Top 10 Tips: Contract Manufacturing
September 2, 2024
Collaborating with the right Contract Manufacturer (CM) can have many benefits. The right CM provides program management, which anticipates the needs of…
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Pharmaceutical and Medical Device Sterilization Services
MANAGING THE PROCESS
Comprehensive Packaging, Labeling, and Sterilization Services for Medtech and POC Devices
At SMC Ltd., we act not just as a contract manufacturer, but as a trusted partner for fully integrated sterilization workflows. Whether you’re manufacturing a point-of-care (POC) diagnostic device, a single-use medical implant, or a combination device requiring terminal sterilization, we ensure your product arrives at the customer sterile, compliant, and ready for use.
These sterilization services are distinct from our state-of-the-art, in-house sterile fill finish capabilities for the pharmaceutical market.
WHAT WE DO
End-to-End Managed Medical Sterilization Services
We coordinate the entire process, from selecting the optimal sterilization method, through validation, processing, and final release, so you don’t have to piece together multiple vendors. Our services include:
- Contract sterilizer selection and management: We help identify and liaise with qualified external sterilization houses (EO, gamma, e-beam, etc.), and manage logistics to ensure process consistency.
- Validation protocol development and execution: Our project-team will create or review your sterilization validation plan (IQ/OQ/PQ or equivalent), execute it and handle re-validation when required.
- Finished-product processing: We package devices in pouches or trays, send them for sterilization, then perform kitting and post-sterile packaging if required, delivering a sterilized “ready-to-distribute” unit.
- Release-to-distribution logistics: Once processed, we can release units directly to your distribution center or POC facility, minimizing hand-offs and simplifying your supply chain.
WHY SMC?
The SMC Sterilization Services Advantage
In medical device and diagnostic manufacturing, sterility assurance is fundamental, not optional. A poorly validated sterilization path can delay launch, increase risk of recalls, or drive up cost. By choosing SMC for sterilization management, you benefit from one partner who wraps manufacturing and sterilization together, giving you more control, less risk, and faster time to commercial launch.
Seamless Device-Manufacturing Integration
Sterilization is built into every stage of your manufacturing process, from molding to packaging, for greater speed, consistency, and risk reduction. All SMC sites are FDA-registered and ISO 13485-certified, ensuring full alignment with med-tech regulatory standards.
Flexible Packaging and Kitting Capabilities
We support finished-device packaging into pouches or trays prior to sterilization and can perform post-sterile kitting or sub-assembly to support your supply chain.
Optimized for POC and Diagnostic Devices
Our sterilization services are tuned for high-mix, fast-cycle diagnostics and POC devices, where time-to-market and regulatory clarity matter most.
Reduced Vendor Complexity and Shorter Timelines
By coordinating sterilization as part of the bigger manufacturing ecosystem, we reduce hand-offs, simplify project management, and help you launch faster.
Thought Leadership
Explore Case Studies, Articles & Other Resources
Our medical device contract manufacturing capabilities, focused on single-use and disposable medical devices, include innovative autoinjector platforms designed for subcutaneous or intramuscular injection. These platforms can be customized to your drug formulation.
