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THE BUILD
Inside the Project
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First-pass FDA validation
100%
Quality rate
99.9%
Cleanroom compatible
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A major pharmaceutical company was launching a new auto-injector platform for their growing biologics portfolio. They needed an assembly solution that could meet aggressive production targets while satisfying rigorous FDA validation requirements. The timeline was tight, and there was no room for error.
Haumiller designed a complete auto-injector assembly line built around continuous motion technology, with full FDA compliance built in from the start. Our engineering team worked closely with the client's validation and quality teams throughout the project.
Key elements included:
Precision needle safety system assembly with 100% inspection. Cartridge handling and filling integration. Complete IQ/OQ/PQ documentation and validation support. GAMP5-compliant control systems with full audit trail. Cleanroom-compatible design meeting ISO Class 7 requirements.
The system passed FDA validation on the first attempt, a testament to the rigorous engineering and documentation process. Production targets were met within weeks of installation, and the line has been running reliably ever since.
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