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Lab automation, contract product development and manufacturing for medical and life science OEMs, regulatory affairs consulting, industrial automation...

Automation / Contract Equipment Design, Development and Manufacturing for Medical and Life Science OEMs / Industrial Automation 

Life Sciences and Laboratory Automation - Lab / Pharmaceutical Automation Equipment. Laboratory Automation for Genomics, Proteomics, Clinical Diagnostics, Stem Cell Research, High Throughput Screening, Microscopy...Robotics and Instrumentation... Compatible Labware:  Microplates, vials, tubes, caps....   Laboratory Instrument Development and Manufactruing:  Contract Electro-Mechanical Design, Styling and Ergonomics, Development, Contract Manufacturing, Global Service and Support of Installed Base...Robotic Automation:  Robotic Systems utilizing SCARA robot arms, 6-axis articulated arms, cartesian xyz gantry robots, etc. Developement and Manufacturing of Microscope Loaders and Automation for Readers, Washers, Incubators, Electron Microscopes, Mass Spectrometers...System  Integration for Laboratory Processes....Reader, Washer, Dispenser, etc, integration with Robotics, Dynamic and Static Scheduling, Instrument Drivers...Turnkey Systems, see FLASH, MINILAB and QUICKSTACKClinical Diagnostics Example:  Blood sample handlers for cholesterol testing.  Developed/manufactured by SSI for OEM.  Fluidics, Robotics, Mass Spec, etc. ISO Standards
Medical device manufacturing, medical equipment development (design, build, manufacture), regulatory affairs/testing/qualification...Biojector Medical equipment contract development and manufacturing for OEM accounts, design validation, testing and design control per ISO 13485, GMP, FDA standards - Robotic oncology table exampleRobotic test automation  Cleanroom Automation for Biological Tissue Processing/Class 1 Medical Devices:  Fluid handling, sterile, aseptic, clean-in-place equipment development and manufacturing.  Heavy Duty Industrial Automation Example:  Multi-purpose, industrial, heavy payload, adhesive dispense, press and rotary table...In-line, conveyorized processing example / assembly, test, packaging...

General Services Guide

 
Services Info Request  
Contact Us
Products  Standard products page
Overview  Overview of Services 
Automated Manufacturing Equipment  - Assembly and Manufacturing Equipment
  -Medical Automation  - Past Medical Device Manufacturing Equipment Projects
Contract OEM Services - Contract Product Development/Manufacturing/Regulatory
  -Contract Product Development - Outsource your Equip. Development to SSI 
  -Contract Equipment Manufacturing - Outsource your Equip. Mfg. to SSII
  -Example Projects - Contract Development and Manufacturing Examples 
 
 
 
Other Related Pages:   
Products Page - Standard Automation Systems - Flash, MiniLab, QuickStack...
Robot Integration Page Industrial Automation and Robotics
Semiconductor Page Automated Test / Inspection
Machine Vision Page Machine Vision Integration
Labeling / Marking Page Labeling / Laser / Inkjet Marking
Capping Systems Tube Cappers / Uncappers...
Machine Tending Material Handling and Machine Tending
Injection Molding Page Injection Mold Loading/Unloading and Automated Insert Molding 
Publications - Cleanrooms Magazine / Journal for Structural Biology 
Home Back to Home Page
 

Overview

General Overview:  Our primary services include process automation, contract equipment development and manufacturing for OEM clients and regulatory affairs assistance in combination with our equipment development/manufacturing contracts.  

Life Sciences Overview:  We adapt our Lab Automation products (FLASH, MINILAB, QUICKSTACK, etc) to a wide range of bio/med/pharma processes.  We also develop and manufacture specialty systems for the laboratory automation (biotech / clinical diagnostics / clinical trials / research), medical and pharmaceutical markets.  Specific niche areas may include genomics, proteomics, cellular research, molecular diagnostics, cellular analysis, histology, tissue growth/storage/analysis, biological tissue processing systems (sanitary / aseptic / CIP - Clean In Place equipment for human-implantable devices such as heart valves, etc), bioengineering and analytical chemistry.  Our systems and capabilities include robotic automation and instrument integration, machine vision, automated testing, data acquisition and control, software integration for LIMS, Databases and Networks, lab process scheduling, data analysis, automated labware handling, pharmaceutical process automation, cleanroom automation, contract medical device development / manufacturing, contract laboratory instrument development and manufacturing for OEMs, automated medical device assembly and packaging equipment, fluid and powder dispensing / filling, marking / labeling, information systems, data analysis, etc.  For standard automation platforms see our separate Products Page , or explore the links at the top of this Services Page to learn more.

 

Certifications and Compliance:

bulletISO 9001 Certified
bulletISO 13485 Certified
bulletGMP Compliant
bullet21 CFR Part 820 and Part 11 (As Required)
bulletMDD (Medical Device Directive - As Required) 
bulletIVDD (In Vitro Diagnostic Devices - As Required)
bulletFDA Registered

 

Automation, Manufacturing Equipment and Robotics  

Cleanroom Automation for Biological Tissue Processing/Class 1 Medical Devices:  Fluid handling, sterile, aseptic, clean-in-place equipment development and manufacturing.  High speed robotics, automated test, labeling, etc.Heavy Duty Industrial Automation Example:  Multi-purpose, industrial, heavy payload, adhesive dispense, press and rotary table...Robotic Automation:  Robotic Systems utilizing SCARA robot arms, 6-axis articulated arms, cartesian xyz gantry robots, etc. In-line, conveyorized processing example / assembly, test, packaging...

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Industrial / Factory Automation

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Special Machinery Design, Development and Build

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Robot Integration / Motion Control (See Robot Integration Page)

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Lab Instrument Integration / Labware Handling 
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See Lab Products Page

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See Compatible Laboratory Instruments Page

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Cleanroom Process Automation (See Medical Device Automation Section)

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Dispensing / Filling (See Dispensing Page)

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Sorting and Compound Management (See Compound Mgt and Tube Sorter Pages)

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Drug Discovery Workcells (See Drug Discovery Page)

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Automated Test / Inspection (See Semiconductor Page)

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Machine Vision Integration (See Machine Vision Page)

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Labeling / Laser / Inkjet Marking (See Labeling / Marking Page)

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Capping / Uncapping (See Capper Page)  

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Assembly / Manufacturing Machinery

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Material Handling / Machine Tending / Mold Unload (See Machine Tending and  Injection Molding Page)

bulletMedical Device Manufacturing Equipment (See Medical Device Automation Section)
bulletFor Implantables, Disposables…
bulletISO 13485, FDA, USDA, GMP, 21 CFR
bulletSanitary / Aseptic / Sterile / Cleanroom
bulletProcess (Temp, Press, Flow..) / SPC
bulletSoftware Development
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PLC - Allen-Bradley, GE, Omron, Mitsubishi…

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PC - C, C++, Visual Basic, LabView…(~30 languages)

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HMI - Touch Screen, Graphical User Interfaces…

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Data Acquisition - Pressure, Temperature, Position…

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Scheduling - Scheduling Software Integration for Lab Automation

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Drivers - For Instruments, Tools, Machinery...

Medical Device Manufacturing Equipment Examples

 Cleanroom Automation for Biological Tissue Processing/Class 1 Medical Devices:  Fluid handling, sterile, aseptic, clean-in-place equipment development and manufacturing.
 

 

 

Medical Device Manufacturing Equipment: 
bulletImplantable Medical Devices 
bulletSanitary, Aseptic, Sterile
bulletClean in Place (CIP)
bulletHuman / Animal Tissue Processing
bulletProcess Control (Temp, Press, Flow, SPC)  

Example Heart Valve System (Left Image) - 5 systems process 2,000 human heart valves simultaneously per customer specifications.

 

 
 

 

 

Medical Device Assembly Systems: 
bulletDisposables - Catheters, Syringes...
bulletElectromechanical Devices 
bulletFDA, USDA, GMP, 21 CFR Part 11 
bulletPackaging, Inspection...

High Speed Assembly Example (left image) - 2 systems automatically feed, fill, heat seal and assemble 288,000 disposable devices per 8-hour shift 

 

Services Info Request - Contact SSI for CD's, product details or to discuss your specific application.   

Contract OEM Services

Contract Product Development
Contract Equipment Manufacturing
Example Projects 
 

Medical equipment contract development and manufacturing for OEM accounts, design validation, testing and design control per ISO 13485, GMP, FDA standards - Robotic oncology table exampleLaboratory Instrument Development and Manufactruing:  Contract Electro-Mechanical Design, Styling and Ergonomics, Development, Contract Manufacturing, Global Service and Support of Installed Base...Developement and Manufacturing of Microscope Loaders and Automation for Readers, Washers, Incubators, Electron Microscopes, Mass Spectrometers...

Contract Product Development

We develop (and manufacture) automated equipment, laboratory instruments and medical devices to meet the requests of OEM's. This strategy enables our OEM "partners" to focus on the development of their scientific methods or other core technology, instead of diluting resources to develop the "ready-to-sell" product.  Let SSI take on this burden as we specialize in turning concepts into products.  We are also the ideal source to manufacture and support such products over the long term.  Applicable capabilities include:

bulletEngineering / Consulting (Mechanical, Electrical, Industrial...)
bulletContract design, develop and manufacture
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Project Management / Coordination Between Parties

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Computer-Aided Design (SolidWorks, Pro Engineer, AutoCad and Inventor)

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Contract design and analysis / Engineer and Ph.D level

bulletIndustrial product design and styling
bulletPrototyping / machining partners / fabrication
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Confidential Projects

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Separate and secure building available for proprietary projects

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Software / Programming
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Instrument Drivers and Interfacing

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Laboratory Process Scheduling / LIMS Interface (See Drug Discovery

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Compound Management (See Compound Management)

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Motion Control, Machine Control

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C++, Visual Basic, Ladder Logic, Lab View

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HMI (Human Machine Interface), GUI (Graphical User Interface) Development

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Network and Database Interfacing

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Custom Software Applications

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Vision System Programming (Cognex, DVT, Keyence...)

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Industrial Robot Programming (Parker, Staubli, Bosch, Motoman, Yamaha, Adept, Epson, Fanuc, ABB).

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Medical and Laboratory Equipment Development
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Robotic and Motion Systems  

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Fluid Handling Systems

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Robotic Oncology Tables (Develop for OEM)

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Design Control / Testing / Certification / Validation  

A few examples are provided below in the Example Projects section.  

Contract Equipment Manufacturing

Many OEM instrumentation firms have the capability to manufacture automated equipment and instruments.  Instead, they choose to focus on furthering the development of their core technology, leaving the manufacturing and service/support task to SSI.  SSI has the experience and capacity to provide hundreds of identical, highly reliable systems per year for each of its OEM partners.  As needed, we also provide support of the installed base through our global service network.  Manufacturing services include:
bulletContract Manufacturing for OEMs
bulletManufacturing per:
bulletISO 13485
bulletISO 9001
bulletGMP (Good Manufacturing Practices)
bulletFDA Registered
bulletAssembly according to strict procedures
bullet100% product testing 
bulletDesign Controls
bulletQuality Assurance / Quality Control
bulletService and Support (North America, Europe and Asia)
bulletFull documentation, user's manuals, etc.
bulletWorld-wide Installation and training

Example Projects - Contract Development/Manufacturing Projects: 

Examples of Contract Development and Contract Manufacturing of Equipment/Instruments/Medical Devices for private labeling by our OEM partner/customers follow.  
 
 
 
"SSI Robotics has developed practical 'outside of the box' solutions to our technical challenges"                                     -Customer/Director of Engineering
 
 
 
 
Medical equipment contract development and manufacturing for OEM accounts, design validation, testing and design control per ISO 13485, GMP, FDA standards - Robotic oncology table example 
 

Medical Device / Oncology / Robotic Tables:  The images above depict an Oncology Table Development and Manufacturing Project performed for SSI's customer.  SSI was contracted to develop and manufacture oncology table retrofit kits per ISO 13485 / FDA standards.  SSI performed the conceptual analysis by presenting a wide range of potential table concepts.  One of the electro-mechanical versions was selected which SSI then designed and manufactured for the customer.  

 

 

Robotic test automation

Semiconductors / Test Handlers:  The chances are high that the memory boards in your computer were tested using SSI's test handlers. Several hundred of the memory board handler shown above (left) were produced at rates of up to 10 units per week and then sold/supported/serviced world wide.  The systems shown above were produced both for SSI's in-house sales effort, and for OEM's to private label and sell in conjunction with their test equipment.   DFM (Design For Manufacturing), DFA (Design For Assembly) and additional methods were applied by SSI to flush out costs.  FMEA (Failure Modes and Effects Analysis) and a wide range of engineering methods and quality programs were implemented to ensure fail-safe operation during high-throughput, 24/7 use.  Many systems are still in use today around the globe after 10 years of service.  

 

 

Biojector Example
 
 
 
Medical Device Expertise / The Biojector:  Note - The Biojector Needle-Free Injection Managment System is shown above.  The founder of SSI Robotics is a co-inventor of The Biojector including US Patents 5,520,639, 5,399,163 and 5,383,851.  This project was performed prior to founding SSI.

 

Publications

CleanRooms Magazine article covering SSI's approach to cleanroom and lab automation projects featuring the MINILAB (see pages 11 and 12)
Journal of Structural Biology article covering SSI's early FLASH version, applied in these case as the world's first Automated Transmission Electron Microscope (TEM) Loader.  This project was funded by the NIH through a grant to The Scripps Research Institute, which  subcontracted to SSI Robotics.