I am writing this email to find impact of addition of manual chamber for porous coating in Bridgend. Currently we only have Robotic chamber at Bridgend site. Due to closure of Swindon manufacturing site, manual chamber has been moved to Bridgend. As a result of this, manufacturing history records (MHRs) will be updated to change the porous coating work centre from Robotic Chamber 1160.005 to a new generic work centre 1160.017 that will incorporate both the Robotic and the manual chambers.
The porous coating materials and manufacturing process remains unaffected. Manual chamber has been re-validated and show identical results to the Robotic chamber. Process master file for porous coating will remain unaffected as the process is not changed.
Effective date of the change-TBC
Part Number affected-Products affected are Taperloc, Taperloc update, BiMetric Stems, Ringloc- X, Ringloc Multi hole, Mallory Shells, BiHapro, ABT Standard and ABT 15 Deg shells. List of part numbers is attached with this email.
Reason for change- Capacity extension in Bridgend and manual chamber moved from Swindon to Bridgend due to closure of manufacturing site in Swindon.
Can you please let me know the impact in your market and complete other columns such as approval time, documentation required in case of re-registrations or notification and if stock segregation is required until the change is approved. Kindly complete information in the following table.