Sterilization Services for Medical Devices
Life Science Outsourcing has in-depth expertise selecting and executing sterilization services in strict compliance with regulations and ISO standards.
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.
- Quick-turn single LOT release EtO sterilization run in our in-house 3M chambers (chamber size: 8 ft^3, 0.22 m^3)
- In-house testing of biological indicator sterility, to reduce turnaround times for lot release
- Expedited validation services that leverage preexisting validated cycles
- Two pallet chamber cycles based on Sustainable “low concentration” cycles the meet future EPA guidelines
- Two pallet chamber cycles that reduce initial lead time by as much as 8 months due to our Strategic Relationship with the Sterilizer
- Validations developed for our small LOT chambers that can be transitioned to a 2 Pallet cycle as required
In-House Contract Sterilization Solutions
- In-House Steam Sterilization with 17 ft3, 19 ft3, and 74 ft3 sterilizers
- In-House EtO Sterilization – 8 ft3 sterilizers
- Biological Indicator (BI) Testing
- Contracted Gamma and e-beam
- Contracted Large Chamber EtO capabilities
Sterilization Methods
Sterilization methods remove or destroy all forms of microbial life including bacterial spores by either physical or chemical processes.
Sterilization is accomplished principally by steam under pressure, dry heat, or chemical sterilants. The choice of the method for sterilization depends on a number of factors including the type of material of the object to be sterilized, the number and type of microorganisms involved, the classification of the item, and the availability of sterilization methods.
- Wet/steam sterilization
- Dry heat sterilization
- Ethylene oxide
- Sporicidal chemicals
- Glass Plasma
- Irradiation (Gamma rays)
