Recently KEN HYGIENE SYSTEMS released state-of-the-art GMP utensil washers to a Danish pharmaceutical company. The utensil washers are manufactured in compliance with a very high level of GMP requirements.
The GMP utensil washers are designed for cleaning utensils in API production which makes the cleaning process extremely critical due to the impact on patient safety, and product quality. The impact on data integrity also makes the design of the GMP utensil washers critical to the API production.
KEN HYGIENE SYSTEMS’ close proximity to the customer has enabled our project team to be in close dialogue with the customer throughout the entire life cycle of the project.
Before shipment of the GMP utensil washers they were tested and approved in accordance with +200 requirements resulting in – amongst other things:
- Meeting requirements for data integrity
- Providing automatic audit trail functions
- Safe cleaning by surveillance of washing arm rotations and rotation speed
- Full traceability of FDA approved components
- Authorised inspection and qualification of weldings
- A risk-based approach in compliance with GAMP5