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Life Science Outsourcing Inc.

830 Challenger Street
Brea, CA 92821 USA
Tel: +1 714 672 1090
Fax: +1 714 672 1093

Web: http://www.lso-inc.com
E-mail: cricci@lso-inc.com


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About Life Science Outsourcing

 

    Life Science Outsourcing, Inc. is full service MEDICAL DEVICE CONTRACT MANUFACTURER, located in the heart of Southern California's healthcare and biotechnology region. LSO manufactures Class I through Class III devices including PMA products. LSO is registered for and certified to the following standards:

    • FDA 21 CFR-Part 820 (Contract Manufacturer & Contract Sterilizer)
    • ISO 13485: 2003 by NSAI (National Standards Authority of Ireland)
    • EN 554:1994 by; Contract Sterilization of Medical Devices by Moist Heat
    • State Of California; Device Manufacturing License
    • Canada; CMDCAS Health Canada
    • Japan; Certificate of Foreign Medical Device Manufacturer
    • Board of Pharmacy; Designated Representative License
    • ISTA (International Safe Transit Association)

    Please review all of our services and capabilities below and contact us with any questions that you may have. We are glad to be of service.

 

Business Services

 

 

Corporate Divisions

 

LSO's list of Contract Manufacturing Services include:

Medical Device Assembly

10,000 sq ft. Class 10,000 Clean Room

Biopharmaceutical Manufacturing

Class 100 Manufacturing Conditions

Offshore Manufacturing

Electro-Mechanical Manufacturing

Regulatory / Quality Support

Process Validation

Engineering Support

Micro Soldering

Micro Welding

Packaging Development

Packaging Validation

Medical Device Package Testing

Accelerated Aging Studies

Laboratory Testing Services

Gamma Sterilization

Ethylene Oxide Sterilization

E-Beam Sterilization

Dry Heat Sterilization

On-site Steam Sterilization

Sterilization Validation

Supply Chain Management

 

DEVICE ASSEMBLY

Solvent Bonding

UV Cure

Ultrasonic Welding

Electromechanical Assembly

Ultrasonic Washing

Micro Soldering

Micro Welding

Process Validation

PACKAGING

Package Design & Development

Heat Seal Qualification

Vendor Sourcing & Qualification

Pouch & Tray Sealers Onsite

PACKAGE VALIDATION

Acclerated Aging

Distribution Testing- ASTM

Package Integrity Testing

Package Strength Testing

Microbial Barrier Testing

Final Report

STERILIZATION

Validation Services for all types

On Site Steam Sterilization

EtO, Gamma, E-Beam

Turnkey-Protocol to Finished Report

Microbial Testing

FACILITY UTILIZATION OPTION

No minimum quantities required

Prototype development or small lot builds

Daily fee schedule

Engineering assistance available

OFFSHORE MANUFACTURING

30,000 SF Operation in Tijuana

ISO Certified

High Volume-Cost Effective

BIOPHARM MANUFACTURING

Class 100 Filling Suite

Terminal Sterilzation

Aseptic Transfer

 

ELECTROMECHANICAL MFG.

Active Electronical Devices

Control Systems

Procurement and Calibration Services

FULFILLMENT & DISTRIBUTION

Controlled Storage Facility

Worldwide Shipments

Instant Tracking Information

 

 


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