Frequently Asked Questions
Company-wide FAQs
LSO works with medical device companies of many sizes and types. Our model is best suited for organizations seeking the following advantages:
- Turnkey Solutions
- Cost & Efficiency Savings
- Reduced Overhead
- Ability and Flexibility to Focus on your Core Activities
- Quicker Time to Market
- Access to Industry Expertise
- Staffing Flexibility
- Risk-Sharing / Management
LSO has been in business for nearly 25 years and has served more than 1,400 companies. We specialized in several medical device sectors.
- Orthopedic
- Cardiac Rhythm Systems
- Cardiovascular
- Neurovascular
- Respiratory
- Gastrointestinal
- Dental Implants
- Minimally Invasive Devices
- Specialty Kits
- Oncology
LSO can provide Class 10,000/ISO 7-rated cleanroom space to early-stage companies that may not be registered with the FDA or that do not have their own facilities. We provide an option to rent cleanroom space on a daily basis to build prototypes or small lots and use equipment and engineering staff to assist you in the early stages of product development.
We maintain the following certificates as part of our quality system.
- FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer
- State of California: Device Manufacturing License
- State of California: Drug Manufacturing License
- International Standard ISO 13485:2016
- International Standard ISO 17665-1:2006 Moist Heat Sterilization
- International Standard ISO 11135:2014 Contract Ethylene Oxide Sterilization and Validation Services
- Japan Minister of Health: Medical Device Manufacturer, Sterile and Non-Sterile Devices
- ISTA Certified Package Testing Laboratory
- California Board of Pharmacy: Drug Wholesaler License
- California Water Boards: General Permit to Discharge Storm Water
Visit our certifications page to view or download a copy of each certificate.
Medical Device Manufacturing FAQs
Yes. Our Medical Device Manufacturing division has proven experience working with dental products. We also work with orthopedic and in vitro products and services, plus many more.
Yes, Life Science Outsourcing can provide expedited manufacturing services. This is just one of many offerings our customers benefit from and may utilize when needed.
Engineering Services at MDM encompass:
- Process Development and Validation
- Process Optimization & Efficiency
- Documentation Support
- Product/Package Design Assistance
- Clinical Trial Builds
- Packaging Design & Development
A summary of MDM services:
- Precision Assembly & Testing
- Catheter Assembly
- Electromechanical Assembly
- Combination Products
- Process Development
- Facility Utilization Option
Our Medical Device Manufacturing team works with all sizes and levels of organizations and does not require a firm forecast to build product. We have the flexibility and capacity to build quantities as low as clinical builds to as high as mass production.
We have ample dedicated warehouse space for your finished goods and components. Products can be shipped to you as and when needed, based on your convenience.
We can create custom labels for your product or project.
Medical Package Testing FAQs
This relates to the Food and Drug Administration (FDA) standard, ASTM F1980, “Accelerated Aging of Sterile Barrier Systems for Medical Devices.” It is the most appropriate standard for medical packaging. We typically see 55°C or 60°C, and for good reason. High-temperature aging tests can impact your study in a couple of different ways. Higher temperatures mean less time is necessary to complete the accelerated aging study. But higher temperatures also have higher risks. Some of the defects we might see are:
- Over time, seals can soften and loosen up.
- The material can delaminate.
- The packaging could change color.
Packaging materials can withstand these risks most of the time.
We follow International Organization for Standardization (ISO) standards for this. In ISO 11607-1: 2019, section 8.1, note #2, it says the following:
“Stability testing and performance testing are separate entities. Performance testing evaluates the interaction between the packaging system and the products in response to the stresses imposed by the manufacturing and sterilization processes and the handling, storage, and shipping environment.”
All medical device manufacturers must follow this standard in regard to sterile medical devices, ISO 11607, as they consider stability testing and performance testing as separate items.
Life Science Outsourcing has been writing protocols for many years for various size medical device manufacturers – from start-ups to multi-million-dollar companies. These protocols describe what exactly will be tested, what testing will be performed, the acceptance criteria for each test, and the standards to which each test will be run to.
It is highly suggested that if the testing being performed and the data from that testing is going to be used for an FDA, MDD, or any other type of regulatory submission, that you generate a protocol for the testing.
It’s easy to assume you won’t need to perform real-time aging if accelerated aging is a requirement of ISO 11607. But that assumption is not accurate.
ISO 11607 says stability testing shall determine that the sterile barrier maintains integrity over time and shall be performed using real-time aging. Furthermore, it states that real-time aging shall be started prior to commercialization. So, the answer is yes. Real-time aging has to happen and should not be overlooked.
We offer a comprehensive suite of package testing services:
- Accelerated Aging
- Package Validation Testing
- Visual Inspection Test
- Peel Strength Test
- Burst Test
- Dye Penetration Test
- Creep Test
- Bubble Emission Test
- Real-Time Aging
- Distribution Simulation
- Drop Test
- Vibration Test
- Compression Test
- Atmospheric Pre-Conditioning
- Shock Test
- Altitude Testing
- ISO 13485
- ISO 11607
- ANSI – American National Standards Institute
- AAMI – Association for the Advancement of Medical Instrumentation
- ASTM – American Society for Testing & Materials
- ISO – International Organization for Standardization
- ISTA – International Safe Transit Association
- ASTM-D4169
- ASTM-D642
- ASTM-F1140
- ASTM-F1980
- ASTM-F17
- ASTM-D4728
- ASTM-D999
- ASTM-F1886
- ASTM-F2096
- ASTM-E171
- ASTM-D5276
- ASTM-D4332
- ASTM-F1929
- ASTM-F88
- ISTA 1A
- ISTA 2A
- ISTA 3A
- ISO 11607
- ICH
- AAMI TIR22
LSO will perform customized Accelerated Aging Studies, specific to each customer’s needs. In most cases, temperatures range from 55-60 degrees Centigrade. Any desired humidity, refrigerated and freezing temperatures can be achieved.
Accelerated Aging Chambers
- 13 Accelerated Aging Chambers
- Temperature (-40C to 250C)
- Relative Humidity (5% to 90%)
Stability Chamber Environment Setting Ranges
- 6 Multipurpose Chambers
- Temperature (-40C to 250C)
- Relative Humidity (5% to 90%)
We can accommodate up to 120 Cu Ft. on our testing equipment.
We can advise clients on the following:
- Packaging Design (primary & secondary)
- Package Testing protocol
- Product material
- Complete packaging system
Sterilization & Validation FAQs
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.
We offer a comprehensive suite of sterilization validation services.
- 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
- ISO 13485:2003
Requirements for Quality Management System of Medical Device companies - ISO 25424:2009
Low-temperature steam and formaldehyde method - ISO11135-1:2007
Ethylene Oxide method - ISO17665-1:2006
Moist Heat/Steam Sterilization method - ISO15882:2008
Guidance on Chemical indicators during Sterilization - ISO11137-1:2012
Radiation/Gamma Ray method
Life Science Outsourcing 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. We provide clients additional value through our comprehensive set of solutions.
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 – Level 1
- Disinfecting – Level 2
- Sterilization – Level 3
Cleaning & Decontamination FAQs
Yes. We can perform a validation study that is specific to a product. We may assign one of our existing processes to decontaminate a medical device to allow for safe handling during field failure investigation. Your account representative will work with you on the best solution.
Yes, Life Science Outsourcing can perform high level disinfection studies. Speak with one of our representatives for more details on how we can work with your project.
Life Science Outsourcing follows decontaminant label Instructions and PPE as required per our procedures. Our process involves adopting one of our qualified cleaning work instructions to your device needs. We will have you review and approve the work instruction before use.
The cost for this service is anywhere between $140.00 and $250.00 per device (depending on device complexity), with one-time documentation set up of $500.00.
We will need information on the device, such as diagrams and pictures.
We would need to review and approve the daily quantity expectation and logistics to and from Life Science Outsourcing. Contact our service representatives for more information.
Fulfillment & Distribution FAQs
We can store inventory and ship products upon request. It depends on the size and number of shipments per day.
Facility features:
- 43,000 sq. ft Warehouse, Shipping facility, and Incubator Offices
- Secure GMP Warehouse
- Climate controlled storage available
- Three dock level shipping doors
- Two additional bay doors
- Ground-level access for trailers up to 53 ft
We are an ISO 13485 certified, FDA-registered facility and we follow GMP practices. Specific quality practices that we follow for warehousing and shipping are:
- 24-hour dock to stock
- FIFO System
- Lot Control for Traceability
- Monthly monitoring of expiration dates
- Live inventory reporting
Yes. Simply provide the manuals and we will follow the rules. If you need special labels, we can add them to your packaging, too. In many cases, we can produce special labels ourselves, but there is an additional charge.
- Same Day Shipping
- 100% of same day shipments received before 12:00 PST are processed and shipped
- 90% of standard shipments received before 12:00 PST will ship the same business day
- 100% of all orders are processed within 24 hours
- International shipments require 48 hours
Quality Incubator Support FAQs
