Aseptic scale-up, on time, inspection-ready.
Damgaard Solutions scaled seeding and media preparation into an aseptic isolator at Bavarian Nordic in Kvistgaard, Denmark, leading the full URS-through-process-verification chain under EU GMP Annex 1 with one specialist and no handover gaps.
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.
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.
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.