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Commissioning & Validation

Overview

Biopharmax group has many year of experience with installation, commissioning and qualification procedures for pharmaceutical facilities, as it is an essential part of GMP. Biopharmax group provides services of protocol preparation as well as tests execution of site. The pharmaceutical and therapeutic industry is committed by the regulation authorities to produce its products using validated […]

Related Projects

Manufacturing Facilities

Manufacturing Facilities

OSD manufacturing plant – Stouffville and Hood Road sites
Purified water system Pretreatment, production, storage and distribution PC/PLC consolidated control system for all systems and subsystems Full commissioning and validation FDA compliant

Clean Rooms

Clean Rooms

Human plasma manufacturing plant – Factor VIII, IVIG, Albumin – FDA Compliant
100,000 liter per year IVIG production department Albumin factor VIII production facility Biological glue production facility Filling and packaging Clean utilities, clean rooms, HVAC, laboratories…

Laboratories

Laboratories

Biotechnology production plant – Insulin crystals and other recombinant products
7,500 SQM building Process equipment, fermenters Upstream, Downstream and final purification Clean utilities and general utilities Warehouses, laboratories, offices Software per CFR21part11 Complete commissioning and…