PRE-DELIVERY INSPECTION
OVERVIEW
Pre-Delivery Inspection services are provided on bioprocessing equipment at the manufacturer / vendor’s facility. These services focus on the product contact portions of the FAT protocol including the VDR.
Typical equipment inspected includes vessels, sprayballs, bio-reactors, portable tanks, agitators, skids, heat exchangers, filter housings, pumps, transfer panels, baggers, bins, and valves.
OVERVIEW
Pre-Delivery Inspection services are provided on bioprocessing equipment at the manufacturer / vendor’s facility. These services focus on the product contact portions of the FAT protocol including the VDR. Typical equipment inspected includes vessels, sprayballs, bio-reactors, portable tanks, agitators, skids, heat exchangers, filter housings, pumps, transfer panels, baggers, bins, and valves.
Project Organization
Inspection Types
PDI services will vary based on the type of inspection trip which includes in-process, final, pre-FAT, or FAT assist. Single or multiple inspection trips can be made based on schedule, inspection requirements, and complexity of the equipment.
Inspection Plan
We take a systematic approach to each inspection which starts with front end inspection planning that aligns the end user inspection and verification requirements to specific PDI services to ensure conformance to purchase specifications and drawings. This enures all checkpoints are covered during the inspection trip.
RESOURCES
STAFF
Our PDI Manager and inspectors have unprecedented experience in bioprocessing equipment fabrication, inspection, FAT, and VDR requirements. The inspection team has performed inspections in all of the top bio-processing equipment fabrication facilities in the US .
equipment
Inspection and material testing equipment is maintained by our full time Equipment Manager ensuring equipment is operating to the OEM specifications and is calibrated in accordance with our Quality System.
INSPECTION
frame assembly
Inspect welds / finish and verify dimensions, square and plumb, mounting plate, surface roughness, supports, and coating as applicable.
Visual Inspection
Product contact surfaces and external surfaces are inspected for conformance to purchase specifications and the acceptance criteria.
Weld Inspection
Welds in the as welded condition are inspected to the weld acceptance criteria in accordance with the inspection plan and that finished welds meet the specified condition.
Surface Roughness / Profilometer Testing
Surface roughness measurements are taken on product contact surfaces to verify requirements of the engineering design.
XRF/PMI Testing
Alloy verification is performed in accordance with the inspection plan percentage to confirm post fabrication materials of construction.
Slope Verification
Slope is verified to the specification and drawings to ensure system drainability.
Jumper, Header, Proximity Switch
Inspect and verify configuration, fit-up, and jumper points to drawings and functional requirements.
Supports
Inspection and verification of lugs, legs, base plate, pads, guides, or casters to drawings.
WITNESSING
Riboflavin / CIP Coverage Testing
Witness spray ball performance at specified conditions.
Drain Testing
Witness drainability test.
PRESSURE Testing
VERIFICATION
identification
Verify equipment identification markings to the specification and VDR.
P & ID
Verify tubing systems are in alignment with the P&ID including component location and tagging.
Dimension and Drawing
Verify overall dimensions, internal / external attachments, nozzles, overall arrangement, orientations, service connections, and BOM to the drawings. Dimensions are verified to the fabrication drawings.
VDR
Verify materials of construction, welding documentation, electropolish, passivation, functional testing, NDT, and pressure test documentation to the VDR.
REPORTING
Equipment specific inspection reports are completed and when necessary punch lists for the equipment inspected. Inspection reports are designed to align with the inspection plan.
FABRICATION COMPANIES WORKED WITH
