Following the launch of an ultra-modern clean room cell at its Czech location in Sadská, Parker-Prädifa now has extended capabilities specifically designed to meet the exacting demands of the medical and pharmaceutical industries. The central focus of the operation is on manufacturing custom solutions made up of elastomer and plastic components developed at the German locations Pleidelsheim and Bietigheim.
The GMP-conformant clean room cell consists of several ISO 7 to ISO 9 class clean rooms and has been designed to allow for a quick and easy extension of the facility as needed. A connection of manufacturing cells exclusively dedicated to custom products (such as high-volume 2-component solutions or component assemblies) is possible as well.
Latest-generation injection moulding technology
Injection moulding technology using latest-generation machines for various materials such as silicones (LSR and HCR), TPE and other elastomers is a key element of the cell. Even 2-component solutions (e.g. silicone/plastic or TPE/plastic) are possible in clean room class 8.
For particle-free moulded parts and seals, a new automatic micro-injection moulding machine in cleanroom class 7 is available. Even high-transparency liquid silicones can be processed here.
Over-moulding for single-use systems
For the pharmaceutical production the over-moulding technology is of particular interest. It is used specifically for so-called single-use systems, primarily to combine silicone and TPE tubes with other plastic components or various tubes with each other. These components, for example, include aseptic connectors, filters and transport containers. Among other things, these systems are subsequently used to extract samples in vaccine production. Cable ties are still frequently used for these component assemblies but this generally harbours a higher risk of leakage. This risk can be significantly reduced by means of over-moulding technology.
Purity in assembling plastic components
Another focal point of the cell’s activities is the assembly of plastic components. As well as conventional bonding or gluing, ultrasonic welding work is performed in clean room class 7. Apart from the high reproducibility the fact that no additives are required is a major advantage of this process which thus benefits the purity of the product. PTFE or PES diaphragms can be securely and reliably affixed to plastic components.
Packaging options as needed
Various options are available for the selection and design of packaging the products manufactured in the clean room, from the simple PE bag and PETG single blisters with Tyvek covers through to moulded pallets.
Article contributed by Berthold Röhrich, Market Manager Life Science, Engineered Materials Group Europe
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