at high temperatures.
- Films thickness 0,19 to 0,25 mm
- Tubing 6,2 x 8,2 mm in rolls
The machine design is “energy saver” with 80% electric and 20% pneumatic.
Type of construction:
- Frame in Stainless steel and anodized aluminum
- Contact materials AISI 3045
- Bag Internal material contact in AIS 316
- Molds in special Aluminum alloy treated
The machine is designed to meet the CE safety standards:
- EC – Machinery directive 2006/42/EC Appendix 1
- EC – EMC Directive 2004/108/EC
Machine designed and build in conformity with following standards: EN ISO 12100-1:2003, EN ISO 12100-2, DIN EN 60204-1, VDE 0113-1:2007.
Space requirements for installation
The floor space occupied by the machine is approx. m. 8,00 x 2,00 x 2,20 H.
Considering the necessary working space around the machine we suggest to allocate the following minimum space for installation: 10,00 x 4,00 x 3,00 H.
The machine design is considering some extra space on the machine for printer and additional equipment’s to be installed on the basic machine. However should it be required the machine can be extended in length anything from 50 to 100 cm to accommodate additional devices.
Transport and installation
The machine is designed to be transported in 2 separated units, this to facilitate transport and installations, once the machine is mechanically assembled electrical connection is made by quick plug to set up electrical wiring in no time.