Pharmaceutical facilities design

“PURS: Product, Process, Plant User Requirements Specifications”, laws and regulations analysis.
Design of general “Site Master File: SMF”.
Transfer technology services.
Skids of production, processes, Layout, cleanrooms, HVAC, design & specifications.
Clean utilities and pharmaceutical systems design & specifications.
Warehouse areas, vaults, cold rooms, and Labs quality control areas.
Personal protective equipment (PPE) and Containment.
Personnel, material & finished goods Flows & Cross-Contamination (CC) Risks assessment & mitigation.
Manufacturing cleanrooms integrity asepsis, equipment & products requirements.
Functional Technical Program (PFT) & Facility Design Qualification (FDQ).
Gowning & Protective Equipment (PPE).
Establishment Licenses, Cannabis Producers License, Drugs & NHP registration: DIN & NPN.

“PURS: Product, Process, Plant User Requirements Specifications”, laws and regulations analysis.
Design of general “Site Master File: SMF”.
Transfer technology services.
Cannabis Plants Drying Technologies, ATEX Safety, energy efficiency.
THC & CBD Cannabis oils extraction and purification technologies.
QPIC & THC Cannabis (Vault) classification, Health Canada application for Controlled Substances Licenses.
Skids of production, processes, Layout, cleanrooms, HVAC, design & specifications.
Waters quality for plants watering systems & greenhouses HVAC specifications.
Clean utilities and pharmaceutical systems design & specifications.
Indoor plants harvest (temperature, humidity, light) specifications & HVAC control.
Personal protective equipment (PPE) and Containment Technologies.
Personnel, material & finished goods Flows & Cross-Contamination Risks assessment & mitigation.
Functional Technical Program (PFT) & Facility Design Qualification (FDQ).
Management of construction projects (EPCMV).
Audit of Regulatory Compliance and Gap Analysis.
Validation, Quality Assurance & Regulatory Affairs.
Warehouse areas, vaults, cold rooms, and Labs quality control areas.
Design of specific facilities for cannabis.
Establishment Licenses, Cannabis Producers License, Drugs & NHP registration: DIN & NPN.

“PURS: Product, Process, Plant User Requirements Specifications”, laws and regulations analysis.
Design of general “Site Master File: SMF”.
Transfer technology services.
Skids of production, processes, Layout, cleanrooms, HVAC, design & specifications.
Clean utilities, pharmaceutical systems, BSL Containment design & specifications.
Warehouse areas, vaults, cold rooms, and Labs quality control areas.
Personal protective equipment (PPE) and Biological Containment.
Personnel, material & finished goods Flows & Cross-Contamination (CC) Risks assessment & mitigation.
Manufacturing cleanrooms integrity asepsis, equipment & products requirements.
Functional Technical Program (PFT) & Facility Design Qualification (FDQ).
Gowning & Personnel Protective Equipment (PPE).
Establishment Licenses, DIN Drugs registration.

“PURS: Product, Process, Plant User Requirements Specifications”, laws and regulations analysis.
Design of general “Site Master File: SMF”.
Transfer Technology Services
Skids of production, processes, Layout, cleanrooms, HVAC, design & specifications.
Clean utilities and pharmaceutical systems design & specifications.
Warehouse areas, vaults, cold rooms, and Labs quality control areas.
Personal protective equipment (PPE) and Containment.
Personnel, material & finished goods Flows & Cross-Contamination (CC) Risks assessment & mitigation.
Manufacturing cleanrooms integrity asepsis, equipment & products requirements.
Functional Technical Program (PFT) & Facility Design Qualification (FDQ).
Gowning & Personnel Protective Equipment (PPE).
Establishment Licenses, Drugs & NHP registration: DIN & NPN.

“PURS: Product, Process, Plant User Requirements Specifications”, laws and regulations analysis.
Design of general “Site Master File: SMF”.
Skids of production, processes, Layout, cleanrooms, HVAC, design & specifications: USP797.
Clean utilities and pharmaceutical systems design & specifications.
Warehouse areas, vaults, cold rooms, and Labs quality control areas.
Personal protective equipment (PPE) and Containment.
Personnel, material & finished goods Flows & Cross-Contamination (CC) Risks assessment & mitigation.
Critical cleanrooms for surgery & oncological disease treatment integrity, asepsis, equipment & products requirements.
Functional Technical Program (PFT) & Facility Design Qualification (FDQ).
Gowning & Personnel Protective Equipment (PPE)

“PURS: Product, Process, Plant User Requirements Specifications”, laws and regulations analysis: HACCP, SQF, ISO-22000, GFSI, ISO-9001.
Design of general “Site Master File: SMF”.
Sanitary Design of skids of production, processes, Layout, cleanrooms, HVAC, design & specifications.
Hygienic design of critical manufacturing cleanrooms.
Specifications of cleaning & sanitisation systems and compliance procedures Clean In Place – CIP.
Specifications of the suitable drying systems of food.
Warehouse areas, vaults, cold rooms, and quality control Labs.
Personnel, material & finished goods Flows & Cross-Contamination (CC) Risks assessment & mitigation.
Critical cleanrooms, equipment & products requirements.
Hazards Analysis of Critical Control Points: HACCP & Functional Technical Program (PFT) & Facility Design Qualification (FDQ).
Gowning & Personnel Protective Equipment (PPE).

PURS: Product, Process, Plant User Requirements Specifications”, laws and regulations analysis, ISO-9001.
Design of general “Site Master File: SMF”.
Design of manufacturing equipment, processes, black utilities, Layout & facilities specifications.
Warehouse areas, vaults, cold rooms, and quality control Labs.
HAZOP, Hazards Analysis & Functional Technical Program (PFT) & Facility Design Qualification (FDQ).
Process Optimization, reduction of operating costs OPEX and CAPEX investment.
Waste (gas, liquid & solid) neutralization treatment technologies.
Support in certificates of authorization “CA” to comply with environmental regulation & requirements.
Selection and implantation of manufacturing equipment and systems.
Instruments Calibration and transition to the Industry 4.0.
Maintenance of equipment and performances traceability.

PURS: Product, Process, Plant User Requirements Specifications”, laws and regulations analysis, ISO-9001.
Design of general “Site Master File: SMF”.
Design of manufacturing equipment, processes, black utilities, Layout & facilities specifications.
Warehouse areas, vaults, cold rooms, and quality control Labs.
HAZOP, Hazards Analysis & Functional Technical Program (PFT) & Facility Design Qualification (FDQ).
Process Optimization, reduction of operating costs OPEX and CAPEX investment.
Waste (gas, liquid & solid) neutralization treatment technologies.
Support in certificates of authorization “CA” to comply with environmental regulation & requirements.
Selection and implantation of manufacturing equipment and systems.
Instruments Calibration and transition to the Industry 4.0.
Maintenance of equipment and performances traceability.