PDI

Pre-Delivery Inspection services are provided on bioprocessing equipment at the manufacturer / vendor’s facility. These services focus on the product contact, partial FAT protocols, and VDR of the equipment. Typical equipment includes vessels, sprayballs, bio-reactors, portable tanks, agitators, skids, heat exchangers, filter housings, pumps, transfer panels, baggers, bins, and valves.

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.

STAFF

Our PDI Manager and inspectors have unprecedented experience in bioprocessing equipment fabrication, inspection, FAT, and VDR requirements. The team’s collective experience as welders, grinders, material receiving, and QC examination equates to more effective and efficient inspections.

equipment

Inspection and material testing equipment is maintained by our equipment department ensuring equipment is operating to the OEM specifications and is calibrated in accordance with our Quality System.

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 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.

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.

Riboflavin / CIP Coverage Testing

Witness spray ball performance at specified conditions.

Drain Testing

Witness drainability test.

PRESSURE Testing

Witness the hydro or pneumatic pressure test.

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.