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

The SVS Solution

Through the use of process maps, we illustrate the benefits of outsourcing loaner kit processing activities to SVS. Scenarios are designed based on the level of OEM involvement you wish to maintain — as the degree of outsourcing increases, OEMs realize greater cost savings and free internal resources for core manufacturing and commercialization.

We want clients to feel secure and comfortable in their partnership with us. Multiple service options are available depending on operational control preferences and internal capacity.

Scenario 1: OEM-Managed Loaner Kit Processing

The traditional in-house model. OEM retains all processing activities; hospitals return kits to the OEM directly.

OEM

Original validation & qualification of loaner kits. Initial distribution. Collect contaminated kits from hospitals. Perform cleaning & decontamination. Packaging & kitting of reprocessed kits. Inventory and warehousing. Redeploy cleaned kits.

Hospital

Receives clean loaner kits. Uses the kits. Ships contaminated kits back to OEM.

Scenario 2: SVS Cleaning & Decontamination Partnership

OEM outsources cleaning and reprocessing to LSO. OEM still handles kit distribution and receipt.

OEM

Original validation & qualification. Initial distribution of loaner kits. Receives contaminated kits and ships them to LSO. Receives processed kits and redistributes to hospitals.

Hospital

Receives clean loaner kits. Uses the kits. Ships contaminated kits back to OEM.

LSO

Cleaning and decontamination of contaminated kits. Packaging & kitting of reprocessed kits. Redeploys cleaned kits to OEM.

Scenario 3: Direct-to-LSO Cleaning Partnership

Hospital ships contaminated kits directly to LSO, removing a transit step.

OEM

Original validation & qualification. Initial distribution. Receives processed kits and schedules distribution to hospitals.

Hospital

Receives clean loaner kits. Uses the kits. Ships contaminated kits directly to LSO.

LSO

Receives contaminated kits. Cleaning and decontamination. Packaging & kitting of reprocessed kits. Redeploys cleaned kits to OEM.

Scenario 4: Full Loaner Kit Program Management

LSO manages the entire lifecycle — cleaning, warehousing, scheduling, and distribution to hospitals.

OEM

Original validation & qualification. Initial distribution of loaner kits.

Hospital

Receives clean loaner kits. Uses the kits. Ships contaminated kits to LSO.

LSO

Receives used kits. Cleaning and decontamination. Packaging & kitting of reprocessed kits. Warehousing of cleaned kits. Schedules and distributes loaner kits directly to hospitals.

FDA-Registered

Manufacturing Facility

ISO 13485

Certified Quality System

12 Cleanrooms

Class 5–8

125,000+ Sq Ft

Regulated Manufacturing

3 Facilities

CA | NH | Costa Rica

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The SVS Solution | LSO