Haefner starts clean room production of germ-free spools for medical technology
Specialist plastic spools manufacturer Haefner, of Leopoldshoehe in Germany, has set up a medical clean room in just nine months. The production module is certified to cleanroom Class 8 (ISO 14644) and is free of particles/germs in accordance with cGMP Class D.
An injection moulding machine with a locking force of 3,500 kN forms the core of the new production module. The first products to be manufactured are spools weighing approximately 500g made from impact-resistant ABS.
The cleanroom was designed to eliminate any human contact with the product. This results in any possible contamination being reduced to a minimum. The spool bodies are injection moulded in fully automatic fashion in the cleanroom. A five-axis robot withdraws the parts from the mould and stacks and packs them in a double-film packaging material as specified by the customer. Within the cleanroom an operator is responsible for the supply of new packaging tubes and the removal of the finished packaged units.
The spools arrive free of micro-organisms and particles at the premises of the customer, B. Braun Melsungen, where they are used without additional finishing costs and also under cleanroom conditions for winding capillaries and flexible tubes with diameters of 0.7 to 5.0mm for applications including permanent venous catheters.
A particular feature of Haefner’s cleanroom solution is the complete accessibility of all key process control systems from the “grey zone”. This applies to the injection moulding machine, the control of materials supply and the temperature control systems for the machine and mould. This saves the cost of the machine setter having to don special clothing and enter the cleanroom in the event of a fault or to change parameters.
Dittel Clean Room Technology, based in Ried/Kochel in Germany, was responsible for the design, planning and certification of Haefner’s cleanroom, as well as for assistance in bringing the system into operation.
According to Jan Haefner, the company’s activities in this field are to be stepped up. “Our move into cleanroom technology opens up for us as spool manufacturers completely new target groups and applications,” he said.