PBE Expert Incis a leading consulting Engineering company in GPP-GMP Design of  Automatic Medical  Cannabis Grow and Supercritical CO2 Extraction of THC & CBD Oils ingredients  (API, DMF), involving a Health Canada & MAPAQ Expert.

PBE Expert Inc, has successfully accomplished several Medical Cannabis projects, implementing various technologies of Supercritical CO2, Aqueous or Alcoholic Extractions, which require the design and Control of Dehumidification and Environmental conditions that comply with EMA & Health Canada: e-GMP/ACMPR/ NHP regulatory requirements, ISO-22000 and ATEX standards.


Culture de Chanvre Industriel (≤0,3 % de THC)



Cannabuy Equipments



Cannabuy Services



Cultivation of Cannabis inside



THC & CBD Cannabis Facility



Cannabis cultivation in greenhouses



Patient Guide To Medical Cannabis



Humidity and temperature control



Cannabis Control Laboratory



Extraction cannabis oil (CHT)



Extraction cannabis oil (CBD)



Patient Guide To Medical Cannabis



Cannabis resin manufacturing



Manufacture of cannabis oil capsules CHT



Manufacture of cannabis oil capsules CBD



Patient Guide To Medical Cannabis



Process, Building, Energy



Dried CBD cannabis extract



Pre-filled oral vaporizers



Natural health products



Patient Guide To Medical Cannabis



PKG 1re & 2nd & labeling



Storage



Arch & QPIC



Layouts & clean rooms



Explosive & flammable (ATEX, NFPA)



Patient Guide To Medical Cannabis



Pharmaceutical Systems



Clean utilities



Antioxidant properties of Cannabis



PBE Expert Inc, provides to the cannabis production and processing industry with outstanding expertise in process engineering, extraction technologies of THC & CBD, Layout, Validation, Calibration, Maintenance, Quality Assurance, Compliance and Regulatory Affairs.

PBE Expert Inc offers GMP design services for Medical Cannabis Manufacturing sites: Vertical Growing, Drying, Grinding | Extraction and Purification of active ingredients such as THC and CBD Oils (API, DMF) | Drug Devlopment, Manufacturing Pharmaceutical & Nutraceutical products such as syrup, tablets, soft gel and semi-solid capsules.

The design of Medical Cannabis Facilities implies the compliance with e-GMPs and ASME-BPE and ISPE standards, so the design of GMP Layouts is ensured by efficient Environmental Control, Dehumidification, MILDEW and Odours removal technologies.


PBE Expert services

  • Cannabis facilities design
  • Clean utilities & Pharmaceutical systems
  • Sanitary design & Process engineering (ASME-BPE)
  • Layouts design & Technical specifications
  • EPCMV & Project management
  • cGMP Compliance Audit, PAI & Training
  • C&Q – Validation & Maintenance
  • Quality assurance & Regulatory affairs
Cannabis facilities design
  • Licenses Establishment, Cannabis Producers LicenseNHP registration: NPN.
  • PURS: Product, Process, Plant User Requirements Specifications”, laws and regulations analysis.
  • Business plan development, Feasibility story and Project management.
  • 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 Safety 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, lux 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.
Clean utilities & Pharmaceutical systems
  • Processes, clean utilities and pharmaceutical systems functional analysis and design (ASTM2500).
  • Equipment, utilities, systems, production rooms, infrastructure cross matrices.
  • Warehouse Layout, 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”, 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”.
Sanitary design & Process engineering (ASME-BPE)
  • Sanitary Design & Process Engineering (ASME-BPE) basic and detailed, 3D drawing and performance specifications.
  • Development of PURS(9), URS(11), BOD, DDE, PFD, P&ID and “CPP, & 3D drawings.
  • 3D design of Cannabis plants Drying systems, ATEX Safety, energy efficiency.
  • 3D design of the THC and CBD cannabis ingredients extraction and purification technologies.
    • Specification of materials and internal finishes.
    • Sanitary design, dead-legs reduction, optimization of slopes, speeds, CPP.
    • Specifications of the valves (diaphragm, Block-Bleed), TC fittings, pumps, filters, exchangers.
  • 3D design of processes skids and related equipment.
  • 3D design of formulation, mixing and filling tanks.
  • 3D design of filling machines, freeze-drying, primary and secondary packaging.
  • 3D design of Clean in Place (CIP) skids, COP, sanitisation.
  • 3D design of process transfer lines (orbital welding).
  • 3D design of the clean utilities, production and distribution: PW, PCA, N2, CO2 …
  • 3D design of pharmaceutical systems: HVAC, FFU, CIP, freeze-drying, vacuum, vent, …
  • 3D design of protective equipment: laminar flow hood, weighing & sampling (UDAF) cabinet, LEV.
  • Interlock between the process equipment and building systems & safety devices.
  • Automation, PLC, SCADA, integration, BMS, BAS, ERP, SAP, Industry 4.0.
Layouts design & Technical specifications
  • Classified areas (A, B, C, D, ISO5-8) and (3D) architectural drawings integration.
  • Layout integration of the environmental conditions and the specifications of the products: hygroscopic, electrostatic, explosive, flammable ATEX.
  • Development of cleanrooms URS and Critical Environmental Parameters Reviews “CEP.
  • Flow of personnel, equipment, raw material, release of primary & 2nd PGK materials and finished products, waste.
  • Functional grouping, pressure & cleanliness cascades and classification of cleanrooms, ATEX, HR%, BSL, OEL.
  • Physical (PAL, MAL, corridors) and mechanical segregations, SOP, gowning.
  • Functional grouping, pressure & cleanliness cascades and classification of cleanrooms, ATEX, HR%.
  • Physical (PAL, MAL, corridors) and mechanical segregations, SOP, gowning.
  • Aeraulic diagrams: HVAC, FFU and laminar flow HEPA filters and hoods.
  • Weighing & sampling (UDAFcabinet.
  • Design of warehouses, “Push-Back racking”, freezers -20°C, cold rooms 2-8°C.
  • Raw materials & drugs, in Quarantine, Stability & Batch release (ERP).
  • Vaults of controlled substances, alcohol, cannabis, THC, QPIC Services.
  • Explosion proof (XP) design (NFPA, ATEX), and chemical (OEL).
  • Layout of quality control of physical & chemical, microbiological and R&D Labs.
EPCMV & Project management
  • Engineering, validation and construction projects management.
  • Suppliers and contractor’s selection.
  • Works timeline, resource planning, sub-contractors coordination.
  • Management, control & optimization of the project costs.
  • Follow-up & technical support, review and approval of the workshop drawings.
  • Plans and procedures approval of supervision and health safety (ATEX, NFPA, Safe-brige).
  • Equipment accessibility, reception, installation & commissioning.
  • Supervision and approval of onsite contractors & suppliers drawings for execution.
  • Engineering tests, “Troubleshooting & setting of the PLC processes.
  • Management and control  of work quality and equipment performances.
  • Onsite works progress reports follow-up, benchmark and end of the work certificate delivery.
  • Update and approval of all the facility, cleanrooms and equipment drawings and documentations As Built.
  • Certificate of Conformity, release of payments, customer facility and documentation “hand-over”.
cGMP Compliance Audit, PAI & Training
  • Sites c-GMP compliance certification, chemical containment license, QPIC.
  • cGMP compliance Audit and pre-approval inspection (PAI).
  • Development of PAI plan and procedure: before, during and after inspection.
  • Corrective and Preventive Actions: CAPA, RAPA, GAPA.
  • Plans for remediation.
  • Management and Implementation of a change control system.
  • Continuous Improvement & Quality Audit of supplier’s qualification.
  • Drafting and revision of suppliers Quality Assurance Agreements (QAA).
  • Development of the Site Master File (SMF).
  • cGMP Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.
C&Q – Validation & Maintenance
  • Traceability matrix and URS and validation cross references.
  • Validation Master Plan, (VMP).
  • Predictive, systemic, and preventive maintenance plan.
  • Metrology, calibration program, calibration of the instruments, and traceability.
  • Mapping (temperature, humidity) cold room, warehouse, freezer, incubator, autoclave, freeze dryer.
  • Commissioning (DQ, FAT, SAT).
  • Qualification DQ, IQ, OQ: equipment & classified cleanrooms, quality control Labs equipment, freezer & cold rooms, autoclave, freeze-dryer, oven, stability room, CIP, SIP, HVAC, PW, EPPI, compressed air, N2.
  • Sampling Plan, and MACO.
  • Process Validation, of cleaning and sterilization (FDA 2011, EMA 2015).
  • Sterilization cycles development, Media-Fill tests.
  • Computer validation, CSV: BMS, PLC, qualification of ERP software, SAP (GAMP, CFR21-11), data integrity.
Quality assurance & Regulatory affairs
Détails des services

Applicable Standards &

Regulations

BPF | FDA | ANSM | Santé Canada | GCC | ISO14644 | ASME-BPE | ISPE | ICH Q9 | AMDEC | ATEX | NFPA | HSE | SIMDUT


Are you looking for a Partner in Process Engineering, Clean Utilities, Project Management, CIP, Layout, Compliance, Validation, QA, Audit, PAI, Calibration or Energy Efficiency?


More :

Sectors


Pharmaceuticals



Cannabis



Biotechnology



Fine Chemicals & API



Foods



Pulp & Paper



Biofuel



Industry 4.0



Process, Building, Energy



Healthcare, Hospitals & Pharmacies


Our Offices

CANADA

For commercial information, partnership and marketing requests with PBE Expert Inc, please contact :
+1 (514) 616-2692

+ 1 (450) 600-0790 x 253

pbe@pbe-expert.com

pbe@pharmabioeng.com3210, Francis Hughes Street, Laval, QC H7L 5A7

Our International Offices in :

Morocco


+(212) 661142327+ 212 522343291www.kimia.maa.elbahraoui@kimia.co.maRésidence EL HADIKA, 4E étage N°88 Ain Sebaa,Casablanca

Algeria


+213 (0) 5-40-96-12-34+ 213 (0) 31-76-61-83tm.ferlab@gmail.comcontact.ferlab@gmail.com147 bloc C, Ben Zakri, les Terrases, Constantine Algeria

Tunisia


+(216) 96-751-330

pbe@pbe-expert.com

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