Healthcare, Hospitals & Pharmacies USP-797

PBE Expert Inc, is a leading consulting company providing innovative and practical solutions to your building systems, clean utilities, sterilisation & sanitisation equipment, RABS, laminar air flow cabinets and layouts design, meeting USP797, CLSI regulations, standards and codes.

We are committed to providing skilled resources by delivering projects on time, on budget and compliant to regulatory requirements.

PBE Expert Inc serves since several years healthcare & hospitals, surgery cleanrooms, research centers, laboratories for analysis, with dedicated consulting services meeting USP797 standards and cGMP regulations.

PBE Expert Inc was involved in the engineering of the clean utilities (clean steam, CLSI-3 purified water), Layouts design for BSL2 & BSL3 containment Labs, validation, calibration, maintenance, quality assurance & PM.

The design of bioprocesses, clean utilities and systems implies at the outset the conformity to ASME-BPE, USP797 and ISPE standards. The design of Layouts involving OEL2-6 or BSL3 containment involves the control of clean environments (ISO-14644-4 and ISPE), prevention technologies against cross-contamination, as well as chemical & biological compounds risks & Mix-Up mitigation and cGMP compliance.

Healthcare & Hopitals facilities design
Clean utilities & Pharmaceutical systems
Process engineering “ASME-BPE”
Layouts design & Technical specifications
EPCMV & Project management
cGMP Compliance Audit, PAI & Training
C&Q – Validation & Maintenance
Quality assurance & Regulatory affairs

Healthcare & Hopitals facilities design

“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)

Clean utilities & Pharmaceutical systems

Processes, clean utilities and pharmaceutical systems functional analysis.
Purity, sterility and the risk level audit assessment (ASTM2500, FMEA).
Cleanrooms & Critical equipment Sanitisation & appropriate Sterilization technologies (SIP, Autoclave).
Equipment, utilities, systems, production rooms, infrastructure list & Cross-Matrix.
Biological Containment (BSL 1-3) and Biotechnology, effluents thermal kill decontamination system, autoclave.
Oncological and cytotoxic, High Potent chemical containment (OEL HP2-6), BIBO.
Single Use Technology requirements and 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 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”.

Process engineering “ASME-BPE”

Sanitary Design & Process 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 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 Chemical Containment OEL1-6, explosive, flammable ATEX 1-4, 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, OEL.
Physical (PAL, MAL, corridors) and mechanical segregations, SOP, gowning.
Aeraulic diagrams: HVAC, FFU and laminar flow.
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) 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 (HSE, 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 validation cross 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, registration of drugs.