Sterilisation of Systems
This project involved the qualification and validation of sterilization procedures for complex pharmaceutical manufacturing systems, including product-contact equipment, transfer lines, vessels, and isolators. The main objective was to ensure microbiological integrity and reproducible sterility across all critical components prior to aseptic manufacturing.
QPS Engineering led the definition of sterilization strategies based on system design, material compatibility, and regulatory requirements. This included development and execution of moist heat sterilization cycles (autoclave and SIP), dry heat sterilization (DHS), and H₂O₂ vapor sterilization within isolators.
Comprehensive biological and chemical indicator studies were conducted to verify lethality and uniformity of sterilization. The qualification followed a risk-based approach and was documented according to EU GMP Annex 1 and ISO 14937 standards.
Scope of Services
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Definition of sterilization strategy per equipment and material type
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Development and qualification of SIP and H₂O₂ cycles
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Thermocouple mapping and cold spot identification
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Use of biological indicators (BI) and chemical indicators (CI)
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Alarm testing, system hold-time studies, and requalification planning
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Final reporting for internal QA and regulatory inspections
