Biotechnology

PBE Expert Inc, is a consulting company in the biotech industries sector involving a Health Canada Expert.

PBE Expert Inc, has successfully completed several projects involving explosive products (ATEX), confined (BSL3) and comply with the regulatory requirements BPF / cGMP in Canada, USA (FDA), Europe (ANSM), as well as North Africa regulations.

PBE Expert Inc provides the biotech and bioprocessing (BSL3 containment) industry with skilled resources, in process engineering, layout, validation, calibration, maintenance, quality assurance and regulatory compliance.

The design of bioprocesses, clean utilities, and containment systems (BSL3) implies from the beginning compliance with ASME-BPE and ISPE standards.

The containment layout design BSL3 also involves the control of clean environments (ISO-14644-4 and ISPE), cross-contamination prevention technologies, BSL3 risks and Mix-Up crossings, break-downs integrity, consistency and conformity.

Biotechnology facilities design
Clean utilities & Pharmaceutical systems(
Sanitary design & Bioprocess engineering “ASME-BPE”
Layouts Design & Technical Specifications
EPCMV & Project management
cGMP Compliance Audit, PAI & Training
C&Q – Validation & Maintenance
Quality Assurance & Regulatory Affairs

Biotechnology 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, 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.

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.
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”.

Sanitary design & Bioprocess engineering “ASME-BPE”

Sanitary Design & BioProcess Engineering (ASME-BPE) basic and detailed, 3D drawing and performance specifications.
Development of PURS, URS, BOD, DDE, PFD, P&ID and “CPP“:
- 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, sterilization (SIP).
3D design of process transfer lines (orbital welding).
3D design of the clean utilities, production and distribution: PW, WFI, PS, PCA, N2, …
3D design of pharmaceutical systems: HVAC, FFU, autoclave, freeze-drying, vacuum, vent, …
3D design of BSL containment systems: Isolator, RABS, IBC, biological hood, …
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 ATEX1-4, biological containment BSL1-4.
Development of cleanrooms URS and Critical Environmental Parameters Reviews “CEP“.
Flow of personnel, equipment, raw material, primary & 2nd PGK materials, finished products, waste.
Functional grouping, pressure & cleanliness cascades and classification of cleanrooms, ATEX, HR%, BSL.
Physical (PAL, MAL, corridors) and mechanical segregations, SOP, gowning.
Aeraulic diagrams: HVAC, FFU and laminar flow.
BSL Containment: RABS, isolator, “Glove-Box”, closed equipment and “Split-Valves”, LEV.
Weighing & sampling (UDAF) cabinet.
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), biological containment (BSL).
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.
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 validationcross references.
Validation Master Plan, (VMP).
Plan of predictive maintenance, systemic, and preventive.
Metrology, calibration program, calibration of the instruments, and traceability.
Mapping (temperature, humidity) cold room, warehouse, freezer, incubator, depyrogenation, autoclave, freeze dryer.
Commissioning (DQ, FAT, SAT).
Qualification DQ, IQ, OQ: equipment & classified cleanrooms, quality control Labs equipment, freezer & cold rooms, autoclave, freeze-dryer, isolator, oven, stability room, CIP, SIP, HVAC, PW, EPPI, pure steam, 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

Quality Assurance & batch release.
QPIC services for controlled substances: THC cannabis, opiates, morphine.
Drafting of procedures: SOP.
Manufacturing operation support and health & safety services.
Change Control, CAPA, Failure Modes Effect Analysis : FMEA.
Root Causes Analysis “RCA“.
Annual product review “APR“, Information technology & Data integrity: Capability.
Risks management, analysis, and mitigation. Gap analysis and impact study RAPA/GAPA FMEA: ICH Q9, ATEX, FMD-135.
Industry 4.0, IoT, collection and data integrity, CSV, ERP, SAP, LIMS.
Cannabis producer’s licenses registration, DIN/NPN of THC & CBD.
Regulatory Affairs, (DIN) registration of drugs.
Registration of the establishment licenses (DEL).