MSD Ballydine OSD

MSD Ballydine OSD

A €150M three-storey expansion at MSD’s Ballydine campus — bridging R&D innovation with commercial-scale oral solid dosage manufacturing, with 223 complex interdependent systems commissioned and 150 partners trained across a 24-month lean construction and lean commissioning programme.

Last Planner® System

Value Stream Mapping

6S Methodology

Lean Commissioning

CQV Optimisation

Client
MSD Ireland
Location
Ballydine, Tipperary
Sector
OSD Pharmaceutical
Distinction
R&D to Production Bridge
LTS Role
Lean Construction & Commissioning

Strategic Significance: Connecting R&D Innovation to Commercial OSD Manufacturing

The Ballydine B-Con OSD project did not just build new facilities — it created the infrastructure that transforms MSD's scientific discoveries into medicines. By integrating a new three-storey manufacturing extension with the existing R&D and Formulation Building, this project enabled MSD to scale promising compounds from laboratory-scale development directly into full commercial oral solid dosage production. Lean construction was the operating system that made this technically and operationally complex bridge possible.

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MSD Ballydine B-Con OSD — Bridging R&D and Commercial Pharmaceutical Production

Project Value Duration Teams Collaborated with Systems Installed & Comissioned Partners Trained & Certified
€ 150M 24 Months 8 223 150
Project Value € 150M
Duration 24 Months
Teams Collaborated with 8
Systems Installed & Commissioned 223
Partners Trained & Certified 150

Project Overview

The MSD Ballydine B-Con OSD Project represents a strategically critical investment at MSD’s Ballydine campus in County Tipperary — one of MSD’s most important Irish manufacturing sites. Valued at €150 million and executed over 24 months, the project delivered a new three-storey extension comprising two fully interconnected blocks — Block A and Block B — integrated directly with the existing R&D and Formulation Building on the campus.

The facility was specifically designed to support advanced Oral Solid Dosage (OSD) manufacturing — one of the most widely prescribed drug formats in global pharmaceuticals. OSD manufacturing encompasses tablets, capsules, and other solid oral drug products, each requiring precisely controlled granulation, blending, compression, coating, and packaging processes. The technical complexity of the systems involved — and the stringent GMP requirements governing their installation, commissioning, and validation — made this one of the most demanding pharmaceutical construction and commissioning programmes Lean Touch Solutions has delivered.

Critically, the expansion also included car parking and critical site infrastructure upgrades — reflecting the scope of this programme as not just a facility build but a comprehensive campus development that strengthened Ballydine’s long-term operational capacity.

The R&D bridge: By integrating the new OSD manufacturing blocks directly with the existing R&D and Formulation Building, MSD created a seamless pathway from drug discovery to commercial-scale production. Lean construction — and specifically the cross-functional collaborative planning the Last Planner® System creates — was essential to managing the interface between research operations and active construction throughout the 24-month programme.

223

Complex Interdependent Systems Installed & Commissioned

Each of the 223 systems required precise installation, testing, and commissioning to meet GMP standards for OSD manufacturing. The interdependencies between systems — where the commissioning sequence of one system directly affects another — demanded structured, collaborative planning discipline.

Project Scope: Three-Storey Two-Block Extension

The physical scope of the B-Con OSD project was defined by two interconnected building blocks, each serving distinct but complementary functions in the expanded OSD manufacturing operation.

A
Block A — Manufacturing
Three-storey manufacturing suites housing advanced OSD production equipment — tablet compression, granulation, and coating systems installed and commissioned to GMP standard across multiple cleanroom-classified areas.
B
Block B — Support & Utilities
Mechanical, electrical, HVAC, and utility systems supporting full OSD manufacturing operations — including environmental monitoring, material handling, and quality control laboratory infrastructure integrated with Block A and the existing R&D building.
C
R&D Integration Interface
Full structural and systems integration with the existing R&D and Formulation Building — creating the physical R&D-to-production bridge that allows scientific discoveries to move directly into commercial-scale OSD manufacturing.
D
Site Infrastructure
Car parking and critical site infrastructure upgrades supporting the expanded campus workforce and operational logistics — ensuring the site can sustain increased manufacturing activity at commercial scale.

Our Lean Programme –

End-to-End Lean Construction & Lean Commissioning

Lean Touch Solutions provided comprehensive lean construction and lean commissioning services throughout the full lifecycle of the B-Con OSD project — from design through to GMP-compliant handover. Our programme was uniquely designed to address both the construction challenge and the commissioning challenge as a single integrated lean system.

Because the project occurred within a live R&D environment and involved complex OSD processes, lean practices were not optional — they were critical. The proximity to live R&D operations demanded precise interface management, and the complexity of the 223 interdependent systems demanded collaborative planning that no traditional scheduling approach could provide.

Lean Commissioning — a distinctive feature of this programme. Unlike most construction projects where lean engagement ends at practical completion, Lean Touch Solutions extended its lean programme into the commissioning and qualification phases. Our Lean Commissioning approach notably reduced the gap between construction completion and GMP-compliant readiness — accelerating the time from handover to commercial manufacturing capability.

Lean Services Deployed

📅

Last Planner® System

The operational backbone of the expansion — collaborative weekly work planning across all 10 teams, with structured look-ahead scheduling and constraint removal specifically designed to protect live operations from construction interference.

⚙️

Value Stream Mapping

Current-state and future-state mapping of critical construction and commissioning workflows — identifying and eliminating non-value-adding activities, particularly at the boundaries between live operations and new construction.

🔍

6S Methodology

Comprehensive 6S site organisation across all construction and new-facility zones — creating clean, safe, well-organised workspaces that minimised contamination risks to adjacent live GMP areas throughout the 24-month programme.

💡

Kaizen Events

Interface processes between construction and live operations mapped in detail — from utility outage procedures to commissioning handover protocols — ensuring every cross-boundary activity had a defined, optimised, and agreed process.

📊

Process Mapping

Interface processes between construction and live operations mapped in detail — from utility outage procedures to commissioning handover protocols — ensuring every cross-boundary activity had a defined, optimised, and agreed process.

🤝

Lean Behaviours Programme

Cultural transformation across all 10 teams and 300 certified partners — building the five lean behaviours (Trust, Accountability, Transparency, Respect, Continuous Improvement) that underpinned the collaborative planning needed for live-site delivery.

Unique to This Project

The first Lean Touch Solutions project to deploy A3 Problem Solving and full Lean Commissioning as integrated programme tools — extending lean beyond construction into CQV to accelerate GMP-ready manufacturing capability.

Lean Commissioning –

What Is Lean Commissioning?

Lean Commissioning applies the principles of lean — eliminating waste, creating flow, and building in collaborative planning — to the Commissioning, Qualification, and Validation (CQV) phases of pharmaceutical facility delivery. On conventional projects, the transition from construction completion to GMP readiness is frequently the most delayed and most waste-intensive phase of the entire programme.

The reasons are predictable: documentation backlogs, unresolved punch-list items from construction, sequential IQ/OQ/PQ protocols that create waiting waste, and poor visibility of who is doing what and when. Lean Commissioning addresses all of these systematically — applying Last Planner® System pull planning to CQV workflows, using Value Stream Mapping to redesign commissioning processes, and using A3 problem solving to resolve complex technical issues quickly.

On the MSD Ballydine B-Con OSD project, Lean Commissioning noticeably reduced the gap between construction completion and GMP-compliant readiness — directly accelerating MSD’s ability to begin OSD commercial production in the new facility.

Project Approach –

Unified Lean Strategy — Construction Through Commissioning

From the outset, Lean Touch Solutions developed and led a unified lean construction and commissioning strategy — one that treated the entire journey from ground-breaking to GMP handover as a single lean system, not as two separate phases with separate planning approaches.

We collaborated closely with MSD’s leadership, R&D and engineering teams, contractors, equipment suppliers, and validation experts. This early multi-disciplinary alignment ensured the strategy addressed the unique challenges of live R&D integration, OSD technology complexity, and the CQV demands of an advanced pharmaceutical manufacturing facility.

Phase 1
Assessment & Design

Multi-Disciplinary Strategy Co-Design:

Lean programme developed jointly with MSD construction leadership, R&D teams, engineering managers, equipment suppliers, and CQV experts. Unique challenge: the strategy had to address three distinct environments simultaneously — active construction, live R&D, and future OSD manufacturing — all on the same campus.

Phase 2
Launch & Embed

Stakeholder Buy-In Across All Disciplines:

Full commitment secured from MSD leadership, site operations, R&D management, all 8 trade contractors, and equipment suppliers. Particularly critical was aligning the R&D team — whose ongoing research activities created the live-environment interface challenge — with the construction planning commitments required to protect their operations.

Phase 3
Continuous Improvement

Construction Phase — Lean Framework Deployment:

Last Planner® System launched, 5S deployed site-wide, and visual management boards installed. 150 partners trained and certified. A3 problem solving introduced as the structured approach for cross-team technical challenges. Weekly work planning cycles embedded across all 8 teams with interface windows to R&D activities managed through the look-ahead schedule.

Phase 4
Lean Delivery

Systems Integration & VSM:

Value Stream Mapping deployed as the 223 complex systems entered installation — mapping the current-state installation and commissioning sequence, identifying interdependency bottlenecks, and designing future-state workflows that compressed the critical path between installation and qualification readiness.

Phase 5
Compliance

Lean CQV Delivery:

As construction neared completion, the lean programme transitioned seamlessly into Lean Commissioning — applying pull planning to IQ/OQ/PQ protocol execution across all 223 systems. A3 problem solving used to rapidly resolve technical commissioning issues. The result: construction-to-GMP-readiness gap significantly reduced, enabling MSD's commercial OSD production capability to come on stream on schedule.

Lean Construction process during Parliament Hotel Dublin refurbishment

Outcomes & Results –

On Schedule, On Standard, GMP-Ready

The lean programme on the B-Con OSD project delivered on every critical metric — schedule, quality, system commissioning, partner capability, and GMP readiness. Uniquely, this is the project in our portfolio where Lean Commissioning played the most distinctive and measurable role.

€150M

Facility delivered on time across 24-month construction & commissioning programme

223

Complex interdependent systems installed, commissioned, and GMP validated

150+

Partners trained and certified in lean construction and commissioning methodology

8+

Specialist teams unified through a single lean planning and problem-solving system

Lean Touch Solutions

MSD Ballydine B-Con OSD Programme Summary

“By training and certifying 150 partners in these lean tools, we fostered a unified, quality-focused project culture. Consequently, the MSD Ballydine B-Con OSD Project was completed on schedule, achieved full compliance, and stands ready to meet future pharmaceutical production demands.”

OSD Construction & Lean Commissioning –

Why OSD Pharmaceutical Projects Demand Both Lean Construction and Lean Commissioning

Oral solid dosage pharmaceutical facilities are among the most technically complex environments for construction and commissioning. The interdependencies between systems — granulation, blending, compression, coating, packaging, environmental controls, utilities, and quality systems — create a commissioning web that can consume months of avoidable delay when managed by conventional sequential approaches.

The Ballydine B-Con OSD project demonstrates the power of treating lean construction and lean commissioning as a single, integrated programme. When the same collaborative planning discipline, the same constraint management processes, and the same lean behaviours that drove construction performance are extended into CQV, the result is a dramatically shorter path to GMP-ready manufacturing capability.

Lean Touch Solutions is the only LCI-registered lean construction consultancy in Ireland that delivers comprehensive lean construction and lean commissioning as an integrated service. Our track record across five MSD facilities — from Swords and Carlow to Ballydine — demonstrates what this integrated approach achieves on the most demanding pharmaceutical programmes.

Our integrated lean construction and lean commissioning approach is uniquely suited to OSD and pharmaceutical facility programmes. Let’s talk.

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Integrated Lean Construction & Lean Commissioning for Pharma Ireland

The only approach that delivers both the build and the GMP handover — from ground-breaking to commercial manufacturing readiness, with lean embedded throughout.

A3 Problem Solving in Pharmaceutical Construction

The A3 Problem Solving methodology — named after the A3 paper format used to capture the full problem-solving cycle on a single page — was a distinctive feature of the Ballydine OSD lean programme. On a project with 223 interdependent systems and 8 specialist teams, complex technical problems are inevitable. What determines project performance is how quickly and systematically those problems are resolved.

A3 provides a structured PDCA (Plan-Do-Check-Act) framework that forces clarity about the problem, the root cause, the countermeasure, and the verification method — all visible on a single page. When deployed across multi-disciplinary teams spanning construction, R&D, and commissioning, A3 becomes a powerful tool for cross-functional alignment and rapid issue resolution.

Lean Commissioning: Closing the Construction-to-GMP Gap

The gap between construction completion and GMP-ready manufacturing capability is consistently the most overlooked source of pharmaceutical project delay. Conventional commissioning approaches — sequential IQ/OQ/PQ protocols, reactive issue resolution, and poor cross-functional coordination — routinely extend this gap by weeks or months.

  • Last Planner® System pull planning applied to CQV protocol execution.
  • VSM used to identify and eliminate commissioning process waste.
  • A3 problem solving for rapid resolution of technical commissioning issues.
  • Cross-functional planning rooms integrating construction and CQV teams.
  • Lean behaviours programme ensuring collaborative CQV culture

Oral Solid Dosage Construction in Ireland

OSD pharmaceutical manufacturing requires one of the most technically demanding construction and commissioning environments in the industry. Granulation, blending, compression, coating, and packaging systems — each with stringent environmental classification, cross-contamination control, and validation requirements — create a commissioning programme of extraordinary complexity when 200+ systems are involved.

Lean Touch Solutions has the OSD-specific experience to deploy lean construction and lean commissioning methods in this environment — understanding the technical context, the regulatory requirements, and the interdependency challenges that define OSD facility delivery.

Ireland's Integrated Lean Construction & Commissioning Specialists

Lean Touch Solutions is the only LCI-registered lean construction consultancy in Ireland that delivers lean construction and lean commissioning as a fully integrated service. Our five major MSD programmes — from Swords and Carlow to Ballydine — span €2.5Bn+ in pharmaceutical construction and commissioning delivery.

Based in Naas, Co. Kildare, we serve pharmaceutical, biotech, OSD, and life sciences construction projects across Ireland and Europe. Contact our team to discuss how integrated lean construction and commissioning can transform delivery on your next pharmaceutical programme.

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