Hospitals and pharmacies
Sterile and oncology injectable compounding rooms, operating rooms, laboratories and pharmacies, compliant with USP <797> and GMP.
Standards GMP · USP <797> · FDA · ANSM · Health Canada · ISO 14644 · ASME-BPE · ISPE · ICH Q9 · FMEA
Our experts, with more than 35 years of combined experience in life sciences and health technologies, have delivered several projects in hospitals, pharmacies and CSSS (Quebec health and social services centers): aseptic compounding of injectables and oncology products, laminar airflow hoods and OEL 6 containment enclosures (chemospheres, glove boxes). Our team includes a Health Canada scientific expert.
We also fit out operating rooms, research centers and testing laboratories, and we design the clean utilities: clean steam for sterilization, and CLSI Type 1, 2 and 3 purified water. In containment (OEL 2–6), our layouts control clean environments (ISO 14644-4), cross-contamination and highly potent compounds.
Hospital pharmacy
Pressure protects the product.
In a compounding room, air always flows from the cleanest area toward the less clean ones. For a hazardous drug, the room switches to negative pressure: then it is the staff who need protecting.
Buffer room +15 Pa, anteroom +7.5 Pa. Air flows out of the cleanroom toward the corridor: particles and microorganisms stay out.
Buffer room −5 Pa, anteroom +7.5 Pa. Air flows into the buffer room and never out of it: cytotoxic drugs stay contained, and the anteroom stays clean.
Example values: they are set project by project, during room qualification.
Products and processes
Our services on video
For hospitals and CSSS.
Our services in this industry
Each service in detail, as we deliver it in this industry.
Facility design9 items
- Analysis of preliminary requirements (PURS), laws and regulations
- Design of compounding areas for sterile injectables and highly potent, radioactive and allergenic products
- Specifications for production skids, processes, layout, cleanrooms and classified areas: USP 797
- Clean utility and pharmaceutical system specifications
- Specifications for storage areas, vaults, cold rooms and quality control (QC) laboratories
- Personal protective equipment (PPE) and containment specifications
- Analysis of flows, contamination and cross-contamination (CCC) risks
- Preserving the integrity and asepsis of rooms, equipment and products
- Functional and technical program (PFT)
Clean systems integration9 items
- Functional analysis of processes, clean utilities and pharmaceutical systems
- Verification of purity, sterility and risk level
- Choice of sterilization technology: aseptic, filtration, steam
- 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
- Chemical containment of highly potent, toxic, oncology and cytotoxic products
- Gowning and personal protective equipment (PPE)
- Risk management, impact assessment and mitigation (RAPA, GAPA): ICH Q9, FMEA, ATEX
- 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 clean-in-place (CIP), sanitization and sterilization-in-place (SIP) skids
- 3D design of clean utilities, generation and distribution: PW, WFI, PS, PCA, N2
- 3D design of pharmaceutical systems: HVAC, FFU, CIP, SIP, autoclave, depyrogenation, vacuum, drainage…
- 3D design of containment equipment: isolators, RABS, IBCs, biosafety cabinets
- 3D design of protective equipment: laminar airflow hoods, weighing booths (UDAF), LEV
- Design of the warehouse, push-back racking, vaults, cold rooms and quality control (QC) laboratory equipment: physicochemical testing, microbiology, R&D
- Interlocks between process equipment, systems and building safety systems
- Automation, PLCs, SCADA, integration, BMS, BAS, ERP, SAP, Industry 4.0
- Selection and layout of manufacturing equipment and systems
Layouts and technical specifications14 items
- Classified areas (grades A, B, C, D, ISO Class 5–8) and integration into architectural drawings (3D)
- Building environmental conditions and product properties into the layout: hygroscopic, electrostatic, chemical containment OEL 1–6, 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, OEL
- 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)
- Design of vaults for controlled substances (alcohol, cannabis, THC), QPIC services
- 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)
- Stability, efficacy and sterility testing by risk level (low, medium, high), single-dose or multi-dose vials
- 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, isolators, ovens, stability chambers, CIP, SIP, HVAC, PW, WFI, pure steam, compressed air, N2
- Sampling plan, bracketing matrix (MACO) and sterilization cycle development
- Process, cleaning and sterilization validation (FDA 2011, ANSM 2015)
- 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 chemical 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, SafeBridge)
- 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 compliance12 items
- Quality assurance and batch release
- QPIC services for controlled substances: cannabis (THC), opiates
- Operations and health and safety support
- Procedure writing: SOPs and work instructions
- 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
- Predictive, systemic and preventive maintenance plan
- Metrology: calibration program and traceability
- Temperature and humidity mapping: cold rooms, warehouses, freezers, incubators, ovens and depyrogenation ovens
- Industry 4.0: digitization, data collection and integrity, ERP, SAP
Pharmaceutical
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