Standards / Validation

IAI BioPharma’s applies a quality management framework that ensures a level of control in conformity with clients’ requirements.

We are capable of issuing conformity certification on the majority of FAT and SAT test criteria, such as:

  • Ra surface finish
  • Spray ball coverage
  • Boroscope inspection videoscopy
  • Dye penetrant test
  • IQ and OQ
  • Traceability (equipment, mill tests, etc.)

IAI BioPharma holds U, UM as well as National Board certifications. Equipment fabricated can be delivered with Canadian Registration Number (CRN). Our welding procedures as well as our welders have been approved by the Quebec regulating Agency in accordance with Section IX of ASME code.

Pharmaceutical and biotech domains are two industrial sectors subjected to very high quality standards. IAI BioPharma produces in conformity with ASME – Section VIII; Division 1 standards. We have adapted our corporate quality control procedures to comply with all of ASME BPE-2002 code requirements.

IAI BioPharma has qualifications to fabricate in conformity with the following standards:

  • CSA
  • cGMP
  • Agriculture Canada and USDA
  • Health Canada and FDA

CSA ASME U GMP