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Expertise

Engineering disciplines for pharmaceutical facilities.

A pharmaceutical facility depends on disciplines that are often designed in isolation. We coordinate them around one project strategy, one model and one set of requirements.

Disciplines

Engineering Behind Compliance.

Architecture, HVAC, utilities, process and automation are resolved together in one coordinated model, not handed over in sequence.

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Architecture

GMP layouts, room data sheets, cleanable finishes and envelope details aligned with process flows.

ABCDEF12345N750075007500750075005500550055005500CNCGRADE CGRADE BGRADE CGRADE BGRADE CCNCGRADE D+30 Pa+15 Pa+45 Pa+10 PaAHU-01CH-01B-01P-01/02GEN-01MDB-01DB-02DB-03R-101SK-102FL-103WFI-01PW-01CA-01WFI LOOPDN25BMS-01T/RHEXITEXITFC-01FED. MODELWAREHOUSEMALGOWNINGAIRLOCKPROCESSCORRIDORQC LABPACKINGAHU / PLANTUTILITIES

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Layer

A-WALL

Drawing

A-02.01

Scale

Not to scale

Illustrative layout, not a project drawing.

GMP & Compliance

Compliance Is Designed, Not Added Later.

Compliance considerations should shape the layout, the airflow strategy and the documentation from the first design stage. Adding them after construction costs time, budget and requalification effort.

Pressure cascade

  1. Process room

    Grade B

    +45 Pa

    ΔP 15 Pa

  2. Gowning

    Grade B

    +30 Pa

    ΔP 15 Pa

  3. Airlock

    Grade C

    +15 Pa

    ΔP 5 Pa

  4. Corridor

    Grade C

    +10 Pa

Air flows towards lower pressure

Illustrative pressure cascade. Values are indicative and are set for each project.

Design considerations

  1. 01Layouts
  2. 02Personnel Flow
  3. 03Material Flow
  4. 04Pressure Cascades
  5. 05Air Classification
  6. 06Utilities
  7. 07Documentation
  8. 08Commissioning
  9. 09Qualification

Designed with consideration for applicable international GMP guidelines and project-specific regulatory requirements.

Project Lifecycle

One Partner. Across the Project Lifecycle.

Decisions made at feasibility shape what is qualified at the end. We carry one technical basis from the first study through commissioning and qualification.

  1. 01

    Discover

    Assess the product portfolio, capacity, site options and a feasible investment envelope.

  2. 02

    Define

    Capture user requirements, regulatory basis and design criteria in an approved URS.

  3. 03

    Plan

    Set the master plan, phasing, budget, schedule and validation strategy.

  4. 04

    Design

    Develop coordinated architecture, cleanroom, HVAC, utilities and process design through DQ.

  5. 05

    Procure

    Specify, tender and evaluate equipment packages; witness FAT before shipment.

  6. 06

    Build

    Construct and install to approved drawings under documented site quality controls.

  7. 07

    Commission

    Start up, test, adjust and balance systems; complete SAT and punch lists.

  8. 08

    Validate

    Execute IQ/OQ/PQ protocols and compile evidence that systems perform as intended.

  9. 09

    Operate

    Support handover, SOPs, maintenance planning, periodic requalification and change control.

Next step

Planning a pharmaceutical project?

Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.

+20 101 171 1700
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