Service 18 / 27 · Facility Upgrades & Retrofit
Upgrade the Facility. Protect the Operation.
Upgrading an operating facility starts with an honest assessment of what exists: condition, capacity, gaps and the constraints of ongoing production. Work is engineered in phases, with shutdown windows, interfaces and migration planned so that disruption is limited and product supply is protected. Commissioning and requalification are planned with the client quality team from the outset.
Engineering phases
Where this service fits
08 / 09 phases in scope
- 01FeasibilityIn scope
- 02Conceptnot in scope
- 03Basic EngineeringIn scope
- 04Detailed EngineeringIn scope
- 05ProcurementIn scope
- 06ConstructionIn scope
- 07CommissioningIn scope
- 08ValidationIn scope
- 09OperationIn scope
Scope
What the service covers
- 01Existing condition assessment and compliance gap review
- 02Capacity analysis and debottlenecking
- 03Cleanroom, HVAC, water, laboratory, warehouse and containment upgrades
- 04Phased engineering, shutdown planning and interface coordination
- 05Commissioning, requalification and operational-readiness closeout
Method
From inputs to deliverables
INInputs
05 items- I01As-built drawings and existing documentation where available
- I02Production schedule and operating constraints
- I03Upgrade objectives and capacity targets
- I04Known deficiencies, audit observations or change requests shared by the client
- I05Existing qualification status
WORKActivities
05 items- W01Site survey and condition assessment
- W02Gap and capacity analysis
- W03Phasing and shutdown planning
- W04Upgrade engineering and interface coordination
- W05Commissioning and requalification planning
OUTDeliverables
06 items- D-18.01Existing condition and gap assessment report
- D-18.02Capacity and debottlenecking study
- D-18.03Phased upgrade plan and schedule
- D-18.04Shutdown and migration plan
- D-18.05Upgrade design and tender documents
- D-18.06Commissioning and requalification plan
Technical detail
Upgrades and how we approach them
Contents · 04
01 / 04
Upgrade types
Upgrades range from a single system to a full production area, each with its own interfaces and risks.
- Factory expansion
- Capacity increase
- Cleanroom upgrade
- HVAC upgrade
- Water system upgrade
- Utility upgrade
- Production line upgrade
- Compliance upgrade
- Warehouse upgrade
- Laboratory upgrade
- Retrofit
- Debottlenecking
02 / 04
Existing facility compliance upgrade
When an operating facility has to close technical gaps, the work starts from a structured review of what exists and is delivered in phases the operation can absorb.
- Compliance gap review of layout, systems and documentation
- Phased retrofit plan prioritized by risk
- Cleanroom envelope, zoning and pressure cascade upgrades
- HVAC zoning, filtration and monitoring upgrades
- Pharmaceutical water and clean utility upgrades
- Laboratory and warehouse upgrades
- Containment upgrades for hazardous handling areas
03 / 04
Working around a live operation
Construction and tie-ins inside a running facility are a contamination and supply risk in their own right, and are planned as such.
- Operating-facility interface and temporary segregation
- Shutdown windows agreed with production planning
- Migration strategy for rooms, equipment and utilities
- Temporary utilities and contingency arrangements
- Requalification scope for affected systems
- Operational-readiness closeout: records, training interfaces and handover
04 / 04
How we approach it
The approach is built around keeping the facility operating while the change is delivered.
- Existing condition assessment
- Gap identification
- Capacity analysis
- Phased engineering
- Shutdown planning
- Interface coordination
- Migration strategy
- Commissioning strategy
Sequence
Upgrade delivery sequence
A typical sequence; phases and shutdown windows are agreed with the client operations and quality teams.
01 / 08ASSESS
Assess
Survey the existing condition and documentation.
Select a step to read what it involves.
ASSESS
Assess
Survey the existing condition and documentation.
IDENTIFY GAPS
Identify gaps
Compare the current state with the upgrade objectives.
PLAN PHASES
Plan phases
Sequence the work around production commitments.
ENGINEER
Engineer
Design the upgrade and its interfaces with existing systems.
SHUTDOWN WINDOW
Shutdown window
Execute tie-ins and changes in the agreed window.
COMMISSION
Commission
Start up and verify the modified systems.
REQUALIFY
Requalify
Support requalification as defined by the client quality team.
HANDOVER
Handover
Return the area to operation with updated documentation.
Deliverables
Typical documents and outputs
- D-18.01Existing condition and gap assessment report
- D-18.02Capacity and debottlenecking study
- D-18.03Phased upgrade plan and schedule
- D-18.04Shutdown and migration plan
- D-18.05Upgrade design and tender documents
- D-18.06Commissioning and requalification plan
Services
Related services
- 27
GMP Gap Assessment & CAPA Support
Technical gap assessment and corrective-action planning, traced from each finding to verified evidence.
- 13
Pharmaceutical Water & Clean Utility Systems
Pretreatment, generation, storage and distribution engineered as one coordinated water system.
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