Transforming a 1,000+ SKU orthopedic portfolio into sterile-packed, single-use products

We helped a global orthopedic device leader transform a 1,000+ SKU implant portfolio from non-sterile to sterile-packed products through optimized sterile barrier packaging and enhanced medical device cleaning and sterilization management services. This scalable solution reduced waste, improved commercial performance and ensured hospitals and surgical teams could receive ready-to-use, sterilized implants for faster, safer procedures.

The challenge

A global orthopedic company needed a scalable, standardized sterile-barrier packaging solution for more than 1,000 orthopedic spinal screw SKUs, enabling them, for the first time, to present their products in portfolio-enhancing sterile barrier packaging. The solution needed to be fully validated, cost-efficient, and delivered within an 18-month timeframe, while also reducing packaging variation to streamline operations and minimize waste.

The complexity of the challenge lay in:

Devising and delivering a fully validated solution to meet commercial launch deadlines: The strict timeframe required a partner able to seamlessly integrate into the customer’s program and carry the initiative through to completion, not only bringing specialist sterile barrier packaging expertise and cleanroom manufacturing capabilities, but able to maintain operational continuity and execute at speed.

Operational complexity: The customer needed to manage extensive SKU variation across a high-volume implant portfolio with many small-batch production runs, while ensuring consistent quality, full traceability, and compliance.

End-user requirements: For hospitals and surgical teams, the packaging needed to be space-efficient, easy to handle and intuitive to use. The final format had to support efficient inventory management and enable faster access to the correct implants during spinal procedures.

The solution

We developed a tailored, scalable sterile barrier packaging strategy by consolidating more than 1000 SKUs into eight product groups, using product drawings, dimensions, weights, and forecasted volumes as the basis for rationalization.

To meet the project timelines, the final packaging solution followed our standard-plus approach, with the customized solution building on an existing double-blister tray or double-pouch sterile barrier system.

(See Packaging Systems Guide)

The execution

The comprehensive and industry-leading process we devised is conventionally difficult to achieve for projects and portfolios at this level of scale and complexity. It included:

Portfolio rationalization: review of the non-sterile 1,000+ SKU portfolio to consolidate it into the smallest possible number of packaging families with optimized sizes.

Packaging system development: design and development of double sterile-barrier packaging systems tailored to the consolidated portfolio.

Final implant processing: spinal implants rinsing and preparation for sterilized packaging.

Project implementation and process validation: covering supply chain recommendations and management, material selection, packaging tooling build, rinsing validation, packaging validation, gamma irradiation validation, accelerated and real-time aging studies, and distribution testing.

Commercial runs processing: rinsing, cleanroom sterile barrier packing and sterilization management for ongoing production.

Routine microbiological monitoring: Routine microbiological and environmental monitoring conducted through our ISO 17025–accredited laboratory, aligned with cleanroom control and biocontamination monitoring standards, including sterile barrier system and bioburden testing as part of our validated manufacturing environment.

The sterile end-of-line elements of our solution were executed within our ISO 7 and ISO 8 cleanroom environments to ensure full compliance with customer requirements.

Impact

By consolidating and simplifying packaging across multiple SKU variations, we helped our customer enhance the operational efficiency of their valued portfolio:

Accelerated production timelines by 18 months.

Delivered environmental and operational benefits by reducing material use and minimizing packaging waste.

Further accelerated project delivery and reduced NPI costs through our “worst case scenario” validation approach.

Supported long-term scalability by establishing a framework that allows our customer to respond rapidly to changing market needs and add new packaging systems seamlessly under existing validated processes.

Enabled clinicians to access sterile implants ready for use during spinal procedures, supporting a faster, safer and fully traceable workflow at the point of care.

Talk to our sterile-barrier packaging experts for orthopedic single-use devices

Discover how we can optimize sterile-barrier packaging, scale complex implant portfolios and accelerate your pathway to market. Get in touch today. We’re ready to help.

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