Single-use consumable qualification
End-to-end qualification of the bags, tubing, connectors, cartridges, and assemblies that make your manufacturing platform work.
The problem
Your manufacturing platform uses custom single-use consumables - bags, tubing sets, connectors, assemblies - and they aren't formally qualified. No specifications, no biocompatibility data, no E&L testing, and the contract manufacturers don't have quality agreements in place. This is where programs stall.
My approach
Risk-based qualification - not every component gets the same treatment. A product-contact bag holding patient cells for 72 hours gets a different strategy than a non-contact housing. I start with a full inventory and risk assessment, classify components by contact level and change category, then build the testing and documentation program from there. The output is actual documentation - protocols, test plans, specifications, and reports - not a recommendation deck.
What I deliver
Consumable risk assessment
Full inventory and classification by contact level, exposure duration, and change category.
Materials qualification
Materials of construction analysis, polymer ID, biocompatibility per ISO 10993.
E&L testing strategy
Risk-based study design per USP <665>, BPOG, ISO 10993-18. Protocol development and CRO coordination.
Qualification protocols & reports
Protocols with acceptance criteria, execution support, final reports.
Supplier qualification
Quality agreements, component specs, incoming inspection for each supplier.
Regulatory filing support
Documentation organized for CMC sections. Comparability strategy per ICH Q5E.
Who this is for
Cell therapy and biotech companies with custom single-use consumables that haven't been formally qualified. Programs preparing for PAS, BLA, or pre-approval inspections where consumable documentation is a gap.