What does SVS stand for?
SVS stands for Sterilization Validation Services, which is a division of Life Science Outsourcing, Inc.
What services does SVS provide?
- 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
Does LSO handle all types of product sterilization?
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.
What Certifications and Regulations does SVS hold or abide by?
- 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
What is so unique about Contract Steam Sterilizations services at SVS?
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).
What is the capacity of LSO's Steam Sterilizer?
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.
Does SVS supply a Certificate of Sterility with each of its sterile products?
Yes, SVS supply a Certificate of Sterility with each sterilization of your products.
I have used devices that require decontamination. Can LSO help?
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.
What support services can SVS provide?
Through our six divisions, LSO strives to provide customers with a complete solution to their product development requirements. Service divisions include,
- Medical Device Manufacturing (MDM)
- Medical Package Testing (MPT)
- Sterilization Validation Services (SVS)
- Fulfillment & Distribution Services (FDS)
- Offshore Manufacturing
- LSO Incubator Services (LSOIS)
How can I stay updated on LSO services, events and news?
In addition to the company Website, LSO and industry news is regularly updated on to our Facebook page and Twitter account. You can also follow us on the Company Blog where we delve deeper into industry events and trends. Finally you can find us on YouTube through our corporate channel. In the near future we also hope to bring to you an industry newsletter.
What markets does LSO primarily serve?
LSO has been in business for fourteen years and has served approximately 250 companies. There are several clinical spaces and market segments that we have served. Please see the list below for a broad list:
- Cardiac Rhythm Systems
- Dental Implants
- Minimally Invasive Devices
- Specialty Kits