Valicare engineers dispose of deep expertise in the area of inspection systems
Visual inspection of medicinal products for parenteral use should detect any readily identifiable visible container defect and ensure constant quality of the product in terms of absence of particular matter and/or turbidity, and correct or uniform appearance of a lyo cake (Visual Inspection of medicinal products, ECA Good Practice Guide Version 3.0).
As a 100% daughter of Syntegon Technology GmbH, the manufacturer of inspection machines, the Valicare engineers are well experienced with inspection systems especially with fully automated ones.
We therefore offer an excellent validation and qualification support for automated inspection systems independent of the manufacturer and help you to fulfill the official requirements regarding a 100 % optical control of parenterals.
Additional to the special technical expertise Valicare GmbH has a long experience in risk-based qualification and validation of pharmaceutical equipment and processes.
Our specialists are well experienced in moderating workshops at customer site to determine the validation strategy and process optimization aiming the efficient performance qualification (PQ) and optimal inspection results in routine application.
These workshops result in the definition of the parameters for efficient validation such as the relevant product and failure types, test samples and the optimization of the inspection process based on Knapp-Kushner.