End-to-End Aseptic Scale-Up, Delivered on Time and Ready for Inspection
A compressed-timeline project to scale seeding and media preparation into an aseptic isolator environment. Full scope from User Requirement Specification through Process Verification, compliant with EU GMP ANNEX 1 throughout.
URS → PfV
Full Scope Delivered
ANNEX 1
GMP Framework
EU
Delivery Region
Challenge
Scaling Seeding and Media Preparation to an Aseptic Isolator Without Compromising Product Integrity
Bavarian Nordic needed to move seeding and media preparation processes into an aseptic isolator environment to meet increasing production demand. The dual constraint was unforgiving: every engineering and documentation decision had to satisfy EU GMP ANNEX 1, and the project timeline left no room for rework. Any compromise on product integrity during the transition, or any gap in the qualification chain, would reset the schedule entirely.
Solution
Single Specialist Lead Across the Full Qualification Chain
Damgaard Solutions provided a single specialist with end-to-end accountability. From feasibility assessment through final handover. Keeping one lead across the full scope eliminated handover gaps between phases and ensured consistent traceability from the first requirement to the last qualification record.
1
Mock-up durability study before procurement
Before committing to any vendor or specification, a comprehensive durability study was conducted using mock-ups to confirm that all working procedures could be performed effectively within the aseptic isolator environment. This step identified potential design issues early and eliminated costly corrections downstream.
2
URS, Engineering Specification, and tender documentation
Following feasibility confirmation, the full documentation suite was prepared: User Requirement Specification, Engineering Specification, and tender materials. These formed a traceable foundation for the entire qualification chain and defined procurement requirements with the precision needed to hold vendors accountable.
3
Design Qualification with full traceability to FAT and SAT
A comprehensive Design Qualification was executed to verify that all requirements in the URS and Engineering Specification were reflected in the isolator design. Traceability from design to Factory Acceptance Test and Site Acceptance Test was established and maintained throughout, ensuring no requirement dropped out of the qualification chain.
4
IQ / OQ / PQ execution and final handover
Installation, Operational, and Performance Qualifications were executed and documented in full. All deviations arising during qualification were assessed, mitigated, and closed before handover. The project was delivered on time and within budget.
Results and Impact
Project delivered on time and within budget, with full compliance with EU GMP ANNEX 1 maintained throughout every phase.
All deviations arising during qualification were identified, mitigated, and formally closed before handover. No open points carried into operations.
Complete qualification documentation package delivered. Traceable from URS through DQ, FAT, SAT, and IQ/OQ/PQ. Ready for regulatory inspection from day one.
Seeding and media preparation successfully transitioned to the aseptic isolator environment without compromise to product integrity.
On a fast-track project, the qualification chain is only as strong as its weakest handover point. Keeping a single specialist accountable across the full scope. From mock-up study through final qualification. Meant nothing was lost between phases and the documentation held up under scrutiny.
Project Facts
At a glance
Client
Bavarian Nordic
Site
Kvistgaard, Denmark
Project Duration
2022–2023
Service Area
Aseptic Isolator Filling
Scope
URS through Process Verification (PfV)
Regulatory Framework
EU GMP ANNEX 1
Delivery Model
Fast-track, single specialist lead
Outcome
On time · On budget · Inspection-ready
Topics
About the specialist
Kasper Carlsen is a Senior Specialist at Damgaard Solutions with 21 years of experience across isolators, washing and sterilization, clean utilities, and environmental monitoring. He is known for leading complex, time-critical GMP projects with the focus and precision that fast-track schedules demand. Ensuring that the qualification chain holds up under inspection, not just on paper.
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