Ekium Air Consult offers a methodology to define projects at an early stage in all aspects and impacts, adapted to the size of the project, from small renovations to full installation and maturity of the organisation.
- Scope of application :
Aseptic and/or confined areas in (radio-) pharmaceutical production according to GMP
R&D Laboratories and Biological Risk Production Areas, Radioisotopes, Fine Chemistry,...
Cellular Therapy, Immuno Therapy, Medical Diagnostics, Pet shops
Food & beverages, Flavours & Fragrances, Aerospace
Hospital Critical Areas: Production of cytotoxics and sterile products...
Climatic chambers (Ecotrons,...) and Biotechnology Incubation Chambers
Production equipment (Insulators, Weighing, Washing, Sterilization, Lyos,...)
Project Definition, Programming, Block diagrams, PFD, P&ID
Analysis of Regulatory Gaps
Flow diagram, locations
Simulation of Production & Logistics Capacities, Utility Balances
Master Plans, Feasibility Studies
APD, APS, Detailed Studies of all techniques and Equipment
Sizing, Definition & Technical and Functional Specifications, Tender Documents
Project management and EPCMV
Risk Analyses (GMP, HAZOP,...), ATEX zoning, Irradiation, nuclear contamination, ...
Budget estimates and planning
Validation and Verification Plans (ASTM 2500)
Assistance with Specifications and Management of Interfaces with Production Equipment
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