Hello all,
New to the site, so I appologize if this is not the correct forum for posting this question…
Here is my issue;
I have a contract manufacturer responsable for sealing a subcomponent of my final kit. The subcomponent, post sealing, is then terminally sterilized via EtO. Recently the sealing equipment experianced a PLC fault, and through the investigation of the sealing equipment manufacturer it was identified that the PLC for the equipment was required to be replaced. However, the PLC in the equipment is no longer manufactured and was replaced with a current model (which the sealing euipment manufacturer deemed like-for-like). My contract manufacturer replaced the PLC, loaded the exact version of software that was originally on the PLC which faulted, closed out the work order, and manufatured my trays (which is a PETG tray with a Tyvek lid). The isssue that I have is that all work perfomred was completed by the Engineerig department, no QA or Validation department assessment or signatures prior to placing the equipment back into the production suite. In addittion, no calibration was performed post PLC replacement, no validation (IOQ) took place. Now I have trays that have been packaged with equipment to me is considred unqualified. I should also mention that we have a peel strength spec on the trays that has also not been tested and destructive testing on this product is an option, but very costly based on the monetary loss of material.
What is your take on the above? How do I justify to my QA department that post sterilization the trays are acceptable to release to market?
I lok forward to your replies…