Quality Assurance Management (QAM)

Quality Assurance Management (QAM) provides quality assurance and control (QAQC) services to pharmaceutical and biotechnology manufacturing facilities.

Inspection and analytical services for bioprocess systems

QAM specialises in cost-effective examination, testing and commissioning services for bio-pharmaceutical facility systems worldwide.

The company maintains one of the largest inventories of analytical equipment in the world.

Inspection and analytical services for hygienic bioprocess systems are available, including testing and commissioning of gas, chemical, compressed air and water systems.

QAM supplies an orbital weld inspection service on 316l stainless steel hygienic piping for water for injection, clean in place and process water systems.

The company’s compressed air system testing services detect trace moisture and oil content such as liquid, vapour and aerosols, as well as particle content and microbial contamination.

QAM’s services include dimensional tolerance checks, positive material identification, surface roughness, chemical composition and weld ferrite analysis of materials.

ASME fabricated heat exchangers are tested in accordance with ASTM E499.

The company performs supplier quality audits for critical components and equipment to help ensure an effective validation process on-site.

QAM supplies third-party QAQC professionals and project supervisors to pharmaceutical companies.

Internal visual weld inspection borescope of hygienic piping systems

QAM conducts internal visual inspections of stainless steel piping systems using video detection tools and image management software.

Company personnel are qualified to perform American Welding Society (AWS) and ASME BPE weld inspections.

The company can support ASME bioprocess code installations with onsite weld assessment, quality surveillance, welder certification and procedure qualification services.

Particles, water, microbial and oil content analysis for compressed air

QAM provides ISO: 8573 based analysis of clean, dry and oil-free compressed air used in biotechnology and pharmaceutical manufacturing.

The company offers the latest analytical technologies for moisture analysis, particle counting, oil mist and total hydrocarbon analysis.

Microbial impact sampling for biological contamination monitoring is available, and is part of QAM’s qualification and commissioning services for compressed air and other process gases.

Ferrite content, positive material identification and surface finish analysis

QAM supports factory acceptance testing (FAT) and pre-fabrication for biotechnology and pharmaceutical projects by analysing materials and facility subsystems.

QAM conducts contact profilometry for surface finish analysis of sterile product contact surfaces used in the vessels, tanks, skids, and other facility equipment.

The company works to ensure that construction materials meets the required specification by positive material identification (PMI) and analysis of ferrite content in 304l, 316l and 316l welded subassemblies.

Leak testing services for critical process systems, vessels, tanks and heat exchangers

QAM deploys advanced equipment and procedures to test, certify and commission newly installed equipment and guarantee it is leak-free. Field tested experts can help identify, locate, quantify and repairs leaks in operating facility systems.

Its personnel are qualified according to American Society for Non-Destructive Testing (ASNT) standards.

Helium leak detection services provide the fastest, safest and most sensitive leak detection technology. The company uses ASTM and ASME standard practices with advanced helium mass spectrometer leak detectors.

Source inspection services

QAM’s domestic and international offices provide support for construction projects requiring FAT and IQ-related pre-delivery inspection of facility or process equipment such as tanks, vessels, skid and process equipment.

On-premises pre-delivery inspection services include materials analysis, supplier quality audit, surface finish analysis, weld inspection, drawing, installation and documentation verification, as well as pre-shipment functional tests.

Third party independent QA/QC

QAM is a trusted partner of facility owners and vendors serving biotechnology and pharmaceutical construction projects.

System experts supervise process piping and facility equipment installations and ensure project specifications are met and critical facility systems are validated.