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

Witness the hydro or pneumatic pressure test.

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

CSI
A&B PROCESS
IPEC
Allegheny Bradford
MUELLER
Holloway America
Cotter Brothers
Steris Corporation
ASAHI KASEI BIOPROCESSING
COORSTEK
SANI-MATIC
SHARPER TEK
T&C STAINLESS
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