Sterilization & Validation
Discover LSO's expert sterilization and validation services for medical devices, ensuring compliance and innovation for medical devices.
Contract sterilization and validation services for single use and reusable devices
LSO offers comprehensive contract sterilization services and expertise to guide all medical device clients through the sterilization and validation of single use and reusable products and related documentation.
Services and Expertise
Our experienced sterilization and validation team has performed hundreds of validations and has extensive experience with all sterilization methods. Our turnkey sterilization solutions include consulting services to help navigate regulatory processes and determine the right sterilization methodology along with validation, testing, and sterilization activities, all backed by our stringent quality assurance system.
Sterilization
From heat and high pressure to chemical and radiation sterilization processes, our team ensures the proper methods are used to deliver a safe and compliance-ready product.
Testing
From biological indicator testing to chemical indicator testing, our medical device testing services ensure the proper sterility assurance level for all projects and products.
Validation
From purpose and objectives to detailed test methods and acceptance criteria, our validation services ensure protocols and documentation outline an effective and compliant process across all sterilization methods.
Your Partner in Innovation
Life Science Outsourcing’s Medical Package Testing services offer a turnkey solution for medical and pharmaceutical start-ups as well as original equipment manufacturers. With more than two decades of experience, our manufacturing and engineering experts work as an extension of your team, turning ground-breaking concepts into commercial-ready products.
We are ISO 13485 certified and FDA-registered with 10,000 square feet of state-of-the-art Class 10,000/ISO 7-rated cleanroom space.
Standards
Life Science Outsourcing has a proven track record in guiding companies through ISO standards across the medical device manufacturing process, including sterilization and validation.
Don't take our word for it!
We have been extremely impressed with LSO’s responsiveness, integrity, technical knowledge, attention to detail, passion for schedule and value. They surpass many of the larger more well known labs in all of these categories. LSO is our new go-to vendor for laboratory services!
- Bob, Director of Research
Knowledgeable team, prompt, professional service and a great partner for startup medical device companies. I would recommend LSO to my colleagues.
- Kit, Dir. Product & Market Development
...the team at LSO have been great to work with. Their decades of experience in packaging, sterilization, and validation, helped us accelerate the release of our medical device in record time.
- Goutam, CEO
Life Science Outsourcing has in-depth experience across sterilization processes.
- Wet/Steam Sterilization
- Ethylene Oxide (EtO)
- Gamma Sterilization
- E-Beam Sterilization
Methods
Heat/High Pressure
• Wet/Steam Sterilization • Dry Heat Sterilization Learn More
Chemical
• Ethylene Oxide (EtO) Learn More
Radiation
• Gamma Sterilization • E-Beam Sterilization Learn More [elementor-template id="2086"]
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
ISO 17025
Accredited Packaging Lab
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