Parker Hannifin has followed the launch of an ultra-modern clean room cell at its Czech location in Sadská Parker-Prädifa with the extension of its 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 in Pleidelsheim and Bietigheim.
The 130-square metre GMP-conformant clean room cell currently consists of several ISO 7 to ISO 9 clean rooms and has been designed to allow quick-and-easy extension of the facility as needed. A connection of manufacturing cells exclusively dedicated to custom products is also possible.
Injection moulding technology
Injection moulding technology to process a wide range of materials such as silicones (LSR and HCR), TPE and other elastomers is the centrepiece of the cell. 2-component solutions (such as silicone/plastic or TPE/plastic) in clean room class 8 are possible as well. A new micro-injection moulding machine in clean room class 7 is available for manufacturing high-precision, particle-free moulded parts and seals as well as processing high-transparency liquid silicones.
Over-moulding for single-use systems
Advanced over-moulding technology for single-use systems is available as an alternative to conventional cable ties. This technology primarily serves to combine silicone and TPE tubes with other plastic components, such as aseptic connectors, filters or transport containers, or various tubes with each other. Due to the lower risk of leakage compared to cable ties, over-moulding is particularly well-suited for assembling products intended for use in critical process areas.
Clean room assembly of plastic components
As well as conventional bonding or gluing, ultrasonic welding work is performed in a class 7 clean room. The significant advantages of this method are high reproducibility and the elimination of the need to use additives, which benefits the purity of the product. PTFE or PES diaphragms can be securely and reliable affixed to plastic components. Ultrasonic welding is mainly used in the assembly of products for clinical use in the area of infusion therapies.
Fast support for system solutions
With the new clean room manufacturing cell in Sadská, growing quality requirements can now be met through faster and better support of relevant system solutions. For quality assurance Parker-Prädifa uses inspection and testing technology that meets the exacting safety requirements of the medical and pharmaceutical industry as well as the needs for cost efficiency and economy. Various packaging options are available for products manufactured in the clean room cell, these range from simple PE bags and PETG single blisters with Tyvek covers through to moulded pallets.
The Sadská location is currently certified to ISO/TS 16949. Certification to ISO 13485:2012 is planned for the beginning of 2014.