In-House Steam Sterilization for Drug Delivery Components
In-house, CDER-certified contract steam sterilization for drug delivery components like vials, syringes, and closures.
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 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.
What is Steam Sterilization for Drug Delivery Components?
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.
Who Needs Steam Sterilization for Drug Delivery Components?
How Does Steam Sterilization Work?
Our in-house autoclave uses saturated steam under pressure to achieve sterilization temperatures between 121°C and 134°C.
- Air overpressure cycles for sealed containers and liquid loads
- Pre-vacuum cycles for porous or complex components
- Every cycle is validated to ensure uniform steam penetration and reproducible microbial inactivation
By managing the sterilization process in-house, we reduce risk, improve traceability, and provide faster turnaround.
What Standards Apply?
Our in-house steam sterilization services are designed to meet:
- FDA requirements for drug and biologic components
- CDER certification for drug sterilization
- ISO 13485 for medical device quality systems
- USP <1211> and <1229> for sterility assurance
- 21 CFR Part 210/211 CGMP for pharmaceuticals
Why LSO?
- Everything In-House: Sterilization is performed on site at our FDA-registered, ISO-certified West Coast facility including a full validation team on staff to develop protocols per current ISO standards.
- CDER-Certified: Validated for sterilizing drug-contacting components used in injectable products
- Operational Efficiency: Eliminate shipping delays with sterilization, packaging, and labeling all in one place
- Responsive & Ready: Our technical team supports fast, compliant turnarounds for pharma and biotech clients
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