The advent of ready to use single use filling line has revolutionized the fill-finish process for sterile injectables, enabling faster product changeovers and reducing risks related to cleaning validation and cross-contamination. However, concerns remain around E&L, particulate contamination, variable fills, adsorption, and product loss, especially with high-value drugs.
These challenges can be addressed by careful material selection, Efficient design, and monitoring and Control of Particulate Matter during manufacture of these complex single use systems.
Careful Selection of Materials
Careful selection of single-use components with low extractables is crucial to minimize leachable risks, avoiding costly redesigns and delays. At MDI, our advanced analytical labs offer extractables profiling and toxicological assessments to identify target leachables. To address product loss from adsorption, especially in low-volume or high-value drug; we provide validation services to evaluate component compatibility and recommend surface modifications or material change, or flush volumes to ensure label claim compliance.
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