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.
Customized and Efficient Design
MDI collaborates with process owners to understand their specific filling requirements to deliver a Modular and Customized Design. Ready-to-use, tailored systems reduce setup time, minimize errors, and ensure compatibility with various drug formulations and container types. Some of the key design requirements are -Consistent and Accurate Fill Volumes: Achieving consistent and accurate fill volumes is challenging in disposable systems. To address these issues, the assemblies can be designed using MDI AcuFlo™ accurate pump PCS Tubing and Acufil™ disposable SS filling needles that ensure accurate and consistent filling performance
Minimal Filling Losses: Despite design optimizations, residual hold-up may still lead to measurable product loss, particularly in high value low volume biologics. MDI AseptiBag™ HV, with negligible hold up volumes,are specially designed for minimizing losses of high value drug products in final fill operations. Optimized Flow Path: Smooth, low-hold-up flow paths and correctly sized tubing minimize shear stress, air bubbles, and ensure consistent, accurate filling.
Monitoring and Control of Particulate Matter
Particulate contamination in injectable drug manufacturing can lead to product rejection and serious patient risks. Key sources include component degradation, abrasion and environmental exposure. At MDI, all single- use systems are produced in ISO Class 7 cleanrooms under GMP. To further minimize particulate risks, AseptiBag HV’s fluid contact surfaces remain protected throughout manufacturing, and all tubing is flushed with 0.2μm filtered air to remove visible particles.
Technical and Regulatory Support
MDI offers end-to-end technical support, from prototype trials to installation and operation, along with complete documentation and regulatory guidance to ensure compliance and performance.