In the following case the company was asked to remediate several findings following increased scrutiny of their technical file by a Notified Body auditor. Together with increased focus on critical areas of the technical file linked to the clinical safety and performance of their device, their approach to biocompatibility and validation of the cleaning their process was reviewed, with increased requirements stated to take into account recent developments within related standards.
During validation of implant cleaning one of the key points to understand, is the process to be validated, what are the critical steps and the anticipated variability within in a process. As a first step it is useful to clearly summarise the cleaning process, identifying the introduction of raw materials, equipment to be used, as well as any adjuvants that are used in the process such as cutting fluids, abrasive or polishing media, cleaning solvents or surfactants.
This clear overview of the process will help to identify the limits of the day to day variation anticipated during the process. As well as the critical steps, and critical contaminants or residuals of the process, both of which can provide feedback to, or in part be indicated from ongoing risk analysis activities. Identification of these critical points will form the basis in defining the worst case cleaning conditions, and critical intra-lot variation your implantable device can expected to be subjected to, both for consideration during operational qualification and process qualification.
Medidee is able to assist in all aspects related to cleaning process validation for all types of implantable devices, including orthopaedic and active implantable devices. Assistance can be provided from identification of critical aspects to be considered, designing of test plans and protocols as per IQ, OQ, PQ methods, coaching during execution and writing of all documentation aspects to required levels. Medidee also provides support for discussion with Notified Body, where needed to ensure all expectation are defined and met.