Validation Testing Services
Validation Testing Services LSO Medical Device Validation Testing for Sterility and Compliance Sterilization and validation testing are essential to ensuring medical device safety, regulatory compliance, and successful commercialization. Life Science Outsourcing (LSO) provides end-to-end validation testing services to support medical device manufacturers from development through commercial production. As an FDA-registered, ISO 13485–certified contract manufacturer, LSO […]
In-House Steam Sterilization for Drug Delivery Components
In-House Steam Sterilization for Drug Delivery Components LSO LSO offers in-house, CDER-certified contract steam sterilization for drug delivery components like vials, syringes, and closures. Improve compliance and reduce delays with on-site processing and full regulatory alignment. Steam Sterilization for Drug Delivery Components At Life Science Outsourcing (LSO), we offer in-house, CDER-certified steam sterilization for pharmaceutical […]
The SVS Solution
The SVS Solution LSO Through the use of process maps we try to show you the benefits of outsourcing Loaner Kit Processing activities to SVS. Scenarios have been designed based on the level of control the OEM wishes to maintain throughout the process. The further the degree of outsourcing by the OEM, the greater are its savings […]
Glossary
Glossary LSO Sterilization Validation Services Glossary of Terms Bacteria Living single cell w/out organized nucleus (>0.22 micron). Biological Indicator (BI) A test system containing viable microorganisms providing a defined resistance to a specified sterilization process Cleaning Physical removal of organic soil from an item to the extent necessary for further processing or for the intended […]
ISO Standards
ISO Standards LSO The purpose of regulations and best practices for Sterilization/Decontamination is to create operating procedures that ensure safety of the staff and the medical device. Regulatory bodies stipulate standards on personal protective gear (gloves and face masks), work environment, sterilization equipment utilization and maintenance (Autoclaves, Dry ovens and Gamma ray Irradiators) and much […]
Gamma and E-Beam sterilization and Validation
Gamma and E-Beam sterilization and validation LSO Managed Gamma and E-Beam Sterilization Services Maximize the safety and sterility of your medical devices with LSO’s managed gamma and E-Beam sterilization services, complemented by our in-house steam and EtO sterilization capabilities. Gamma and E-Beam offer residue-free, efficient solutions ideal for a variety of products, from disposable medical […]
Cleaning & Decontamination
Cleaning & Decontamination LSO Decontamination is the process of cleaning and disinfecting used medical devices so that they may be reused or tested by engineers. But before the used device is handled by anyone, it is required by law that it be decontaminated to ensure safety of the staff. To perform this task, the company […]
Contract Sterilization
Contract Sterilization LSO Sterilization is critical as the last process performed before a device is used. As with all of LSO’s comprehensive one-stop-shop offerings to manufacturers, our contract sterilization services are offered and performed with criticality and reliability in mind. Short cuts are simply not an option when it comes to sterilization and our customers […]
Loaner Kit Processing
Loaner Kit Processing LSO Loaner Kit Processing and Program Management Loaner kit processing is an essential operational requirement for original equipment manufacturers that support surgical procedures. Managing loaner kits internally consumes time, labor, and capital that would otherwise be directed toward core manufacturing and commercialization activities. Outsourcing loaner kit processing to LSO’s Sterilization Validation Services […]
Services
Services LSO Sterilization Validation Services are a part of our complete turnkey solution for customers. From initial assessments of product resistance to final validation summary reports, our expert team of sterilization scientists are here to navigate the sterilizer validation process with you. We take great pride in our commitment to provide clients with unparalleled responsiveness, […]