PBE Expert Français
Production room with staff in sterile gowning

Expertise

From requirement to evidence.

We design, build and qualify facilities for the health industries. Three areas of expertise under one roof, for a project that stays compliant from the first drawing to the inspection.

Designing a compliant plant is demanding. We’ve done it more than more than 300 times.

Engineers looking over a modern production plant

ProcessGMP design and engineering

Design that passes
the EMA-Annex 1 inspection.

From written requirements to detailed drawings, every design decision builds in EMA-Annex 1, other regulatory requirements and process risks.

  • Sanitary process equipment and clean utilitiesURS · P&ID · ASME BPE
  • Cleanroom layout and HVACISO 14644
  • Aseptic processing, injectables and high-potency productsOEL 5+
  • Vaccines, biosimilars, cell and gene therapies, containmentBSL-2 to BSL-3
  • Explosion-proof design and complianceATEX
  • Risk assessment and mitigationICH Q9 · FMEA
  • Traceability matrix and change controlISPE
Engineers at an industrial site

BuildingProject management and on-site services

On site, through to handover.

Our engineers follow the project in the field: equipment delivery, testing, commissioning and site documentation.

  • Delivery, installation and commissioningFAT · SAT
  • PLC engineering and control, HVAC and cleanroom testingPLC
  • On-site construction, construction monitoring and benchmarkingEPCMV
  • Repackaging, packaging and labeling in our GMP facilitiesGMP
  • New drug development and formulationR&D
  • Site Master File and cGMP FormAction™SMF
Gloved hand holding a sample vial

ExpertiseValidation and quality assurance

Demonstrating that everything complies.

Every requirement written at the outset is verified at the finish: qualification, validation and the quality system, all the way to site certification under EMA-Annex 1.

  • Validation Master Plan, qualificationsVMP · IQ · OQ · PQ
  • Calibration, and cleanroom, HVAC and clean utility testingISO 14644
  • Computerized system validation, BMS and ERPCSV · GAMP 5
  • Cleaning and process validationFDA 2011 · ANSM 2015
  • Quality assurance: SOPs, batch records, investigationsRCA · CAPA
  • Compliance audit, pre-approval inspection, site certificationPAI

Our services

Eight services, one team.

Each service has its own page: what it covers, and what is added for your industry.

  1. Facility designMaster plans, cleanrooms, utilities, warehousing and licensing: a compliant facility from the very first drawing.
  2. Clean systems integrationClean utilities, sterilization, automation and containment: systems that work together.
  3. Process engineering (ASME-BPE)Basic and detailed sanitary design, PFD, P&ID, 3D models and performance specifications.
  4. Layouts and technical specificationsCleanrooms, pressure cascades, flows and segregation: a layout that protects the product.
  5. CQV, CSV & maintenanceValidation Master Plan, qualification, mapping, computerized system validation and maintenance.
  6. Compliance audit and GMP FormAction™GMP audits, pre-approval inspections, inspection readiness and FormAction™ from an approved training organization.
  7. Construction project management (EPCMV)Engineering, procurement, construction, management and validation, under one roof.
  8. Quality assurance and EMA-Annex 1 complianceBatch release, procedures, CAPA, Site Master File, licenses, and DIN and NPN registrations.

Our method

From product requirements to batch release.

  1. Two engineers mapping out requirements on a whiteboard
    01

    Requirements and regulations

    Needs and requirements analysis, design review, user requirements specification (URS).

  2. Design drawings and calculations
    02

    Design

    Concept development, functional specifications, drawings and impact assessment.

  3. A process skid being assembled
    03

    Build

    Construction, equipment delivery, installation and commissioning.

  4. A row of filled and stoppered PBE Expert vials: the released batch
    04

    Qualification

    IQ, OQ and PQ qualification, validation and inspection readiness.

Contact us

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.

Project requestPBE-DP-001 · Rev. 0

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Approved byThe PBE Expert team

Keep exploringAnnex 1EMA-Annex 1: the PBE Expert team designs, implements and demonstrates the contamination control strategy for your sterile facilities.

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