This presentation will provide elements for creating a comprehensive passivation validation package and understanding the different options to passivate.
Quality System Expectations : Single-Use Materialsgueste42f6b5
Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.
FDA and other governing bodies controlling the standards of medical devices are reaching deeper into the supply chains that support OEMs. As a result, OEMs are now re-evaluating their supplier quality strategies to ensure that every machined component and piece of raw material entering their production floor is 100 percent validated – making quality management a more complex undertaking. Evaluating material suppliers from a risk mitigation standpoint has become a challenging, and somewhat elusive, undertaking for manufacturers of medical devices. The session will answer the questions: What is risk mitigation as it applies to raw material suppliers in the medical device industry? How can orthopaedic device companies combat it?
This presentation will provide elements for creating a comprehensive passivation validation package and understanding the different options to passivate.
Quality System Expectations : Single-Use Materialsgueste42f6b5
Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.
FDA and other governing bodies controlling the standards of medical devices are reaching deeper into the supply chains that support OEMs. As a result, OEMs are now re-evaluating their supplier quality strategies to ensure that every machined component and piece of raw material entering their production floor is 100 percent validated – making quality management a more complex undertaking. Evaluating material suppliers from a risk mitigation standpoint has become a challenging, and somewhat elusive, undertaking for manufacturers of medical devices. The session will answer the questions: What is risk mitigation as it applies to raw material suppliers in the medical device industry? How can orthopaedic device companies combat it?
US Patent Pending 12/978,469
Single Valve Cylinder Head
Investment Opportunity for a disruptive technology with potential to affect many internal combustion engine applications. Engine has 30% less part count, substantial emission/polution reduction, and major gains in fuel efficiency and power. This is due to the superior breathing ability of the cylinder head. Basically, the design makes multiple poppet valve heads obsolete by allowing the single valve to be similar in diameter to the cylinder bore.
This presentation discusses how isolator-barrier technology integrated with robotics enhances product sterility, aseptic manufacturing flexibility and regulatory compliance.
With the biopharma industry focus on producing biologic and protein based therapies the manufacturing paradigm is requiring a shift from dedicated high volume manufacturing strategy to one that requires flexibility to produce low volumes of high value products in multiple delivery systems. Technologies are emerging that provide not only a high degree of flexibility, but also provide a foundational manufacturing template that can be leveraged to reduce cost and risk. One of the key enabling technologies is the more recent introduction of ready-to-use vials and cartridges, which compliment well established pre-filled syringes options, allows manufacturers to adapt their current manufacturing mindset to one that is more affordable and responsive to current and future pipelines. This presentation will discuss the key market trends associated with the manufacture of biotherapies, automated aseptic processing of pre-sterilized ready-to-use (RTU) containers (e.g. vials, syringes, and cartridges) on a modular manufacturing platform for these products, and experiential based recommendations for implementation of RTU formats in aseptic processes.
Anecto's ISO 17025 accredited test facility provides world class support to product developers, designers and manufacturers. The state of the art laboratory is supported by technologists and engineers who also design and manufacture specialist products and support customer's warranty programmes.
With over 12 years experience as a company providing Product and Packaging Testing, Consultancy, Support, Bespoke Test Equipment and Protocol Development to the Medical Device Industry Anecto understands and responds to those challenges.
Anecto have a totally up to date knowledge of, understanding of and adherence to the pertinent regulations and standards stipulated by the FDA, the European Medical Device Directive, ISO 11607. We also understand that our clients successful compliance may require a combination of these and other relevant regulation depending on where in the world the product is to be distributed
A review / introduction of problem solving tools for achieving process improvement / control and waste reduction - this is available as an animated PowerPoint presentation
NeoSeal Adhesive is manufacturer and supplier of the finest quality solvent cement for PVC, UPVC (PVC-U), CPVC and ABS piping system. NeoSeal products are used for potable water, irrigation, SWR, conduit, sewer, drain, waste and vent system in agriculture, residential, commercial and industrial plumbing applications. We offer a complete line of solvent cement in the industry with products specifically formulated for a wide variety of applications.
Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technolog...Merck Life Sciences
Watch the interactive on-demand webinar here: https://bit.ly/2G8KSMu
The cost to develop and manufacture monoclonal antibodies has been highlighted as a substantial hurdle towards the widespread availability of these effective therapies for patients. Facility costs, utilization and labor are key contributing factors to the overall cost of these critical medicines. A proven method to increase utilization of a facility, increase process and quality robustness and lower overall costs of manufacturing is through the automation of a manufacturing process. The transformative impact that digital technologies have had on other industries’ manufacturing operations through IT and OT can be applied to the evolution happening in biopharma today. Examples of commonly used unit operations such as bioreactor, mixing and chromatography will be presented to illustrate incremental improvements that can be achieved today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.
In this webinar, you will learn:
- Incremental improvements that can be achieved today using process automation
- Practical examples of commonly used operations to illustrate the impact of automation
- How the automated facility will look like in the future
US Patent Pending 12/978,469
Single Valve Cylinder Head
Investment Opportunity for a disruptive technology with potential to affect many internal combustion engine applications. Engine has 30% less part count, substantial emission/polution reduction, and major gains in fuel efficiency and power. This is due to the superior breathing ability of the cylinder head. Basically, the design makes multiple poppet valve heads obsolete by allowing the single valve to be similar in diameter to the cylinder bore.
This presentation discusses how isolator-barrier technology integrated with robotics enhances product sterility, aseptic manufacturing flexibility and regulatory compliance.
With the biopharma industry focus on producing biologic and protein based therapies the manufacturing paradigm is requiring a shift from dedicated high volume manufacturing strategy to one that requires flexibility to produce low volumes of high value products in multiple delivery systems. Technologies are emerging that provide not only a high degree of flexibility, but also provide a foundational manufacturing template that can be leveraged to reduce cost and risk. One of the key enabling technologies is the more recent introduction of ready-to-use vials and cartridges, which compliment well established pre-filled syringes options, allows manufacturers to adapt their current manufacturing mindset to one that is more affordable and responsive to current and future pipelines. This presentation will discuss the key market trends associated with the manufacture of biotherapies, automated aseptic processing of pre-sterilized ready-to-use (RTU) containers (e.g. vials, syringes, and cartridges) on a modular manufacturing platform for these products, and experiential based recommendations for implementation of RTU formats in aseptic processes.
Anecto's ISO 17025 accredited test facility provides world class support to product developers, designers and manufacturers. The state of the art laboratory is supported by technologists and engineers who also design and manufacture specialist products and support customer's warranty programmes.
With over 12 years experience as a company providing Product and Packaging Testing, Consultancy, Support, Bespoke Test Equipment and Protocol Development to the Medical Device Industry Anecto understands and responds to those challenges.
Anecto have a totally up to date knowledge of, understanding of and adherence to the pertinent regulations and standards stipulated by the FDA, the European Medical Device Directive, ISO 11607. We also understand that our clients successful compliance may require a combination of these and other relevant regulation depending on where in the world the product is to be distributed
A review / introduction of problem solving tools for achieving process improvement / control and waste reduction - this is available as an animated PowerPoint presentation
NeoSeal Adhesive is manufacturer and supplier of the finest quality solvent cement for PVC, UPVC (PVC-U), CPVC and ABS piping system. NeoSeal products are used for potable water, irrigation, SWR, conduit, sewer, drain, waste and vent system in agriculture, residential, commercial and industrial plumbing applications. We offer a complete line of solvent cement in the industry with products specifically formulated for a wide variety of applications.
Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technolog...Merck Life Sciences
Watch the interactive on-demand webinar here: https://bit.ly/2G8KSMu
The cost to develop and manufacture monoclonal antibodies has been highlighted as a substantial hurdle towards the widespread availability of these effective therapies for patients. Facility costs, utilization and labor are key contributing factors to the overall cost of these critical medicines. A proven method to increase utilization of a facility, increase process and quality robustness and lower overall costs of manufacturing is through the automation of a manufacturing process. The transformative impact that digital technologies have had on other industries’ manufacturing operations through IT and OT can be applied to the evolution happening in biopharma today. Examples of commonly used unit operations such as bioreactor, mixing and chromatography will be presented to illustrate incremental improvements that can be achieved today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.
In this webinar, you will learn:
- Incremental improvements that can be achieved today using process automation
- Practical examples of commonly used operations to illustrate the impact of automation
- How the automated facility will look like in the future
DCN Diagnostics. Design and Development of Lateral Flow Assay SystemsBrendan O'Farrell
DCN Diagnostics designs and develops rapid assay systems for medical and veterinary diagnostics, bio-defense, agriculture, environmental testing and other market segments. DCN's service offering includes contract assay development, education and training courses in lateral flow technologies, industrial design and mechanical engineering services related to development of related devices for rapid diagnostics. Our specialties include lateral flow, flow through and microfluidic assay formats, and we have developed qualitative, quantitative, visual or fluorescent assay systems. DCN's ISO 9001:228 and EN 13485 compliant quality system is set up to allow us to deliver the full FDA compliant design history file. Our process and unique teams of highly experienced development scientists working alongside our engineering teams allow us to deliver the product, not just the parts. DCN Diagnostics is the sole supplier of cellulose nanobead technology for lateral flow diagnostics outside of Japan and can supply technical consulting and development assistance to companies wishing to develop and manufacture highly sensitive and quantitative lateral flow assays using the NanoAct (tm) beads. Our experience in multiplexing and joint ownership in the Symbolics patents covering aspects of multipex arraying in lateral flow formats allows DCN to assist our clients in creating highly unique and functional assays for any environment or application. DCN also provides our unique UltraGold (tm) colloidal gold for use in lateral flow assays. DCN's 40nm gold colloid is highly controlled, very stable and designed specifically for use in lateral flow and flow through assays.
Proven Process Medical Devices, Design, Development, Testing, and ManufactureMichael Kanis
Medical Device, Diagnostics, Therapeutics, Surgical tools, FDA, QSR, Therapeutics, Implantables, Drug Delivery Pumps, RF Ablation Devices, Project Management, Class 7 clean room, High risk Class II and III devices.
Aligning QMS and Engineering Processes in Medical Product DevelopmentIntland Software GmbH
Intland Software's presentation at MedConf 2019
Learn more about Intland Retina and our template for MedTech product development: https://content.intland.com/blog/introducing-intlands-new-medtech-development-templates
Considerations for Manufacturing Commercial Antibody Drug Conjugates (ADCs) -...Merck Life Sciences
ADC manufacturing presents a unique set of challenges as compared to the well established practices employed for more traditional biologic products.
The development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re well informed when it comes to the dos and don'ts of manufacturing commercial Antibody Drug Conjugates (ADCs). Tune in to hear a CMO perspective for an in-depth understanding on the subject of manufacturing commercial ADCs. Our team will discuss all of the considerations that must be addressed to successfully manufacture ADCs.
In this webinar you will learn:
- Facility Design and Cleaning Validation
- Advantages of Single Use Systems
- Process Control and Regulatory Strategies
Considerations for Manufacturing Commercial Antibody Drug Conjugates (ADCs) -...MilliporeSigma
ADC manufacturing presents a unique set of challenges as compared to the well established practices employed for more traditional biologic products.
The development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re well informed when it comes to the dos and don'ts of manufacturing commercial Antibody Drug Conjugates (ADCs). Tune in to hear a CMO perspective for an in-depth understanding on the subject of manufacturing commercial ADCs. Our team will discuss all of the considerations that must be addressed to successfully manufacture ADCs.
In this webinar you will learn:
- Facility Design and Cleaning Validation
- Advantages of Single Use Systems
- Process Control and Regulatory Strategies
Globalization has made it easier than ever to ignore where our clothes come from. The fashion industry has complex connections to many other fields, including manufacturing, advertising, production of raw materials, transportation and retailing. Begin to educate consumers about the importance of APPAREL STANDARDS.
Brownlie Design Overview Process and ProductsScott Ryan
An overview of our firm, process and the recent products we have developed. As a passionate Industrial Design firm, committed to excellence we welcome any opportunity to share our vision.
1. Catheter Research, Inc.
Company Overview
2012
Catheter Research, Inc.
5610 W. 82nd Street
Indianapolis, IN 46278
Phone: (317) 872-0074
Fax: (317) 872-0169
2. About CRI
Catheter Research Inc. (CRI) specializes in catheters and tubing, and
has expanded as a developer and manufacturer of medical devices.
Our goal is to provide the most cost-effective product development
combined with quality OEM medical device manufacturing.
3. About CRI
• History: Established in 1987 as • Business Model
an engineering firm focused on 20% 3%
Contract Manufacturing
catheter development. CRI proprietary products
sold directly to end user
Contract design and
design for manufacturing
77%
• Current Status:
• ISO 13485:2003 Certified.
• Thomas Medical
• 100% Medical Portfolio. • Proprietary product line
• 130 Employees. for OB/GYN market.
• 100% ESOP – Employee
Owned.
• Customer Types: Medium to
large medical device
manufacturers.
6. Manufacturing
• Assembly Capabilities • Extrusion Sub-Contractors
• Heat Forming • Multi Lumen / Metal Reinforced
• Welding/Bonding Tubing
• Ultrasonic Welding • Bump / Taper Extrusion
• RF Welding • Cleanroom Operations
• Plasma Treatment • ISO Class 8 Cleanroom Facility
• Balloon Bonding
• Packaging and Labeling
• UV / CA & Solvent Bonding
Techniques • Laser Etching/Marking
• Pad Printing • Tooling for high volume
• Insert Molding throughput
• Tipping • Test and Calibration
• Swaging/ Crimping • Tensile Testing
• Accelerated Aging
• Hole Punching / Skiving • Sterilization validations
• Extrusion In-House • Bioburden / Biocompatibility
• Single lumen, high volume • Burst Testing
7. Manufacturing
• Manufacturing Principals: • Made to Manage ERP System:
• Lean Manufacturing: • Fully integrated sales,
• Maximizes customer value while engineering and production
minimizing waste .
• Results in lower and controlled costs. modules with financial reporting.
• Visual Manufacturing:
• Organized work centers and • Team Approach for
processes .
• Indicators at all stages of process.
manufacturing transfers:
• Assign dedicated Project
• Document Control: Manager.
• Fully implemented change • Focus on improving process and
control system for all documents product, resulting in lower costs
for a fully compliant Quality and improved quality.
Management System. • Minimize effort for customers.
• Device Master Records (DMR)
• Device History Records (DHR)
8. Design & Engineering
• Engineering staff with extensive • Software
background in all phases of • Solidworks 3D CAD system
design & development. • MiniTab
• Types of Engineers: • Adobe Professional Programs
• Design
• Manufacturing
• Biomedical
• Quality
• Specialize in medical
device disposables
• Design for Manufacturing (DFX)
• Rapid Prototyping
9. Project Management
• Dedicated Project Manager assigned for:
• New Design
• Design Changes
• Manufacturing Transfers
• Project Management
• Device review including regulatory requirements.
• Document review coordinated with CRI team.
• Manufacturing transfer coordinated with project plan and outline.
• Inventory transfer documentation and coordination.
• Inventory control for product life cycle.
• Project cost estimates.
• Budget & performance tracking monthly.
• Detailed invoicing with individual time logs.
10. Supply Chain Management
• Supply Chain Management
• Focus on economic order quantities
based on:
• Price
• Delivery
• Storage Costs
• Minimal obsolescence with excellent
communication to customers.
• Change management agreements
including multiple department
approvals at critical suppliers.
• Utilizing MRP system for ensuring
on time deliveries to meet customer’s
due dates.
11. Quality and Regulatory
• FDA registered manufacturer, • Recent audits:
and specification developer • FDA
• Only one minor finding
recorded during last two FDA
• ISO 13485:2003 – CAMCAS inspections in eight years.
Certified
• Registrar is BSI America. • BSI Americas
• No major non-conformances.
• CE and CMDR compliance • Minor observations and
recommendations only.
• Notified Body is BSI (UK).
• Major medical device
• Quality System: customers
• Fully implemented, simple to use • No major non-conformances.
and compliant. • Minor observations and
• Three page Quality Manual recommendations only.
designed as a tool to navigate
the Quality System. • Internal audit program
• CAPA system utilized and fully • Twelve employees trained by BSI
compliant during audits. to perform internal audits.
• 100% on time per schedule.
13. Customer Focus
• Customer Service staff focused on being the internal advocates
for our customers to ensure a high level of satisfaction.
• Receives and confirms all customer orders.
• Manages special requests for shipping,
receiving, and invoicing.
• Documents customer inquiries and tracks
RMAs, complaints, and feedback.
• Provides quotations.
• Monitors on time delivery
and customer satisfaction.
• Coordinates surveys from customers
for vendor approval:
• Vendor Capabilities, Quality surveys/certifications,
ROHS, DEHP, BPA, Latex.
• Initial point of contact when customers
want to initiate change.
• Customer Focus is part of CRI’s
Quality Policy and is valued by all employees.
14. News, Events, and Community
• Recent News and • Community:
Upcoming Events: • Annual ACS ‘Strides Against Breast
• January, 2012 BioCrossroads Cancer’ walk in October.
Frameworx Event Featured COO • Annual Thanksgiving Campaign:
Christine Cook as Panelist. • Food Drives and/or Monetary Donations
• CRI to host IUPUI Biomedical benefiting Wheeler Missions, Local
Families, Gleaner’s Food Bank.
Engineering senior design class
visit in April 2012. This will be the • Annual Christmas Campaign:
4th annual event. • Gift Drives and/or Monetary Donations
benefiting Samaritan’s Purse, United
• Thomas Medical to exhibit at 2012 Christmas Service.
ACOG May 5th-9th, San Diego,
• Many other community events
booth # 730.
including:
• Thomas Medical to Exhibit at 2012 • School Supply drive for employees, Flu
ASRM Oct 20th -24th , San Diego, shots for employees, American Red
booth # 219. Cross Donations for national disasters.