We do not have a commercial-size chamber on-site, but we do work with business partner resources that have commercial chambers from 1 to 30 pallets. Speak with a service representative for more details.
Life Science Outsourcing provides documentation that meets FDA and EU requirements with each study.
We carry ISO 13485 certification with ISO 11135, ISO 11137, and ISO 17665, along with cleaning and decontamination within scope.
We do not use large commercial sterilization chambers and have not in any way been troubled by issues that shut down ETO plants outside California.
Life Science Outsourcing can perform/provide the repetitive cycle processing using a customer provided protocol that includes acceptance criteria.
- Gamma Sterilization
- Wet/Steam Sterilization
- Dry heat Sterilization
- Ethylene Oxide
- Sporicidal Chemicals
- Glass Plasma
- Irradiation (Gamma rays)
- Consulting Services
- Protocol Creation
- Cleaning & Decontamination Services
- Medical Device Testing
- Medical Device Validation
At LSO we have an onsite steam sterilizer and manage EtO, Gamma radiation, and E-Beam methods. We will develop a protocol, validate the sterilization process and provide a final written report that can be submitted to regulatory bodies.
- ISO 13485:2003
Requirements for Quality Management System of Medical Device companies
- ISO 25424:2009
Low-temperature steam and formaldehyde method
Ethylene Oxide method
Moist Heat/Steam Sterilization method
Guidance on Chemical indicators during Sterilization
Radiation/Gamma Ray method
LSO (parent company) via SVS is the only provider of Contract Steam Sterilization services on the West Coast. We can program any desired cycle parameters and duplicate an existing sterilization cycle or develop a cycle for specialized requirements. Sterilization Validations are performed according to ANSI/AAMI/ISO guidelines. Our staff will prepare the protocol, perform all required sterilization cycles, conduct all testing and generate a complete final report.
Finally, we are able to provide clients additional value through our sister divisions – Medical Device manufacturing (MDM), Medical Package Testing (MPT), Fulfillment & Distribution Services (FDS), Offshore Manufacturing, and Incubator Services (LSOIS).
At present, we have in our facility a 19 cubic feet Getinge Steam Sterilizer. Due to our current expansion activities, a 74 cubic feet Steam Sterilizer will be available soon.
Yes, SVS supply a Certificate of Sterility with each sterilization of your products.
Cleaning & Decontamination Services for reusable and test devices is offered at SVS. Based on exposure to biohazardous materials, a device might/might not have to undergo all three levels to achieve sterility. The levels in increasing order of intensity of are:
- Cleaning (Low level – Level 1)
- Disinfecting (Intermediate level – Level 2)
- Sterilization (High level – Level 3)
For further information visit our Cleaning & Decontamination Services page.