medaccred

How Medical Device Alloys Are Heat Treated

/ FEATURED NEWS, MEDICAL HEAT TREAT, MEDICAL HEAT TREAT NEWS, TITANIUM PROCESSING TECHNICAL CONTENT, VACUUM FURNACES TECHNICAL CONTENT

Roger Jones, FASM–CEO Emeritus, Solar Atmospheres (source: Solar Atmospheres)

Heat Treat Today’s Medical and Heat Treating December 2019 issue featured an article on medical alloys.  Heat Treat Today asked Roger Jones, CEO Emeritus of Solar Atmospheres, Inc., to comment on how specialty medical metals are heat treated. These include titanium, niobium, tantalum, nitinol, and copper, to name a few, which in turn are used to create such standard medical devices and equipment as diagnostic guide wires, miniscule screws for implants, complex surgical tools that are operated robotically, and more. Read to see how Roger describes the hot zone and conditions under which medical device alloys are heat treated.

To read the full article to which Roger Jones’ comments pertain, go to Medical Alloys Their Uses and Heat Treatments

Vacuum furnace chambers processing titanium, niobium, chrome cobalt, and other medical device alloys are typically constructed from stainless steel. The hot zones are comprised entirely of metal (moly); graphite materials are never used in the construction of the hot zone or in fixturing parts. These furnaces process medical device alloys exclusively to avoid cross-contamination of the hot zone or the medical parts being treated.

Ultimate vacuum levels should be 1 X 10-6 Torr or better, with leak rates no greater than 2 microns Hg per hour. Gas system isolation valves aid in achieving tight vacuum, as they eliminate constant pumping on the quench system. Vacuum furnace leak up procedures are performed weekly, as well as a bake out at 2400 °F for one hour.

Horizontal, front-loading vacuum furnace with all-metal hot zone in a cleanroom setting typically used for heat treatment of medical alloys and devices (source: Solar Atmosphere)

Because of the alloys processed, cooling gases are mainly high purity argon from a liquid source. Very seldom is nitrogen used for cooling. Either type K or type N Inconel clad work thermocouples are imbedded in the loads for precise temperature readouts at +/- 10 °F or better. Processes include vacuum annealing, aging, stress relieving, solution treating, hardening, tempering, and other special processing. All furnaces are approved to the MedAccred quality standard, are surveyed to AMS 2750E, and comply with AS9100D in their processing parameters. Because the alloys are thermally treated, the vacuum furnaces operate in an air conditioned clean room with controlled temperatures and humidity levels.

To read the full article to which Roger Jones’ comments pertain, go to Medical Alloys Their Uses and Heat Treatments

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15 Quick Heat Treat News Items to Keep You Current

/ FEATURED NEWS, HEAT TREAT NEWS INDUSTRIES

15 Quick Heat Treat News Items to Keep You Current

Heat Treat Today offers News Chatter, a feature highlighting representative moves, transactions, and kudos from around the industry.

Personnel and Company Chatter

  • Construction on an expansion recently broke ground for Premier Furnace/BeaverMatic's plant 1 facility in Farmington Hills, Michigan. This expansion will provide space for a state of the art testing and training facility, additional manufacturing capabilities, as well as increased office space to allow Premier/BeaverMatic to accommodate business growth and customer needs. The additional 22,000-square foot space is expected to be completed by fall 2018.
  • Paul Banks as plant manager for Novelis Inc.'s recently announced $300 million automotive aluminum sheet manufacturing facility in Guthrie, Kentucky. Banks assumes the role of plant manager after previously serving as unit manager at Logan Aluminum, a Novelis joint venture in nearby Logan, Kentucky.
  • Electroplating and heat treating specialists Electro-Spec, headquartered in Franklin, Indiana, is expanding its operations with a new plating facility in Lexington, South Carolina, that will serve the automotive, aerospace, telecommunication, military, radio frequency and microwave, and medical markets in the southeast U.S.
  • A heat treating company based in Lima, Ohio, recently expanded its capacity with a new draw furnace and quench tank. Heat Treating Technologies expects the $3 million investment to boost the company's thermal processing offerings in carburizing, carbonitriding, annealing, hardening, normalizing, and carbon restoration.
  • An industrial oven manufacturer based near Williamsport, Pennsylvania, recently added a second manufacturing facility to its operation. JPW Industrial Ovens and Furnaces' Plant 2, will produce the company’s expanding line of standard industrial ovens. Plant 1, located in Trout Run, will continue to craft custom-made industrial ovens and serve as the company’s headquarters. The new plant is expected to create 25 new jobs within the next two years.

Equipment Chatter

  • Three natural gas-fired box furnaces were recently shipped to a parts manufacturer for the oil and gas industry by Lindberg/MPH, to be used to develop process control requirements for heat-treating and stress relieving of underground mining/drill heads. The goal is to double the life of the tooling through research which would revolutionize industry standards. The maximum operating temperature rating for the stress relieving box furnaces is 2050°F and work chamber dimensions are 36" wide x 20" deep x 24" high. The box furnaces were designed to meet a temperature uniformity of +/-15°F at 1700°F and 2050°F per the requirements of AMS 2750E, Class 3 furnaces and Instrumentation D.
  • An aluminum casting company recently received shipment of an electrically heated horizontal quench system to be used for solution treating aluminum castings for the aerospace and automotive industries. The solution treating furnace was designed and manufactured by Wisconsin Oven Corporation to heat a 2,500-pound load of aluminum, plus basket and work grid to an operating temperature of 1,020°F. The maximum temperature rating for this horizontal quench system is 1,250°F, sized for a 5'0" wide x 5'0" long x 5'0" high basket. The horizontal quench system was designed to meet AMS2750E (Class 2, Instrumentation Type C) and with reporting to meet AMS 2771E requirements.
  • A heat treating equipment manufacturer recently shipped ten furnaces to companies in California, Georgia, Ohio, Washington and Wisconsin, and also to one location in Asia. This equipment will be used to process parts for companies in the aerospace, commercial heat treating, and medical industries. Ipsen USA shipped: two TITAN® furnaces – one H2 12-bar with a 18" x 24" x 18" (457 mm x 610 mm x 457 mm) work zone and one vertical 2-bar furnace; two MetalMaster® furnaces – one vertical 6-bar with a 96" D x 96" H (2,438 mm x 2,438 mm) work zone and 10,000 pound (4,500 kg) load capacity, and one horizontal 10-bar with a 96" x 84" x 96" (2,438 mm x 2,134 mm x 2,438 mm) work zone; one VFS® horizontal internal quench 10-bar vacuum heat-treating and brazing furnace; and several custom-built atmosphere furnaces that will process parts for the aerospace industry.
  • A retort furnace was recently shipped by L&L Special Furnace Co., Inc., to a northeastern US manufacturer of motor laminations to be deployed on motors primarily for government-based aerospace products. The furnace has a work zone of 17" square with a typical load weight of 250 pounds and is built in accordance with ASTM standards. Annealing of silicon iron and similar laminations are treated in a pure dry hydrogen atmosphere. A pure dry hydrogen atmosphere is provided to balance strength and magnetics in these laminations. There is also an oxidization process that can provide a thin oxide coating layer for improved durability and resistance.
  • A global manufacturer of environmental testing equipment announced the shipment of three fast change rate automotive test chambers. These test chambers, built by Tenney Environmental, will be used for temperature and humidity testing of automotive parts. The maximum temperature rating of the automotive test chambers is 180°C and the operating temperature range is -68°C to 180°C. The work chamber dimensions are 30” W X 28.8” D X 36” H. The fast change rate test chambers can transition the air temperature in remote chambers from 20°C to -40°C with a 30-minute transition rate.

Kudos Chatter

  • Sintavia, LLC, a leading Tier One metal additive manufacturer, announced that it has achieved National Aerospace and Defense Contractors Accreditation Program (NADCAP) approval for its laser and electron beam powder bed fusion applications. The NADCAP accreditation is the latest quality certification achieved by the company and resulted from a year-long application process.
  • AIM Aerospace has earned Nadcap Merit Status at their Orange City, Iowa, facility, for AC7118 Composites Processing.  The company processes structural carbon fiber composites for key aerospace customers.
  • Plastics Extrusion has been added to the growing list of audit opportunities available through MedAccred, the medical device industry’s collective approach to critical process supply chain oversight. This newest opportunity comprises audit criteria which covers Tubing/Profile, Sheet, Film, Blown Film, Over-Jacketing, Co-Extrusion and Ram Extrusion. The audit criteria are developed by leaders in the medical device industry who are part of the MedAccred program and are focused on improving product quality and patient safety.
  • Sunlite Plastics of Germantown, Wisconsin, has become the first manufacturing facility in the world to achieve MedAccred Plastics Extrusion Accreditation, with a Scope of Accreditation covering Tubing/Profile Extrusion. Following the MedAccred audit, technical experts from leading medical device companies reviewed the audit findings and corrective actions before voting on granting each MedAccred Accreditation.
  • Medical tools manufacturers increasingly commission SECO/WARWICK technologies for product quality and strict standards compliance, according to a recent company report. For example, a U.K. company installed a 6 Bar vacuum furnace for the production of medical tools such as those used for heart bypass procedures.

 

Heat Treat Today is pleased to join in the announcements of growth and achievement throughout the industry by highlighting them here on our News Chatter page. Please send any information you feel may be of interest to manufacturers with in-house heat treat departments especially in the aerospace, automotive, medical, and energy sectors to the editor at editor@heattreattoday.com.

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A Baker’s Dozen Quick Heat Treat News Items to Keep You Current

/ FEATURED NEWS, HEAT TREAT NEWS INDUSTRIES

 

 

 

A Baker's Dozen Quick Heat Treat News Items to Keep You Current

Heat Treat Today offers News Chatter, a feature highlighting representative moves, transactions, and kudos from around the industry.

Personnel and Company Changes and Moves

  • Super Systems Europe recently announced that Rob Wilcox has joined the sales and engineering team, where he will also operate as a general consultant to help commercial and captive heat treaters improve the quality and efficiency of the entire operation, covering the UK and Ireland.
  • Brian Robbins, CEO of MidWest Materials, has been named Steel Man of the Year by the Association of Steel Distributors. "I am honored to be chosen for this prestigious award. My family has been associated with the steel industry for more than 65 years, and it is humbling to follow in the footsteps of my grandfather, Joseph Koppelman, founder of MidWest Materials, who was one of the earliest members of the ASD and served as its president 50 years ago," said Robbins, who served as president of ASD from March 2014 to April 2016. He led the association’s effort to rebuild the steel manufacturing sector by encouraging young talent to join the industry.
  • Ryan Kelly recently rejoined the team at Advanced Heat Treat Corp. (AHT) where he will be leading all quality initiatives as a senior quality specialist.
  • Senior Vice President Douglas Matthews has assumed day-to-day operations of Pittsburgh-based U.S. Steel’s Tubular division. He replaces David J. Rintoul, who retired to become the president and CEO of GrafTech, a graphite company that supplies technology to the steel industry.

  • Dana Incorporated announced the election of two more members to its board of directors: Michael J. Mack, who recently retired from Deere & Co., where he had served as chief financial officer; president of the company's Worldwide Construction & Forestry Division; and most recently as group president of John Deere Financial Services, Global Human Resources, and Public Affairs; and Diarmuid B. O'Connell, who spent the last 11 years at Tesla, most recently as vice president of business development.
  • International Thermal Systems (ITS) recently announced Tom Stricker as the new president. Stricker joined ITS in 2015 as the general manager of the Metal Packaging and Parts Washer product groups and brings more than 20 years of professional experience to his new role.
  • Herbert J. “Hawk” Carlisle has been elected to the Allegheny Technologies Incorporated (ATI) board of directors. General Carlisle is president and CEO of the National Defense Industrial Association (NDIA) and is a retired four-star general from the United States Air Force (USAF).

Equipment Transactions

  • A supplier of the battery industry received shipment of a nine tube gas-fired immersion tube lead melting and holding furnace from Lindberg/MPH, to be used in the production of lead plates for automotive batteries. The furnace has over 28,000 square inches of heat transfer area for efficient heating of the metal without super heating and the resulting metal losses. In addition, Lindberg/MPH announced the shipment of a three-zone tube furnace to an American University with a footprint which makes it ideal for research facilities with limited space. The maximum temperature rating for this tube furnace is 2012°F.
  • Ipsen recently designed and built a vertical, high-pressure quenching furnace, complete with twin cooling systems and a work volume of 350 cubic feet. During the testing phase, the furnace quenched with 1,000 horsepower (.75 megawatts) – a remarkable achievement that began as an idea just months prior.
  • An aviation engine repair services facility located in the western region of the United States recently received shipment of two vacuum furnaces from Solar Manufacturing. The customer witnessed full testing at Solar Manufacturing and approved shipment in late 2017. Both new furnaces are tailored specifically to fit the needs of aerospace engine component repair processing to the aerospace specification AMS2750E and incorporate the new SolarVac® 5000 supervisory control and data acquisition system (SCADA). The system provides gas quench rate control utilizing a variable frequency drive and precise temperature control from ambient to 2400° F (1316° C) utilizing digital power trimming technology.
  • An aluminum manufacturer received shipment of two electrically heated standard horizontal aluminum quench systems from Wisconsin Oven Corp., of East Troy, Wisconsin. The systems guarantee temperature uniformity of ±10°F at 775°F and 1075°F, ensuring that the furnaces meet AMS 2750E, Class 2 furnaces and Instrumentation Type C requirements. Each system is designed to heat 1000 pounds of aluminum to a 950°F operating temperature.

Accreditations, Certifications, Patents, and More

  • MedAccred has recognized Solar Atmospheres of Western PA for its commitment to continual improvement in medical device heat treat and brazing quality. In receiving the prestigious MedAccred Heat Treating accreditation, Solar Atmospheres has become only the eighth plant internationally and the fifth plant domestically to receive this certification.
  • H.C. Starck recently announced that it has received the certification for processing of “conflict-free” tantalum raw materials the seventh year in a row. The audit included the H.C. Starck Tantalum and Niobium GmbH subsidiary and the H.C. Starck Smelting GmbH & Co. KG associated company. This means all subsidiaries that process tantalum at the Goslar, Mito, Tokyo, Map Ta Phut, and Laufenburg locations remain certified. The audit was performed by the independent company SGS, acting on behalf of the Responsible Business Alliance (RBA, formerly Electronics Industry Citizenship Coalition EICC) and the Responsible Minerals Assurance Process (RMAP formerly Conflict-Free Smelter Program) as part of the Responsible Minerals Initiative (RMI, formerly CFSI).

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New Brazing Audit Criteria Released by MedAccred

/ BRAZING TECHNICAL CONTENT, FEATURED NEWS, MEDICAL HEAT TREAT

In response to industry demand, the MedAccred program has recently released new audit criteria for brazing. AC8102/1 MedAccred Audit Criteria for Heat Treating – Brazing will be used during MedAccred audits conducted at companies performing brazing in an atmosphere or vacuum furnace or  in a dip salt bath.

The new audit criteria were developed by the MedAccred Heat Treating Task Group which is comprised of technical experts from Johnson & Johnson, Stryker, GE Healthcare, Medtronic, Applied Thermal Technologies, Bodycote, Harterei Gerster, Hansen Balk, Lake City Heat Treating, Paulo Products and Solar Atmospheres. To date the Task Group is one of the most successful within the MedAccred program. It has released six audit criteria in total and has several companies who have already achieved accreditation; these include Solar Atmospheres, Hansen Balk and Bodycote.

The industry chairperson of the Heat Treating Task Group is Bruce Dall, Senior Staff Quality Engineer – Metal Injection Molding of Stryker. He is very proud of the achievements of the program to date:  “I would like to thank my fellow members of the Heat Treating Task Group for their hard work and the commitment they have shown in the development of these new audit criteria for brazing. In most other environments we are competing organizations but when we come together as a MedAccred Task Group, we are able to put aside our rivalries in the interest of quality and working towards consistently safer products for our patients. The fact that we are now seeing suppliers stepping forward to pro-actively gain a Heat Treating accreditation MedAccred is a strong indication of how important this program will be to the future of the industry and I am proud to be at the forefront of this effort.”

Companies interested in gaining accreditation for Heat Treating are encouraged to contact Justin McCabe, MedAccred Co-Lead (jmccabe@p-r-i.org) for more information. Companies achieving accreditation will be listed on MedAccred’s Qualified Manufacturers List (located at www.eAuditNet.com).

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What the Medical Industry Can Learn from the Aerospace Industry

/ FEATURED NEWS, MEDICAL HEAT TREAT, MEDICAL HEAT TREAT NEWS, TITANIUM PROCESSING

BOTW-50w Source: mdtmag.com

Heat treatment standards are stricter in the aerospace industry than in the medical industry where lives are on the line. This doesn’t make sense and something is being done about it.

Click here to read more about how Bob Hill, President of Solar Atmospheres of Western Pennsylvania believes the medical industry could benefit from adopting quality standards from the aerospace industry.

Author: Bob Hill, President, Solar Atmospheres of Western Pennsylvania

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First Accreditation for MedAccred in Europe Awarded to Bodycote

/ FEATURED NEWS, HIPING NEWS, MEDICAL HEAT TREAT

Bodycote, the world’s largest heat treating services provider, is pleased to announce that its Derby, UK location is the first facility in Europe to earn the MedAccred accreditation underlining the high standards of quality achieved. The official approval was awarded on 7th of April 2016.

MedAccred, administered by Performance Review Institute (PRI), is an industry managed approach to ensuring critical manufacturing process quality throughout the medical device supply chain. It establishes stringent consensus audit criteria based on industry and specific OEM requirements that ensure compliance and quality. Adherence to these requirements leads to greater process discipline, operational efficiency and ongoing improvement which results in higher quality and performance.

Strategically located in the East Midlands, Bodycote Derby, which offers heat treatment and hot isostatic pressing (HIP) services, is fast becoming a centre of excellence serving the medical device and implants markets for the UK, Ireland and Europe. Bodycote continues to invest in new capacity and technology to support opportunities within the growing medical industry for classic heat treatment and HIP along with its Specialty Stainless Steel Processes (S3P) and Ion Implantation services in Europe. For Bodycote, the benefits of MedAccred to the supplier are evident. The process provides for consistent and standardised critical process audits which result in fewer redundant onsite audits by multiple OEMs and first tier customers. The MedAccred certification should reinforce customer confidence in Bodycote as a premier quality provider of heat treating.

Joe Pinto, Executive Vice President and Chief Operating Officer of the Performance Review Institute, the organisation which administers the MedAccred program on behalf of the medical device industry, sent his congratulations to the team at the Bodycote Derby facility: “We are delighted that Bodycote has the honour of becoming the first company to receive an accreditation from MedAccred in Europe. To be the first in anything demonstrates a high level of foresight and commitment to a long term strategy. The MedAccred audit is challenging and in achieving accredited status, Bodycote’s Derby facility has proven it has the capability to meet and exceed the requirements of its medical customers. The entire team should be proud of their success.”

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Solar Atmospheres Receives First Reaccreditation from MedAccred

/ FEATURED NEWS, HEAT TREAT NEWS, MEDICAL HEAT TREAT, MEDICAL HEAT TREAT NEWS

Solar Atmospheres, Inc. has announced that it has become the first company to receive MedAccred critical process reaccreditation.  Furthermore, Solar Atmospheres, Inc. successfully expanded its scope of accreditation to include Hardness Testing and Metallography & Microindentation Hardness.  MedAccred is an industry-managed critical process supply chain oversight program which was developed by leading medical device companies to improve device quality and most importantly enhance patient safety.

The effort to establish MedAccred began in 2010 when the Performance Review Institute (PRI) was asked to consider the development of a Nadcap-style special process supplier accreditation program for the medical device industry.  An industry roundtable was organized and convened in 2012 among interested medical device companies and PRI.  Following this roundtable meeting, briefings were held with the FDA Center for Devices and Radiological Health’s (CDRH) Office of Compliance and the FDA’s Office of Global Operations within the Office of the Commissioner. The program purpose and scope was discussed, along with the results of proof of concept audits which were conducted to demonstrate the program’s viability. The FDA provided positive feedback and strong encouragement to pursue the development of the program.

By 2014, several critical process Task Groups were operating on a formal basis, program documents were drafted, circulated and approved by the executives of the participating companies and audit criteria had been published in several critical process areas.  Solar Atmospheres, Inc. committed to hosting the first MedAccred audit.

In early 2015 the first MedAccred critical process accreditation was issued to Solar Atmospheres Inc. for Heat Treating.

Today’s functioning critical process Task Groups include Cable & Wire Harnesses, Heat Treating, Plastics Injection Molding, Printed Circuit Board Assemblies, Sterilization and Welding.  The industry managed task groups develop audit criteria, conduct audits, and award MedAccred Critical Process Accreditations to leading suppliers at all tiers in the Medical Device Supply Chain.  Many companies are seeking MedAccred Accreditation to demonstrate their commitment to quality and patient safety. Future MedAccred Task Groups under consideration for development include Material Testing Laboratories, Assemblies, PCBs, Batteries, Chemical Processing, NDT, Cleaning, Coating, Optics, Packaging, etc.  Active OEM and Contract Manufacturer participants include: Johnson & Johnson, Philips, Stryker, GE Healthcare, Medtronic, NYPRO Jabil, Steris, etc.  The list of participating suppliers is growing steadily.

Joe Pinto, Executive Vice President and Chief Operating Officer of PRI explained the significance of Solar Atmospheres’ accomplishment: “Gaining a critical process accreditation from MedAccred is recognition of a company’s commitment to quality and the high standards of critical process manufacturing which they maintain.  The successful completion of a reaccreditation audit is a clear indication that a company is able to consistently uphold those extremely high standards over an extended period of time.   I would like to congratulate the whole team at Solar Atmospheres on this important achievement.”

Solar Atmospheres Receives First Reaccreditation from MedAccred Read More »

Heat Treating Opportunities Available in Medical Industry

/ FEATURED NEWS, HEAT TREAT ECONOMIC NEWS, HEAT TREAT NEWS, MEDICAL HEAT TREAT, MEDICAL HEAT TREAT NEWS

BOTW-62w Source: Q1 Productions

Executive Vice President & Chief Operating Officer
Performance Review Institute (PRI)

“2016 is going to be a milestone year in terms of MedAccred’s development. The program has established itself in 6 critical process areas (PCBAs, Cable & Wire Harnesses, Heat Treating, Sterilization, Plastics and Welding) and numerous companies are now stepping forward to participate in the audit process and gain accreditation.”

Read More: 3rd Annual Medical Device Supplier Quality Conference: Speaker Interview – Joseph Pinto/Performance Review Institute

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