Biotechnology and vaccines
Bioprocesses, BSL-3 biological containment and sterile products, GMP-compliant in Canada, the United States (FDA), Europe (ANSM) and North Africa.
Standards GMP · FDA · ANSM · Health Canada · GCC · ISO 14644 · ASME-BPE · ISPE · ICH Q9 · FMEA · ATEX · NFPA · HSE
PBE Expert brings biotechnology and bioprocessing its expertise in process engineering, layouts, validation, calibration, maintenance, quality assurance and regulatory compliance, including for explosive products (ATEX) and products that require containment (BSL-3). Our team includes a Health Canada scientific expert.
Bioprocesses, clean utilities and containment systems are designed to ASME-BPE and ISPE from the outset. In BSL-3 containment, our layouts also control clean environments (ISO 14644-4), cross-contamination, biological hazards and crossing flows.
For cell therapies, we offer turnkey deployment of GMP facilities for CAR-T cell therapy, with FormAction™, know-how and technology transfer, project management and quality assurance, for hospitals and health centers as well as production sites.
Biotechnology, vaccines, medicines: PBE Expert
Products and processes
Our services in this industry
Each service in detail, as we deliver it in this industry.
Facility design11 items
- Analysis of preliminary requirements (PURS), laws and regulations
- Site design, industrial master plans and Site Master File (SMF)
- Specifications for production skids, processes, layout, cleanrooms and classified areas
- Specifications for clean utilities, clean systems and biological containment
- Specifications for storage areas, vaults, cold rooms and quality control (QC) laboratories
- Personal protective equipment (PPE) and biological containment specifications
- Analysis of flows, contamination and cross-contamination (CCC) risks, and biosafety (BSL)
- Preserving the integrity and asepsis of rooms, equipment and products
- Functional and technical program (PFT)
- Gowning and personal protective equipment (PPE)
- Establishment licenses and drug registration (DIN)
Clean systems integration12 items
- Functional analysis of processes, clean utilities, clean systems and biological containment
- Verification of purity, sterility and risk level
- Choice of sterilization technology: aseptic, filtration, steam, depyrogenation
- Cross-matrix of equipment, utilities, systems, production rooms and infrastructure
- Biological containment (BSL-1 to BSL-3) and biotechnology, continuous and autoclave thermal effluent decontamination
- Techno-economic assessment of single-use technologies
- Selection and layout of manufacturing equipment and systems
- Design of the warehouse, push-back racking, vaults, cold rooms and quality control (QC) laboratory equipment: physicochemical testing, microbiology, R&D
- Risk management, impact assessment and mitigation (RAPA, GAPA): ICH Q9, FMEA, ATEX
- Treatment of hazardous biological effluents (BSL): gaseous, liquid and solid
- Support with environmental certificate of authorization (CA) applications
- Energy efficiency, energy, water and material balances, renewable energy integration (trigeneration)
Process engineering (ASME-BPE)15 items
- Sanitary design and process engineering (ASME-BPE), basic and detailed, 3D drawings and performance specifications
- Development of PURS, URS, BOD, detailed design, PFD, P&ID and critical process parameters (CPP): material and interior finish specifications
- Sanitary design: fewer dead legs, optimized slopes and velocities
- Specifications for valves (diaphragm, block-and-bleed), tri-clamp (TC) fittings, pumps, filters and heat exchangers
- 3D design of manufacturing equipment and process skids
- 3D design of formulation, mixing and filling tanks
- 3D design of filling, freeze-drying, and primary and secondary packaging machines
- 3D design of clean-in-place (CIP), sanitization and sterilization-in-place (SIP) skids
- 3D design of process transfer lines (orbital welding)
- 3D design of clean utilities, generation and distribution: PW, WFI, PS, PCA, N2, CO₂
- 3D design of clean systems: HVAC, FFU, CIP, SIP, autoclave, freeze-drying, vacuum, drainage…
- 3D design of containment equipment: isolators, RABS, IBCs, biosafety cabinets
- 3D design of protective equipment: laminar airflow hoods, weighing booths (UDAF), RABS, LEV
- Interlocks between process equipment, systems and building safety systems
- Automation, PLCs, SCADA, integration, BMS, BAS, ERP, SAP, Industry 4.0
Layouts and technical specifications14 items
- Classified areas (grades A, B, C, D, ISO Class 5–8)
- Integration into architectural drawings (3D)
- Building environmental conditions and product properties into the layout: hygroscopic, electrostatic, explosive and flammable ATEX 1–4, biological containment BSL-1 to BSL-4
- Development of URS and critical environmental parameters (CEP)
- Layout of personnel, equipment, raw material, primary and secondary packaging material, finished product and waste flows, with biological containment constraints
- Functional grouping, pressure, cleanliness and room classification cascades: classified areas, ATEX, relative humidity, BSL
- Physical separations (personnel airlocks, PAL; material airlocks, MAL; corridors), plus mechanical, procedural and gowning separations
- Review and approval of airflow diagrams: HVAC, FFU and laminar flow
- Containment: isolators, RABS, glove boxes, closed equipment, split valves, LEV
- Weighing and sampling booths (UDAF)
- Warehouse design, push-back racking, −20 °C freezers, 2–8 °C cold rooms
- Quarantine, stability and release areas for raw materials and drug products (ERP)
- Explosive atmospheres (NFPA, ATEX), biological (BSL) and chemical (OEL) containment
- Quality control laboratory layout: physicochemical testing, microbiology, R&D
CQV, CSV & maintenance11 items
- Traceability matrix: mapping URS requirements to validation
- Validation Master Plan (VMP)
- Predictive, systemic and preventive maintenance plan
- Metrology: instrument calibration program and traceability
- Temperature and humidity mapping: cold rooms, warehouses, freezers, incubators, ovens and depyrogenation ovens, autoclaves, freeze dryers
- Commissioning: DQ, FAT, SAT
- DQ, IQ and OQ qualification of equipment, classified manufacturing rooms and laboratory (QC) equipment: refrigerators and freezers, autoclaves, freeze dryers, isolators, ovens, stability chambers, CIP, SIP, HVAC, PW, WFI, pure steam, compressed air, N2
- Sampling plan, bracketing matrix and MACO
- Process, cleaning and sterilization validation (FDA 2011, ANSM 2015)
- Sterilization cycle development
- Computerized system validation (CSV): BMS, PLCs, ERP and SAP software qualification (GAMP, 21 CFR Part 11), data integrity
Compliance audit and GMP FormAction™10 items
- Site GMP compliance certification, licenses and biological containment permits
- GMP compliance audit and pre-approval inspection (PAI)
- Inspection readiness plan and procedure: before, during and after
- Corrective and preventive actions: CAPA, RAPA, GAPA
- Remediation plans
- Setting up and managing a change control system
- Continuous improvement and supplier qualification quality audits
- Drafting and review of quality agreements (QAA)
- Drafting the Site Master File (SMF)
- GMP FormAction™: PBE Expert, CPMT-approved training organization (No. 0059104), CIPE and OIQ
Construction project management (EPCMV)13 items
- Engineering, validation and construction project management
- Owner’s engineer services, supplier and contractor selection
- Project schedule, workforce planning, subcontractor coordination
- Cost management, control and optimization
- Technical follow-up and support, shop drawing review and approval
- Approval of monitoring, health and safety plans and procedures (ATEX, NFPA)
- Equipment accessibility, receiving, installation follow-up and commissioning
- Supervision and approval of on-site execution plans
- Engineering tests, troubleshooting and process PLC configuration
- Quality management and control of the work and of facility performance
- Construction progress reports, benchmarking and certificate of completion
- Production and approval of as-built drawings
- Certificate of conformity, release of payments, client acceptance of the facility
Quality assurance and EMA-Annex 1 compliance10 items
- Quality assurance and batch release
- Procedure writing: SOPs and work instructions
- Operations and health and safety support
- Change control, CAPA, failure mode and effects analysis (FMEA)
- Root cause analysis (RCA)
- Annual product review (APR), IT and data integrity, process capability
- Risk management, assessment and mitigation, impact study (RAPA, GAPA): FMEA, ICH Q9, ATEX, FMD-135
- Temperature and humidity mapping: cold rooms, warehouses, freezers, incubators, ovens and depyrogenation ovens, autoclaves, freeze dryers
- Industry 4.0: digitization, data collection and integrity, ERP, SAP
- Regulatory affairs: drug registration (DIN) and Drug Establishment Licences (DEL)
Pharmaceutical
Process engineering
Every flow, under control.
Product, water for injection, pure steam, compressed air: the PBE Expert team designs the processes and utilities that come into contact with your product, then qualifies them.
Process engineering
Let’s talk about your project.
A new site, an expansion, an inspection to prepare for: describe your project and one of our experts will get back to you.