VHP studies. BioTrak interference testing. Operator training. Smoke study pre-testing. Catalyst reactivation. Run by senior engineers who have qualified isolators at Novo Nordisk and Bavarian Nordic. By the assignment.
A working aseptic isolator in our Allerod facility, scoped for VHP-related studies, training, and engineering support. Every engagement is quoted as a written proposal. Most are scoped as a study with a defined deliverable.
All assignments are run by senior engineers, with the isolator as the platform. Pricing is on request. Each service ladders into the broader Damgaard Solutions portfolio of aseptic isolator filling, environmental monitoring, CQV, qualification, process validation, and technology transfer.
Know your biological challenge before entering qualification.
Test programs for understanding VHP resistance before qualification. Useful for teams developing or refining a VHP cycle, comparing indicator suppliers, or validating biological indicator selection against enzyme indicators.
Before you trust the count, test the interference.
Testing whether customer materials create false positive signals in rapid viable monitoring systems. Built for QA, microbiology, and validation teams troubleshooting unexpected viable count alarms or qualifying new materials against rapid monitoring.
Train operators on a real working isolator before production risk begins.
Hands-on training in a working aseptic isolator for operators, engineers and quality teams. Designed for teams preparing for qualification, requalification, or first production runs.
Prepare your airflow visualization before entering the cleanroom.
Preparation and method development before performing formal smoke studies in production equipment. Used by validation teams who need to rehearse smoke generation, camera setup, and critical-area assessment before going on a production unit.
Understand whether your catalyst is still protecting your cycle time.
Testing and restoring H2O2 catalyst performance after exposure to VHP, smoke studies, or filter integrity testing. For maintenance, quality assurance, and supplier dialogue when aeration times start drifting.
Verify spray performance before reinstalling critical VHP components.
Functional testing of VHP spray nozzles after service, repair, or upgrade. Used to confirm the spray pattern and distribution before putting refurbished components back into the production cycle.
Rent the capability, not just the instrument.
Short-term access to specialist equipment, combined with senior engineering support. For teams who need an instrument plus the protocol plus the report, on-site or off-site.
Run the process before the process becomes GMP-critical.
Low-risk process testing before entering a GMP-critical production environment. Useful for new product introductions, line transfers, and operator readiness reviews.
Turn Annex 1 expectations into practical engineering actions.
Technical support for translating Annex 1 expectations into practical isolator and aseptic process requirements. For project teams and quality assurance preparing for or responding to Annex 1 audits.
Technical seminars for teams who need to understand the test before approving the result.
Specialist seminars for teams working with VHP, isolators, biological indicators, and rapid microbiological methods. Delivered at our facility or on-site.
A short scoping conversation or a written brief. We need to understand what you are trying to learn, by when, and what regulatory frame the output will live in.
Scope, deliverables, named engineer, timeline, price, and terms. Quoted as a written proposal, not a per-hour estimate. Reply within two business days.
Senior engineer in the room. Engineering report signed by name. Raw data exports. Annex 1 interpretation where relevant. Integrate into your CCS or your URS.
The platform for every service on this page. A rigid-wall, positive-pressure aseptic isolator with an H2O2 vapor sterilizer. Maintained by Damgaard Solutions engineers between assignments.
Two operator stations work through gloved sleeves on a sealed face-to-face workstation. Input lock-chamber for transfer. Cycle traces and documented qualification status on request.
Every engagement is quoted as a written proposal scoped to the work. Pricing depends on the service, the number of operators, duration, consumables, and reporting depth. We reply within two business days.
No. We do not operate a sterility testing laboratory or quality system for that purpose. We offer pre-sterility feasibility studies, aseptic process simulation, contamination risk pre-testing, and related engineering services on a working aseptic isolator.
Self-run assignments are possible for teams with documented operator qualifications. Our senior engineer reviews competency before the booking confirms. A damage deposit applies.
The isolator is a working engineering asset. Engagements deliver engineering studies and qualification evidence, not GMP-released production. Clients integrate the output into their own quality system, with our reports as documented evidence.
An approved-materials list is shared on quote. Standard consumables (gloves, gowns, biological indicators, chemical indicators, wipes, common solvents) are accepted. Aggressive chemistry, controlled substances, cannabis materials, and unapproved decontamination chemistries are excluded.
Allerod, near Copenhagen. Easy reach from Sweden, Norway, Finland, Germany, and the Netherlands. Direct rail from central Copenhagen. Approximately 30 minutes from Copenhagen Airport.
Standard lead time is 3 to 4 weeks. Faster turnarounds are possible when the calendar allows. Rush bookings inside 7 days are quoted at a premium.
Yes, with prior notice. Most clients film their own smoke study pre-tests and training. Damgaard Solutions retains rights to use anonymized images for marketing unless the client opts out in writing.
Every quote is a written proposal with a defined deliverable and a named senior engineer. No call required for a first response. If a call helps, we book one inside the same email.
Kasper Carlsen
Founder & Lead Engineer · Your senior contact