Facilities & Equipment
Tour LSO's FDA-registered, ISO 13485 certified manufacturing facilities. 12 cleanrooms (Class 5-8), 125,000+ sq ft across California, New Hampshire, and Costa Rica.
Three Facilities, One Quality System
LSO operates 125,000+ square feet of FDA-registered, ISO 13485 certified manufacturing space across three locations. Each facility is purpose-built for regulated medical device production — not repurposed industrial space.
California (Brea) — Headquarters. Cleanroom assembly, packaging, sterilization, and the primary tooling center. Serves West Coast and international customers.
New Hampshire (Somersworth) — East Coast manufacturing hub. Cleanroom assembly, custom tooling, engineering labs, and prototyping. Serves East Coast and European customers.
Costa Rica — Nearshore manufacturing for cost-optimized production at scale. Cleanroom assembly and packaging with the same validated processes and quality system as the US facilities.
All cleanrooms are CEPA-certified with client observation access. Cleanroom class is matched to your device classification and assembly requirements.
12 Cleanrooms, Class 5 Through 8
Class 5 (ISO 100)
The highest level of particulate control. Used for implantable devices and components requiring the most stringent contamination control during assembly.
Class 6 (ISO 1,000)
Precision assembly for sterile devices with direct tissue or blood contact. Controlled access, gowning, and environmental monitoring.
Class 7 (ISO 10,000)
Standard sterile device assembly. Includes a dedicated Class 7 dry room for low-humidity manufacturing and solvent scouring of bioabsorbable polymers — a capability most CMOs cannot offer.
Class 8 (ISO 100,000)
Controlled environments for packaging, kitting, labeling, and non-sterile assembly. The most common cleanroom class for medical device packaging operations.
In-House Capabilities That Eliminate Outsourcing
Custom Tooling Center
An extensive tool room in the Somersworth facility enables rapid development of custom jigs, fixtures, and tooling for nearly any medical device or diagnostic application. LSO's ownership of precision machinery means your custom requirement gets met without the lead time and cost of third-party tooling vendors.
Engineering & Prototyping Labs
On-site labs support process development, quick-turn prototyping, and DFM (design for manufacturability) assessments. This is where validated processes are developed before they move to the production floor.
Quality Control Lab
Trained inspectors monitor incoming components, in-process assemblies, and final product releases. Inspection equipment includes optical measurement systems, force testers, and environmental monitoring tools.
In-House Sterilization
Steam sterilizers (17, 19, and 74 ft³) and EtO sterilizers (8 ft³ 3M chambers) provide quick-turn, single-lot release sterilization under one roof. Biological indicator (BI) testing is performed in-house for faster lot release. Contracted gamma, e-beam, and large-chamber EtO are available for high-volume or specialized requirements.
Warehouse & Logistics
Each facility includes 30,000+ square feet of GMP warehouse space with dock-level doors, 53-foot trailer access, climate-controlled storage, and barcode-based inventory tracking. Raw materials and finished goods are staged separately with full lot traceability from receiving through shipment.
Medical Device Incubator
LSO's incubator program gives early-stage companies access to cleanroom infrastructure, quality management guidance, FDA registration support, and validated manufacturing processes — without the capital investment of building their own. If you're launching your first device and need to go from prototype to production, the incubator program is designed for you.
Key Capabilities
125,000+ Sq Ft
Regulated manufacturing space across three FDA-registered facilities
12 Cleanrooms
Class 5 through 8, including a Class 7 dry room for bioabsorbable polymers
3 Locations
California, New Hampshire, and Costa Rica — geographic redundancy and cost optimization
In-House Sterilization
Steam and EtO sterilizers on-site for quick-turn, single-lot release
Custom Tooling
Rapid jig and fixture development — no third-party tooling vendor delays
GMP Warehouse
30,000+ sq ft climate-controlled storage per site with barcode tracking
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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