Inspection Types
In-process, final, pre-FAT, or FAT-assist trips: single or multiple visits based on schedule, inspection requirements, and equipment complexity.
Pre-Delivery Inspection
Find it at the vendor's facility, before it ships.
PDI services are provided on bioprocessing equipment at the manufacturer's facility, focused on the product-contact portions of the FAT protocol including the VDR. Typical equipment: vessels, sprayballs, bio-reactors, portable tanks, agitators, skids, heat exchangers, filter housings, pumps, transfer panels, baggers, bins, and valves.
Project organization
Inspection Plan
Front-end planning aligns end-user inspection and verification requirements to specific PDI services, ensuring every checkpoint is covered during the trip.
Staff
Our PDI Manager and inspectors have worked in every major US bioprocessing fabrication facility. They know equipment fabrication, FAT protocols, and VDR requirements first-hand.
Equipment
Inspection and material testing equipment maintained by our full-time Equipment Manager, operating to OEM specifications, calibrated to our Quality System.
Inspection
Frame Assembly
Welds and finish inspected; dimensions, square and plumb, mounting plate, surface roughness, supports, and coating verified as applicable.
Visual Inspection
Product-contact and external surfaces inspected to purchase specifications and acceptance criteria.
Weld Inspection
Welds in the as-welded condition inspected to the acceptance criteria per the inspection plan; finished welds verified to the specified condition.
Surface Roughness / Profilometer
Measurements taken on product-contact surfaces to verify the engineering design.
XRF / PMI Testing
Alloy verification per the inspection plan percentage to confirm post-fabrication materials of construction.
Slope Verification
Verified to specification and drawings to ensure system drainability.
Jumper, Header, Proximity Switch
Configuration, fit-up, and jumper points verified to drawings and functional requirements.
Supports
Lugs, legs, base plates, pads, guides, and casters inspected and verified to drawings.
Witnessing & verification
Riboflavin / CIP Coverage
Sprayball performance witnessed at specified conditions.
Drain & Pressure Testing
Drainability tests and hydro or pneumatic pressure tests witnessed.
Identification & P&ID
Equipment identification markings verified to specification and VDR; tubing systems verified to the P&ID including component location and tagging.
Dimensions & Drawings
Overall dimensions, attachments, nozzles, arrangement, orientations, service connections, and BOM verified to the fabrication drawings.
VDR Review
Materials of construction, welding documentation, electropolish, passivation, functional testing, NDT, and pressure test documentation verified to the VDR.
Reporting
Equipment-specific inspection reports aligned to the inspection plan, with punch lists when necessary.