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.
At Life Science Outsourcing (LSO), we offer in-house, CDER-certified steam sterilization for pharmaceutical drug delivery components—including vials, syringes, and closures. Our on-site autoclave supports validated sterilization of heat- and moisture-stable materials, providing a compliant and reliable method to eliminate microbial contaminants. With everything under one roof, we help you simplify supply chains, accelerate timelines, and maintain full control from development to commercialization.
Steam sterilization uses pressurized saturated steam to eliminate microbial life from drug-contacting components. It’s one of the most established sterilization methods in pharmaceutical manufacturing, preferred by regulatory agencies for its effectiveness and repeatability.
Our in-house 74 ft³ (2.1 m³) autoclave is equipped with air overpressure and pre-vacuum cycles, supporting a range of applications from SVP solutions to porous loads. We do not perform pharmaceutical filling, but we specialize in sterilizing primary packaging and delivery components on-site, eliminating the need to outsource sterilization to a secondary vendor.
Pharmaceutical Manufacturers
Ensure compliance and sterility for injectable packaging components—without shipping product cross-country for sterilization.
Biotech Companies
Maintain control and minimize risk by sterilizing containers for biologics directly at our in-house facility.
Medical Device Companies
Sterilize drug-device combination components that require validated steam sterilization—performed under one roof.
Regulatory Affairs & Quality Teams
Work with a partner that provides in-house, CDER-certified services aligned with FDA and CGMP standards.
Hospital and Clinical Labs
Outsource sterilization of delivery tools and drug-contacting accessories with confidence in consistent, traceable, on-site processing.
Our in-house autoclave uses saturated steam under pressure to achieve sterilization temperatures between 121°C and 134°C.
By managing the sterilization process in-house, we reduce risk, improve traceability, and provide faster turnaround.
Our in-house steam sterilization services are designed to meet:
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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