ENBRA - Ingeniería en Automatización y Seguridad Industrial
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ENBRA · Sector · Life Sciences

Pharmaceutical

Safety, validation and OT cybersecurity for pharmaceutical plants: filling lines, cleanrooms and GMP-regulated environments.

EN ISO 12100 · EN ISO 13849 · IEC 62443 · GMP

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01 — Alcance

Areas of work

From machine safety to OT control in environments with high documentary requirements.

EN ISO 12100 · EN ISO 13849

Line and equipment safety

Risk assessment and upgrading of filling, packaging and peripheral lines in pharmaceutical plants.

In-line hazard analysis · Safety control systems · Functional validation · CE documentation

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Incluye

  • Risk assessment report
  • Measure specification
  • Validation report

EN ISO 13849-2 · CSV

System validation

Validation by analysis and testing of SRP/CS and support for documentary traceability required in life sciences.

Validation plan · Functional tests · Documentary traceability · Conformity report

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Incluye

  • Validation plan
  • Test records
  • Final report

IEC 62443

OT cybersecurity

Protection of OT networks and control systems in pharmaceutical plants, aligned with operational continuity and change control.

OT asset inventory · Network segmentation · IEC 62443 gap analysis · Incident response

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Incluye

  • OT risk report
  • Zone architecture
  • Prioritised roadmap

Safety PLC · Cleanrooms

Engineering and integration

Safety engineering and automation integration in controlled environments: clear interfaces and documented commissioning.

Safety PLC · Line integration · OT / installer interfaces · Assisted commissioning

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Incluye

  • Technical architecture
  • Interface specification
  • Commissioning support

02 — Método

How we work

Documentary rigor and plant pace from the first scope definition.

  1. 01

    Scope

    Line, room and validation requirements.

  2. 02

    Assessment

    Risks, OT gaps and prioritisation by impact.

  3. 03

    Implementation

    Measures, validation and controlled integration.

  4. 04

    Close-out

    Dossier, handover and operational support.

03 — Criterios

Why ENBRA

Life Sciences

  • Filling and packaging lines
  • Controlled environments
  • No friction with production

Validation

  • ISO 12100 / 13849
  • Testing and traceability
  • Auditable documentation

Industrial OT

  • IEC 62443 on the plant floor
  • Operational continuity
  • OT focus, not generic IT

Siguiente paso

Need safety or validation in a pharma plant?

Tell us the type of line or room. We will respond with a technical proposal.

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