Qualification LYO for Big Batch Sizes
This project focused on the qualification of a large-scale freeze dryer (lyophilizer) designed to process high batch volumes of parenteral drug products. The goal was to ensure GMP-compliant installation, operation, and performance of the equipment under real production conditions, with a particular emphasis on load capacity, uniformity of drying, and integration into existing cleanroom infrastructure.
QPS Engineering oversaw the entire qualification lifecycle, including the definition of User Requirements Specifications (URS), execution of IQ, OQ, and PQ protocols, and the coordination of loading system validation. Special attention was given to shelf temperature mapping, vacuum control, condenser performance, and product chamber uniformity to ensure consistent drying across the full batch size.
The project also included cycle development support and test runs using placebo product to simulate real loads. Final documentation was compiled in alignment with GAMP 5 and EU GMP Annex 1 guidelines for sterile manufacturing.
Scope of Services
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URS definition and vendor alignment
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Installation and commissioning of large-scale freeze dryer (HOF system)
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IQ/OQ execution including shelf mapping and system alarms
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Performance Qualification (PQ) using placebo vials at maximum load
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Integration with isolator, loading system, and clean utilities
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Development support for robust and scalable freeze-drying cycles
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Final qualification report and audit support package