Life Science Outsourcing, Inc.
LSO provides comprehensive medical device sterilization, packaging, and testing services. They are FDA-registered and ISO 13485-certified, offering end-to-end solutions for OEMs and startups.
Life Science Outsourcing (LSO) is an FDA-registered and ISO 13485-certified provider specializing in end-to-end solutions for the medical device industry. They offer a full suite of services including cleanroom assembly, kitting, packaging, labeling, and sterilization. LSO coordinates multiple sterilization modalities such as EtO, steam, gamma, and ebeam, ensuring full validation to ISO 11135 and ISO 11137 standards. Their packaging testing services include ISO 11137 validations for accelerated aging, seal integrity, and distribution simulation, ensuring market readiness and regulatory compliance. As a single-source partner, LSO streamlines late-stage builds and documentation, reducing risk, lead time, and handoffs. They empower innovation and accelerate time-to-market with flexible, cost-effective solutions designed to scale with client growth, from startups to commercial OEMs.
About
**Who they are**
Life Science Outsourcing, Inc. (LSO) provides comprehensive medical device sterilization, packaging, and testing services. They are FDA-registered and ISO 13485-certified, offering end-to-end solutions.
**Expertise & scope**
* Offers contract sterilization services for single-use and reusable products, meeting all regulations and reporting requirements.
* Provides comprehensive end-to-end solutions, integrating assembly, kitting, packaging, and quick-turn sterilization under one roof.
* Specializes in sterilization validation services, including assistance with the evaluation of ideal sterilization methodologies.
* Supports various sterilization methods: Gamma, E-Beam, EtO, Steam, and Dry Heat.
* Conducts post-sterilization testing to ensure desired sterility levels are attained and assists in interpreting test results.
* Performs validation of sterilization processes to provide evidence of compliance to regulatory bodies, creating final reports that satisfy industry standards.
* Offers packaging validation, testing, and design to minimize costs while ensuring regulatory requirements are met.
* Provides cleaning and decontamination services.
**Reputation / proof points**
* FDA-registered
* ISO 13485-certified
Life Science Outsourcing, Inc. (LSO) provides comprehensive medical device sterilization, packaging, and testing services. They are FDA-registered and ISO 13485-certified, offering end-to-end solutions.
**Expertise & scope**
* Offers contract sterilization services for single-use and reusable products, meeting all regulations and reporting requirements.
* Provides comprehensive end-to-end solutions, integrating assembly, kitting, packaging, and quick-turn sterilization under one roof.
* Specializes in sterilization validation services, including assistance with the evaluation of ideal sterilization methodologies.
* Supports various sterilization methods: Gamma, E-Beam, EtO, Steam, and Dry Heat.
* Conducts post-sterilization testing to ensure desired sterility levels are attained and assists in interpreting test results.
* Performs validation of sterilization processes to provide evidence of compliance to regulatory bodies, creating final reports that satisfy industry standards.
* Offers packaging validation, testing, and design to minimize costs while ensuring regulatory requirements are met.
* Provides cleaning and decontamination services.
**Reputation / proof points**
* FDA-registered
* ISO 13485-certified
Additional information
Life Science Outsourcing, Inc. (LSO) emphasizes a partnership approach, acknowledging their crucial role in client success and adapting to evolving customer needs. They aim to accelerate product time-to-market and reduce costs through in-house expertise and efficiency. Clients benefit from access to pre-validated packaging solutions and validation services. LSO's Sterilization Validation Services (SVS) division handles the sterilization and validation of products and related documentation, archiving process records to remind clients about upcoming revalidations. They offer flexible sterilization cycles and full EtO validation, ensuring products are safe and compliance-ready.
Key Highlights
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Offers contract sterilization services for single-use and reusable products, meeting all regulations and reporting requirements.
Source
“Contract sterilization services for single-use and reusable products that meet all regulations and reporting requirements.”
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Provides comprehensive end-to-end solutions, integrating assembly, kitting, packaging, and quick-turn sterilization under one roof.
Source
“comprehensive end-to-end solutions such as integrating assembly, kitting, packaging, and quick-turn sterilization – all under one roof.”
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Supports multiple sterilization methods including Gamma, E-Beam, EtO, Steam, and Dry Heat.
Source
“SVS offers all popular sterilization methods including Gamma, E-Beam, EtO, Steam and Dry Heat.”
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Specializes in sterilization validation services, creating final reports to satisfy industry standards and customer-specific conditions.
Source
“SVS will create a final report with detailed information collected over the duration of the sterilization process. This report is designed to satisfy requirements of all prominent industry standards.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking end-to-end sterilization, packaging, and testing solutions.
- Companies needing support with sterilization validation and regulatory compliance.
How engagement typically works
- Partnership-focused approach.
- End-to-end service integration.
Typical deliverables
- Sterilized medical devices (single-use and reusable).
- Validated sterilization processes and reports.
- Medical device packaging and kitting.
- Testing services (e.g., bacterial endotoxin, bioburden).
Good to know
- Best when requiring a comprehensive, integrated service provider for medical device sterilization and validation.
HQ:
Brea, US
Languages:
English
Timezones:
America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Sterilization Methods Supported:
EtO (Ethylene Oxide), Steam (Moist Heat), Gamma Radiation, E-Beam
Validation Types Offered:
Revalidation, Full validation (IQ/OQ/PQ)
Microbiology Tests Offered:
Bacterial Endotoxin (LAL), Sterility
Standards Supported:
ISO 11135 (EtO), ISO 11137 (Radiation), ISO 17665 (Steam)
Is Accredited:
Yes
GMP Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Rush Available:
Yes
Accreditation Body:
ISO
Glp Compliant:
Yes
Quote SLA:
< 24 hours
Nda Support:
Yes
Lead Time Band:
Start in 0-2 weeks
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
EtO (Ethylene Oxide), Gamma Radiation, Electron Beam (E-Beam) Radiation, Steam (Moist Heat), Dry Heat
Validation Types Offered
Full validation, Revalidation
Microbiology Tests Offered
Bacterial Endotoxin Testing
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Custom
