Clean utilities & Pharmaceutical systems

Processes, clean utilities and pharmaceutical systems functional analysis.
Purity, sterility and the risk level audit assessment (ASTM2500, FMEA).
Sterilization technologies: by steam, depyrogenation, SIP, and aseptic filtration.
Equipment, utilities, systems, production rooms, infrastructure list & Cross-Matrix.
Biological Containment (BSL 1-3) and Biotechnology, effluents thermal kill decontamination system, autoclave.
Oncological and cytotoxic, High Potent chemical containment (OEL HP2-6), BIBO.
Single Use Technology requirements and Process and CIP alternative.
Equipment supplier’s selection and implementation.
Risk management, impact, gap analysis and mitigation: RAPA, GAPA, ICH Q9, FMEA, ATEX.
Warehouse, “Push-Back racking”, vaults, cold rooms and quality control Labs design.
Hazardous chemical & biological waste gas, liquid and solid treatment technologies.
Support in approval certification “CA” related to environment protection (MDDELCC).
Energy and water consumption efficiency optimization. Integration of Renewable Energies “trigeneration”.

Processes, clean utilities and pharmaceutical systems functional analysis and design (ASTM2500).
Equipment, utilities, systems, production rooms, infrastructure cross matrices.
Warehouse Layout, THC vault, cold rooms, and quality control laboratories CQM, specifications.
Flow functional analysis, Mix-ups & Cross-Contamination Risks mitigation.
Functional program Technical (PFT).
Specifications of the Protective Equipment PPE, explosion proof, and containment equipment.
Cleanrooms integrity, equipment & THC/CBD products quality and purity compliance.
Risk management, impact & gap analysis and mitigation: RAPA, GAPA, ICH Q9, FMEA, ATEX.
Warehouse, “Push-Back racking”, THC vaults, cold rooms and quality control Labs design.
Equipment supplier’s selection and implementation.
Hazardous chemical & biological waste gas, liquid and solid treatment technologies.
Support in approval certification “CA“ related to environment protection (MDDELCC).
Energy and water consumption efficiency optimization. Integration of Renewable Energies “Trigeneration”.

Processes, clean utilities and pharmaceutical systems functional analysis.
Purity, sterility and the risk level audit assessment (ASTM2500, FMEA).
Sterilization technologies: by steam, depyrogenation, SIP, and aseptic filtration.
Equipment, utilities, systems, production rooms, infrastructure list & Cross-Matrix.
Biological Containment (BSL 1-3) and Biotechnology, effluents thermal kill decontamination system, autoclave.
Single Use Technology requirements, Process and CIP alternative.
Equipment supplier’s selection and implementation.
Risk management, impact & gap analysis and mitigation: RAPA, GAPA, ICH Q9, FMEA, ATEX.
Warehouse, “Push-Back racking”, vaults, cold rooms and quality control Labs design.
Hazardous biological waste gas, liquid and solid treatment & Inactivation technologies.
Support in approval certification “CA“ related to environment protection (MDDELCC).
Energy and water consumption efficiency optimization. Integration of Renewable Energies “trigeneration”.

Processes, clean utilities and pharmaceutical systems functional analysis.
Purity, sterility and the risk level audit assessment (ASTM2500, FMEA).
Sterilization technologies: by steam, depyrogenation, SIP, and aseptic filtration.
Equipment, utilities, systems, production rooms, infrastructure list & Cross-Matrix.
Single Use Technology requirements and Process and CIP alternative.
Equipment supplier’s selection and implementation.
Risk management, impact & gap analysis and mitigation: RAPA, GAPA, ICH Q9, FMEA, ATEX.
Warehouse, “Push-Back racking”, vaults, cold rooms and quality control Labs design.
OEL Hazardous chemical waste gas, liquid and solid treatment technologies.
Support in approval certification “CA“ related to environment protection (MDDELCC).
Energy and water consumption efficiency optimization. Integration of Renewable Energies “trigeneration”.

Processes, clean utilities and pharmaceutical systems functional analysis.
Purity, sterility and the risk level audit assessment (ASTM2500, FMEA).
Cleanrooms & Critical equipment Sanitisation & appropriate Sterilization technologies (SIP, Autoclave).
Equipment, utilities, systems, production rooms, infrastructure list & Cross-Matrix.
Biological Containment (BSL 1-3) and Biotechnology, effluents thermal kill decontamination system, autoclave.
Oncological and cytotoxic, High Potent chemical containment (OEL HP2-6), BIBO.
Single Use Technology requirements and Process and CIP alternative.
Equipment supplier’s selection and implementation.
Risk management, impact & gap analysis and mitigation: RAPA, GAPA, ICH Q9, FMEA, ATEX.
Warehouse, “Push-Back racking”, vaults, cold rooms and quality control Labs design.
Hazardous chemical & biological waste gas, liquid and solid treatment technologies.
Support in approval certification “CA“ related to environment protection (MDDELCC).
Energy and water consumption efficiency optimization. Integration of Renewable Energies “trigeneration”.

Sanitary design of processes, clean utilities and sanitary systems functional analysis.
Purity, sterility and the risk level audit assessment (ASTM2500, FMEA).
Critical equipment & manufacturing cleanrooms Sanitisation & appropriate sterilization technologies (Autoclave).
Equipment, utilities, systems, production rooms, infrastructure list & Cross-Matrix.
Single Use Technology requirements and Process and CIP alternative.
Equipment supplier’s selection and implementation.
Risk management, impact & gap analysis and mitigation: RAPA, GAPA, ICH Q9, FMEA, ATEX.
Warehouse, “Push-Back racking”, vaults, cold rooms and quality control Labs design.
Hazardous chemical & biological waste gas, liquid and solid treatment technologies.
Support in approval certification “CA“ related to environment protection (MDDELCC).
Energy and water consumption efficiency optimization. Integration of Renewable Energies “trigeneration”.

Functional analysis of processes, utilities and systems.
Cross-matrix of equipment, utilities, systems, manufacturing areas, facilities.
Analysis of flow & risks.
HAZOP & ATEX management, impact analysis & risks mitigation.
Design of the warehouse, “racking: Push-Back” and equipment Quality control laboratories: physico-chemical, microbiological and R&D.
Optimization of the costs of investment CAPEX and OPEX operation.
Energy, water & materials balances optimization.
Energy grants applications related to 2nd & 3rd biomass generation.
Energy efficiency, integration of renewable energies “trigeneration”.

Functional analysis of processes, utilities and systems.
Cross-matrix of equipment, utilities, systems, manufacturing areas, facilities.
Analysis of flow & risks.
HAZOP & ATEX management, impact analysis & risks mitigation.
Design of the warehouse, “racking: Push-Back” and equipment Quality control laboratories: physico-chemical, microbiological and R&D.
Optimization of the costs of investment CAPEX and OPEX operation.
Energy, water & materials balances optimization.
Energy grants applications related to 2nd & 3rd biomass generation.
Energy efficiency, integration of renewable energies “trigeneration”.