Closing PPV PL1 On Time, Late-Stage Qualification Done Right
Environmental monitoring and process validation for a new Grade D API dissolution area at Novo Nordisk Kalundborg. Embedded before the study phase and through PFV, securing room qualification, closing EM excursions, and holding the documentation discipline that kept a late-stage qualification on schedule.
GRADE D
Cleanroom Class
EM
Environmental Monitoring
EU
Delivery Region
Project ongoingEnvironmental Monitoring · Grade D cleanroom
Challenge ———
Closing a Late-Stage Qualification on a New API Facility Under System and Coordination Risk
A new dissolution area in Grade D classified cleanrooms in PPV PL1 needed to be qualified and released for manual API handling. The work covered an initial study phase and subsequent Process Performance Verification (PFV), demonstrating that the environment stayed in control under realistic operating conditions.
Several overlapping challenges made this more than a standard qualification. Securing approval for the rooms to be qualified was the central hurdle. PAS-X introduced complex system integration, validation, and user acceptance issues. The HVAC system had to be adapted to meet strict environmental and quality requirements, which called for cross-disciplinary coordination. EM excursions had to be investigated and closed, and operators needed training in cleaning and product handling to protect product quality. The specialist also joined shortly before qualification, so ramp-up had to be fast and the documentation had to stay defensible throughout.
Solution ———
Embedded EM and PFV Execution From Study Phase Through Release
Damgaard Solutions provided an Environmental Monitoring specialist embedded in the Dissolution area team in PPV PL1, from before the study phase through PFV completion. The focus was practical execution and audit-ready documentation, delivered in close coordination with operators, QA, and the EM team.
1
EM execution, trend analysis, and excursion investigation
Managed environmental monitoring across study and PFV, including data analysis, trend reporting in PEMS, and investigation of EM excursions. Used CCTV review and microbiological screening to identify contamination sources and support corrective actions.
2
Validation documentation and cleaning rationale in TIMS
Prepared facilities, equipment, and documentation for Study and PFV, including test plans, validation reports, and execution in TIMS. Reviewed and optimized cleaning rationales to ensure both compliance and efficiency.
3
GMP compliance and structured deviation handling
Performed room inspections, cleaning verification, and deviation handling. Monitored HVAC and EM data and drove excursions to closure with QA, keeping records traceable and documentation defensible throughout study and PFV.
4
Operator training and cross-functional coordination
Trained operators in cleaning procedures and documentation standards. Ran daily status meetings and visual board sessions with EM and operator teams, and proactively coordinated external partners for facility services, repairs, and equipment fabrication to avoid delays.
Results and Impact ———
Study and PFV completed on time and in compliance with GMP and Novo Nordisk site standards, despite a late start and early system instability.
Room qualification approvals secured through structured coordination and consistent cross-functional communication.
EM excursions investigated and closed with documented root cause and corrective actions, supported by CCTV review and microbiological screening.
Cleaning rationales reviewed and optimized for both compliance and efficiency.
Equipment qualified for manual API handling, with robotics integration assessed and ultimately excluded from scope.
Stronger alignment across EM, QA, Production, and project management, built through daily status meetings and visual management.
A late-stage qualification is won on coordination as much as technical work. The value of embedded EM expertise is connecting systems, procedures, training, and data into one evidence story, and keeping the team aligned to meet critical deadlines.
Project Facts ———
At a glance
Client
Novo Nordisk
Site
Kalundborg, Denmark
Project Duration
2025–2026 (Apr 2025 – Jan 2026)
Service Area
Environmental Monitoring (EM)
Scope
Study phase through Process Performance Verification (PFV)
Damgaard Solutions provides Environmental Monitoring specialists with deep GMP experience in classified cleanroom qualification, deviation handling, and audit-ready documentation. Our EM specialists embed within client teams from study phase through PFV, connecting systems, procedures, training, and data into one coherent qualification story.
To discuss EM project needs or speak with one of our specialists directly, visit our specialists page →
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