GxP Project Management : Cleanroom Supplier Selection In 2023
A 'well-established' cleanroom supplier proposed cleanroom fans unsuitable for a new sterile manufacturing facility, required by a Cell and Gene Therapy client.
It was Zener Engineering Services who scrutinised the proposed design and found the technically flawed specifications.
The fan manufacturer confirmed that the fans specified by the cleanroom supplier were actually only suitable for retail or office premises!
The cleanroom supplier in question was later discounted from the supplier selection process.
Such a mistake could have cost thousands to rectify, not to mention the potential impact on the product or patient, if the design error had gone unnoticed.
Zener Engineering Services Ltd act regularly on behalf of GxP manufacturers, to ensure suppliers supply to the right specifications, standards and user requirements.
Contact ZES for Supplier Management and Specification Review.
Contact ZES, For Help With Supplier Selection
