Bruni Manufacturing Systems
for Industrial Plants
Bruni Manufacturing Systems designs, integrates and validates the MES, automation and OT/IT systems that run regulated pharmaceutical productions - extended to Food & Beverage, Power&Enegy - from single recipe changes to multi-site digital rollouts.

About the company

Bruni Manufacturing Systems supports pharmaceutical manufacturers in designing, integrating and validating the digital systems that run regulated production.

  • Engineering-led

    We work at the intersection of automation, IT and quality — turning operational requirements into GMP-compliant digital systems.

     

  • Compliance by design

    Every system is built to hold up under inspection, with documentation and validation support aligned to the client’s quality framework.

     

  • Scoped to fit

    Engagements range from sigle-site MES and DCS engineering to multi-vendor, multi-site program coordination.

We help manufacturers move from paper-based processes to connected, standards-based digital manufacturing — designing MES recipes, integrating shop-floor systems with ERP and LIMS, and coordinating the vendors and system integrators involved along the way.

Our focus is Drug Substance and Drug Products – Food&Beverage and Power&Energy – manufacturing environments, where system changes have to satisfy both operational and regulatory requirements at once. That means documentation, validation and change control are built into the engineering work, not added afterward.

Bruni Manufacturing Systems is built to bring senior, hands-on expertise to organizations that need it — for a single project or an ongoing program.

Let's talk about your manufacturing systems.

Whether it’s a single MES recipe, an OT/IT integration, or program management across multiple sites — get in touch to discuss scope.

Services

Manufacturing Systems

MES & Recipe Engineering
  • MES design, configuration & engineering (PAS-X, POMs, Tulip)
  • MES Recipe Authoring (PAS-X, POMs, Tulip) — master recipe design and configuration
  • Paper-to-Digital transformation — migration from paper-based batch records to electronic batch records and digital workflows
Data Integration & Architecture
  • OT/IT integration — DCS (DeltaV, PCS7, Foxboro, Schneider Electric), PLC (Siemens, Allen-Bradley), BMS/EMS
  • Historian – OSI PI
  • Manufacturing Data Gateway installation — Ignition, HighByte, COPADATA
  • Manufacturing Data Standardization (ISA-95/88) — harmonized data models across sites for Manufacturing SW
  • Alarm Management — rationalization and design aligned with ISA-18.2
  • Enterprise system integration — SAP ECC/S4HANA, LIMS (LabVantage), warehouse automation (ASRS, WCS, AGV, EWM)
Validation & Compliance
  • Validation support (CSV) — validation strategy, validation plan, risk analyses, IQ/OQ/PQ protocols writing, test execution, documentation (execution-level, per client Quality Unit approval)
  • Technical & GMP documentation — SOPs, master batch records, qualification/validation reports
  • Validation methodology & digital tools — Waterfall and Agile validation approaches; application of CSV/QMS e-VLM tools (Kneat, MasterControl, TrackWise)
Program & Project Management
  • Digital architecture & Industry 4.0 roadmaps — vendor scouting, technology selection, URS authoring
  • Program & project management — MES rollout coordination across multi-site, multi-vendor environments
  • Vendor & system integrator coordination — scope, planning, risk management across parallel projects
  • Cross-functional engineering — bridging Business, QA, Engineering, IT/OT stakeholders
Training & Support
  • Training & knowledge transfer — end-user and technical team training on MES/automation platforms, DCS, and ISA-
    95/88 data standards
  • Post-implementation support — site troubleshooting, continuous improvement

Technology & Standards

Platforms and frameworks we work with across MES, automation, historian, ERP and warehouse projects.

MES

PAS-X, PharmaSuite, POMS / POMSnet (incl. Weigh & Dispense), Tulip, Syncade, Honeywell TWM, Opcenter

DCS / SCADA / PLC

Emerson DeltaV, Siemens PCS7, Foxboro I/A Series, Schneider Electric, Siemens PLC, Allen-Bradley, Comi Condor

Data Gateways & Historians

Ignition, HighByte, COPADATA, AVEVA PI / OSI-PI, AspenTech Inmation

ERP / LIMS

SAP ECC, SAP S/4HANA, LabVantage LIMS

CMMS / Maintenance

IBM Maximo, electronic logbooks (MES–CMMS integration)

Warehouse & Logistics

ASRS, WCS, AGV, fleet management, SAP EWM

Standards & Frameworks

ISA-95, ISA-88, GxP, GAMP 5-aligned validation practices

Program Tools

JIRA Software, Primavera P6, Microsoft Project

BMS & EMS

Schneider Electric, Honeywell EBI

Standards & Frameworks

Standards & Frameworks

Standards and regulatory frameworks supporting manufacturing, quality, validation and logistics projects.

Standard / Framework Application / Description
ISA-95 Manufacturing data standardization and harmonization of data models across sites
ISA-88 Batch control and recipe standardization, coupled with ISA-95
ISA-18.2 Alarm management, including alarm rationalization and design
GxP General regulatory quality framework
GAMP 5 GAMP 5-aligned validation practices
ICH E6(R2) Good Clinical Practice (GCP) Guidelines (certification)

Basel, Switzerland — MES & automation engineering

Manufacturing systems built to hold up under GMP scrutiny.

Bruni Manufacturing Systems designs, integrates and validates the MES, automation and OT/IT systems that run regulated pharmaceutical production — from single recipe changes to multi-site digital rollouts.

25+
Years of industry experience
Drug Product; Drug Substances; Biopharmaceuticals
3
MES implementations
Global installations; Recipes Autoring; DCS, ERP, and LIMS & interfacing; W&D modules; E-Logbooks
3
DCS Upgrades
Virtualization; Brownfields Upgrade; Recipe and Phases Programming

Contacts

Contact Us

    Copyright © Bruni Manufacturing Systems. Basel, Switzerland.