Packaging & Kitting
We offer cleanroom packaging and kitting for small volume clinical builds and commercial manufacturing volumes.
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About
Insights
Industries
Solutions
Capabilities
About
Insights
We offer cleanroom packaging and kitting for small volume clinical builds and commercial manufacturing volumes.
The right packaging protects your product, your patients, and your launch timeline. Sanner provides validated medical device packaging, kitting, and assembly services for diagnostics and drug-device combination products, performed in ISO Class 7 and 8 cleanrooms under an ISO 13485-certified quality system that meets FDA, cGMP, and international combination product regulations.
Our packaging workflows ensure distribution readiness from first article to full-scale supply. Our process is documented to meet regulatory requirements and maintain product safety, with in-process controls and final inspection built into every run.
Sterile barrier packaging is performed using validated processes including pouch sealing, tray sealing and labeling. Barrier systems and formats are chosen for sterility needs and regulatory classification to protect product integrity during clinical and commercial use.
Our assembly services are built to scale with your product’s commercial journey. We assemble multi-component kits that combine devices, accessories, labeling, and instructions into a single, verified configuration. Our engineers create exceptional assembly and kitting processes for complex products that scale easily as volumes grow.
Sanner has provided desiccated packaging for optimized drug, diagnostic, and nutraceutical product stability for decades. We integrate drop-in, fit-in, and built-in desiccant solutions, supported by the Sanner Atmo Guard System® for predictive moisture management, to extend shelf life and safeguard moisture-sensitive products through the supply chain. This provides dependable supply chain support from development through commercial launch.
Labeling, final inspection, and release are managed under documented, validated workflows with complete traceability, keeping every lot compliant and audit-ready.
Packaging and kitting take place across Sanner’s in-house manufacturing network, including our Pittsboro, North Carolina facility with ISO Class 7 and 8 cleanrooms for device assembly and packaging, and our Tijuana facility with two ISO Class 8 cleanrooms totaling 14,000 square feet for sterile and non-sterile packaging at high volumes.
Our facilities are capable of packaging drug-device combination products within secondary containers, allowing us to kit drugs within pre-filled cartridges and pre-filled syringes. We offer drug kitting for clinical trials and the initial market release of new combination products.
All packaging sites are FDA-registered, ISO 13485-certified, and cGMP-compliant, giving you the reassurance of consistency and quality at every step.
