Life Science Outsourcing

Loaner kit reprocessing with the turnaround surgeons expect

Cleaning, decontamination, and inspection for loaner kits and reusable surgical instruments

Loaner kit
FDA-Registered Manufacturing FacilityISO 13485 Certified Quality System12 Cleanrooms Class 5–8125,000+ Sq Ft Regulated Manufacturing3 Facilities CA | NH | Costa Rica

Kits sitting in limbo. Hospitals calling about missing instruments. Surgeons waiting on trays that should have been back days ago. And somewhere in the back of your mind, you're wondering if your cleaning validation would survive an audit.

Reprocessing Capabilities

End-to-End Loaner Kit Management

Receive, clean, inspect, repackage, and ship — the full cycle under one roof with complete traceability. 24–48 hour standard turnaround with expedited options for urgent surgical cases. Your kits move through a validated process, not a backlog.

Validated Cleaning Processes

EPA-registered cleaning agents and validated protocols for surgical instruments, implants, and reusable devices.

Visual & Functional Inspection

Trained inspectors verify device integrity, cleanliness, and functionality against your specifications.

Real-Time Inventory Tracking

Track every kit from hospital return through cleaning, inspection, and reshipment. No more spreadsheets, no more phone calls asking where a tray is.

Biocompatibility Testing

Residual contamination and endotoxin testing to verify cleaning effectiveness.

24–48 hour standard turnaround. Real-time kit tracking. FDA-registered facility with validated cleaning processes. Your kits are never out of sight or out of compliance.

From Assessment to Ongoing Operations

1

Program Assessment

Review your kit inventory, turnaround requirements, and cleaning specifications.

2

Protocol Development

Develop validated cleaning and inspection procedures specific to your devices.

3

Pilot Processing

Process initial kits to validate workflow, turnaround time, and quality standards.

4

Full Production

Routine kit processing with real-time tracking and quality reporting.

5

Continuous Improvement

Monthly quality reviews and process optimization based on throughput data.

Any of This Happening?

Your loaner kit program has grown past what your team can process internally. Kits are sitting longer. Surgeons are waiting.
Hospitals are calling about missing instruments or kits that aren't arriving clean. Your field team is firefighting instead of selling.
An FDA or ISO auditor asked for your cleaning validation records. What you have won't hold up.
You're promising 48-hour turnaround but consistently missing it. Surgeon satisfaction is slipping.
You're launching a new reusable instrument and need validated cleaning protocols before you can go to market.

Get a turnaround assessment for your program

Tell us about your kit volume, device types, and turnaround requirements. Our program management team will assess your needs and propose a processing plan within 48 hours. Best fit for orthopedic loaner kits and reusable surgical instruments requiring validated reprocessing at scale.

What Happens Next

Who

A cleaning & decontamination program manager

When

Within one business day

About

Kit volume, device types, current turnaround challenges, and quality requirements

Frequently Asked Questions

Our standard turnaround is 24–48 hours from receipt to ship-ready. This includes incoming inspection, validated cleaning, visual and functional inspection, repackaging, and final release. For urgent surgical cases, we offer expedited processing with same-day or next-day turnaround. Turnaround commitments are defined in your program agreement and tracked against KPIs that we review with you monthly.

Every kit is scanned at each stage — receipt, cleaning, inspection, packaging, and shipment. You have real-time visibility into where each kit is and what stage of processing it's in. No more calling to ask where a tray is. We provide a tracking dashboard and can integrate with your inventory management system. At any point, you can see exactly how many kits are in-process, completed, or in transit.

During inspection, our team checks every instrument against your tray configuration and specifications. If we find damage (bent tips, worn surfaces, failed functionality) or missing components, we flag it immediately and notify your field team before the kit ships. You decide whether to ship with a noted exception, hold for replacement instruments, or route to repair. Damaged and missing component reports are tracked over time so you can identify patterns and address systemic issues.

When you add a new instrument or device to your program, we develop a cleaning validation protocol specific to that device's geometry, materials, and soil load. Validation includes cleaning effectiveness testing (visual, TOC, endotoxin) across worst-case conditions. Once validated, the protocol is locked into our QMS and applied consistently to every processing cycle. If the device or cleaning agent changes, we revalidate.

Yes — scalability is a core part of our program design. We've supported loaner kit programs from initial launch through hundreds of kits in circulation. Our capacity planning accounts for your growth forecast, seasonal volume spikes (orthopedic procedures peak in Q4 and Q1), and geographic expansion. If you're adding new surgical specialties or expanding into new territories, we adjust processing capacity ahead of demand so turnaround times don't slip as you grow.

We use EPA-registered enzymatic and alkaline cleaning agents validated for medical device reprocessing. Cleaning methods are matched to your device requirements — ultrasonic cleaning for complex geometries, manual cleaning for delicate instruments, and automated washer-disinfectors for high-throughput processing. Every cleaning protocol is validated per your specifications and documented in our QMS. We can also accommodate specific cleaning agent requirements if your device IFU mandates a particular chemistry.

You receive monthly quality reports covering: turnaround time performance vs. commitment, kit throughput volume, inspection findings (damage, missing components, cleanliness), CAPA status, and trend analysis. These reports are the basis for our monthly quality review meetings. We also provide real-time alerts for critical findings — if we see a pattern of damage on a specific instrument, you'll know about it before the next monthly report.