PBE Expert Inc, is a leading consulting company providing innovative and practical solutions to your building systems, clean utilities, sterilisation & sanitisation equipment, RABS, laminar air flow cabinets and layouts design, meeting USP797, CLSI regulations, standards and codes.
We are committed to providing skilled resources by delivering projects on time, on budget and compliant to regulatory requirements.
PBE Expert Inc serves since several years healthcare & hospitals, surgery cleanrooms, research centers, laboratories for analysis, with dedicated consulting services meeting USP797 standards and cGMP regulations.
PBE Expert Inc was involved in the engineering of the clean utilities (clean steam, CLSI-3 purified water), Layouts design for BSL2 & BSL3 containment Labs, validation, calibration, maintenance, quality assurance & PM.
The design of bioprocesses, clean utilities and systems implies at the outset the conformity to ASME-BPE, USP797 and ISPE standards. The design of Layouts involving OEL2-6 or BSL3 containment involves the control of clean environments (ISO-14644-4 and ISPE), prevention technologies against cross-contamination, as well as chemical & biological compounds risks & Mix-Up mitigation and cGMP compliance.
BPF | FDA | ANSM | Santé Canada | GCC | ISO14644 | ASME-BPE | ISPE | ICH Q9 | AMDEC | ATEX | HSE | USP 797 |