FAQ
Answers to the most common questions Life Science Outsourcing receives in forging client relationships and bringing medical innovations to life.
Who is LSO’s typical customer?
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
What markets does LSO primarily serve?
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
What measures do you take to protect client intellectual property?
What does LSO offer with its Facility Utilization Option?
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.
Where are you located?
What Certifications does LSO currently hold?
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.
How can I stay updated on LSO services, events, and news?
Is there a minimum quantity for orders?
Does Life Science Outsourcing work with dental products?
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.
Can Life Science Outsourcing work with blister packaging?
Can Life Science Outsourcing provide expedited services for manufacturing?
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.
Does Life Science Outsourcing offer machining or molding capability?
What type of Engineering Services can you provide?
Engineering Services at MDM encompass:
- Process Development and Validation
- Process Optimization & Efficiency
- Documentation Support
- Product/Package Design Assistance
- Clinical Trial Builds
- Packaging Design & Development
What is the range of services that the Medical Device Manufacturing service provides?
A summary of MDM services:
- Precision Assembly & Testing
- Catheter Assembly
- Electromechanical Assembly
- Combination Products
- Process Development
- Facility Utilization Option
What about longer production runs/mass production?
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.
Do you supply raw materials/components?
I don't have any place to store my products; can you inventory them and ship them to me when needed?
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.
Do you provide the label or label design?
We can create custom labels for your product or project.
What are your lead times?
Can you produce products internationally?
What is the capacity of your Cleanrooms?
What temperature is typically used for accelerated aging?
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.
Why is it ok to perform distribution simulation and aging separately (in parallel)?
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.
Does Life Science Outsourcing perform testing in-house?
Do we need a testing protocol for our study? Can Life Science Outsourcing write the protocol?
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.
Do we have to perform real-time aging?
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.
What are the services/tests that the Medical Package Testing team provides?
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
What Certifications and Regulations does Medical Package Testing incorporate into its 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
What specific regulations followed by us for Medical Package Testing?
- 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
What is the range of testing conditions for Accelerated Aging that Medical Package Testing services provides?
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%)
What size packaging fits Medical Package Testing equipment best?
We can accommodate up to 120 Cu Ft. on our testing equipment.
What is Medical Package Testing’s ISTA test lab number?
Does Medical Package Testing provide consulting services?
We can advise clients on the following:
- Packaging Design (primary & secondary)
- Package Testing protocol
- Product material
- Complete packaging system
Does Life Science Outsourcing have a pallet-size chamber?
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.
Can you help with sterilization documentation related to 510(K) submission or CE Mark?
Is Life Science Outsourcing certified to ISO 11135?
Are you subject to the same issues that shut down ETO plants in other states?
Can you perform biological indicator qualification studies?
What services does Sterilization & Validation provide?
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
Does Life Science Outsourcing handle all types of product sterilization?
What Certifications and Regulations does Sterilization & Validation 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 - 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
What is so unique about Contract Steam Sterilizations services?
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.
What is the capacity of Life Science Outsourcing’s Steam Sterilizer?
Does Sterilization & Validation supply a Certificate of Sterility with each of its sterile products?
I have used devices that require decontamination. Can Life Science Outsourcing 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 – Level 1
- Disinfecting – Level 2
- Sterilization – Level 3
Does Life Science Outsourcing perform a validation to decontaminate field returned devices?
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.
Can Life Science Outsourcing perform high level disinfection studies?
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.
What are the requirements for shipping soiled medical devices to Life Science Outsourcing for decontamination?
What are field return prices and what standards are followed?
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.
Can Life Science Outsourcing handle large volumes of surgical trays for cleaning and steam sterilization?
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.
Can Life Science Outsourcing take over our operations (purchasing/inventory/shipping)?
We can store inventory and ship products upon request. It depends on the size and number of shipments per day.
Can we view our inventory through access to the Life Science Outsourcing system?
Can you give us better freight/parcel rates than we already get?
What type of reporting is available for our inventory/shipments?
Can we have a dedicated contact available immediately for the highest service levels?
How big is your facility / warehouse?
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
I don't have any place to store my products. Can you inventory and ship them to me when needed?
Can Fulfillment & Distribution distribute products to our clients?
What quality and warehousing system does Fulfillment & Distribution follow?
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
Does Fulfillment & Distribution require bar coding?
Can you follow vendor manual requirements?
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.
What are Fulfillment & Distribution distribution/shipping commitments?
- 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
Does Fulfillment & Distribution distribute to international locations?
What are the benefits of the Life Science Outsourcing’s Quality Incubator Support resources?
Who is a good candidate for Life Science Outsourcing quality incubator system services?
Who is Responsible for maintaining the quality management system?
Will Life Science Outsourcing register my company with the FDA?
Can Life Science Outsourcing quality incubator system services assist my company with GS1 barcode registration?
Bringing communication and clarity to our work with clients.
Company-wide FAQs
Who is LSO’s typical customer?
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
What markets does LSO primarily serve?
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
Learn More About the Markets We Serve
What measures do you take to protect client intellectual property?
Life Science Outsourcing operates under a Non-Disclosure Agreement with all companies prior to beginning discussions. When these companies become customers, they are assigned a three-letter code to protect their privacy. All internal discussions, documentation and warehousing facilities reflect only the companies’ letter code to insure privacy and confidentiality.
What does LSO offer with its Facility Utilization Option?
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.
Learn More About Our Facilities and Equipment
Where are you located?
LSO is located in Brea, California, about 30 minutes from the nearest Medical Device hub in Irvine. We are also near LAX Airport and Long Beach Port. Our location allows for greater monitoring and on-hands involvement with our offshore manufacturing partner, conveniently located just south of the border in Tijuana, Mexico.
What Certifications does LSO currently hold?
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.
Learn More About Our Certifications
How can I stay updated on LSO services, events, and news?
Medical Device Manufacturing FAQs
Is there a minimum quantity for orders?
There are no minimum orders. Our flexibility sets Life Science Outsourcing apart from most CMOs.
Does Life Science Outsourcing work with dental products?
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.
Can Life Science Outsourcing work with blister packaging?
Blister packaging depends on the blister pack and the size of the job. Two key elements are influential for such a project: Material and tooling cost(s), and touch-time. Speak with your service representative for more details.
Can Life Science Outsourcing provide expedited services for manufacturing?
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.
Does Life Science Outsourcing offer machining or molding capability?
We do not currently offer machining or molding capability. However, we do have preferred business partners we can recommend for your particular project.
What type of Engineering Services can you provide?
Engineering Services at MDM encompass:
- Process Development and Validation
- Process Optimization & Efficiency
- Documentation Support
- Product/Package Design Assistance
- Clinical Trial Builds
- Packaging Design & Development
What is the range of services that the Medical Device Manufacturing service provides?
A summary of MDM services:
- Precision Assembly & Testing
- Catheter Assembly
- Electromechanical Assembly
- Combination Products
- Process Development
- Facility Utilization Option
What about longer production runs/mass production?
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.
Do you supply raw materials/components?
Medical Device Manufacturing services group purchases, receives, inspects and warehouses components for many of their customers. Over the years we have built a very robust and reliable supply chain network that we use to source products.
I don't have any place to store my products; can you inventory them and ship them to me when needed?
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.
Do you provide the label or label design?
We can create custom labels for your product or project.
What are your lead times?
Lead times depend on many factors such as product complexity, logistics, resource requirements and other project considerations.
Can you produce products internationally?
LSO/MDM does not have a manufacturing operation outside the US, with the exception of our partner facility in Tijuana, Mexico. For more information, visit our Offshore Manufacturing website.
What is the capacity of your Cleanrooms?
Each company is granted the necessary square footage and tables necessary to develop and build its products. All Cleanrooms are CEPA certified and allow clients to closely observe and participate in product assembly.
- Class 100 Room (ISO Class 5) – 180 sq. ft
- Class 1,000 (ISO Class 6) – 500 sq. ft
- Class 10,000 (ISO Class 7) – 10,000 sq. ft
Medical Package Testing FAQs
What temperature is typically used for accelerated aging?
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.
Why is it ok to perform distribution simulation and aging separately (in parallel)?
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.
Does Life Science Outsourcing perform testing in-house?
Yes. We perform testing in-house at our Brea location in Southern California.
Do we need a testing protocol for our study? Can Life Science Outsourcing write the protocol?
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.
Do we have to perform real-time aging?
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.
What are the services/tests that the Medical Package Testing team provides?
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
What Certifications and Regulations does Medical Package Testing incorporate into its 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
What specific regulations followed by us for Medical Package Testing?
- 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
What is the range of testing conditions for Accelerated Aging that Medical Package Testing services provides?
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%)
What size packaging fits Medical Package Testing equipment best?
We can accommodate up to 120 Cu Ft. on our testing equipment.
What is Medical Package Testing’s ISTA test lab number?
The Medical Package Testing group is part of Life Science Outsourcing, Inc. (LSO), and is an ISTA-certified packaging test lab (ID Number ST-2339).
Does Medical Package Testing provide consulting services?
We can advise clients on the following:
- Packaging Design (primary & secondary)
- Package Testing protocol
- Product material
- Complete packaging system
Sterilization & Validation FAQs
Does Life Science Outsourcing have a pallet-size chamber?
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.
Can you help with sterilization documentation related to 510(K) submission or CE Mark?
Life Science Outsourcing provides documentation that meets FDA and EU requirements with each study.
Is Life Science Outsourcing certified to ISO 11135?
We carry ISO 13485 certification with ISO 11135, ISO 11137, and ISO 17665, along with cleaning and decontamination within scope.
Are you subject to the same issues that shut down ETO plants in other states?
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.
Can you perform biological indicator qualification studies?
Life Science Outsourcing can perform/provide the repetitive cycle processing using a customer provided protocol that includes acceptance criteria.
What services does Sterilization & Validation provide?
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
Does Life Science Outsourcing handle all types of product sterilization?
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 Sterilization & Validation 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 - 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
What is so unique about Contract Steam Sterilizations services?
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.
What is the capacity of Life Science Outsourcing’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 Sterilization & Validation supply a Certificate of Sterility with each of its sterile products?
Yes, we supply a Certificate of Sterility with each sterilization of your products.
I have used devices that require decontamination. Can Life Science Outsourcing 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 – Level 1
- Disinfecting – Level 2
- Sterilization – Level 3
Cleaning & Decontamination FAQs
Does Life Science Outsourcing perform a validation to decontaminate field returned devices?
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.
Can Life Science Outsourcing perform high level disinfection studies?
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.
What are the requirements for shipping soiled medical devices to Life Science Outsourcing for decontamination?
This is a common question from most companies we work with. Life Science Outsourcing prioritizes policy and guidelines. We defer to end-user site policy and follow the Association of Surgical Technologists (AST) guidelines. You can view the AST guidelines for reference.
What are field return prices and what standards are followed?
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.
Can Life Science Outsourcing handle large volumes of surgical trays for cleaning and steam sterilization?
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
Can Life Science Outsourcing take over our operations (purchasing/inventory/shipping)?
We can store inventory and ship products upon request. It depends on the size and number of shipments per day.
Can we view our inventory through access to the Life Science Outsourcing system?
We do not currently offer a digital tool to view inventory. We are considering future options to meet this request.
Can you give us better freight/parcel rates than we already get?
Life Science Outsourcing does not currently receive special shipping rates from shipping providers.
What type of reporting is available for our inventory/shipments?
Life Science Outsourcing can provide an inventory/lot number report upon request. We can also provide daily tracking to shipments that were sent out.
Can we have a dedicated contact available immediately for the highest service levels?
Our goal is to provide the best service available. We do not typically assign a dedicated contact. This allows us the flexibility to handle service requests quickly. We will do our best to accommodate your request if you need a dedicated contact.
How big is your facility / warehouse?
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
I don't have any place to store my products. Can you inventory and ship them to me when needed?
Our Fulfillment & Distributions solutions including ample dedicated warehouse space for your finished goods. Products can be shipped to you as and when needed, based on your convenience.
Can Fulfillment & Distribution distribute products to our clients?
We distribute finished goods to you as the customer or your end-users. We are certified to offer both domestic and international shipping. Our location in Brea, California, puts us in very close proximity to the Ports of Los Angeles and Long beach, major domestic airports and the Los Angeles International Airport (LAX). Our location is advantageous for international shipping and is convenient to meet the shipping needs of the majority of our clientele.
What quality and warehousing system does Fulfillment & Distribution follow?
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
Does Fulfillment & Distribution require bar coding?
While bar coding isn’t required, we will scan packages/products if the customer requires it. It especially saves time when receiving goods.
Can you follow vendor manual requirements?
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.
What are Fulfillment & Distribution distribution/shipping commitments?
- 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
Does Fulfillment & Distribution distribute to international locations?
Yes, we offer customers international fulfillment and shipping. International shipments require 48 hours for fulfillment.
Quality Incubator Support FAQs
What are the benefits of the Life Science Outsourcing’s Quality Incubator Support resources?
A big benefit for our customers is a virtual location. Customers use the Life Science Outsourcing address, conference room, and a cubical in the reception area. This flexibility allows our clients to focus on their priorities in-house as part of the Life Science Outsourcing team.
Who is a good candidate for Life Science Outsourcing quality incubator system services?
Start-ups are excellent candidates for our Quality Incubator Support services. Any start-up company that has a medical product will greatly benefit from teaming up with Life Science Outsourcing.
Who is Responsible for maintaining the quality management system?
Life Science Outsourcing will set up the quality system and provide it to customers for review and approval. We will maintain the quality management system as per regulations.
Will Life Science Outsourcing register my company with the FDA?
Yes. Life Science Outsourcing will assist with the FDA registration. If a customer uses our address, the FDA inspections will be conducted at the Life Science Outsourcing facility. The customer will represent the product, and we will represent the facility and process.
Can Life Science Outsourcing quality incubator system services assist my company with GS1 barcode registration?
Yes. Life Science Outsourcing can set up the registration and implementation of the UDI requirements.
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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