LIFE SCIENCES

PHARMACEUTICALS & BIOLOGICS

Our inspection and verification services eliminate materials of construction deviations, installation errors, and TOP punch lists when it counts the most…..at turnover. Meet your construction and IQ validation schedule with QAM’s third party experience, fully electronic and searchable TOP,  and proprietary PreVal System. Also see our ISO 8573 Compressed Air Testing services.

PHARMACEUTICALS & BIOLOGICS

Our inspection and verification services eliminate materials of construction deviations, installation errors, and TOP punch lists when it counts the most…..at turnover. Meet your construction and IQ validation schedule with QAM’s third party experience, fully electronic and searchable TOP,  and proprietary PreVal System. Also see our ISO 8573 Compressed Air Testing services.

Project Organization

Project Quality Plan

We take a systematic approach to each project which starts with front end validated process system planning that aligns the fabricator’s processes, QAM services, and your validation team’s expectations to the project specifications ensuring the installation and TOP/IQ documentation will meet project requirements before the first weld is made.

Project Training

The project team will develop project specific training courses which includes the GDP protocol, weld documentation, welding and installation requirements, and acceptance criteria. This course is given to all fabrication and QAM personnel that work on validated process systems.

RESOURCES

STAFF

Our management team and VT Level 2 PI inspectors are the most experienced in the industry. A PI (Pharma Industry) certification means they have been trained in the Pharma Industry specific training courses, passed Pharma Industry specific examinations, and satisfied the experience requirements. The QAM certification program is administered by the Training Manager and QAM’s ASNT NDT Level 3.

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. Equipment is functionally tested before shipment to the project. Calibration documents are provided for all calibrated inspection equipment.

MATERIALS OF CONSTRUCTION

Validated Material Inspection

The foundation of any project is the materials of construction (MOC) meeting quality standards, having traceable documentation, and meeting the engineering design. Our procedures ensure product contact materials and material documentation comply with the engineering design, material standards, and the ASME BPE. Our Electronic Documentation System provides the MOC TOP in a fully content searchable PDF format.

PVDF and PFA Systems

Material traceability and material documentation for PVDF or PFA systems are drastically different than stainless steel systems. These systems require detailed planning regarding purchase specifications, material documentation requirements, and validation requirements. QAM has the experience to plan for these challenges before construction begins.

WELDING VERIFICATION

WELDING PROCEDURE SPECIFICATION

Auto-GTAW process WPS/PQR is evaluated for conformance to ASME Section IX and/or BPE and approved by project engineering.

WELDING OPERATOR PERFORMANCE QUALIFICATION

Auto-GTAW process WOPQ is evaluated for conformance to ASME Section IX and/or BPE and approved by VT Level 2 inspectors.

WELDING BACKING / SHIELDING GAS

Each gas source used for hygienic welding is verified that the container is traceable to documentation that demonstrates conformance to the project specification for purity and specified impurities and impurity limits.

FABRICATION AND INSTALLATION SURVEILLANCE

Production welding and welding operators are verified for conformance to the approved WPS / WOPQ. Weld sample coupons are made in accordance with project requirements. Fabrication and installation is verified for overall compliance with approved SOPs and the engineering design.

WELD INSPECTION, WELD AUDIT & MOC VERIFICATION

WELD INSPECTION (SS, PVDF, PFA)

Production welds are inspected by direct visual or use of video or fiber-optic borescopes based on the project inspection plan and evaluated to the project weld acceptance criteria. Weld, welding operator, MOC, welding machine, and welding gas data is entered into the Electronic Documentation System for processing.

WELD DOCUMENTATION AUDITS

ISO drawings and weld logs are audited at the point of inspection and prior to turnover. Weld data entered into the Electronic Documentation System is auto verified by our proprietary PreVal system where materials of construction, welding operator qualification, and gas certification documentation is verified.

AUTO TOP VERIFICATION

PreVal performs hourly auto-verification cycles which pre-validate ISO drawing data to inspection and verification reports. The system notifies inspectors and document control personnel of all deviations.

WELDING STATISTICS

Weekly welding statistics are automatically generated from by PreVal  which provides data such as total weld counts per contractor and location, individual weld counts, rejection rates, defect count, charts, and more.

XRF/PMI TESTING

Alloy verification testing can be performed during incoming material inspection and / or performed after fabrication to confirm materials of construction. XRF testing is most beneficial when there are more than one grade of material being installed such as 316L, AL-6XN®, or HASTELLOY® C-22. C22 consumable inserts can also be tested on a random basis.

INSTALLATION VERIFICATION (IV)

FINAL INSPECTION

Some IV processes are performed to extend possible during construction, however final IV is performed at mechanical completion of the system to verify conformance to the ISO drawings and engineering design.

HANGERS / SUPPORTS

Hangers and supports are verified to the ISO drawing and hanger detail requirements including specification conformance for installation, welding, materials, and surface finish.

SLOPE

Slope is verified in accordance with P&ID / ISO drawings once the hangers and supports are accepted. Slope direction and degree are measured for conformance to the engineering design including dead leg evaluation and valve drain angle verification.

AS-BUILT

The overall installation is verified to the ISO drawings. Red lines are made on the ISO drawings to provide an accurate representation of the system for future P&ID verification. PreVal provides another value add for tagged item verification during this process.

FINAL WELD AUDIT

Weld audits are performed during weld inspection, however this cannot be the only weld audit. A final audit is always required before final turnover so any changes will be evaluated.

PUNCH / TASK LIST

IV deviations are recorded per ISO drawing. The deviations are tracked and re-inspected or re-verified until corrected. QAM IV Stamps are a typical method for documenting final ISO drawing acceptance.

TESTING & CLEANING VERIFICATION

PRESSURE TEST

The pressure test is verified for conformance to the engineering design and / or piping code. The pressure test package is verified for conformance to project specific requirements.

CLEANING, FLUSHING, OR BLOWDOWN

System conditioning required by the engineering design is verified for circuit, boundary, criteria and documentation requirements.

PASSIVATION

System passivation is verified for circuit, boundary, and other parameters determined by the owner.

TURNOVER PACKAGE

ORIGINAL PAPER TOP

The original paper TOP is provided in the tradition manner. The paper TOP is organized to mirror the electronic TOP, and each document is traceable to the electronic TOP.

ELECTRONIC TOP

Each TOP document is in a completely text searchable PDF format allowing tag numbers, etc. to be searched among thousands of files and found in seconds. Real time access to the TOP can be provided to the customer, transmitted to local drives, or uploaded into any file sharing platform.

OUR CUSTOMERS

FLUOR
Genentech
SKANSKA
Alcon
TURNER
Astra Zeneca
JACOBS
SANOFI PASTEUR
NOVARTIS
DPR
SANOFI GENZYME
Pfizer
Agilent Technologies
Biogen
Agilent Technologies
Takeda
LEND LEASE
MERCK
AMGEN
AMGEN
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QAM’s experience, planning, inspections, verifications, and PreVal will eliminate construction deviations before the validation process begins.