Frequently Asked Questions

Bringing communication and clarity to our work with clients.

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

Learn More About the Markets We Serve

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.

 

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

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.

 

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

Medical Device Manufacturing FAQs

There are no minimum orders. Our flexibility sets Life Science Outsourcing apart from most CMOs.

 

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.

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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.

 

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.

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We do not currently offer machining or molding capability. However, we do have preferred business partners we can recommend for your particular project.

 

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

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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.

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.

 

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.

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We can create custom labels for your product or project.

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Lead times depend on many factors such as product complexity, logistics, resource requirements and other project considerations.

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.

 

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

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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.

Yes. We perform testing in-house at our Brea location in Southern California.

 

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.

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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

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  • 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

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  • 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

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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%)

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We can accommodate up to 120 Cu Ft. on our testing equipment.

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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).

 

We can advise clients on the following:

  • Packaging Design (primary & secondary)
  • Package Testing protocol
  • Product material
  • Complete packaging system

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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.

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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.

 

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

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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
  • 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.

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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, we 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 – Level 1
  • Disinfecting – Level 2
  • Sterilization – Level 3

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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.

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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.

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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.

 

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.

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Fulfillment & Distribution FAQs

We can store inventory and ship products upon request. It depends on the size and number of shipments per day.

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We do not currently offer a digital tool to view inventory. We are considering future options to meet this request.

 

Life Science Outsourcing does not currently receive special shipping rates from shipping providers.

 

Life Science Outsourcing can provide an inventory/lot number report upon request. We can also provide daily tracking to shipments that were sent out.

 

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.

 

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

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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.

 

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.

 

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

While bar coding isn’t required, we will scan packages/products if the customer requires it. It especially saves time when receiving goods.

 

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.

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  • 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

Yes, we offer customers international fulfillment and shipping. International shipments require 48 hours for fulfillment.

 

Quality Incubator Support FAQs

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.

 

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.

 

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.

 

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.

 

Yes. Life Science Outsourcing can set up the registration and implementation of the UDI requirements.

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