Highest product and process reliability for sterile applications in pharmaceuticals and cosmetics. IWK offers GMP-compliant systems that perfectly combine precision, efficiency and hygiene.
Request solutionSterility is not an option, but a prerequisite.
With the machines of the FP-Sterile platform, IWK offers aseptic filling solutions that take product quality and process reliability to a new level. Our systems meet all relevant EHEDG and cGMP guidelines internationally, optimized for the requirements of regulated industries. This means that all paste-like products can be filled into metal, plastic or laminate tubes under sterile conditions.
IWK’s aseptic filling solutions combine state-of-the-art dosing technologies with intelligent hygienic design.
In the event of product or batch changes, all parts in contact with the product can be cleaned and sterilized via the integrated CIP/SIP system without removal or reinstallation in order to reliably exclude contamination. All parts in contact with the product are e-polished and have a surface finish of ≤ 0.8 μm as standard. Optionally available laminar flow systems, sterile air modules and isolators create the prerequisites for reproducible product quality – with high output at the same time.
IWK systems have a modular design and can be integrated into existing packaging lines.
All systems are designed for easy validation in accordance with GAMP 5, IQ/OQ and Annex 15. This speeds up commissioning and meets compliance requirements in the long term.
Sustainability starts with construction:
Durable stainless steel components, energy-efficient servo drives and maintenance-optimized assemblies reduce the use of resources and extend the service life of the machine.
Typical applications include sterile creams, ointments, gels, liquids, and pharmaceutical formulations.
All machines are CIP/SIP capable and optionally equipped with automatic cleaning and sterilization.
IWK supports according to GAMP 5, EU Annex 15, ISO 9001 and FDA 21 CFR Part 1.
